Trial Outcomes & Findings for Study of Pembrolizumab and Olaparib in Bile Duct Cancer (NCT NCT04306367)
NCT ID: NCT04306367
Last Updated: 2025-02-17
Results Overview
The objective response rate (ORR) is the number of subjects with confirmed Partial Response or Complete Response according to RECIST 1.1, for target lesions assessed by Computed tomography (CT) Scan.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
14 participants
Primary outcome timeframe
up to 2 years
Results posted on
2025-02-17
Participant Flow
Participant milestones
| Measure |
Experimental
Pembrolizumab Q3W, IV infusion (day 1 of each 3 week cycle)
Olaparib bid, Oral tablet continuously
Pembrolizumab: 200 mg given intravenously.
Olaparib: 300 mg given orally.
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
Experimental
Pembrolizumab Q3W, IV infusion (day 1 of each 3 week cycle)
Olaparib bid, Oral tablet continuously
Pembrolizumab: 200 mg given intravenously.
Olaparib: 300 mg given orally.
|
|---|---|
|
Overall Study
Progression of Disease
|
9
|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Study of Pembrolizumab and Olaparib in Bile Duct Cancer
Baseline characteristics by cohort
| Measure |
Experimental
n=14 Participants
Pembrolizumab Q3W, IV infusion (day 1 of each 3 week cycle)
Olaparib bid, Oral tablet continuously
Pembrolizumab: 200 mg given intravenously.
Olaparib: 300 mg given orally.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 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
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 2 yearsPopulation: 1 subject only received 1 cycle, so was not included in ORR.
The objective response rate (ORR) is the number of subjects with confirmed Partial Response or Complete Response according to RECIST 1.1, for target lesions assessed by Computed tomography (CT) Scan.
Outcome measures
| Measure |
Experimental
n=13 Participants
Pembrolizumab Q3W, IV infusion (day 1 of each 3 week cycle)
Olaparib bid, Oral tablet continuously
Pembrolizumab: 200 mg given intravenously.
Olaparib: 300 mg given orally.
|
|---|---|
|
Objective Response Rate (ORR)
|
2 Participants
|
SECONDARY outcome
Timeframe: 3 yearsDuration of response (DOR), number of months from first response to progression.
Outcome measures
| Measure |
Experimental
n=13 Participants
Pembrolizumab Q3W, IV infusion (day 1 of each 3 week cycle)
Olaparib bid, Oral tablet continuously
Pembrolizumab: 200 mg given intravenously.
Olaparib: 300 mg given orally.
|
|---|---|
|
Duration of Response
|
19.75 months
Interval 6.1 to 33.4
|
SECONDARY outcome
Timeframe: 3 yearsProgression free survival (PFS) is the time from enrollment to progression or death from any cause.
Outcome measures
| Measure |
Experimental
n=13 Participants
Pembrolizumab Q3W, IV infusion (day 1 of each 3 week cycle)
Olaparib bid, Oral tablet continuously
Pembrolizumab: 200 mg given intravenously.
Olaparib: 300 mg given orally.
|
|---|---|
|
Progression Free Survival (PFS)
|
5.45 months
Interval 1.25 to 7.82
|
SECONDARY outcome
Timeframe: 3 yearsoverall survival (OS) of subjects from the time of enrollment to death from any cause.
Outcome measures
| Measure |
Experimental
n=13 Participants
Pembrolizumab Q3W, IV infusion (day 1 of each 3 week cycle)
Olaparib bid, Oral tablet continuously
Pembrolizumab: 200 mg given intravenously.
Olaparib: 300 mg given orally.
|
|---|---|
|
Overall Survival (OS)
|
7.21 months
Interval 4.5 to 13.77
|
SECONDARY outcome
Timeframe: 1 yearNumber of participants with a treatment-related adverse events as assessed by an Investigator according to CTCAE v4.0
Outcome measures
| Measure |
Experimental
n=13 Participants
Pembrolizumab Q3W, IV infusion (day 1 of each 3 week cycle)
Olaparib bid, Oral tablet continuously
Pembrolizumab: 200 mg given intravenously.
