Trial Outcomes & Findings for Galinpepimut-S in Combination With Pembrolizumab in Patients With Selected Advanced Cancers (NCT NCT03761914)
NCT ID: NCT03761914
Last Updated: 2024-11-19
Results Overview
Percentage of patients who have received at least one dose of pembrolizumab and have responded (and have completed imaging requirements). Best overall response is defined as the best overall visit response in the following order: CR, PR, SD, PD, or UE as measured by RECIST 1.1
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
26 participants
Primary outcome timeframe
33 months
Results posted on
2024-11-19
Participant Flow
Participant milestones
| Measure |
Ovarian Cancer (OvC)
* Metastatic platinum-resistant or refractory OvC previously treated with ≥1 line of prior platinum-containing therapy
* Galinpepimut-S + Montanide + GM-CSF + pembrolizumab
|
Colorectal Cancer (CRC)
* Metastatic CRC previously treated with ≥ 2 lines of prior systematic chemotherapies
* Galinpepimut-S + Montanide + GM-CSF + pembrolizumab
|
Small Cell Lung Cancer (SCLC)
* Advanced SCLC previously treated with one line of prior systemic chemotherapy
* Galinpepimut-S + Montanide + GM-CSF + pembrolizumab
|
Triple Negative Breast Cancer (TNBC)
* TNBC previously treated with one line of prior systemic chemotherapy
* Galinpepimut-S + Montanide + GM-CSF + pembrolizumab
|
Acute Myelogenous Leukemia (AML)
* AML (any age) who are not eligible for allogeneic hematopoietic stem cell transplant and have been able to achieve partial response (PR) while receiving frontline therapy with hypomethylating agents (HMAs)
* Galinpepimut-S + Montanide + GM-CSF + pembrolizumab
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
1
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
25
|
1
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
Baseline characteristics by cohort
| Measure |
Ovarian Cancer (OvC)
n=25 Participants
* Metastatic platinum-resistant or refractory OvC previously treated with ≥1 line of prior platinum-containing therapy
* Galinpepimut-S + Montanide + GM-CSF + pembrolizumab
|
Colorectal (CRC)
n=1 Participants
Metastatic CRC previously treated with ≥ 2 lines of prior systematic chemotherapies Galinpepimut-S + Montanide + GM-CSF + pembrolizumab
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65 years
n=99 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
40 years
n=107 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
65 years
n=206 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
|
Sex: Female, Male
Female
|
25 Participants
n=99 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
1 Participants
n=107 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
26 Participants
n=206 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
0 Participants
n=107 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
0 Participants
n=206 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=99 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
0 Participants
n=107 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
8 Participants
n=206 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=99 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
1 Participants
n=107 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
15 Participants
n=206 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
0 Participants
n=107 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
3 Participants
n=206 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
0 Participants
n=107 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
0 Participants
n=206 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
0 Participants
n=107 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
0 Participants
n=206 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
0 Participants
n=107 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
0 Participants
n=206 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
1 Participants
n=107 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
2 Participants
n=206 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
|
Race (NIH/OMB)
White
|
19 Participants
n=99 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
0 Participants
n=107 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
19 Participants
n=206 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=99 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
0 Participants
n=107 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
5 Participants
n=206 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
0 Participants
n=107 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
0 Participants
n=206 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
|
Weight
|
61.7 kg
n=99 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
69.5 kg
n=107 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
61.7 kg
n=206 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
|
Height
|
160 cm
n=99 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
169 cm
n=107 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
160 cm
n=206 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
|
BMI
|
25.03 kg/m^2
n=99 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
24.3 kg/m^2
n=107 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
25.03 kg/m^2
n=206 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
|
Baseline ECOG
0
|
8 Participants
n=99 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
0 Participants
n=107 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
8 Participants
n=206 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
|
Baseline ECOG
1
|
17 Participants
n=99 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
1 Participants
n=107 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
18 Participants
n=206 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
|
Lines of prior therapy
1
|
2 Participants
n=99 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
0 Participants
n=107 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
2 Participants
n=206 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
|
Lines of prior therapy
2
|
13 Participants
n=99 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
0 Participants
n=107 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
13 Participants
n=206 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
|
Lines of prior therapy
3
|
3 Participants
n=99 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
0 Participants
n=107 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
3 Participants
n=206 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
|
Lines of prior therapy
4
|
1 Participants
n=99 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
1 Participants
n=107 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
2 Participants
n=206 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
|
Lines of prior therapy
5
|
1 Participants
n=99 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
0 Participants
n=107 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
1 Participants
n=206 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
|
Lines of prior therapy
Unknown / Not reported
|
5 Participants
n=99 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
0 Participants
n=107 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
5 Participants
n=206 Participants • Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
|
PRIMARY outcome
Timeframe: 33 monthsPopulation: Participants who have received at least one dose of pembrolizumab (mITT population). Patients only enrolled in the Ovarian Cancer (OvC) arm. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy can be assessed. The other arms/groups were removed from this study.
