Trial Outcomes & Findings for Safety and Activity of PolyPEPI1018 Plus Atezolizumab in Colorectal Cancer. (NCT NCT05243862)
NCT ID: NCT05243862
Last Updated: 2026-08-07
Results Overview
Number of patients with clinically meaningful differences observed with respect to group mean laboratory values over time
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
From baseline to end of study, up to 12 months.
Results posted on
2026-08-07
Participant Flow
This was a multicenter study involving 3 study sites in the United States (US) - Mayo clinic (MN, FL, AZ).
Participant milestones
| Measure |
PolyPEPI1018 Plus Atezolizumab
Participants receive every 3 weeks PolyPEPI1018 CRC Vaccine (Emulsified solution, 0.2 mg/peptide, 6 peptides total, and Montanide™ ISA51VG adjuvant), by SC injection in combination with Atezolizumab (Injectable solution,1200mg/20mL) by IV injection.
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
18
|
Reasons for withdrawal
| Measure |
PolyPEPI1018 Plus Atezolizumab
Participants receive every 3 weeks PolyPEPI1018 CRC Vaccine (Emulsified solution, 0.2 mg/peptide, 6 peptides total, and Montanide™ ISA51VG adjuvant), by SC injection in combination with Atezolizumab (Injectable solution,1200mg/20mL) by IV injection.
|
|---|---|
|
Overall Study
Death
|
9
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
discontinued study treatment, but completed the 90-day safety follow-up
|
5
|
Baseline Characteristics
Safety and Activity of PolyPEPI1018 Plus Atezolizumab in Colorectal Cancer.
Baseline characteristics by cohort
| Measure |
PolyPEPI1018 Plus Atezolizumab
n=18 Participants
Participants receive every 3 weeks PolyPEPI1018 CRC Vaccine (Emulsified solution, 0.2 mg/peptide, 6 peptides total, and Montanide™ ISA51VG adjuvant), by SC injection in combination with Atezolizumab (Injectable solution,1200mg/20mL) by IV injection.
|
|---|---|
|
Age, Continuous
|
55.7 years
STANDARD_DEVIATION 11.4 • n=20 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic/Latino · Asian
|
1 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic/Latino · Black or African American
|
2 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic/Latino · White
|
11 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic/Latino · Other
|
2 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic/Latino · Not reported
|
2 Participants
n=20 Participants
|
|
Body mass index
|
29.468 kg/m2
STANDARD_DEVIATION 6.8428 • n=20 Participants
|
|
ECOG Performance Status
ECOG = 0
|
10 Participants
n=20 Participants
|
|
ECOG Performance Status
ECOG = 1
|
8 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: From 1st dose until 90-Days after last dose, up to 7.5 months.The incidence and severity \[according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 (v5.0)\] of all Treatment-Emergent Adverse Events (TEAEs), related TEAEs, all SAEs, and related SAEs
Outcome measures
| Measure |
PolyPEPI1018 Plus Atezolizumab
n=18 Participants
Participants receive every 3 weeks PolyPEPI1018 CRC Vaccine (Emulsified solution, 0.2 mg/peptide, 6 peptides total, and Montanide™ ISA51VG adjuvant), by SC injection in combination with Atezolizumab (Injectable solution,1200mg/20mL) by IV injection.
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|---|---|
|
The Incidence and Severity Treatment Related Adverse Events
TEAE Related to PolyPEPI1018 · Any TEAE
|
17 Participants
|
|
The Incidence and Severity Treatment Related Adverse Events
Any TEAE · Any TEAE
|
18 Participants
|
|
The Incidence and Severity Treatment Related Adverse Events
TEAE related to Atezolizumab · Any TEAE
|
14 Participants
|
|
The Incidence and Severity Treatment Related Adverse Events
Grade 3+ TEAE · Any TEAE
|
4 Participants
|
|
The Incidence and Severity Treatment Related Adverse Events
TEAE during vaccine site evaluation · Any TEAE
|
1 Participants
|
|
The Incidence and Severity Treatment Related Adverse Events
SAE · Any TEAE
|
4 Participants
|
|
The Incidence and Severity Treatment Related Adverse Events
SAE related to PolyPEPI1018 · Any TEAE
|
0 Participants
|
|
The Incidence and Severity Treatment Related Adverse Events
SAE related to Atezozilumab · Any TEAE
|
0 Participants
|
|
The Incidence and Severity Treatment Related Adverse Events
Grade 3+ SAE · Any TEAE
|
3 Participants
|
|
The Incidence and Severity Treatment Related Adverse Events
TEAE leading to study treatment discontinuation · Any TEAE
|
0 Participants
|
|
The Incidence and Severity Treatment Related Adverse Events
TEAE leading to death · Any TEAE
|
2 Participants
|
PRIMARY outcome
Timeframe: From baseline to end of study, up to 12 months.Number of patients with clinically meaningful differences observed with respect to group mean laboratory values over time
Outcome measures
| Measure |
PolyPEPI1018 Plus Atezolizumab
n=18 Participants
Participants receive every 3 weeks PolyPEPI1018 CRC Vaccine (Emulsified solution, 0.2 mg/peptide, 6 peptides total, and Montanide™ ISA51VG adjuvant), by SC injection in combination with Atezolizumab (Injectable solution,1200mg/20mL) by IV injection.
