Trial Outcomes & Findings for Pembrolizumab and Carboplatin in Treating Patients With Relapsed or Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (NCT NCT03029598)
NCT ID: NCT03029598
Last Updated: 2022-07-26
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI/CT scans: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
COMPLETED
PHASE1/PHASE2
29 participants
6 months
2022-07-26
Participant Flow
Participant milestones
| Measure |
Treatment (Pembrolizumab, Carboplatin)
Patients receive pembrolizumab IV over 30 minutes on day 1 and carboplatin IV over 30 minutes on days 8 and 15. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pembrolizumab and Carboplatin in Treating Patients With Relapsed or Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Pembrolizumab, Carboplatin)
n=29 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1 and carboplatin IV over 30 minutes on days 8 and 15. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Age, Continuous
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI/CT scans: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Outcome measures
| Measure |
Treatment (Pembrolizumab, Carboplatin)
n=23 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1 and carboplatin IV over 30 minutes on days 8 and 15. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Response Rate (RR) Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Patients that achieved a Partial Response (PR)
|
3 Participants
|
|
Response Rate (RR) Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Patient achieved Stable Disease (SD)
|
15 Participants
|
|
Response Rate (RR) Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Patients that had Progressive Disease (PD)
|
5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsAnalyzed using the Kaplan-Meier method. Kaplan-Meier estimates of the survival function with 95% confidence intervals (CIs) at specific time points (using Greenwood's formula for the standard error) were computed. Comparisons with the historical control PFS will be conducted by examining whether the 95% confidence internal covers the historical control proportions. Progression-free survival (PFS) is defined as the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse. Participants are evaluated by RECIST1.1 to determine if/when a participant's disease has progressed defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Outcome measures
| Measure |
Treatment (Pembrolizumab, Carboplatin)
n=29 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1 and carboplatin IV over 30 minutes on days 8 and 15. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Progression-free Survival (PFS) Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
|
4.63 months
Interval 4.3 to 4.97
|
SECONDARY outcome
Timeframe: Up to 3.5 yearsThe safety evaluation of the population included all patients who received at least one dose of study medication. The descriptions and grading scales found in the revised NCI CTCAE version 4.0 will be utilized for adverse event reporting where Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild; asymptomatic or mild symptoms Grade 2 Moderate; minimal Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care of activity of daily living Grade 4 Life-threatening consequences; urgent intervention indicated Grade 5 Death related to AE
Outcome measures
| Measure |
Treatment (Pembrolizumab, Carboplatin)
n=29 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1 and carboplatin IV over 30 minutes on days 8 and 15. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Count of Adverse Events Evaluated by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Grade 1 - Total Number of Reported AEs
|
597 adverse events
|
|
Count of Adverse Events Evaluated by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Grade 2 - Total Number of Reported AEs
|
169 adverse events
|
|
Count of Adverse Events Evaluated by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Grade 3 - Total Number of Reported AEs
|
40 adverse events
|
|
Count of Adverse Events Evaluated by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Grade 4 - Total Number of Reported AEs
|
2 adverse events
|
SECONDARY outcome
Timeframe: Up to 3.5 yearsPD-L1 antibody-stained archival tumor was evaluated by a board-certified pathologist and given a modified proportion score (MPS), or the overall percent of positive cells expressing PD-L1, and a MPS ≥ 5% was defined as PD-L1 positive.
Outcome measures
| Measure |
Treatment (Pembrolizumab, Carboplatin)
n=23 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1 and carboplatin IV over 30 minutes on days 8 and 15. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Number of Participants That Were PD-L1 Positive Based On PD-L1 Expression of Primary Tumor Blocks Assessed by Immunohistochemical Staining
|
7 Participants
|
SECONDARY outcome
Timeframe: Up to 3.5 yearsAnalyzed using the Kaplan-Meier method. Kaplan-Meier estimates of the survival function with 95% CIs at specific time points (using Greenwood's formula for the standard error) were computed. Comparisons with the historical control OS will be conducted by examining whether the 95% confidence internal covers the historical control proportions.
