Trial Outcomes & Findings for Study of VE800 and Nivolumab in Patients With Selected Types of Advanced or Metastatic Cancer (NCT NCT04208958)
NCT ID: NCT04208958
Last Updated: 2025-10-27
Results Overview
Safety and tolerability of VE800 in combination with nivolumab: Number of Participants with Adverse Events
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
56 participants
Primary outcome timeframe
From the first dose to the last dose (up to 56.7 weeks), plus 100 days of post-treatment follow-up
Results posted on
2025-10-27
Participant Flow
Up to 111 evaluable patients were to be enrolled: 42 patients with melanoma, 42 patients with gastric/gastroesophageal junction (GEJ) adenocarcinoma, and 27 patients with CRC-MSS.
Participant milestones
| Measure |
VE800 combination treatment with nivolumab
Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks.
VE800: VE800 is a PO LBP consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response.
Nivolumab: Nivolumab is an approved medication that blocks antibodies for certain types of cancer.
Vancomycin Oral Capsule: Vancomycin is an antibiotic used to treat or prevent infection.
|
|---|---|
|
Overall Study
STARTED
|
56
|
|
Overall Study
gastric/GEJ adenocarcinoma
|
20
|
|
Overall Study
Melanoma
|
20
|
|
Overall Study
CRC-MSS
|
14
|
|
Overall Study
not treated with VE800
|
2
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
56
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Analyzed separately for each tumor type.
Baseline characteristics by cohort
| Measure |
VE800 combination treatment with nivolumab
n=55 Participants
Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks.
VE800: VE800 is a PO LBP consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response.
Nivolumab: Nivolumab is an approved medication that blocks antibodies for certain types of cancer.
Vancomycin Oral Capsule: Vancomycin is an antibiotic used to treat or prevent infection.
|
|---|---|
|
Age, Continuous
Melanoma
|
60.2 years
STANDARD_DEVIATION 17.53 • n=21 Participants • Analyzed separately for each tumor type.
|
|
Age, Continuous
Gastric/GEJ
|
62.6 years
STANDARD_DEVIATION 11.51 • n=20 Participants • Analyzed separately for each tumor type.
|
|
Age, Continuous
CRC-MSS
|
56.6 years
STANDARD_DEVIATION 13.44 • n=14 Participants • Analyzed separately for each tumor type.
|
|
Age, Continuous
Total
|
60.1 years
STANDARD_DEVIATION 14.47 • n=55 Participants • Analyzed separately for each tumor type.
|
|
Sex: Female, Male
Melanoma · Female
|
11 Participants
n=21 Participants • Two of the 56 enrolled subjects did not receive VE800/nivolumab. One subject in the melanoma group received vancomycin only and is included in the baseline characteristics analysis; one subject in the gastric/GEJ adenocarcinoma group did not receive any study-related treatment and is not included in this analysis.
|
|
Sex: Female, Male
Melanoma · Male
|
10 Participants
n=21 Participants • Two of the 56 enrolled subjects did not receive VE800/nivolumab. One subject in the melanoma group received vancomycin only and is included in the baseline characteristics analysis; one subject in the gastric/GEJ adenocarcinoma group did not receive any study-related treatment and is not included in this analysis.
|
|
Sex: Female, Male
Gastric/GEJ · Female
|
7 Participants
n=20 Participants • Two of the 56 enrolled subjects did not receive VE800/nivolumab. One subject in the melanoma group received vancomycin only and is included in the baseline characteristics analysis; one subject in the gastric/GEJ adenocarcinoma group did not receive any study-related treatment and is not included in this analysis.
|
|
Sex: Female, Male
Gastric/GEJ · Male
|
13 Participants
n=20 Participants • Two of the 56 enrolled subjects did not receive VE800/nivolumab. One subject in the melanoma group received vancomycin only and is included in the baseline characteristics analysis; one subject in the gastric/GEJ adenocarcinoma group did not receive any study-related treatment and is not included in this analysis.
|
|
Race (NIH/OMB)
Melanoma · Black or African American
|
0 Participants
n=21 Participants • Two of the 56 enrolled subjects did not receive VE800/nivolumab. One subject in the melanoma group received vancomycin only and is included in the baseline characteristics analysis; one subject in the gastric/GEJ adenocarcinoma group did not receive any study-related treatment and is not included in this analysis.
|
|
Race (NIH/OMB)
Melanoma · White
|
21 Participants
n=21 Participants • Two of the 56 enrolled subjects did not receive VE800/nivolumab. One subject in the melanoma group received vancomycin only and is included in the baseline characteristics analysis; one subject in the gastric/GEJ adenocarcinoma group did not receive any study-related treatment and is not included in this analysis.
|
|
Race (NIH/OMB)
Melanoma · More than one race
|
0 Participants
n=21 Participants • Two of the 56 enrolled subjects did not receive VE800/nivolumab. One subject in the melanoma group received vancomycin only and is included in the baseline characteristics analysis; one subject in the gastric/GEJ adenocarcinoma group did not receive any study-related treatment and is not included in this analysis.
