Trial Outcomes & Findings for A Study of Pembrolizumab With Standard Treatment in Patients With Recurrent Platinum-resistant Ovarian Cancer (NCT NCT02608684)
NCT ID: NCT02608684
Last Updated: 2022-03-23
Results Overview
Defined as complete or partial response per RECIST 1.1 criteria with assessment every 6 weeks during first 6 cycles of therapy and every 9 weeks thereafter. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2022-03-23
Participant Flow
Participant milestones
| Measure |
Cisplatin+Gemcitabine+Pembrolizumab
2 cycles of 750mg gemcitabine and 30mg cisplatin chemotherapy (standard of care) followed by 4 cycles of gemcitabine and cisplatin combined with pembrolizumab in 21-day treatment cycles followed by single-agent pembrolizumab maintenance therapy for up to 2 years of treatment (6 cycles combination treatment + 28 cycles maintenance).
Gemcitabine 750 mg/m2 every 3 weeks (Q3W) x 6 cycles IV infusion
-Day 1 and Day 8 of each 3 week cycle Standard of care
Cisplatin 30 mg/m2 Q3W x 6 cycles IV infusion
-Day 1 and Day 8 of each 3 week cycle after gemcitabine Standard of care
Pembrolizumab 200 mg Q3W starting with cycle 3 IV infusion
-Day 1 of each 3 week cycle after gemcitabine and cisplatin Experimental
Pembrolizumab: Pembrolizumab IV solution
Gemcitabine: Gemcitabine IV solution
Cisplatin: Cisplatin IV solution
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Cisplatin+Gemcitabine+Pembrolizumab
2 cycles of 750mg gemcitabine and 30mg cisplatin chemotherapy (standard of care) followed by 4 cycles of gemcitabine and cisplatin combined with pembrolizumab in 21-day treatment cycles followed by single-agent pembrolizumab maintenance therapy for up to 2 years of treatment (6 cycles combination treatment + 28 cycles maintenance).
Gemcitabine 750 mg/m2 every 3 weeks (Q3W) x 6 cycles IV infusion
-Day 1 and Day 8 of each 3 week cycle Standard of care
Cisplatin 30 mg/m2 Q3W x 6 cycles IV infusion
-Day 1 and Day 8 of each 3 week cycle after gemcitabine Standard of care
Pembrolizumab 200 mg Q3W starting with cycle 3 IV infusion
-Day 1 of each 3 week cycle after gemcitabine and cisplatin Experimental
Pembrolizumab: Pembrolizumab IV solution
Gemcitabine: Gemcitabine IV solution
Cisplatin: Cisplatin IV solution
|
|---|---|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
A Study of Pembrolizumab With Standard Treatment in Patients With Recurrent Platinum-resistant Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Cisplatin+Gemcitabine+Pembrolizumab
n=18 Participants
2 cycles of 750mg gemcitabine and 30mg cisplatin chemotherapy (standard of care) followed by 4 cycles of gemcitabine and cisplatin combined with pembrolizumab in 21-day treatment cycles followed by single-agent pembrolizumab maintenance therapy for up to 2 years of treatment (6 cycles combination treatment + 28 cycles maintenance).
Gemcitabine 750 mg/m2 every 3 weeks (Q3W) x 6 cycles IV infusion
-Day 1 and Day 8 of each 3 week cycle Standard of care
Cisplatin 30 mg/m2 Q3W x 6 cycles IV infusion
-Day 1 and Day 8 of each 3 week cycle after gemcitabine Standard of care
Pembrolizumab 200 mg Q3W starting with cycle 3 IV infusion
-Day 1 of each 3 week cycle after gemcitabine and cisplatin Experimental
Pembrolizumab: Pembrolizumab IV solution
Gemcitabine: Gemcitabine IV solution
Cisplatin: Cisplatin IV solution
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=99 Participants
|
|
Age, Continuous
|
57.2 years
STANDARD_DEVIATION 8.3 • n=99 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Ashkenazi Jewish - 0%
|
14 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Ashkenazi Jewish - 100%
|
3 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Ashkenazi Jewish - Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsDefined as complete or partial response per RECIST 1.1 criteria with assessment every 6 weeks during first 6 cycles of therapy and every 9 weeks thereafter. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Cisplatin+Gemcitabine+Pembrolizumab
n=18 Participants
2 cycles of 750mg gemcitabine and 30mg cisplatin chemotherapy (standard of care) followed by 4 cycles of gemcitabine and cisplatin combined with pembrolizumab in 21-day treatment cycles followed by single-agent pembrolizumab maintenance therapy for up to 2 years of treatment (6 cycles combination treatment + 28 cycles maintenance).