Olaparib: 300 mg given orally.
|
|---|---|
|
Safety and Tolerability
|
11 Participants
|
Adverse Events
Experimental
Serious events: 5 serious events
Other events: 13 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Experimental
n=14 participants at risk
Pembrolizumab Q3W, IV infusion (day 1 of each 3 week cycle)
Olaparib bid, Oral tablet continuously
Pembrolizumab: 200 mg given intravenously.
Olaparib: 300 mg given orally.
|
|---|---|
|
Investigations
Blood bilirubin increased
|
7.1%
1/14 • Number of events 1 • All AEs from the time of treatment through 30 days following cessation of study treatment and all AEs meeting serious criteria, from the time of treatment through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anticancer therapy, whichever is earlier. Up to 2.5 years. All-Cause Mortality monitored up to 3 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
1/14 • Number of events 1 • All AEs from the time of treatment through 30 days following cessation of study treatment and all AEs meeting serious criteria, from the time of treatment through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anticancer therapy, whichever is earlier. Up to 2.5 years. All-Cause Mortality monitored up to 3 years.
|
|
Infections and infestations
Vaginal infection
|
7.1%
1/14 • Number of events 1 • All AEs from the time of treatment through 30 days following cessation of study treatment and all AEs meeting serious criteria, from the time of treatment through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anticancer therapy, whichever is earlier. Up to 2.5 years. All-Cause Mortality monitored up to 3 years.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
7.1%
1/14 • Number of events 2 • All AEs from the time of treatment through 30 days following cessation of study treatment and all AEs meeting serious criteria, from the time of treatment through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anticancer therapy, whichever is earlier. Up to 2.5 years. All-Cause Mortality monitored up to 3 years.
|
|
Blood and lymphatic system disorders
Anemia
|
7.1%
1/14 • Number of events 1 • All AEs from the time of treatment through 30 days following cessation of study treatment and all AEs meeting serious criteria, from the time of treatment through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anticancer therapy, whichever is earlier. Up to 2.5 years. All-Cause Mortality monitored up to 3 years.
|
|
Vascular disorders
Thromboembolic event
|
7.1%
1/14 • Number of events 1 • All AEs from the time of treatment through 30 days following cessation of study treatment and all AEs meeting serious criteria, from the time of treatment through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anticancer therapy, whichever is earlier. Up to 2.5 years. All-Cause Mortality monitored up to 3 years.
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
7.1%
1/14 • Number of events 1 • All AEs from the time of treatment through 30 days following cessation of study treatment and all AEs meeting serious criteria, from the time of treatment through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anticancer therapy, whichever is earlier. Up to 2.5 years. All-Cause Mortality monitored up to 3 years.
|
Other adverse events
| Measure |
Experimental
n=14 participants at risk
Pembrolizumab Q3W, IV infusion (day 1 of each 3 week cycle)
Olaparib bid, Oral tablet continuously
Pembrolizumab: 200 mg given intravenously.
Olaparib: 300 mg given orally.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
7/14 • Number of events 9 • All AEs from the time of treatment through 30 days following cessation of study treatment and all AEs meeting serious criteria, from the time of treatment through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anticancer therapy, whichever is earlier. Up to 2.5 years. All-Cause Mortality monitored up to 3 years.
|
|
Ear and labyrinth disorders
Ear pain
|
7.1%
1/14 • Number of events 1 • All AEs from the time of treatment through 30 days following cessation of study treatment and all AEs meeting serious criteria, from the time of treatment through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anticancer therapy, whichever is earlier. Up to 2.5 years. All-Cause Mortality monitored up to 3 years.
|
|
Endocrine disorders
Adrenal insufficiency
|
7.1%
1/14 • Number of events 1 • All AEs from the time of treatment through 30 days following cessation of study treatment and all AEs meeting serious criteria, from the time of treatment through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anticancer therapy, whichever is earlier. Up to 2.5 years. All-Cause Mortality monitored up to 3 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
21.4%
3/14 • Number of events 4 • All AEs from the time of treatment through 30 days following cessation of study treatment and all AEs meeting serious criteria, from the time of treatment through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anticancer therapy, whichever is earlier. Up to 2.5 years. All-Cause Mortality monitored up to 3 years.