|
|
Race (NIH/OMB)
Melanoma · Unknown or Not Reported
|
0 Participants
n=21 Participants • Two of the 56 enrolled subjects did not receive VE800/nivolumab. One subject in the melanoma group received vancomycin only and is included in the baseline characteristics analysis; one subject in the gastric/GEJ adenocarcinoma group did not receive any study-related treatment and is not included in this analysis.
|
|
Race (NIH/OMB)
Gastric/GEJ · More than one race
|
0 Participants
n=20 Participants • Two of the 56 enrolled subjects did not receive VE800/nivolumab. One subject in the melanoma group received vancomycin only and is included in the baseline characteristics analysis; one subject in the gastric/GEJ adenocarcinoma group did not receive any study-related treatment and is not included in this analysis.
|
|
Race (NIH/OMB)
Gastric/GEJ · Unknown or Not Reported
|
1 Participants
n=20 Participants • Two of the 56 enrolled subjects did not receive VE800/nivolumab. One subject in the melanoma group received vancomycin only and is included in the baseline characteristics analysis; one subject in the gastric/GEJ adenocarcinoma group did not receive any study-related treatment and is not included in this analysis.
|
|
Race (NIH/OMB)
CRS/MSS · American Indian or Alaska Native
|
0 Participants
n=14 Participants • Two of the 56 enrolled subjects did not receive VE800/nivolumab. One subject in the melanoma group received vancomycin only and is included in the baseline characteristics analysis; one subject in the gastric/GEJ adenocarcinoma group did not receive any study-related treatment and is not included in this analysis.
|
|
Race (NIH/OMB)
CRS/MSS · Asian
|
0 Participants
n=14 Participants • Two of the 56 enrolled subjects did not receive VE800/nivolumab. One subject in the melanoma group received vancomycin only and is included in the baseline characteristics analysis; one subject in the gastric/GEJ adenocarcinoma group did not receive any study-related treatment and is not included in this analysis.
|
|
Race (NIH/OMB)
CRS/MSS · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants • Two of the 56 enrolled subjects did not receive VE800/nivolumab. One subject in the melanoma group received vancomycin only and is included in the baseline characteristics analysis; one subject in the gastric/GEJ adenocarcinoma group did not receive any study-related treatment and is not included in this analysis.
|
|
Race (NIH/OMB)
CRS/MSS · Black or African American
|
1 Participants
n=14 Participants • Two of the 56 enrolled subjects did not receive VE800/nivolumab. One subject in the melanoma group received vancomycin only and is included in the baseline characteristics analysis; one subject in the gastric/GEJ adenocarcinoma group did not receive any study-related treatment and is not included in this analysis.
|
|
Race (NIH/OMB)
CRS/MSS · White
|
13 Participants
n=14 Participants • Two of the 56 enrolled subjects did not receive VE800/nivolumab. One subject in the melanoma group received vancomycin only and is included in the baseline characteristics analysis; one subject in the gastric/GEJ adenocarcinoma group did not receive any study-related treatment and is not included in this analysis.
|
|
Race (NIH/OMB)
CRS/MSS · More than one race
|
0 Participants
n=14 Participants • Two of the 56 enrolled subjects did not receive VE800/nivolumab. One subject in the melanoma group received vancomycin only and is included in the baseline characteristics analysis; one subject in the gastric/GEJ adenocarcinoma group did not receive any study-related treatment and is not included in this analysis.
|
|
Race (NIH/OMB)
CRS/MSS · Unknown or Not Reported
|
0 Participants
n=14 Participants • Two of the 56 enrolled subjects did not receive VE800/nivolumab. One subject in the melanoma group received vancomycin only and is included in the baseline characteristics analysis; one subject in the gastric/GEJ adenocarcinoma group did not receive any study-related treatment and is not included in this analysis.
|
|
Sex: Female, Male
CRC-MSS · Female
|
6 Participants
n=14 Participants • Two of the 56 enrolled subjects did not receive VE800/nivolumab. One subject in the melanoma group received vancomycin only and is included in the baseline characteristics analysis; one subject in the gastric/GEJ adenocarcinoma group did not receive any study-related treatment and is not included in this analysis.
|
|
Sex: Female, Male
CRC-MSS · Male
|
8 Participants
n=14 Participants • Two of the 56 enrolled subjects did not receive VE800/nivolumab. One subject in the melanoma group received vancomycin only and is included in the baseline characteristics analysis; one subject in the gastric/GEJ adenocarcinoma group did not receive any study-related treatment and is not included in this analysis.
|
|
Race (NIH/OMB)
Melanoma · American Indian or Alaska Native
|
0 Participants
n=21 Participants • Two of the 56 enrolled subjects did not receive VE800/nivolumab. One subject in the melanoma group received vancomycin only and is included in the baseline characteristics analysis; one subject in the gastric/GEJ adenocarcinoma group did not receive any study-related treatment and is not included in this analysis.
|
|
Race (NIH/OMB)
Melanoma · Asian
|
0 Participants
n=21 Participants • Two of the 56 enrolled subjects did not receive VE800/nivolumab. One subject in the melanoma group received vancomycin only and is included in the baseline characteristics analysis; one subject in the gastric/GEJ adenocarcinoma group did not receive any study-related treatment and is not included in this analysis.