Outcome measures
| Measure |
Treatment (Pembrolizumab, Carboplatin)
n=29 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1 and carboplatin IV over 30 minutes on days 8 and 15. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Overall Survival (OS)
|
11.3 months
Interval 6.094 to 16.506
|
SECONDARY outcome
Timeframe: Up to 3.5 yearsPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI/CT scans: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Outcome measures
| Measure |
Treatment (Pembrolizumab, Carboplatin)
n=23 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1 and carboplatin IV over 30 minutes on days 8 and 15. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Best Overall Response (BOR)
Partial Response
|
3 Participants
|
|
Best Overall Response (BOR)
Stable Disease
|
15 Participants
|
|
Best Overall Response (BOR)
Progressive Disease
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to 3.5 yearsAnalyzed using the Kaplan-Meier method. Kaplan-Meier estimates of the survival function with 95% CIs at specific time points (using Greenwood's formula for the standard error) were computed. Comparisons with the historical control PFS will be conducted by examining whether the 95% confidence internal covers the historical control proportions. Progression-free survival (PFS) is defined as the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse. Participants are evaluated by RECIST1.1 to determine if/when a participant's disease has progressed defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Outcome measures
| Measure |
Treatment (Pembrolizumab, Carboplatin)
n=29 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1 and carboplatin IV over 30 minutes on days 8 and 15. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Progression-free Survival (PFS) Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
|
4.63 months
Interval 4.3 to 4.97
|
SECONDARY outcome
Timeframe: Up to 3.5 yearsPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI/CT scans: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Outcome measures
| Measure |
Treatment (Pembrolizumab, Carboplatin)
n=23 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1 and carboplatin IV over 30 minutes on days 8 and 15. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Immune-related Best Overall Response (BOR) Assessed Using irRECIST (Immune-related Response Evaluation Criteria In Solid Tumors) Derived From Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Partial Response
|
3 Participants
|
|
Immune-related Best Overall Response (BOR) Assessed Using irRECIST (Immune-related Response Evaluation Criteria In Solid Tumors) Derived From Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Stable Disease
|
15 Participants
|
|
Immune-related Best Overall Response (BOR) Assessed Using irRECIST (Immune-related Response Evaluation Criteria In Solid Tumors) Derived From Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Progressive Disease
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to 3.5 yearsProgression-free survival (PFS) is defined as the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse. Participants are evaluated by RECIST1.1 to determine if/when a participant's disease has progressed defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Outcome measures
| Measure |
Treatment (Pembrolizumab, Carboplatin)
n=29 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1 and carboplatin IV over 30 minutes on days 8 and 15. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Immune-related Progression-free Survival (PFS) Using irRECIST (Immune-related Response Evaluation Criteria In Solid Tumors) Derived From Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
|
4.63 months
Interval 4.3 to 4.97
|
Adverse Events
Treatment (Pembrolizumab, Carboplatin)
Serious adverse events
| Measure |
Treatment (Pembrolizumab, Carboplatin)
n=29 participants at risk
Patients receive pembrolizumab IV over 30 minutes on day 1 and carboplatin IV over 30 minutes on days 8 and 15. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
General disorders
Disease progression leading to hospice
|
3.4%
1/29 • Number of events 1 • The safety population included all patients who received at least one dose of study medication. Anyone that received at least 1 treatment dose will be evaluated. After the end of treatment, each subject will be followed for 30 days or prior to initiation of new treatment for adverse event monitoring (serious adverse events will be collected for 90 days after the end of treatment. The complete adverse event evaluation period for all treated participants is 3.5 years.
We used CTCAE v4.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note we recorded every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at the site of treatment administration; each each time an injection site reactions is reported, during the study, it is recorded for that subject.
|
Other adverse events
| Measure |
Treatment (Pembrolizumab, Carboplatin)
n=29 participants at risk
Patients receive pembrolizumab IV over 30 minutes on day 1 and carboplatin IV over 30 minutes on days 8 and 15. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Investigations
Lymphopenia
|
65.5%
19/29 • Number of events 100 • The safety population included all patients who received at least one dose of study medication. Anyone that received at least 1 treatment dose will be evaluated. After the end of treatment, each subject will be followed for 30 days or prior to initiation of new treatment for adverse event monitoring (serious adverse events will be collected for 90 days after the end of treatment. The complete adverse event evaluation period for all treated participants is 3.5 years.
We used CTCAE v4.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note we recorded every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at the site of treatment administration; each each time an injection site reactions is reported, during the study, it is recorded for that subject.
|
|
Blood and lymphatic system disorders
Anemia
|
86.2%
25/29 • Number of events 82 • The safety population included all patients who received at least one dose of study medication. Anyone that received at least 1 treatment dose will be evaluated. After the end of treatment, each subject will be followed for 30 days or prior to initiation of new treatment for adverse event monitoring (serious adverse events will be collected for 90 days after the end of treatment. The complete adverse event evaluation period for all treated participants is 3.5 years.