Gemcitabine 750 mg/m2 every 3 weeks (Q3W) x 6 cycles IV infusion
-Day 1 and Day 8 of each 3 week cycle Standard of care
Cisplatin 30 mg/m2 Q3W x 6 cycles IV infusion
-Day 1 and Day 8 of each 3 week cycle after gemcitabine Standard of care
Pembrolizumab 200 mg Q3W starting with cycle 3 IV infusion
-Day 1 of each 3 week cycle after gemcitabine and cisplatin Experimental
Pembrolizumab: Pembrolizumab IV solution
Gemcitabine: Gemcitabine IV solution
Cisplatin: Cisplatin IV solution
|
|---|---|
|
Overall Response Rate (ORR)
Complete Response
|
1 Participants
|
|
Overall Response Rate (ORR)
Partial Response
|
10 Participants
|
|
Overall Response Rate (ORR)
Stable Disease
|
5 Participants
|
|
Overall Response Rate (ORR)
Progressive Disease
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPer Immune Response Evaluation Criteria In Solid Tumors Criteria (iRECIST) for target lesions and assessed by CT or MRI, where the threshold is reset if RECIST 1.1 progression is followed at the next assessment by tumor shrinkage: 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 |
Cisplatin+Gemcitabine+Pembrolizumab
n=18 Participants
2 cycles of 750mg gemcitabine and 30mg cisplatin chemotherapy (standard of care) followed by 4 cycles of gemcitabine and cisplatin combined with pembrolizumab in 21-day treatment cycles followed by single-agent pembrolizumab maintenance therapy for up to 2 years of treatment (6 cycles combination treatment + 28 cycles maintenance).
Gemcitabine 750 mg/m2 every 3 weeks (Q3W) x 6 cycles IV infusion
-Day 1 and Day 8 of each 3 week cycle Standard of care
Cisplatin 30 mg/m2 Q3W x 6 cycles IV infusion
-Day 1 and Day 8 of each 3 week cycle after gemcitabine Standard of care
Pembrolizumab 200 mg Q3W starting with cycle 3 IV infusion
-Day 1 of each 3 week cycle after gemcitabine and cisplatin Experimental
Pembrolizumab: Pembrolizumab IV solution
Gemcitabine: Gemcitabine IV solution
Cisplatin: Cisplatin IV solution
|
|---|---|
|
Overall Response Rate by iRECIST
Complete Response
|
0 Participants
|
|
Overall Response Rate by iRECIST
Partial Response
|
0 Participants
|
|
Overall Response Rate by iRECIST
Stable Disease
|
0 Participants
|
|
Overall Response Rate by iRECIST
Progressive Disease
|
12 Participants
|
|
Overall Response Rate by iRECIST
Not applicable
|
6 Participants
|
SECONDARY outcome
Timeframe: 6 months and 12 monthsPercentage of patients who have not progressed at 6 and 12 months with progression-free survival calculated from the start of treatment to the date of progression or death from any cause. Progression is measured by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Progressive Disease (PD), At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest sum on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: the appearance of one or more new lesions is also considered progression.
Outcome measures
| Measure |
Cisplatin+Gemcitabine+Pembrolizumab
n=18 Participants
2 cycles of 750mg gemcitabine and 30mg cisplatin chemotherapy (standard of care) followed by 4 cycles of gemcitabine and cisplatin combined with pembrolizumab in 21-day treatment cycles followed by single-agent pembrolizumab maintenance therapy for up to 2 years of treatment (6 cycles combination treatment + 28 cycles maintenance).
Gemcitabine 750 mg/m2 every 3 weeks (Q3W) x 6 cycles IV infusion
-Day 1 and Day 8 of each 3 week cycle Standard of care
Cisplatin 30 mg/m2 Q3W x 6 cycles IV infusion
-Day 1 and Day 8 of each 3 week cycle after gemcitabine Standard of care
Pembrolizumab 200 mg Q3W starting with cycle 3 IV infusion
-Day 1 of each 3 week cycle after gemcitabine and cisplatin Experimental
Pembrolizumab: Pembrolizumab IV solution
Gemcitabine: Gemcitabine IV solution
Cisplatin: Cisplatin IV solution
|
|---|---|
|
Progression-free Survival (PFS) at 6 Months and at 12 Months
PFS rate at 6 months
|
50.00 percentage of participants
Interval 25.93 to 70.05
|
|
Progression-free Survival (PFS) at 6 Months and at 12 Months
PFS rate at 12 months
|
5.56 percentage of participants
Interval 0.37 to 22.42
|
SECONDARY outcome
Timeframe: Up to 2 yearsCalculated in months from the start of treatment to disease progression as defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Progressive Disease (PD), At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest sum on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: the appearance of one or more new lesions is also considered progression.