|
|---|---|
|
Clinical Laboratory Safety
|
0 Participants
|
PRIMARY outcome
Timeframe: From the start of each vaccine administration through 60 minutes after completion of each administration.Number and proportion of participants with any clinically significant change in vital signs (i.e., blood pressure, pulse rate, respiratory rate, body temperature) during the vaccine administration or within 60 minutes following administration
Outcome measures
| Measure |
PolyPEPI1018 Plus Atezolizumab
n=18 Participants
Participants receive every 3 weeks PolyPEPI1018 CRC Vaccine (Emulsified solution, 0.2 mg/peptide, 6 peptides total, and Montanide™ ISA51VG adjuvant), by SC injection in combination with Atezolizumab (Injectable solution,1200mg/20mL) by IV injection.
|
|---|---|
|
Administration Safety
|
0 Participants
|
SECONDARY outcome
Timeframe: From study entry up to 2 yearsBy computed tomography (CT) scan or other appropriate radiographic imaging at Screening Visit and at specified intervals on study therapy by the investigator and per RECIST 1.1
Outcome measures
| Measure |
PolyPEPI1018 Plus Atezolizumab
n=18 Participants
Participants receive every 3 weeks PolyPEPI1018 CRC Vaccine (Emulsified solution, 0.2 mg/peptide, 6 peptides total, and Montanide™ ISA51VG adjuvant), by SC injection in combination with Atezolizumab (Injectable solution,1200mg/20mL) by IV injection.
|
|---|---|
|
Objective Response Rate Assessment
Objective Response Rate
|
0 Participants
|
|
Objective Response Rate Assessment
Disease Control Rate
|
5 Participants
|
|
Objective Response Rate Assessment
Best Overall Response - Complete Response
|
0 Participants
|
|
Objective Response Rate Assessment
Best Overall Response - Partial Response
|
0 Participants
|
|
Objective Response Rate Assessment
Best Overall Response - Stable Disease
|
11 Participants
|
|
Objective Response Rate Assessment
Best Overall Response - Progressive Disease
|
5 Participants
|
|
Objective Response Rate Assessment
Best Overall Response - Not Evaluable
|
2 Participants
|
SECONDARY outcome
Timeframe: From study entry up to 3 yearsPopulation: Because no responses were observed, duration of response analyses could not be performed.
DoR from the first demonstration of response per RECIST 1.1 to the first demonstration of radiographic progression per RECIST 1.1
Outcome measures
| Measure |
PolyPEPI1018 Plus Atezolizumab
Participants receive every 3 weeks PolyPEPI1018 CRC Vaccine (Emulsified solution, 0.2 mg/peptide, 6 peptides total, and Montanide™ ISA51VG adjuvant), by SC injection in combination with Atezolizumab (Injectable solution,1200mg/20mL) by IV injection.
|
|---|---|
|
Duration of Response Assessment
|
0 time
|
SECONDARY outcome
Timeframe: From date of first dose of study therapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 monthsPFS time from the first dose of study therapy to radiographic progression or death from any cause
Outcome measures
| Measure |
PolyPEPI1018 Plus Atezolizumab
n=18 Participants
Participants receive every 3 weeks PolyPEPI1018 CRC Vaccine (Emulsified solution, 0.2 mg/peptide, 6 peptides total, and Montanide™ ISA51VG adjuvant), by SC injection in combination with Atezolizumab (Injectable solution,1200mg/20mL) by IV injection.
|
|---|---|
|
Progression Free Survival Assessment
Time to Progression or Death, 25th Percentile
|
1.4 months
Interval 1.0 to 2.5
|
|
Progression Free Survival Assessment
Time to Progression or Death, Median
|
2.7 months
Interval 1.4 to 3.1
|
|
Progression Free Survival Assessment
Time to Progression or Death, 75th Percentile
|
4.0 months
Interval 2.7 to
NA = Not estimable. The upper bound of the 95% confidence interval was not estimable because an insufficient number of PFS events had occurred at the time of analysis.
