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

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

29 participants

Primary outcome timeframe

6 months

Results posted on

2022-07-26

Participant Flow

Participant milestones

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

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 months

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

Outcome measures

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 months

Analyzed 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

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 years

The 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

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 years

PD-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

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 years

Analyzed 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

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 years

Per 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

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 years

Analyzed 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

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 years

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

Outcome measures

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 years

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

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 events: 1 serious events
Other events: 25 other events
Deaths: 28 deaths

Serious adverse events

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

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

Phone: 2062459258

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place