|
|
Race (NIH/OMB)
Melanoma · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=21 Participants • Two of the 56 enrolled subjects did not receive VE800/nivolumab. One subject in the melanoma group received vancomycin only and is included in the baseline characteristics analysis; one subject in the gastric/GEJ adenocarcinoma group did not receive any study-related treatment and is not included in this analysis.
|
|
Race (NIH/OMB)
Gastric/GEJ · American Indian or Alaska Native
|
0 Participants
n=20 Participants • Two of the 56 enrolled subjects did not receive VE800/nivolumab. One subject in the melanoma group received vancomycin only and is included in the baseline characteristics analysis; one subject in the gastric/GEJ adenocarcinoma group did not receive any study-related treatment and is not included in this analysis.
|
|
Race (NIH/OMB)
Gastric/GEJ · Asian
|
1 Participants
n=20 Participants • Two of the 56 enrolled subjects did not receive VE800/nivolumab. One subject in the melanoma group received vancomycin only and is included in the baseline characteristics analysis; one subject in the gastric/GEJ adenocarcinoma group did not receive any study-related treatment and is not included in this analysis.
|
|
Race (NIH/OMB)
Gastric/GEJ · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants • Two of the 56 enrolled subjects did not receive VE800/nivolumab. One subject in the melanoma group received vancomycin only and is included in the baseline characteristics analysis; one subject in the gastric/GEJ adenocarcinoma group did not receive any study-related treatment and is not included in this analysis.
|
|
Race (NIH/OMB)
Gastric/GEJ · Black or African American
|
1 Participants
n=20 Participants • Two of the 56 enrolled subjects did not receive VE800/nivolumab. One subject in the melanoma group received vancomycin only and is included in the baseline characteristics analysis; one subject in the gastric/GEJ adenocarcinoma group did not receive any study-related treatment and is not included in this analysis.
|
|
Race (NIH/OMB)
Gastric/GEJ · White
|
17 Participants
n=20 Participants • Two of the 56 enrolled subjects did not receive VE800/nivolumab. One subject in the melanoma group received vancomycin only and is included in the baseline characteristics analysis; one subject in the gastric/GEJ adenocarcinoma group did not receive any study-related treatment and is not included in this analysis.
|
PRIMARY outcome
Timeframe: From the first dose to the last dose (up to 56.7 weeks), plus 100 days of post-treatment follow-upPopulation: The analysis population included all subjects who received at least one dose of VE800 or nivolumab. Total number of subjects with at least 1 Treatment Emergent Adverse Event Reported
Safety and tolerability of VE800 in combination with nivolumab: Number of Participants with Adverse Events
Outcome measures
| Measure |
VE800 combination treatment with nivolumab (Melanoma)
n=20 Participants
Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks.
VE800: VE800 is a PO LBP consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response.
Nivolumab: Nivolumab is an approved medication that blocks antibodies for certain types of cancer.
Vancomycin Oral Capsule: Vancomycin is an antibiotic used to treat or prevent infection.
|
VE800 combination treatment with nivolumab (Gastric)
n=20 Participants
Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks.
VE800: VE800 is a PO LBP consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response.
Nivolumab: Nivolumab is an approved medication that blocks antibodies for certain types of cancer.
Vancomycin Oral Capsule: Vancomycin is an antibiotic used to treat or prevent infection.
|
VE800 combination treatment with nivolumab (Colorectal)
n=14 Participants
Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks.
VE800: VE800 is a PO LBP consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response.
Nivolumab: Nivolumab is an approved medication that blocks antibodies for certain types of cancer.
Vancomycin Oral Capsule: Vancomycin is an antibiotic used to treat or prevent infection.
|
VE800 combination treatment with nivolumab (Total)
n=54 Participants
Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks.
VE800: VE800 is a PO LBP consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response.
Nivolumab: Nivolumab is an approved medication that blocks antibodies for certain types of cancer.
Vancomycin Oral Capsule: Vancomycin is an antibiotic used to treat or prevent infection.
