Trial Outcomes & Findings for Pembrolizumab Activity in Patients With Homologous Recombination Competent and Deficient Tumors (NCT NCT03274661)
NCT ID: NCT03274661
Last Updated: 2023-10-19
Results Overview
Immune-related Response Criteria (irRC) will be utilized for assessment of response to therapy, defined as the percent of participants who achieved complete or partial response. Per irRC, for target lesions assessed by CT or MRI: Complete Response (CR), Disappearance of all lesions in two consecutive observations not less than 4 weeks apart; Partial Response (PR), ≥50% decrease in tumor burden compared with baseline in two observations at least 4 weeks apart.
COMPLETED
PHASE2
52 participants
20 weeks
2023-10-19
Participant Flow
Participant milestones
| Measure |
Pembrolizumab 200 mg Q3W
Pembrolizumab 200 mg Intravenous Infusion every 3 weeks administered on Day 1 of each 3 week cycle
Pembrolizumab 200 mg Q3W: Pembrolizumab 200 mg Intravenous Infusion every 3 weeks administered on Day 1 of each 3 week cycle
|
|---|---|
|
Overall Study
STARTED
|
52
|
|
Overall Study
COMPLETED
|
52
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pembrolizumab Activity in Patients With Homologous Recombination Competent and Deficient Tumors
Baseline characteristics by cohort
| Measure |
Pembrolizumab 200 mg Q3W
n=52 Participants
Pembrolizumab 200 mg Intravenous Infusion every 3 weeks administered on Day 1 of each 3 week cycle
Pembrolizumab 200 mg Q3W: Pembrolizumab 200 mg Intravenous Infusion every 3 weeks administered on Day 1 of each 3 week cycle
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
28 Participants
n=5 Participants
|
|
Age, Continuous
|
66 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 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
|
2 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
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
45 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
|
52 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 20 weeksPopulation: Two participants were excluded from analysis: one was deemed not response-evaluable after a further review of baseline CT images demonstrated not clearly measurable disease; another deteriorated rapidly due to tumor progression within a week of the first dose of treatment.
Immune-related Response Criteria (irRC) will be utilized for assessment of response to therapy, defined as the percent of participants who achieved complete or partial response. Per irRC, for target lesions assessed by CT or MRI: Complete Response (CR), Disappearance of all lesions in two consecutive observations not less than 4 weeks apart; Partial Response (PR), ≥50% decrease in tumor burden compared with baseline in two observations at least 4 weeks apart.
Outcome measures
| Measure |
Pembrolizumab 200 mg Q3W
n=50 Participants
Pembrolizumab 200 mg Intravenous Infusion every 3 weeks administered on Day 1 of each 3 week cycle
Pembrolizumab 200 mg Q3W: Pembrolizumab 200 mg Intravenous Infusion every 3 weeks administered on Day 1 of each 3 week cycle
|
|---|---|
|
Immune-related Objective Response Rate
|
9 Participants
|
SECONDARY outcome
Timeframe: 20 weeksPopulation: Two participants were excluded from analysis: one was deemed not response-evaluable after a further review of baseline CT images demonstrated not clearly measurable disease; another deteriorated rapidly due to tumor progression within a week of the first dose of treatment.
Immune-related Response Criteria (irRC) will be utilized for assessment of response to therapy. PFS will be defined as the time from treatment start to time of disease progression or death, whichever comes first. Per irRC, for target lesions assessed by CT or MRI: Progressive Disease (PD), at least 25% increase in tumor burden compared with nadir (at any single time point) in two consecutive observations at least 4 weeks apart.
Outcome measures
| Measure |
Pembrolizumab 200 mg Q3W
n=50 Participants
Pembrolizumab 200 mg Intravenous Infusion every 3 weeks administered on Day 1 of each 3 week cycle
Pembrolizumab 200 mg Q3W: Pembrolizumab 200 mg Intravenous Infusion every 3 weeks administered on Day 1 of each 3 week cycle
|
|---|---|
|
Progression-free Survival (PFS)
|
2.9 months
Interval 2.3 to 5.9
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Two participants were excluded from analysis: one was deemed not response-evaluable after a further review of baseline CT images demonstrated not clearly measurable disease; another deteriorated rapidly due to tumor progression within a week of the first dose of treatment.
Immune-related Response Criteria (irRC) will be utilized for assessment of response to therapy, defined as the duration of time from start of treatment to end of study or death, whichever comes first. Per irRC, for target lesions assessed by CT or MRI:Complete Response (CR) is the disappearance of all lesions in two consecutive observations not less than 4 weeks apart; Partial Response (PR) is a ≥50% decrease in tumor burden compared with baseline in two observations at least 4 weeks apart; and Progressive Disease (PD) is at least 25% increase in tumor burden compared with nadir (at any single time point) in two consecutive observations at least 4 weeks apart. Everything else is considered Stable Disease (SD).