Outcome measures
| Measure |
Cisplatin+Gemcitabine+Pembrolizumab
n=18 Participants
2 cycles of 750mg gemcitabine and 30mg cisplatin chemotherapy (standard of care) followed by 4 cycles of gemcitabine and cisplatin combined with pembrolizumab in 21-day treatment cycles followed by single-agent pembrolizumab maintenance therapy for up to 2 years of treatment (6 cycles combination treatment + 28 cycles maintenance).
Gemcitabine 750 mg/m2 every 3 weeks (Q3W) x 6 cycles IV infusion
-Day 1 and Day 8 of each 3 week cycle Standard of care
Cisplatin 30 mg/m2 Q3W x 6 cycles IV infusion
-Day 1 and Day 8 of each 3 week cycle after gemcitabine Standard of care
Pembrolizumab 200 mg Q3W starting with cycle 3 IV infusion
-Day 1 of each 3 week cycle after gemcitabine and cisplatin Experimental
Pembrolizumab: Pembrolizumab IV solution
Gemcitabine: Gemcitabine IV solution
Cisplatin: Cisplatin IV solution
|
|---|---|
|
Time to Progression
|
6.25 months
Interval 3.78 to 7.7
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Among subjects who had a partial or complete response to treatment
Calculated in months as time from documentation of tumor response to disease progression
Outcome measures
| Measure |
Cisplatin+Gemcitabine+Pembrolizumab
n=11 Participants
2 cycles of 750mg gemcitabine and 30mg cisplatin chemotherapy (standard of care) followed by 4 cycles of gemcitabine and cisplatin combined with pembrolizumab in 21-day treatment cycles followed by single-agent pembrolizumab maintenance therapy for up to 2 years of treatment (6 cycles combination treatment + 28 cycles maintenance).
Gemcitabine 750 mg/m2 every 3 weeks (Q3W) x 6 cycles IV infusion
-Day 1 and Day 8 of each 3 week cycle Standard of care
Cisplatin 30 mg/m2 Q3W x 6 cycles IV infusion
-Day 1 and Day 8 of each 3 week cycle after gemcitabine Standard of care
Pembrolizumab 200 mg Q3W starting with cycle 3 IV infusion
-Day 1 of each 3 week cycle after gemcitabine and cisplatin Experimental
Pembrolizumab: Pembrolizumab IV solution
Gemcitabine: Gemcitabine IV solution
Cisplatin: Cisplatin IV solution
|
|---|---|
|
Duration of Response
|
3.75 months
Interval 0.86 to 25.1
|
SECONDARY outcome
Timeframe: Up to 2 yearsCalculated in months from the start of treatment to the date of death from any cause
Outcome measures
| Measure |
Cisplatin+Gemcitabine+Pembrolizumab
n=18 Participants
2 cycles of 750mg gemcitabine and 30mg cisplatin chemotherapy (standard of care) followed by 4 cycles of gemcitabine and cisplatin combined with pembrolizumab in 21-day treatment cycles followed by single-agent pembrolizumab maintenance therapy for up to 2 years of treatment (6 cycles combination treatment + 28 cycles maintenance).
Gemcitabine 750 mg/m2 every 3 weeks (Q3W) x 6 cycles IV infusion
-Day 1 and Day 8 of each 3 week cycle Standard of care
Cisplatin 30 mg/m2 Q3W x 6 cycles IV infusion
-Day 1 and Day 8 of each 3 week cycle after gemcitabine Standard of care
Pembrolizumab 200 mg Q3W starting with cycle 3 IV infusion
-Day 1 of each 3 week cycle after gemcitabine and cisplatin Experimental
Pembrolizumab: Pembrolizumab IV solution
Gemcitabine: Gemcitabine IV solution
Cisplatin: Cisplatin IV solution
|
|---|---|
|
Overall Survival (OS)
|
17.75 months
Interval 7.47 to 32.24
|
SECONDARY outcome
Timeframe: Up to 2 yearsAs measured at each visit, during safety follow up (30 days after discontinuation of treatment) and during follow up (every nine weeks after discontinuation). Adverse events graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4, with events graded from 1 to 5, where a higher grade reflects greater symptom severity.