|
|---|---|---|---|---|
|
Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events
Adverse Events Leading to Study Discontinuation: Nivolumab Related
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events
Adverse Events Leading to Study Discontinuation: VE800 Related
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events
Any Adverse Event with an Outcome of Death
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events
Immune-Related Adverse Events: VE800 Related
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events
Any Treatment-emergent Adverse Event
|
16 participants
|
19 participants
|
12 participants
|
47 participants
|
|
Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events
Any Treatment Related Adverse Event
|
9 participants
|
9 participants
|
6 participants
|
24 participants
|
|
Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events
Treatment Related Adverse Event : Vancomycin Related
|
1 participants
|
3 participants
|
1 participants
|
5 participants
|
|
Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events
Treatment Related Adverse Event : Nivolumab Related
|
8 participants
|
8 participants
|
5 participants
|
21 participants
|
|
Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events
Treatment Related Adverse Event : VE800 Related
|
3 participants
|
3 participants
|
3 participants
|
9 participants
|
|
Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events
Any Grade 3 or Greater Adverse Event
|
6 participants
|
8 participants
|
2 participants
|
16 participants
|
|
Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events
Grade 3 or Greater Adverse Event : Vancomycin Related
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events
Grade 3 or Greater Adverse Event: Nivolumab Related
|
0 participants
|
3 participants
|
0 participants
|
3 participants
|
|
Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events
Grade 3 or Greater Adverse Event: VE800 Related
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events
Any Serious Adverse Event
|
5 participants
|
9 participants
|
2 participants
|
16 participants
|
|
Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events
Serious Adverse Event: Vancomycin Related
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events
Serious Adverse Event: Nivolumab Related
|
0 participants
|
3 participants
|
1 participants
|
4 participants
|
|
Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events
Serious Adverse Event: VE800 Related
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events
Any Adverse Events of Special Interest
|
1 participants
|
2 participants
|
0 participants
|
3 participants
|
|
Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events
Adverse Events of Special Interest: Vancomycin Related
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events
Adverse Events of Special Interest: Nivolumab Related
|
1 participants
|
2 participants
|
0 participants
|
3 participants
|
|
Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events
Adverse Events of Special Interest: VE800 Related
|
1 participants
|
1 participants
|
0 participants
|
2 participants
|
|
Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events
Any Immune-Related Adverse Events
|
1 participants
|
2 participants
|
0 participants
|
3 participants
|
|
Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events
Immune-Related Adverse Events: Vancomycin Related
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events
Immune-Related Adverse Events: Nivolumab Related
|
1 participants
|
2 participants
|
0 participants
|
3 participants
|
|
Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events
Any Adverse Events Leading to Discontinuation of any Study Drug
|
1 participants
|
1 participants
|
0 participants
|
2 participants
|
|
Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events
Adverse Events Leading to Discontinuation of any Study Drug: Vancomycin Related
|
NA participants
Not a study drug.
|
NA participants
Not a study drug.
|
NA participants
Not a study drug.
|
NA participants
Not a study drug.
|
|
Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events
Adverse Events Leading to Discontinuation of any Study Drug: Nivolumab Related
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events
Adverse Events Leading to Discontinuation of any Study Drug: VE800 Related
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events
Any Adverse Events Leading to Interruption of Study Drug
|
0 participants
|
5 participants
|
3 participants
|
8 participants
|
|
Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events
Adverse Events Leading to Interruption of Study Drug: Vancomycin Related
|
NA participants
Not a study drug.
|
NA participants
Not a study drug.
|
NA participants
Not a study drug.
|
NA participants
Not a study drug.
|
|
Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events
Adverse Events Leading to Interruption of Study Drug: Nivolumab Related
|
0 participants
|
2 participants
|
3 participants
|
5 participants
|
|
Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events
Adverse Events Leading to Interruption of Study Drug: VE800 Related
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events
Any Adverse Events Leading to Study Discontinuation
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events
Adverse Events Leading to Study Discontinuation: Vancomycin Related
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 18 months (first patient enrolled to last patient visit completed)Population: The analysis population included all subjects who received at least one dose of VE800 or nivolumab.
Objective Response Rate (ORR) Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
VE800 combination treatment with nivolumab (Melanoma)
n=54 Participants
Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks.
VE800: VE800 is a PO LBP consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response.
Nivolumab: Nivolumab is an approved medication that blocks antibodies for certain types of cancer.
Vancomycin Oral Capsule: Vancomycin is an antibiotic used to treat or prevent infection.
|
VE800 combination treatment with nivolumab (Gastric)
Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks.
VE800: VE800 is a PO LBP consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response.
Nivolumab: Nivolumab is an approved medication that blocks antibodies for certain types of cancer.
Vancomycin Oral Capsule: Vancomycin is an antibiotic used to treat or prevent infection.
|
VE800 combination treatment with nivolumab (Colorectal)
Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks.
VE800: VE800 is a PO LBP consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response.
Nivolumab: Nivolumab is an approved medication that blocks antibodies for certain types of cancer.
Vancomycin Oral Capsule: Vancomycin is an antibiotic used to treat or prevent infection.
|
VE800 combination treatment with nivolumab (Total)
Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks.
VE800: VE800 is a PO LBP consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response.
Nivolumab: Nivolumab is an approved medication that blocks antibodies for certain types of cancer.
Vancomycin Oral Capsule: Vancomycin is an antibiotic used to treat or prevent infection.
|
|---|---|---|---|---|
|
Objective Response Rate (ORR)
Gastric
|
1 Participants
|
—
|
—
|
—
|
|
Objective Response Rate (ORR)
Melanoma
|
0 Participants
|
—
|
—
|
—
|
|
Objective Response Rate (ORR)
CRC
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to two yearsPopulation: The analysis population includes all subjects who received at least one dose of VE800 or nivolumab and had an objective response.
Defined as the time from first documentation of complete response (CR) or partial response (PR) until the time of first documentation of progressive disease (PD) according to RECIST 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
VE800 combination treatment with nivolumab (Melanoma)
n=1 Participants
Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks.