Percentage of patients who have received at least one dose of pembrolizumab and have responded (and have completed imaging requirements). Best overall response is defined as the best overall visit response in the following order: CR, PR, SD, PD, or UE as measured by RECIST 1.1
Outcome measures
| Measure |
Ovarian Cancer (OvC)
n=16 Participants
* Metastatic platinum-resistant or refractory OvC previously treated with ≥1 line of prior platinum-containing therapy
* Galinpepimut-S + Montanide + GM-CSF + pembrolizumab
|
Colorectal Cancer (CRC)
One subject enrolled but discontinued before efficacy can be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
|---|---|---|
|
Overall Response Rate (ORR) - Best Overall Response
Complete response
|
0 Participants
|
0 Participants
|
|
Overall Response Rate (ORR) - Best Overall Response
Partial response
|
1 Participants
|
0 Participants
|
|
Overall Response Rate (ORR) - Best Overall Response
Stable disease
|
7 Participants
|
0 Participants
|
|
Overall Response Rate (ORR) - Best Overall Response
Progressive disease
|
8 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 33 monthsPopulation: Participants who have received at least one dose of pembrolizumab (mITT population). Patients only enrolled in the Ovarian Cancer (OvC) arm. One subject from the Colorectal Cancer (CRC) arm enrolled but discontinued before efficacy can be assessed. The other arms/groups were removed from this study.
Percentage of patients who have received at least one dose of pembrolizumab and have responded (and have completed imaging requirement). Overall response rate is defined as the proportion of participants with a best overall response of CR or PR as defined by RECIST 1.1
Outcome measures
| Measure |
Ovarian Cancer (OvC)
n=16 Participants
* Metastatic platinum-resistant or refractory OvC previously treated with ≥1 line of prior platinum-containing therapy
* Galinpepimut-S + Montanide + GM-CSF + pembrolizumab
|
Colorectal Cancer (CRC)
One subject enrolled but discontinued before efficacy can be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
|---|---|---|
|
Overall Response Rate (ORR) - Overall Response Rate
|
1 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 33 monthsPopulation: Participants who received at least one dose of pembrolizumab (galinpepimut-S + pembrolizumab); mITT population. Patients only enrolled in the Ovarian Cancer (OvC) arm. One subject from the Colorectal Cancer (CRC) arm enrolled but discontinued before efficacy can be assessed. The other arms/groups were removed from this study.
Time from enrollment to date of first confirmed disease progression or death whichever occurred earlier
Outcome measures
| Measure |
Ovarian Cancer (OvC)
n=16 Participants
* Metastatic platinum-resistant or refractory OvC previously treated with ≥1 line of prior platinum-containing therapy
* Galinpepimut-S + Montanide + GM-CSF + pembrolizumab
|
Colorectal Cancer (CRC)
One subject enrolled but discontinued before efficacy can be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
|---|---|---|
|
Progression-free Survival (PFS) - Kaplan Meier Estimate
|
2.9 months
Interval 2.0 to 5.6
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 33 monthsPopulation: Participants who received at least one dose of pembrolizumab (galinpepimut-S + pembrolizumab); mITT population. Patients only enrolled in the Ovarian Cancer (OvC) arm. One subject from the Colorectal Cancer (CRC) arm enrolled but discontinued before efficacy can be assessed. The other arms/groups were removed from this study.