Outcome measures
| Measure |
Cisplatin+Gemcitabine+Pembrolizumab
n=18 Participants
2 cycles of 750mg gemcitabine and 30mg cisplatin chemotherapy (standard of care) followed by 4 cycles of gemcitabine and cisplatin combined with pembrolizumab in 21-day treatment cycles followed by single-agent pembrolizumab maintenance therapy for up to 2 years of treatment (6 cycles combination treatment + 28 cycles maintenance).
Gemcitabine 750 mg/m2 every 3 weeks (Q3W) x 6 cycles IV infusion
-Day 1 and Day 8 of each 3 week cycle Standard of care
Cisplatin 30 mg/m2 Q3W x 6 cycles IV infusion
-Day 1 and Day 8 of each 3 week cycle after gemcitabine Standard of care
Pembrolizumab 200 mg Q3W starting with cycle 3 IV infusion
-Day 1 of each 3 week cycle after gemcitabine and cisplatin Experimental
Pembrolizumab: Pembrolizumab IV solution
Gemcitabine: Gemcitabine IV solution
Cisplatin: Cisplatin IV solution
|
|---|---|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Alanine aminotransferase increased, Grade 3
|
1 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Platelet count decreased, Grade 1
|
3 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Vomiting, Grade 1
|
6 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Weight gain, Grade 2
|
1 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Alanine aminotrasferase increased, Grade 1
|
1 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Alanine aminotransferase increased, Grade 2
|
1 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Alopecia, Grade 1
|
1 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Anemia, Grade 2
|
3 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Anemia, Grade 3
|
3 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Anorexia, Grade 1
|
2 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Anorexia, Grade 2
|
2 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Aspartate aminotransferase increased, Grade 1
|
1 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Aspartate aminotransferase increased, Grade 2
|
1 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Aspartate aminotransferase increased, Grade 3
|
1 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Bilateral tinnitus, Grade 1
|
1 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Chills, Grade 1
|
1 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Dehydration, Grade 1
|
1 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Dehydration, Grade 3
|
1 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Diarrhea, Grade 1
|
3 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Diarrhea, Grade 3
|
1 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Edema limbs, Grade 2
|
1 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Edema limbs, Grade 3
|
1 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Fatigue, Grade 1
|
7 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Fatigue, Grade 2
|
2 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Fatigue, Grade 3
|
1 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Febrile neutropenia, Grade 3
|
1 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Headache, Grade 1
|
1 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Hearing impaired, Grade 1
|
1 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Hemolysis, Grade 3
|
1 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Hyperthyroidism, Grade 1
|
1 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Hypophysitis, Grade 1
|
1 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Hypothyroidism, Grade 1
|
3 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Hypothyroidism, Grade 2
|
2 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Leukocytosis, Grade 2
|
1 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Localized edema, Grade 1
|
1 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Localized edema, Grade 2
|
1 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Lymphocyte count decreased, Grade 3
|
4 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Memory impaired, Grade 1
|
1 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Mucositis oral, Grade 2
|
1 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Nausea, Grade 1
|
6 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Nausea, Grade 2
|
8 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Nausea, Grade 3
|
4 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Neutrophil count decreased, Grade 1
|
1 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Neutrophil count decreased, Grade 2
|
5 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Neutrophil count decreased, Grade 3
|
11 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Neutrophil count decreased, Grade 4
|
6 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Palpitations, Grade 2
|
1 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Peripheral sensory neuropathy, Grade 1
|
1 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Platelet count decreased, Grade 2
|
1 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Platelet count decreased, Grade 3
|
5 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Platelet count decreased, Grade 4
|
2 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Rash maculo-papular, Grade 1
|
1 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Skin hyperpigmentation, Grade 1
|
1 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Urine output decreased, Grade 3
|
1 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Vomiting, Grade 2
|
7 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Vomiting, Grade 3
|
4 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
Weight gain, Grade 1
|
1 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
White blood cell count decreased, Grade 3
|
6 Participants
|
|
Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
White blood cell count decreased, Grade 4
|
1 Participants
|
Adverse Events
Cisplatin+Gemcitabine+Pembrolizumab
Serious events: 6 serious events
Other events: 18 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
Cisplatin+Gemcitabine+Pembrolizumab
n=18 participants at risk
2 cycles of 750mg gemcitabine and 30mg cisplatin chemotherapy (standard of care) followed by 4 cycles of gemcitabine and cisplatin combined with pembrolizumab in 21-day treatment cycles followed by single-agent pembrolizumab maintenance therapy for up to 2 years of treatment (6 cycles combination treatment + 28 cycles maintenance).