VE800: VE800 is a PO LBP consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response.
Nivolumab: Nivolumab is an approved medication that blocks antibodies for certain types of cancer.
Vancomycin Oral Capsule: Vancomycin is an antibiotic used to treat or prevent infection.
|
VE800 combination treatment with nivolumab (Gastric)
Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks.
VE800: VE800 is a PO LBP consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response.
Nivolumab: Nivolumab is an approved medication that blocks antibodies for certain types of cancer.
Vancomycin Oral Capsule: Vancomycin is an antibiotic used to treat or prevent infection.
|
VE800 combination treatment with nivolumab (Colorectal)
Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks.
VE800: VE800 is a PO LBP consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response.
Nivolumab: Nivolumab is an approved medication that blocks antibodies for certain types of cancer.
Vancomycin Oral Capsule: Vancomycin is an antibiotic used to treat or prevent infection.
|
VE800 combination treatment with nivolumab (Total)
Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks.
VE800: VE800 is a PO LBP consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response.
Nivolumab: Nivolumab is an approved medication that blocks antibodies for certain types of cancer.
Vancomycin Oral Capsule: Vancomycin is an antibiotic used to treat or prevent infection.
|
|---|---|---|---|---|
|
Duration of Response (DOR)
Gastric
|
5.6 months
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: The analysis population included all subjects who received at least one dose of VE800 or nivolumab.
Best response among all overall responses from cycle 1 day 1 (C1D1) until disease progression or start of new anticancer therapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
VE800 combination treatment with nivolumab (Melanoma)
n=54 Participants
Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks.
VE800: VE800 is a PO LBP consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response.
Nivolumab: Nivolumab is an approved medication that blocks antibodies for certain types of cancer.
Vancomycin Oral Capsule: Vancomycin is an antibiotic used to treat or prevent infection.
|
VE800 combination treatment with nivolumab (Gastric)
Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks.
VE800: VE800 is a PO LBP consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response.
Nivolumab: Nivolumab is an approved medication that blocks antibodies for certain types of cancer.
Vancomycin Oral Capsule: Vancomycin is an antibiotic used to treat or prevent infection.
|
VE800 combination treatment with nivolumab (Colorectal)
Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks.
VE800: VE800 is a PO LBP consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response.
Nivolumab: Nivolumab is an approved medication that blocks antibodies for certain types of cancer.
Vancomycin Oral Capsule: Vancomycin is an antibiotic used to treat or prevent infection.
|
VE800 combination treatment with nivolumab (Total)
Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks.
VE800: VE800 is a PO LBP consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response.
Nivolumab: Nivolumab is an approved medication that blocks antibodies for certain types of cancer.
Vancomycin Oral Capsule: Vancomycin is an antibiotic used to treat or prevent infection.
|
|---|---|---|---|---|
|
Best Overall Response
CRC · CR
|
0 Participants
|
—
|
—
|
—
|
|
Best Overall Response
CRC · NE
|
0 Participants
|
—
|
—
|
—
|
|
Best Overall Response
CRC · Unknown
|
1 Participants
|
—
|
—
|
—
|
|
Best Overall Response
CRC · PR
|
0 Participants
|
—
|
—
|
—
|
|
Best Overall Response
CRC · SD
|
3 Participants
|
—
|
—
|
—
|
|
Best Overall Response
CRC · PD
|
10 Participants
|
—
|
—
|
—
|
|
Best Overall Response
Melanoma · CR
|
0 Participants
|
—
|
—
|
—
|
|
Best Overall Response
Melanoma · Unknown
|
2 Participants
|
—
|
—
|
—
|
|
Best Overall Response
Melanoma · PR
|
0 Participants
|
—
|
—
|
—
|
|
Best Overall Response
Melanoma · NE
|
0 Participants
|
—
|
—
|
—
|
|
Best Overall Response
Melanoma · SD
|
9 Participants
|
—
|
—
|
—
|
|
Best Overall Response
Melanoma · PD
|
9 Participants
|
—
|
—
|
—
|
|
Best Overall Response
Gastric · CR
|
0 Participants
|
—
|
—
|
—
|
|
Best Overall Response
Gastric · NE
|
0 Participants
|
—
|
—
|
—
|
|
Best Overall Response
Gastric · Unknown
|
1 Participants
|
—
|
—
|
—
|
|
Best Overall Response
Gastric · SD
|
2 Participants
|
—
|
—
|
—
|
|
Best Overall Response
Gastric · PD
|
16 Participants
|
—
|
—
|
—
|
|
Best Overall Response
Gastric · PR
|
1 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: The analysis population included all subjects who received at least one dose of VE800 or nivolumab.
The percentage of patients who have achieved complete response (CR), partial response (PR), or stable disease (SD) from cycle 1 day 1 (C1D1) until disease progression (DP) or start of new anticancer therapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
VE800 combination treatment with nivolumab (Melanoma)
n=54 Participants
Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks.
VE800: VE800 is a PO LBP consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response.
Nivolumab: Nivolumab is an approved medication that blocks antibodies for certain types of cancer.
