Trial Outcomes & Findings for Paclitaxel, Pembrolizumab and Olaparib in Previously Treated Advanced Gastric Adenocarcinoma (NCT NCT04209686)

NCT ID: NCT04209686

Last Updated: 2026-09-01

Results Overview

Overall survival is the time from the start of first dose of study drug to death or end of follow-up (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

19 participants

Primary outcome timeframe

Up to 27 months

Results posted on

2026-09-01

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 1 - Measurable Disease Paclitaxel (80mg/m\^2) will be administered IV on days 1 and 8 starting with Cycle 2. Olaparib (100mg or 300mg) will be administered orally on Days 1-21 of each Cycle. Pembrolizumab (200mg) will be administered IV on day 1 of each Cycle. Each Cycle is 21 days.	Arm 2: Cohort 2-Unmeasurable Disease Paclitaxel (80mg/m\^2) will be administered IV on days 1 and 8 starting with Cycle 2. Olaparib (100mg or 300mg) will be administered orally on Days 1-21 of each Cycle. Pembrolizumab (200mg) will be administered IV on day 1 of each Cycle. Each Cycle is 21 days.
Overall Study STARTED	18	1
Overall Study COMPLETED	18	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Paclitaxel, Pembrolizumab and Olaparib in Previously Treated Advanced Gastric Adenocarcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 - Measurable Disease n=18 Participants Paclitaxel (80mg/m\^2) will be administered IV on days 1 and 8 starting with Cycle 2. Olaparib (100mg or 300mg) will be administered orally on Days 1-21 of each Cycle. Pembrolizumab (200mg) will be administered IV on day 1 of each Cycle. Each Cycle is 21 days.	Cohort 2-Unmeasurable Disease n=1 Participants Paclitaxel (80mg/m\^2) will be administered IV on days 1 and 8 starting with Cycle 2. Olaparib (100mg or 300mg) will be administered orally on Days 1-21 of each Cycle. Pembrolizumab (200mg) will be administered IV on day 1 of each Cycle. Each Cycle is 21 days.	Total n=19 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=14 Participants	0 Participants n=36 Participants	0 Participants n=324 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=14 Participants	1 Participants n=36 Participants	13 Participants n=324 Participants
Age, Categorical >=65 years	6 Participants n=14 Participants	0 Participants n=36 Participants	6 Participants n=324 Participants
Sex: Female, Male Female	7 Participants n=14 Participants	1 Participants n=36 Participants	8 Participants n=324 Participants
Sex: Female, Male Male	11 Participants n=14 Participants	0 Participants n=36 Participants	11 Participants n=324 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=14 Participants	0 Participants n=36 Participants	1 Participants n=324 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=14 Participants	1 Participants n=36 Participants	18 Participants n=324 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=14 Participants	0 Participants n=36 Participants	0 Participants n=324 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=14 Participants	0 Participants n=36 Participants	0 Participants n=324 Participants
Race (NIH/OMB) Asian	2 Participants n=14 Participants	0 Participants n=36 Participants	2 Participants n=324 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=14 Participants	0 Participants n=36 Participants	0 Participants n=324 Participants
Race (NIH/OMB) Black or African American	2 Participants n=14 Participants	0 Participants n=36 Participants	2 Participants n=324 Participants
Race (NIH/OMB) White	14 Participants n=14 Participants	1 Participants n=36 Participants	15 Participants n=324 Participants
Race (NIH/OMB) More than one race	0 Participants n=14 Participants	0 Participants n=36 Participants	0 Participants n=324 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=14 Participants	0 Participants n=36 Participants	0 Participants n=324 Participants
Region of Enrollment United States	18 Participants n=14 Participants	1 Participants n=36 Participants	19 Participants n=324 Participants

PRIMARY outcome

Timeframe: Up to 27 months

Population: Only patients who received at least one dose of all three study drugs are evaluable for the OS. In Arm 1, 15/18 patients received the three-drug combination.

Outcome measures

Outcome measures
Measure	Arm1 - Measurable Disease n=15 Participants Paclitaxel (80mg/m\^2) will be administered IV on days 1 and 8 starting with Cycle 2. Olaparib (100mg or 300mg) will be administered orally on Days 1-21 of each Cycle. Pembrolizumab (200mg) will be administered IV on day 1 of each Cycle. Each Cycle is 21 days.	Arm 2-Unmeasurable Disease n=1 Participants Paclitaxel (80mg/m\^2) will be administered IV on days 1 and 8 starting with Cycle 2. Olaparib (100mg or 300mg) will be administered orally on Days 1-21 of each Cycle. Pembrolizumab (200mg) will be administered IV on day 1 of each Cycle. Each Cycle is 21 days.
Overall Survival (OS)	9.5 Months Interval 4.6 to 21.6	7.6 Months Only one patient was enrolled to Arm B, no confidence interval since N=1

SECONDARY outcome

Timeframe: 15 months

When calculating the incidence of AEs, each AE (as defined by NCI CTCAE v5.0) will be counted only once for a given subject. Laboratory abnormalities that were asymptomatic and not clinically significant were excluded.