|
|
Gastrointestinal disorders
Constipation
|
7.1%
1/14 • Number of events 1 • All AEs from the time of treatment through 30 days following cessation of study treatment and all AEs meeting serious criteria, from the time of treatment through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anticancer therapy, whichever is earlier. Up to 2.5 years. All-Cause Mortality monitored up to 3 years.
|
|
Gastrointestinal disorders
Diarrhea
|
21.4%
3/14 • Number of events 4 • All AEs from the time of treatment through 30 days following cessation of study treatment and all AEs meeting serious criteria, from the time of treatment through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anticancer therapy, whichever is earlier. Up to 2.5 years. All-Cause Mortality monitored up to 3 years.
|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • Number of events 1 • All AEs from the time of treatment through 30 days following cessation of study treatment and all AEs meeting serious criteria, from the time of treatment through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anticancer therapy, whichever is earlier. Up to 2.5 years. All-Cause Mortality monitored up to 3 years.
|
|
General disorders
Chills
|
7.1%
1/14 • Number of events 1 • All AEs from the time of treatment through 30 days following cessation of study treatment and all AEs meeting serious criteria, from the time of treatment through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anticancer therapy, whichever is earlier. Up to 2.5 years. All-Cause Mortality monitored up to 3 years.
|
|
General disorders
Fatigue
|
28.6%
4/14 • Number of events 5 • All AEs from the time of treatment through 30 days following cessation of study treatment and all AEs meeting serious criteria, from the time of treatment through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anticancer therapy, whichever is earlier. Up to 2.5 years. All-Cause Mortality monitored up to 3 years.
|
|
General disorders
Fever
|
7.1%
1/14 • Number of events 1 • All AEs from the time of treatment through 30 days following cessation of study treatment and all AEs meeting serious criteria, from the time of treatment through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anticancer therapy, whichever is earlier. Up to 2.5 years. All-Cause Mortality monitored up to 3 years.
|
|
General disorders
Non-cardiac chest pain
|
7.1%
1/14 • Number of events 1 • All AEs from the time of treatment through 30 days following cessation of study treatment and all AEs meeting serious criteria, from the time of treatment through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anticancer therapy, whichever is earlier. Up to 2.5 years. All-Cause Mortality monitored up to 3 years.
|
|
Infections and infestations
Hepatic infection
|
7.1%
1/14 • Number of events 1 • All AEs from the time of treatment through 30 days following cessation of study treatment and all AEs meeting serious criteria, from the time of treatment through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anticancer therapy, whichever is earlier. Up to 2.5 years. All-Cause Mortality monitored up to 3 years.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
7.1%
1/14 • Number of events 1 • All AEs from the time of treatment through 30 days following cessation of study treatment and all AEs meeting serious criteria, from the time of treatment through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anticancer therapy, whichever is earlier. Up to 2.5 years. All-Cause Mortality monitored up to 3 years.
|
|
Infections and infestations
Papulopustular rash
|
7.1%
1/14 • Number of events 1 • All AEs from the time of treatment through 30 days following cessation of study treatment and all AEs meeting serious criteria, from the time of treatment through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anticancer therapy, whichever is earlier. Up to 2.5 years. All-Cause Mortality monitored up to 3 years.
|
|
Infections and infestations
Urinary tract infection
|
7.1%
1/14 • Number of events 2 • All AEs from the time of treatment through 30 days following cessation of study treatment and all AEs meeting serious criteria, from the time of treatment through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anticancer therapy, whichever is earlier. Up to 2.5 years. All-Cause Mortality monitored up to 3 years.
|
|
Injury, poisoning and procedural complications
Fall
|
7.1%
1/14 • Number of events 1 • All AEs from the time of treatment through 30 days following cessation of study treatment and all AEs meeting serious criteria, from the time of treatment through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anticancer therapy, whichever is earlier. Up to 2.5 years. All-Cause Mortality monitored up to 3 years.
|
|
Investigations
Alanine aminotransferase increased
|
7.1%
1/14 • Number of events 1 • All AEs from the time of treatment through 30 days following cessation of study treatment and all AEs meeting serious criteria, from the time of treatment through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anticancer therapy, whichever is earlier. Up to 2.5 years. All-Cause Mortality monitored up to 3 years.