Vancomycin Oral Capsule: Vancomycin is an antibiotic used to treat or prevent infection.
|
VE800 combination treatment with nivolumab (Gastric)
Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks.
VE800: VE800 is a PO LBP consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response.
Nivolumab: Nivolumab is an approved medication that blocks antibodies for certain types of cancer.
Vancomycin Oral Capsule: Vancomycin is an antibiotic used to treat or prevent infection.
|
VE800 combination treatment with nivolumab (Colorectal)
Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks.
VE800: VE800 is a PO LBP consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response.
Nivolumab: Nivolumab is an approved medication that blocks antibodies for certain types of cancer.
Vancomycin Oral Capsule: Vancomycin is an antibiotic used to treat or prevent infection.
|
VE800 combination treatment with nivolumab (Total)
Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks.
VE800: VE800 is a PO LBP consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response.
Nivolumab: Nivolumab is an approved medication that blocks antibodies for certain types of cancer.
Vancomycin Oral Capsule: Vancomycin is an antibiotic used to treat or prevent infection.
|
|---|---|---|---|---|
|
Disease Control Rate (DCR)
Gastric
|
3 Participants
|
—
|
—
|
—
|
|
Disease Control Rate (DCR)
Melanoma
|
9 Participants
|
—
|
—
|
—
|
|
Disease Control Rate (DCR)
CRC
|
3 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the first dose to the last dose (up to 56.7 weeks), plus 100 days of post-treatment follow-up and then follow-up for survival every 90 days.Population: The analysis population included all subjects who received at least one dose of VE800 or nivolumab.
Progression-Free Survival (PFS) is defined as the time from start of treatment to the earlier date of assessment of progression or death by any cause in the absence of progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
VE800 combination treatment with nivolumab (Melanoma)
n=54 Participants
Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks.
VE800: VE800 is a PO LBP consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response.
Nivolumab: Nivolumab is an approved medication that blocks antibodies for certain types of cancer.
Vancomycin Oral Capsule: Vancomycin is an antibiotic used to treat or prevent infection.
|
VE800 combination treatment with nivolumab (Gastric)
Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks.
VE800: VE800 is a PO LBP consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response.
Nivolumab: Nivolumab is an approved medication that blocks antibodies for certain types of cancer.
Vancomycin Oral Capsule: Vancomycin is an antibiotic used to treat or prevent infection.
|
VE800 combination treatment with nivolumab (Colorectal)
Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks.
VE800: VE800 is a PO LBP consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response.
Nivolumab: Nivolumab is an approved medication that blocks antibodies for certain types of cancer.
Vancomycin Oral Capsule: Vancomycin is an antibiotic used to treat or prevent infection.
|
VE800 combination treatment with nivolumab (Total)
Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks.
VE800: VE800 is a PO LBP consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response.
Nivolumab: Nivolumab is an approved medication that blocks antibodies for certain types of cancer.
Vancomycin Oral Capsule: Vancomycin is an antibiotic used to treat or prevent infection.
|
|---|---|---|---|---|
|
Progression-Free Survival (PFS)
Gastric
|
1.8 months
Interval 1.7 to 1.8
|
—
|
—
|
—
|
|
Progression-Free Survival (PFS)
Melanoma
|
1.9 months
Interval 1.8 to 3.7
|
—
|
—
|
—
|
|
Progression-Free Survival (PFS)
CRC
|
1.8 months
Interval 1.7 to 2.1
|
—
|
—
|
—
|
|
Progression-Free Survival (PFS)
Total
|
1.8 months
Interval 1.8 to 1.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 18 months (first patient enrolled to last patient visit completed)Population: The analysis population included all subjects who received at least one dose of VE800 or nivolumab.
Overall Survival (OS) as measured from the date of start of treatment to the date of death by any cause will also be evaluated.
Outcome measures
| Measure |
VE800 combination treatment with nivolumab (Melanoma)
n=54 Participants
Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks.
VE800: VE800 is a PO LBP consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response.
Nivolumab: Nivolumab is an approved medication that blocks antibodies for certain types of cancer.
Vancomycin Oral Capsule: Vancomycin is an antibiotic used to treat or prevent infection.
|
VE800 combination treatment with nivolumab (Gastric)
Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks.
VE800: VE800 is a PO LBP consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response.
Nivolumab: Nivolumab is an approved medication that blocks antibodies for certain types of cancer.
Vancomycin Oral Capsule: Vancomycin is an antibiotic used to treat or prevent infection.
|
VE800 combination treatment with nivolumab (Colorectal)
Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks.
VE800: VE800 is a PO LBP consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response.
Nivolumab: Nivolumab is an approved medication that blocks antibodies for certain types of cancer.
Vancomycin Oral Capsule: Vancomycin is an antibiotic used to treat or prevent infection.
|
VE800 combination treatment with nivolumab (Total)
Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks.
VE800: VE800 is a PO LBP consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response.
Nivolumab: Nivolumab is an approved medication that blocks antibodies for certain types of cancer.