Outcome measures
| Measure |
Pembrolizumab 200 mg Q3W
n=50 Participants
Pembrolizumab 200 mg Intravenous Infusion every 3 weeks administered on Day 1 of each 3 week cycle
Pembrolizumab 200 mg Q3W: Pembrolizumab 200 mg Intravenous Infusion every 3 weeks administered on Day 1 of each 3 week cycle
|
|---|---|
|
Overall Response
|
10.9 months
Interval 5.2 to 21.0
|
Adverse Events
Pembrolizumab 200 mg Q3W
Serious adverse events
| Measure |
Pembrolizumab 200 mg Q3W
n=52 participants at risk
Pembrolizumab 200 mg Intravenous Infusion every 3 weeks administered on Day 1 of each 3 week cycle
Pembrolizumab 200 mg Q3W: Pembrolizumab 200 mg Intravenous Infusion every 3 weeks administered on Day 1 of each 3 week cycle
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
9.6%
5/52 • Number of events 6 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.8%
3/52 • Number of events 4 • 3 years
|
|
Gastrointestinal disorders
Constipation
|
5.8%
3/52 • Number of events 3 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
5.8%
3/52 • Number of events 3 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
3.8%
2/52 • Number of events 2 • 3 years
|
|
General disorders
Ascites
|
3.8%
2/52 • Number of events 2 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
3.8%
2/52 • Number of events 2 • 3 years
|
|
Gastrointestinal disorders
Abdominal distension
|
3.8%
2/52 • Number of events 2 • 3 years
|
|
Vascular disorders
Stroke
|
1.9%
1/52 • Number of events 1 • 3 years
|
|
Reproductive system and breast disorders
Pelvic pain
|
1.9%
1/52 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Obstruction - gastric
|
1.9%
1/52 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
1.9%
1/52 • Number of events 1 • 3 years
|
|
Infections and infestations
Sepsis
|
1.9%
1/52 • Number of events 1 • 3 years
|
|
General disorders
Fall
|
1.9%
1/52 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
Urinary retention - Hydronephrosis
|
1.9%
1/52 • Number of events 1 • 3 years
|
|
General disorders
Fatigue
|
1.9%
1/52 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Intestinal obstruction
|
3.8%
2/52 • Number of events 2 • 3 years
|
|
Reproductive system and breast disorders
Female genital tract fistula - rectovaginal fistula
|
1.9%
1/52 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.9%
1/52 • Number of events 1 • 3 years
|
|
Infections and infestations
Urinary retention - Urinary tract infection
|
1.9%
1/52 • Number of events 1 • 3 years
|
|
Vascular disorders
Thromboembolic event
|
1.9%
1/52 • Number of events 1 • 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
1.9%
1/52 • Number of events 1 • 3 years
|
|
General disorders
Dizziness
|
1.9%
1/52 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Colonic obstruction
|
1.9%
1/52 • Number of events 1 • 3 years
|
|
General disorders
Malaise
|
1.9%
1/52 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
1.9%
1/52 • Number of events 1 • 3 years
|
|
Endocrine disorders
Hypercalcemia
|
1.9%
1/52 • Number of events 1 • 3 years
|
Other adverse events
| Measure |
Pembrolizumab 200 mg Q3W
n=52 participants at risk
Pembrolizumab 200 mg Intravenous Infusion every 3 weeks administered on Day 1 of each 3 week cycle
Pembrolizumab 200 mg Q3W: Pembrolizumab 200 mg Intravenous Infusion every 3 weeks administered on Day 1 of each 3 week cycle
|
|---|---|
|
General disorders
Fatigue
|
25.0%
13/52 • Number of events 16 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
13.5%
7/52 • Number of events 8 • 3 years
|
|
Gastrointestinal disorders
Constipation
|
15.4%
8/52 • Number of events 8 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
5.8%
3/52 • Number of events 6 • 3 years
|
|
Renal and urinary disorders
Elevated creatinine
|
9.6%
5/52 • Number of events 5 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
4/52 • Number of events 5 • 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
7.7%
4/52 • Number of events 5 • 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
9.6%
5/52 • Number of events 5 • 3 years
|
|
Gastrointestinal disorders
Anorexia
|
13.5%
7/52 • Number of events 7 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.6%
5/52 • Number of events 5 • 3 years
|
|
General disorders
Back pain
|
5.8%
3/52 • Number of events 4 • 3 years
|
|
Gastrointestinal disorders
Abdominal discomfort
|
7.7%
4/52 • Number of events 4 • 3 years
|
|
Gastrointestinal disorders
Bloating
|
5.8%
3/52 • Number of events 3 • 3 years
|
|
General disorders
Elevated lactate dehydrogenase
|
5.8%
3/52 • Number of events 3 • 3 years
|
|
Cardiac disorders
Edema (leg)
|
5.8%
3/52 • Number of events 3 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.8%
3/52 • Number of events 3 • 3 years
|
|
General disorders
Insomnia
|
5.8%
3/52 • Number of events 3 • 3 years
|
Additional Information
Dr. John Diaz, Principal Investigator
Miami Cancer Institute at Baptist Health, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place