Gemcitabine 750 mg/m2 every 3 weeks (Q3W) x 6 cycles IV infusion
-Day 1 and Day 8 of each 3 week cycle Standard of care
Cisplatin 30 mg/m2 Q3W x 6 cycles IV infusion
-Day 1 and Day 8 of each 3 week cycle after gemcitabine Standard of care
Pembrolizumab 200 mg Q3W starting with cycle 3 IV infusion
-Day 1 of each 3 week cycle after gemcitabine and cisplatin Experimental
Pembrolizumab: Pembrolizumab IV solution
Gemcitabine: Gemcitabine IV solution
Cisplatin: Cisplatin IV solution
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
1/18 • Number of events 2 • Up to 2 years
|
|
Investigations
Alanine aminotransferase increased
|
5.6%
1/18 • Number of events 3 • Up to 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
5.6%
1/18 • Number of events 3 • Up to 2 years
|
|
Gastrointestinal disorders
Bloating
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
General disorders
Death
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Fracture
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Vascular disorders
Hypertension
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Immune system disorders
Hypophysitis
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
5.6%
1/18 • Number of events 2 • Up to 2 years
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
2/18 • Number of events 3 • Up to 2 years
|
Other adverse events
| Measure |
Cisplatin+Gemcitabine+Pembrolizumab
n=18 participants at risk
2 cycles of 750mg gemcitabine and 30mg cisplatin chemotherapy (standard of care) followed by 4 cycles of gemcitabine and cisplatin combined with pembrolizumab in 21-day treatment cycles followed by single-agent pembrolizumab maintenance therapy for up to 2 years of treatment (6 cycles combination treatment + 28 cycles maintenance).
Gemcitabine 750 mg/m2 every 3 weeks (Q3W) x 6 cycles IV infusion
-Day 1 and Day 8 of each 3 week cycle Standard of care
Cisplatin 30 mg/m2 Q3W x 6 cycles IV infusion
-Day 1 and Day 8 of each 3 week cycle after gemcitabine Standard of care
Pembrolizumab 200 mg Q3W starting with cycle 3 IV infusion
-Day 1 of each 3 week cycle after gemcitabine and cisplatin Experimental
Pembrolizumab: Pembrolizumab IV solution
Gemcitabine: Gemcitabine IV solution
Cisplatin: Cisplatin IV solution
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
77.8%
14/18 • Number of events 23 • Up to 2 years
|
|
Metabolism and nutrition disorders
Acidosis
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
6/18 • Number of events 9 • Up to 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
27.8%
5/18 • Number of events 8 • Up to 2 years
|
|
Psychiatric disorders
Anxiety
|
16.7%
3/18 • Number of events 4 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
11.1%
2/18 • Number of events 3 • Up to 2 years
|
|
Gastrointestinal disorders
Ascites
|
27.8%
5/18 • Number of events 7 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
2/18 • Number of events 3 • Up to 2 years
|
|
Ear and labyrinth disorders
Bilateral tinnitus
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Bloating
|
55.6%
10/18 • Number of events 14 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
16.7%
3/18 • Number of events 3 • Up to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain metastasis
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Infections and infestations
Bronchial infection
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Infections and infestations
Catheter related infection
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
General disorders
Chills
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Renal and urinary disorders
Chronic kidney disease
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Psychiatric disorders
Confusion
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Constipation
|
66.7%
12/18 • Number of events 20 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.8%
5/18 • Number of events 5 • Up to 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
11.1%
2/18 • Number of events 3 • Up to 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
6/18 • Number of events 9 • Up to 2 years
|
|
Nervous system disorders
Dizziness
|
11.1%
2/18 • Number of events 3 • Up to 2 years
|
|
Eye disorders
Dry eye
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Reproductive system and breast disorders
Dyspareunia
|
5.6%
1/18 • Number of events 2 • Up to 2 years
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
3/18 • Number of events 5 • Up to 2 years
|
|
Nervous system disorders
Dysphasia
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
3/18 • Number of events 6 • Up to 2 years
|
|
Ear and labyrinth disorders
Ear disorder (hot)
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Ear and labyrinth disorders
Ear disorder (tingling)
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
General disorders
Edema limbs
|
22.2%
4/18 • Number of events 6 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
General disorders
Fatigue
|
72.2%
13/18 • Number of events 22 • Up to 2 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
General disorders
Fever
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
General disorders