Vancomycin Oral Capsule: Vancomycin is an antibiotic used to treat or prevent infection.
|
|---|---|---|---|---|
|
Overall Survival (OS)
Gastric
|
5.8 months
Interval 4.2 to 11.0
|
—
|
—
|
—
|
|
Overall Survival (OS)
Melanoma
|
NA months
Interval 6.5 to
The point estimate of median/quartiles by Brookmeyer and Crowley is not located exactly in the middle of the confidence interval. The upper bound of CI is missing due to sparseness of the data, meaning that there are few data points, few events occurring, or a large number of ties.
|
—
|
—
|
—
|
|
Overall Survival (OS)
Colorectal
|
7.6 months
Interval 5.0 to
The point estimate of median/quartiles by Brookmeyer and Crowley is not located exactly in the middle of the confidence interval. The upper bound of CI is missing due to sparseness of the data, meaning that there are few data points, few events occurring, or a large number of ties.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 18 months (first patient enrolled to last patient visit completed)Detection of VE800 bacterial strain colonization in stool was measured by pharmacokinetics (PK) of VE800
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 18 months (first patient enrolled to last patient visit completed)Measured by pharmacokinetics (PK) of VE800 colonization in stool
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 18 months (first patient enrolled to last patient visit completed)Measured by pharmacokinetics (PK) of VE800 colonization in stool
Outcome measures
Outcome data not reported
Adverse Events
VE800 combination treatment with nivolumab (Melanoma)
Serious events: 5 serious events
Other events: 13 other events
Deaths: 9 deaths
VE800 combination treatment with nivolumab (Gastric)
Serious events: 9 serious events
Other events: 16 other events
Deaths: 12 deaths
VE800 combination treatment with nivolumab (Colorectal)
Serious events: 2 serious events
Other events: 11 other events
Deaths: 10 deaths
VE800 combination treatment with nivolumab (Total)
Serious events: 16 serious events
Other events: 40 other events
Deaths: 31 deaths
Serious adverse events
| Measure |
VE800 combination treatment with nivolumab (Melanoma)
n=21 participants at risk
Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks.
VE800: VE800 is a PO LBP consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response.
Nivolumab: Nivolumab is an approved medication that blocks antibodies for certain types of cancer.
Vancomycin Oral Capsule: Vancomycin is an antibiotic used to treat or prevent infection.
|
VE800 combination treatment with nivolumab (Gastric)
n=21 participants at risk
Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks.
VE800: VE800 is a PO LBP consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response.
Nivolumab: Nivolumab is an approved medication that blocks antibodies for certain types of cancer.
Vancomycin Oral Capsule: Vancomycin is an antibiotic used to treat or prevent infection.
|
VE800 combination treatment with nivolumab (Colorectal)
n=14 participants at risk
Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks.
VE800: VE800 is a PO LBP consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response.
Nivolumab: Nivolumab is an approved medication that blocks antibodies for certain types of cancer.
Vancomycin Oral Capsule: Vancomycin is an antibiotic used to treat or prevent infection.
|
VE800 combination treatment with nivolumab (Total)
n=56 participants at risk
Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks.
VE800: VE800 is a PO LBP consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response.
Nivolumab: Nivolumab is an approved medication that blocks antibodies for certain types of cancer.
Vancomycin Oral Capsule: Vancomycin is an antibiotic used to treat or prevent infection.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
4.8%
1/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
7.1%
1/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
3.6%
2/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Plural Effusion
|
0.00%
0/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
4.8%
1/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
7.1%
1/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
3.6%
2/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
0.00%
0/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
4.8%
1/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
0.00%
0/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
1.8%
1/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.00%
0/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
4.8%
1/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
0.00%
0/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
1.8%
1/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
9.5%
2/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
0.00%
0/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
3.6%
2/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
4.8%
1/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
0.00%
0/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
1.8%
1/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
4.8%
1/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
0.00%
0/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
1.8%
1/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
|
Gastrointestinal disorders
Gastrointestinal Fistula
|
4.8%
1/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
0.00%
0/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
0.00%
0/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
1.8%
1/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
|
Gastrointestinal disorders
Intestinal Perforation
|
4.8%
1/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
0.00%
0/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
0.00%
0/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
1.8%
1/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
|
Infections and infestations
Arthritis Infective
|
4.8%
1/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
0.00%
0/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
0.00%
0/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
1.8%
1/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
|
Infections and infestations
Bacteremia
|
4.8%
1/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
0.00%
0/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
0.00%
0/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
1.8%
1/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
|
Infections and infestations
Sepsis
|
0.00%
0/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
4.8%
1/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
0.00%
0/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
1.8%
1/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
|
Investigations
Alanine aminotransferase Increased
|
0.00%
0/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
4.8%
1/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
0.00%
0/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
1.8%
1/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
4.8%
1/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
0.00%
0/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
1.8%
1/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
0.00%
0/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
4.8%
1/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
0.00%
0/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
1.8%
1/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
|
Investigations
Troponin Increased
|
0.00%
0/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
4.8%
1/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
0.00%
0/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
1.8%
1/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
|
General disorders
Pain
|
4.8%
1/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
0.00%
0/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
0.00%
0/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
1.8%
1/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
4.8%
1/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
0.00%
0/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
1.8%
1/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
4.8%
1/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
0.00%
0/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
0.00%
0/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
1.8%
1/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
4.8%
1/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
0.00%
0/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
1.8%
1/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
4.8%
1/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
0.00%
0/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
1.8%
1/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer Pain
|
0.00%
0/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
4.8%
1/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
0.00%
0/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
1.8%
1/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
4.8%
1/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
0.00%
0/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
1.8%
1/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
|
Psychiatric disorders
Depression
|
4.8%
1/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
0.00%
0/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
0.00%
0/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
1.8%
1/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
|
Vascular disorders
Superior Vena cava Syndrome
|
0.00%
0/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
4.8%
1/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
0.00%
0/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
1.8%
1/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
Other adverse events
| Measure |
VE800 combination treatment with nivolumab (Melanoma)
n=21 participants at risk
Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks.