Time from enrollment to date of death from any cause
Outcome measures
| Measure |
Ovarian Cancer (OvC)
n=16 Participants
* Metastatic platinum-resistant or refractory OvC previously treated with ≥1 line of prior platinum-containing therapy
* Galinpepimut-S + Montanide + GM-CSF + pembrolizumab
|
Colorectal Cancer (CRC)
One subject enrolled but discontinued before efficacy can be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
|---|---|---|
|
Overall Survival (OS) - Kaplan Meier Estimate
|
18.4 months
Interval 8.4 to
Upper 95%CI not reached due to end of study monitoring duration
|
—
|
Adverse Events
Ovarian Cancer (OvC)
Serious events: 5 serious events
Other events: 25 other events
Deaths: 7 deaths
Colorectal Cancer (CRC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ovarian Cancer (OvC)
n=25 participants at risk
* Metastatic platinum-resistant or refractory OvC previously treated with ≥1 line of prior platinum-containing therapy
* Galinpepimut-S + Montanide + GM-CSF + pembrolizumab
|
Colorectal Cancer (CRC)
Metastatic CRC previously treated with ≥ 2 lines of prior systematic chemotherapies Galinpepimut-S + Montanide + GM-CSF + pembrolizumab
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.0%
1/25 • Number of events 1 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
—
0/0 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
|
Renal and urinary disorders
Acute kidney injury
|
4.0%
1/25 • Number of events 1 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
—
0/0 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
|
Renal and urinary disorders
Hydronephrosis
|
4.0%
1/25 • Number of events 1 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
—
0/0 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.0%
1/25 • Number of events 1 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
—
0/0 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
4.0%
1/25 • Number of events 1 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
—
0/0 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
|
General disorders
Fatigue
|
4.0%
1/25 • Number of events 1 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
—
0/0 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
|
Infections and infestations
Sepsis
|
4.0%
1/25 • Number of events 1 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
—
0/0 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.0%
1/25 • Number of events 1 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
—
0/0 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
Other adverse events
| Measure |
Ovarian Cancer (OvC)
n=25 participants at risk
* Metastatic platinum-resistant or refractory OvC previously treated with ≥1 line of prior platinum-containing therapy
* Galinpepimut-S + Montanide + GM-CSF + pembrolizumab
|
Colorectal Cancer (CRC)
Metastatic CRC previously treated with ≥ 2 lines of prior systematic chemotherapies Galinpepimut-S + Montanide + GM-CSF + pembrolizumab
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
5/25 • Number of events 5 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
—
0/0 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
|
Gastrointestinal disorders
Vomiting
|
36.0%
9/25 • Number of events 9 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
—
0/0 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
|
Gastrointestinal disorders
Abdominal pain
|
28.0%
7/25 • Number of events 7 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
—
0/0 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
|
Gastrointestinal disorders
Nausea
|
28.0%
7/25 • Number of events 7 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
—
0/0 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
|
Gastrointestinal disorders
Abdominal distension
|
24.0%
6/25 • Number of events 6 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
—
0/0 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
|
Gastrointestinal disorders
Diarrhea
|
24.0%
6/25 • Number of events 6 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
—
0/0 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
24.0%
6/25 • Number of events 6 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
—
0/0 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
|
Gastrointestinal disorders
Constipation
|
20.0%
5/25 • Number of events 5 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
—
0/0 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
|
Gastrointestinal disorders
Ascites
|
16.0%
4/25 • Number of events 4 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
—
0/0 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
12.0%
3/25 • Number of events 3 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
—
0/0 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.0%
2/25 • Number of events 2 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
—
0/0 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
|
General disorders
Fatigue
|
32.0%
8/25 • Number of events 8 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
—
0/0 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
|
General disorders
Injection site reaction
|
24.0%
6/25 • Number of events 6 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
—
0/0 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
|
General disorders
Edema peripheral
|
16.0%
4/25 • Number of events 4 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
—
0/0 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
|
Gastrointestinal disorders
Pain
|
16.0%
4/25 • Number of events 4 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
—
0/0 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
|
General disorders
Pyrexia
|
12.0%
3/25 • Number of events 3 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
—
0/0 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
|
General disorders
Influenza like illness
|
8.0%
2/25 • Number of events 2 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
—
0/0 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
|
Immune system disorders
Hypersensitivity
|
8.0%
2/25 • Number of events 2 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
—
0/0 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
|
Infections and infestations
Urinary tract infection
|
12.0%
3/25 • Number of events 3 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
—
0/0 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.0%
2/25 • Number of events 2 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
—
0/0 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
|
Metabolism and nutrition disorders
Dehydration
|
8.0%
2/25 • Number of events 2 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
—
0/0 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.0%
3/25 • Number of events 3 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
—
0/0 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.0%
2/25 • Number of events 2 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
—
0/0 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
8.0%
2/25 • Number of events 2 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
—
0/0 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.0%
2/25 • Number of events 2 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
—
0/0 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.0%
2/25 • Number of events 2 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
—
0/0 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
|
Nervous system disorders
Headache
|
32.0%
8/25 • Number of events 8 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
—
0/0 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
|
Nervous system disorders
Aphasia
|
20.0%
5/25 • Number of events 5 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
—
0/0 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
|
Psychiatric disorders
Insomnia
|
8.0%
2/25 • Number of events 2 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
—
0/0 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.0%
2/25 • Number of events 2 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
—
0/0 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.0%
2/25 • Number of events 2 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
—
0/0 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.0%
2/25 • Number of events 2 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
—
0/0 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
8.0%
2/25 • Number of events 2 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
—
0/0 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
|
Vascular disorders
Hypotension
|
8.0%
2/25 • Number of events 2 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
—
0/0 • Adverse event data was collected for 29 months.
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
|
Additional Information
Dr Dragan Cicic, Chief Development Officer
Sellas Life Sciences
Phone: 646-200-5278
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place