Flu-like symptoms
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
11.1%
2/18 • Number of events 2 • Up to 2 years
|
|
Gastrointestinal disorders
Gastroparesis
|
11.1%
2/18 • Number of events 2 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Nervous system disorders
Headache
|
22.2%
4/18 • Number of events 4 • Up to 2 years
|
|
Ear and labyrinth disorders
Hearing impaired
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Cardiac disorders
Heart murmur
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Vascular disorders
Hematoma
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Renal and urinary disorders
Hematuria
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Blood and lymphatic system disorders
Hemolysis
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.6%
1/18 • Number of events 3 • Up to 2 years
|
|
Vascular disorders
Hypertension
|
38.9%
7/18 • Number of events 9 • Up to 2 years
|
|
Endocrine disorders
Hyperthyroidism
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.7%
3/18 • Number of events 5 • Up to 2 years
|
|
Vascular disorders
Hypotension
|
5.6%
1/18 • Number of events 2 • Up to 2 years
|
|
Endocrine disorders
Hypothyroidism
|
27.8%
5/18 • Number of events 6 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Ileal obstruction
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
General disorders
Infusion-related reaction
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Psychiatric disorders
Insomnia
|
27.8%
5/18 • Number of events 8 • Up to 2 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.6%
1/18 • Number of events 2 • Up to 2 years
|
|
General disorders
Localized edema
|
11.1%
2/18 • Number of events 2 • Up to 2 years
|
|
Infections and infestations
Lung infection
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Investigations
Lymphocyte count decreased
|
22.2%
4/18 • Number of events 8 • Up to 2 years
|
|
General disorders
Malaise
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Nervous system disorders
Memory impairment
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Mucositis oral
|
11.1%
2/18 • Number of events 2 • Up to 2 years
|
|
Endocrine disorders
Multinodular goiter
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
88.9%
16/18 • Number of events 27 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.6%
1/18 • Number of events 2 • Up to 2 years
|
|
Investigations
Neutrophil count decreased
|
72.2%
13/18 • Number of events 45 • Up to 2 years
|
|
General disorders
Non-cardiac chest pain
|
27.8%
5/18 • Number of events 7 • Up to 2 years
|
|
General disorders
Pain
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.1%
2/18 • Number of events 3 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Cardiac disorders
Palpitations
|
5.6%
1/18 • Number of events 2 • Up to 2 years
|
|
Infections and infestations
Papulopustular rash
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Reproductive system and breast disorders
Pelvic floor muscle weakness
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Reproductive system and breast disorders
Pelvic pain
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
22.2%
4/18 • Number of events 5 • Up to 2 years
|
|
Investigations
Platelet count decreased
|
38.9%
7/18 • Number of events 14 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
11.1%
2/18 • Number of events 2 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash generalized
|
11.1%
2/18 • Number of events 2 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Cardiac disorders
Sinus tachycardia
|
27.8%
5/18 • Number of events 9 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin atrophy
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
5.6%
1/18 • Number of events 2 • Up to 2 years
|
|
Nervous system disorders
Somnolence
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Vascular disorders
Thromboembolic event
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid nodule
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Ear and labyrinth disorders
Tinnitus
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Renal and urinary disorders
Urinary frequency
|
5.6%
1/18 • Number of events 2 • Up to 2 years
|
|
Renal and urinary disorders
Urinary incontinence
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Renal and urinary disorders
Urinary tract infection
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Investigations
Urine output decreased
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Vaginal extrusion
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vaginal mass
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
|
Reproductive system and breast disorders
Vaginal pain
|
5.6%
1/18 • Number of events 2 • Up to 2 years
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
9/18 • Number of events 29 • Up to 2 years
|
|
Investigations
Weight gain
|
11.1%
2/18 • Number of events 3 • Up to 2 years
|
|
Investigations
Weight loss
|
5.6%
1/18 • Number of events 2 • Up to 2 years
|
|
Investigations
White blood cell count decreased
|
38.9%
7/18 • Number of events 9 • Up to 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place