VE800: VE800 is a PO LBP consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response.
Nivolumab: Nivolumab is an approved medication that blocks antibodies for certain types of cancer.
Vancomycin Oral Capsule: Vancomycin is an antibiotic used to treat or prevent infection.
|
VE800 combination treatment with nivolumab (Gastric)
n=21 participants at risk
Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks.
VE800: VE800 is a PO LBP consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response.
Nivolumab: Nivolumab is an approved medication that blocks antibodies for certain types of cancer.
Vancomycin Oral Capsule: Vancomycin is an antibiotic used to treat or prevent infection.
|
VE800 combination treatment with nivolumab (Colorectal)
n=14 participants at risk
Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks.
VE800: VE800 is a PO LBP consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response.
Nivolumab: Nivolumab is an approved medication that blocks antibodies for certain types of cancer.
Vancomycin Oral Capsule: Vancomycin is an antibiotic used to treat or prevent infection.
|
VE800 combination treatment with nivolumab (Total)
n=56 participants at risk
Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks.
VE800: VE800 is a PO LBP consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response.
Nivolumab: Nivolumab is an approved medication that blocks antibodies for certain types of cancer.
Vancomycin Oral Capsule: Vancomycin is an antibiotic used to treat or prevent infection.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
28.6%
6/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
14.3%
3/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
28.6%
4/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
23.2%
13/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
4.8%
1/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
28.6%
6/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
21.4%
3/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
17.9%
10/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
|
General disorders
Fatigue
|
23.8%
5/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
23.8%
5/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
21.4%
3/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
23.2%
13/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
|
Blood and lymphatic system disorders
Anaemia
|
23.8%
5/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
9.5%
2/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
14.3%
2/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
16.1%
9/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
|
Gastrointestinal disorders
Nausea
|
4.8%
1/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
28.6%
6/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
7.1%
1/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
14.3%
8/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
|
Gastrointestinal disorders
Constipation
|
9.5%
2/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
19.0%
4/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
7.1%
1/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
12.5%
7/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
9.5%
2/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
28.6%
4/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
10.7%
6/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
28.6%
6/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
0.00%
0/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
10.7%
6/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
|
Gastrointestinal disorders
Abdominal Distention
|
0.00%
0/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
9.5%
2/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
7.1%
1/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
5.4%
3/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
|
Gastrointestinal disorders
Abdominal Pain - Upper
|
0.00%
0/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
9.5%
2/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
7.1%
1/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
5.4%
3/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.8%
1/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
4.8%
1/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
7.1%
1/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
5.4%
3/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
14.3%
3/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
0.00%
0/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
5.4%
3/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
19.0%
4/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
4.8%
1/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
7.1%
1/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
10.7%
6/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.8%
1/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
14.3%
3/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
7.1%
1/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
8.9%
5/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.8%
1/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
14.3%
3/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
0.00%
0/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
7.1%
4/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
9.5%
2/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
0.00%
0/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
7.1%
1/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
5.4%
3/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
|
General disorders
Oedema Peripheral
|
4.8%
1/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
4.8%
1/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
7.1%
1/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
5.4%
3/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
4.8%
1/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
21.4%
3/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
7.1%
4/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.8%
1/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
4.8%
1/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
7.1%
1/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
5.4%
3/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Plural Effusion
|
0.00%
0/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
9.5%
2/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
7.1%
1/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
5.4%
3/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
3/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
4.8%
1/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
7.1%
1/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
8.9%
5/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.5%
2/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
4.8%
1/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
7.1%
1/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
7.1%
4/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.5%
2/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
4.8%
1/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
7.1%
1/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
7.1%
4/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
|
Infections and infestations
Urinary Tract Infection
|
4.8%
1/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
9.5%
2/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
0.00%
0/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
5.4%
3/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
|
Investigations
Lymphocyte Count Decrease
|
14.3%
3/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
0.00%
0/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
0.00%
0/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
5.4%
3/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
|
Nervous system disorders
Headache
|
9.5%
2/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
0.00%
0/21 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
7.1%
1/14 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
5.4%
3/56 • From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place