|
SECONDARY outcome
Timeframe: From first dose of study therapy to death from any cause assessed up to 24 monthsOS time from the first dose of study therapy to death from any cause
Outcome measures
| Measure |
PolyPEPI1018 Plus Atezolizumab
n=18 Participants
Participants receive every 3 weeks PolyPEPI1018 CRC Vaccine (Emulsified solution, 0.2 mg/peptide, 6 peptides total, and Montanide™ ISA51VG adjuvant), by SC injection in combination with Atezolizumab (Injectable solution,1200mg/20mL) by IV injection.
|
|---|---|
|
Overall Survival Assesment
Time to Death, 25th Percentile
|
4.5 Months
Interval 1.5 to 12.3
|
|
Overall Survival Assesment
Time to Death, Median
|
12.7 Months
Interval 3.2 to
NA = Not estimable. The upper bound of the 95% confidence interval was not estimable because an insufficient number of OS events had occurred at the time of analysis.
|
|
Overall Survival Assesment
Time to Death, 75th Percentile
|
NA Months
Interval 12.7 to
NA = Not estimable. The estimated value and the upper bound of the 95% confidence interval was not estimable because an insufficient number of OS events had occurred at the time of analysis.
|
SECONDARY outcome
Timeframe: 1 yearList number of PEPIs identified by PEPI Test, where PEPIs are personal epitopes based on human leukocyte antigen (HLA)-genotype likely capable of inducing T-cell responses.
Outcome measures
| Measure |
PolyPEPI1018 Plus Atezolizumab
n=18 Participants
Participants receive every 3 weeks PolyPEPI1018 CRC Vaccine (Emulsified solution, 0.2 mg/peptide, 6 peptides total, and Montanide™ ISA51VG adjuvant), by SC injection in combination with Atezolizumab (Injectable solution,1200mg/20mL) by IV injection.
|
|---|---|
|
PEPI Listing
|
3.6 Number of PEPI per patient
Standard Deviation 2.59
|
SECONDARY outcome
Timeframe: From study entry to last administration, assessed up to 2 yearsPopulation: The Overall Number of Participants Analyzed represents the total unique participants contributing data to at least one component of this outcome measure. Row-specific denominators vary due to sample availability and assay evaluability at individual timepoints.
Effector T cell response against vaccine antigens as measured by ex vivo interferon (IFN)-gamma Enzyme-Linked ImmunoSpot (ex vivo ELISPOT) assay at baseline and at specified intervals on study therapy. The Baseline was the most recent non-missing value obtained immediately prior to administration of the first dose, and Post-treatment (on-treatment) was the maximum of the non-missing results obtained after admininstration of the first dose.
Outcome measures
| Measure |
PolyPEPI1018 Plus Atezolizumab
n=18 Participants
Participants receive every 3 weeks PolyPEPI1018 CRC Vaccine (Emulsified solution, 0.2 mg/peptide, 6 peptides total, and Montanide™ ISA51VG adjuvant), by SC injection in combination with Atezolizumab (Injectable solution,1200mg/20mL) by IV injection.
|
|---|---|
|
Measured Effector T Cell Immune Response
Baseline - CD4+ T-cell response
|
2 Participants
|
|
Measured Effector T Cell Immune Response
Post Treatment - CD4+ T-cell response
|
12 Participants
|
|
Measured Effector T Cell Immune Response
Baseline - CD8+ T-cell response
|
3 Participants
|
|
Measured Effector T Cell Immune Response
Post Treatment - CD8+ T-cell response
|
8 Participants
|
|
Measured Effector T Cell Immune Response
Baseline - Both CD4+ and CD8+ T-cell responses
|
1 Participants
|
|
Measured Effector T Cell Immune Response
Post Treatment - Both CD4+ and CD8+ T-cell responses
|
8 Participants
|
SECONDARY outcome
Timeframe: From study entry to last administration, assessed up to 2 yearsPopulation: Memory T-cell response assessments by IVS ELISPOT were planned at multiple time points; however, no assays were performed for any participants at any time point because insufficient blood samples were available to conduct the analyses.
Memory T cell response against vaccine antigens of PolyPEPI1018 as measured by in vitro stimulated interferon (IFN)-gamma Enzyme-Linked ImmunoSpot (IVS ELISPOT) assay at baseline and at specified intervals on study therapy. The Baseline is the most recent non-missing value obtained immediately prior to administration of the first dose, and Post-treatment (on-treatment) is the maximum of the non-missing results obtained after admininstration of the first dose.