|
|
Investigations
Alkaline phosphatase increased
|
7.1%
1/14 • Number of events 1 • All AEs from the time of treatment through 30 days following cessation of study treatment and all AEs meeting serious criteria, from the time of treatment through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anticancer therapy, whichever is earlier. Up to 2.5 years. All-Cause Mortality monitored up to 3 years.
|
|
Investigations
Blood bilirubin increased
|
21.4%
3/14 • Number of events 3 • All AEs from the time of treatment through 30 days following cessation of study treatment and all AEs meeting serious criteria, from the time of treatment through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anticancer therapy, whichever is earlier. Up to 2.5 years. All-Cause Mortality monitored up to 3 years.
|
|
Investigations
Creatinine increased
|
7.1%
1/14 • Number of events 1 • All AEs from the time of treatment through 30 days following cessation of study treatment and all AEs meeting serious criteria, from the time of treatment through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anticancer therapy, whichever is earlier. Up to 2.5 years. All-Cause Mortality monitored up to 3 years.
|
|
Investigations
INR increased
|
7.1%
1/14 • Number of events 1 • All AEs from the time of treatment through 30 days following cessation of study treatment and all AEs meeting serious criteria, from the time of treatment through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anticancer therapy, whichever is earlier. Up to 2.5 years. All-Cause Mortality monitored up to 3 years.
|
|
Investigations
Neutrophil count decreased
|
14.3%
2/14 • Number of events 5 • All AEs from the time of treatment through 30 days following cessation of study treatment and all AEs meeting serious criteria, from the time of treatment through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anticancer therapy, whichever is earlier. Up to 2.5 years. All-Cause Mortality monitored up to 3 years.
|
|
Investigations
Platelet count decreased
|
14.3%
2/14 • Number of events 4 • All AEs from the time of treatment through 30 days following cessation of study treatment and all AEs meeting serious criteria, from the time of treatment through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anticancer therapy, whichever is earlier. Up to 2.5 years. All-Cause Mortality monitored up to 3 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
7.1%
1/14 • Number of events 1 • All AEs from the time of treatment through 30 days following cessation of study treatment and all AEs meeting serious criteria, from the time of treatment through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anticancer therapy, whichever is earlier. Up to 2.5 years. All-Cause Mortality monitored up to 3 years.
|
|
Nervous system disorders
Dysphasia
|
7.1%
1/14 • Number of events 1 • All AEs from the time of treatment through 30 days following cessation of study treatment and all AEs meeting serious criteria, from the time of treatment through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anticancer therapy, whichever is earlier. Up to 2.5 years. All-Cause Mortality monitored up to 3 years.
|
|
Psychiatric disorders
Agitation
|
7.1%
1/14 • Number of events 1 • All AEs from the time of treatment through 30 days following cessation of study treatment and all AEs meeting serious criteria, from the time of treatment through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anticancer therapy, whichever is earlier. Up to 2.5 years. All-Cause Mortality monitored up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.1%
1/14 • Number of events 1 • All AEs from the time of treatment through 30 days following cessation of study treatment and all AEs meeting serious criteria, from the time of treatment through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anticancer therapy, whichever is earlier. Up to 2.5 years. All-Cause Mortality monitored up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.1%
1/14 • Number of events 1 • All AEs from the time of treatment through 30 days following cessation of study treatment and all AEs meeting serious criteria, from the time of treatment through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anticancer therapy, whichever is earlier. Up to 2.5 years. All-Cause Mortality monitored up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.1%
1/14 • Number of events 1 • All AEs from the time of treatment through 30 days following cessation of study treatment and all AEs meeting serious criteria, from the time of treatment through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anticancer therapy, whichever is earlier. Up to 2.5 years. All-Cause Mortality monitored up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.1%
1/14 • Number of events 1 • All AEs from the time of treatment through 30 days following cessation of study treatment and all AEs meeting serious criteria, from the time of treatment through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anticancer therapy, whichever is earlier. Up to 2.5 years. All-Cause Mortality monitored up to 3 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place