We used CTCAE v4.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note we recorded every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at the site of treatment administration; each each time an injection site reactions is reported, during the study, it is recorded for that subject.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
48.3%
14/29 • Number of events 42 • The safety population included all patients who received at least one dose of study medication. Anyone that received at least 1 treatment dose will be evaluated. After the end of treatment, each subject will be followed for 30 days or prior to initiation of new treatment for adverse event monitoring (serious adverse events will be collected for 90 days after the end of treatment. The complete adverse event evaluation period for all treated participants is 3.5 years.
We used CTCAE v4.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note we recorded every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at the site of treatment administration; each each time an injection site reactions is reported, during the study, it is recorded for that subject.
|
|
Investigations
Thrombocytopenia
|
44.8%
13/29 • Number of events 37 • The safety population included all patients who received at least one dose of study medication. Anyone that received at least 1 treatment dose will be evaluated. After the end of treatment, each subject will be followed for 30 days or prior to initiation of new treatment for adverse event monitoring (serious adverse events will be collected for 90 days after the end of treatment. The complete adverse event evaluation period for all treated participants is 3.5 years.
We used CTCAE v4.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note we recorded every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at the site of treatment administration; each each time an injection site reactions is reported, during the study, it is recorded for that subject.
|
|
Investigations
White blood cell decreased
|
48.3%
14/29 • Number of events 35 • The safety population included all patients who received at least one dose of study medication. Anyone that received at least 1 treatment dose will be evaluated. After the end of treatment, each subject will be followed for 30 days or prior to initiation of new treatment for adverse event monitoring (serious adverse events will be collected for 90 days after the end of treatment. The complete adverse event evaluation period for all treated participants is 3.5 years.
We used CTCAE v4.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note we recorded every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at the site of treatment administration; each each time an injection site reactions is reported, during the study, it is recorded for that subject.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
48.3%
14/29 • Number of events 31 • The safety population included all patients who received at least one dose of study medication. Anyone that received at least 1 treatment dose will be evaluated. After the end of treatment, each subject will be followed for 30 days or prior to initiation of new treatment for adverse event monitoring (serious adverse events will be collected for 90 days after the end of treatment. The complete adverse event evaluation period for all treated participants is 3.5 years.
We used CTCAE v4.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note we recorded every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at the site of treatment administration; each each time an injection site reactions is reported, during the study, it is recorded for that subject.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
48.3%
14/29 • Number of events 27 • The safety population included all patients who received at least one dose of study medication. Anyone that received at least 1 treatment dose will be evaluated. After the end of treatment, each subject will be followed for 30 days or prior to initiation of new treatment for adverse event monitoring (serious adverse events will be collected for 90 days after the end of treatment. The complete adverse event evaluation period for all treated participants is 3.5 years.
We used CTCAE v4.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note we recorded every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at the site of treatment administration; each each time an injection site reactions is reported, during the study, it is recorded for that subject.
|
|
Gastrointestinal disorders
Nausea
|
44.8%
13/29 • Number of events 26 • The safety population included all patients who received at least one dose of study medication. Anyone that received at least 1 treatment dose will be evaluated. After the end of treatment, each subject will be followed for 30 days or prior to initiation of new treatment for adverse event monitoring (serious adverse events will be collected for 90 days after the end of treatment. The complete adverse event evaluation period for all treated participants is 3.5 years.
We used CTCAE v4.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note we recorded every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at the site of treatment administration; each each time an injection site reactions is reported, during the study, it is recorded for that subject.
|
|
Investigations
Neutropenia
|
24.1%
7/29 • Number of events 25 • The safety population included all patients who received at least one dose of study medication. Anyone that received at least 1 treatment dose will be evaluated. After the end of treatment, each subject will be followed for 30 days or prior to initiation of new treatment for adverse event monitoring (serious adverse events will be collected for 90 days after the end of treatment. The complete adverse event evaluation period for all treated participants is 3.5 years.
We used CTCAE v4.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note we recorded every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at the site of treatment administration; each each time an injection site reactions is reported, during the study, it is recorded for that subject.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
48.3%
14/29 • Number of events 24 • The safety population included all patients who received at least one dose of study medication. Anyone that received at least 1 treatment dose will be evaluated. After the end of treatment, each subject will be followed for 30 days or prior to initiation of new treatment for adverse event monitoring (serious adverse events will be collected for 90 days after the end of treatment. The complete adverse event evaluation period for all treated participants is 3.5 years.
We used CTCAE v4.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note we recorded every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at the site of treatment administration; each each time an injection site reactions is reported, during the study, it is recorded for that subject.
|
Additional Information
Director of Clinical Operations
University of Washington - Cancer Vaccine Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place