Outcome measures
Outcome data not reported
Adverse Events
PolyPEPI1018 Plus Atezolizumab
Serious events: 4 serious events
Other events: 18 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
PolyPEPI1018 Plus Atezolizumab
n=18 participants at risk
Participants receive every 3 weeks PolyPEPI1018 CRC Vaccine (Emulsified solution, 0.2 mg/peptide, 6 peptides total, and Montanide™ ISA51VG adjuvant), by SC injection in combination with Atezolizumab (Injectable solution,1200mg/20mL) by IV injection.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
1/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Gastrointestinal disorders
Ascites
|
5.6%
1/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Gastrointestinal disorders
Intestinal obstruction
|
5.6%
1/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Gastrointestinal disorders
Nausea
|
5.6%
1/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
5.6%
1/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
1/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
General disorders
Disease progression
|
11.1%
2/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
Other adverse events
| Measure |
PolyPEPI1018 Plus Atezolizumab
n=18 participants at risk
Participants receive every 3 weeks PolyPEPI1018 CRC Vaccine (Emulsified solution, 0.2 mg/peptide, 6 peptides total, and Montanide™ ISA51VG adjuvant), by SC injection in combination with Atezolizumab (Injectable solution,1200mg/20mL) by IV injection.
|
|---|---|
|
General disorders
Influenza like illness
|
16.7%
3/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
General disorders
Chills
|
11.1%
2/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
General disorders
Non-cardiac chest pain
|
11.1%
2/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
General disorders
Injection site pain
|
5.6%
1/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
General disorders
Oedema peripheral
|
5.6%
1/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Infections and infestations
Urinary tract infection
|
5.6%
1/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Cardiac disorders
Tachycardia
|
11.1%
2/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Endocrine disorders
Hypothyroidism
|
11.1%
2/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Gastrointestinal disorders
Nausea
|
33.3%
6/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Gastrointestinal disorders
Abdominal pain
|
22.2%
4/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Gastrointestinal disorders
Vomiting
|
22.2%
4/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Gastrointestinal disorders
Constipation
|
22.2%
4/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Gastrointestinal disorders
Abdominal distension
|
16.7%
3/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Gastrointestinal disorders
Ascites
|
5.6%
1/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Gastrointestinal disorders
Diarrhoea
|
11.1%
2/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Gastrointestinal disorders
Dysphagia
|
11.1%
2/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Gastrointestinal disorders
Dyspepsia
|
5.6%
1/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Gastrointestinal disorders
Haematochezia
|
5.6%
1/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Gastrointestinal disorders
Proctalgia
|
5.6%
1/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
General disorders
Injection site reaction
|
72.2%
13/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
General disorders
Fatique
|
50.0%
9/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
General disorders
Pyrexia
|
44.4%
8/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
3/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Blood and lymphatic system disorders
Eosinophilia
|
5.6%
1/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Blood and lymphatic system disorders
Lymph node pain
|
5.6%
1/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Injury, poisoning and procedural complications
Fall
|
5.6%
1/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Injury, poisoning and procedural complications
Post procedural erythema
|
5.6%
1/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Injury, poisoning and procedural complications
Procedural pain
|
5.6%
1/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
3/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Investigations
Blood alkaline phosphatase increased
|
16.7%
3/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Investigations
Alanine aminotransferase increased
|
11.1%
2/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Investigations
Blood thyroid stimulating hormone increased
|
11.1%
2/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Investigations
Lymphocyte count decreased
|
11.1%
2/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Investigations
Weight decreased
|
11.1%
2/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Investigations
Amylase increased
|
5.6%
1/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Investigations
Blood chloride increased
|
5.6%
1/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Investigations
Blood creatinine increased
|
5.6%
1/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Investigations
Blood lactate dehydrogenase increased
|
5.6%
1/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Metabolism and nutrition disorders
Decrease appetite
|
22.2%
4/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
3/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.6%
1/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.6%
1/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.6%
1/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.6%
1/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
3/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
2/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.6%
1/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
5.6%
1/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.6%
1/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.6%
1/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Nervous system disorders
Headache
|
27.8%
5/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
16.7%
3/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Nervous system disorders
Dizziness
|
11.1%
2/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Nervous system disorders
Neuropathy peripherial
|
5.6%
1/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Nervous system disorders
Tremor
|
5.6%
1/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Psychiatric disorders
Anxiety
|
11.1%
2/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Renal and urinary disorders
Hydronephrosis
|
5.6%
1/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
27.8%
5/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
3/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
11.1%
2/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.6%
1/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
5.6%
1/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.6%
1/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Respiratory, thoracic and mediastinal disorders
Vocal fold immobility
|
5.6%
1/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
11.1%
2/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.6%
1/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.6%
1/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
5.6%
1/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Vascular disorders
Hypertension
|
22.2%
4/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Vascular disorders
Haematoma
|
5.6%
1/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Vascular disorders
Hot flush
|
5.6%
1/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
|
Vascular disorders
Hypotension
|
5.6%
1/18 • From first dose of study therapy through the 90-day safety follow-up visit for adverse events; from first dose of study therapy through 24 months for all-cause mortality.
AEs were collected by visits
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place