Outcome measures

Outcome measures
Measure	Arm1 - Measurable Disease n=18 Participants Paclitaxel (80mg/m\^2) will be administered IV on days 1 and 8 starting with Cycle 2. Olaparib (100mg or 300mg) will be administered orally on Days 1-21 of each Cycle. Pembrolizumab (200mg) will be administered IV on day 1 of each Cycle. Each Cycle is 21 days.	Arm 2-Unmeasurable Disease n=1 Participants Paclitaxel (80mg/m\^2) will be administered IV on days 1 and 8 starting with Cycle 2. Olaparib (100mg or 300mg) will be administered orally on Days 1-21 of each Cycle. Pembrolizumab (200mg) will be administered IV on day 1 of each Cycle. Each Cycle is 21 days.
Number of Participants Experiencing Grade 3 or Above Study Drug-related Adverse Events (AEs)	7 Participants	0 Participants

SECONDARY outcome

Timeframe: 15 months

Outcome measures

Outcome measures
Measure	Arm1 - Measurable Disease n=18 Participants Paclitaxel (80mg/m\^2) will be administered IV on days 1 and 8 starting with Cycle 2. Olaparib (100mg or 300mg) will be administered orally on Days 1-21 of each Cycle. Pembrolizumab (200mg) will be administered IV on day 1 of each Cycle. Each Cycle is 21 days.	Arm 2-Unmeasurable Disease n=1 Participants Paclitaxel (80mg/m\^2) will be administered IV on days 1 and 8 starting with Cycle 2. Olaparib (100mg or 300mg) will be administered orally on Days 1-21 of each Cycle. Pembrolizumab (200mg) will be administered IV on day 1 of each Cycle. Each Cycle is 21 days.
Number of Participants Experiencing Immune-related Adverse Events (irAEs)	6 Participants	1 Participants

Adverse Events

Arm 1: Measurable Disease

Serious events: 13 serious events

Other events: 18 other events

Deaths: 17 deaths

Arm 2: Unmeasurable Disease

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Katherine Bever, MD

SKCCC, Johns Hopkins Medical Institution

Phone: 443-287-0966

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Arm 1: Measurable Disease n=18 participants at risk Paclitaxel (80mg/m\^2) will be administered IV on days 1 and 8 starting with Cycle 2. Olaparib (100mg or 300mg) will be administered orally on Days 1-21 of each Cycle. Pembrolizumab (200mg) will be administered IV on day 1 of each Cycle. Each Cycle is 21 days.	Arm 2: Unmeasurable Disease n=1 participants at risk Paclitaxel (80mg/m\^2) will be administered IV on days 1 and 8 starting with Cycle 2. Olaparib (100mg or 300mg) will be administered orally on Days 1-21 of each Cycle. Pembrolizumab (200mg) will be administered IV on day 1 of each Cycle. Each Cycle is 21 days.
Gastrointestinal disorders Abdominal pain	11.1% 2/18 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated from start of treatment up to 15 months. All-cause mortality was evaluated from start of treatment up to 27 months.	0.00% 0/1 • Serious and Other (Not Including Serious) Adverse Events were evaluated from start of treatment up to 15 months. All-cause mortality was evaluated from start of treatment up to 27 months.
Psychiatric disorders Delirium	5.6% 1/18 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated from start of treatment up to 15 months. All-cause mortality was evaluated from start of treatment up to 27 months.	0.00% 0/1 • Serious and Other (Not Including Serious) Adverse Events were evaluated from start of treatment up to 15 months. All-cause mortality was evaluated from start of treatment up to 27 months.
Gastrointestinal disorders Diarrhea	5.6% 1/18 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated from start of treatment up to 15 months. All-cause mortality was evaluated from start of treatment up to 27 months.	0.00% 0/1 • Serious and Other (Not Including Serious) Adverse Events were evaluated from start of treatment up to 15 months. All-cause mortality was evaluated from start of treatment up to 27 months.
General disorders Disease progression	16.7% 3/18 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated from start of treatment up to 15 months. All-cause mortality was evaluated from start of treatment up to 27 months.	0.00% 0/1 • Serious and Other (Not Including Serious) Adverse Events were evaluated from start of treatment up to 15 months. All-cause mortality was evaluated from start of treatment up to 27 months.
Nervous system disorders Edema cerebral	5.6% 1/18 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated from start of treatment up to 15 months. All-cause mortality was evaluated from start of treatment up to 27 months.	0.00% 0/1 • Serious and Other (Not Including Serious) Adverse Events were evaluated from start of treatment up to 15 months. All-cause mortality was evaluated from start of treatment up to 27 months.
Investigations Fever	5.6% 1/18 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated from start of treatment up to 15 months. All-cause mortality was evaluated from start of treatment up to 27 months.	0.00% 0/1 • Serious and Other (Not Including Serious) Adverse Events were evaluated from start of treatment up to 15 months. All-cause mortality was evaluated from start of treatment up to 27 months.
Injury, poisoning and procedural complications Fracture	5.6% 1/18 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated from start of treatment up to 15 months. All-cause mortality was evaluated from start of treatment up to 27 months.	0.00% 0/1 • Serious and Other (Not Including Serious) Adverse Events were evaluated from start of treatment up to 15 months. All-cause mortality was evaluated from start of treatment up to 27 months.
Gastrointestinal disorders Gastritis	5.6% 1/18 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated from start of treatment up to 15 months. All-cause mortality was evaluated from start of treatment up to 27 months.	0.00% 0/1 • Serious and Other (Not Including Serious) Adverse Events were evaluated from start of treatment up to 15 months. All-cause mortality was evaluated from start of treatment up to 27 months.
Metabolism and nutrition disorders Hyponatremia	5.6% 1/18 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated from start of treatment up to 15 months. All-cause mortality was evaluated from start of treatment up to 27 months.	0.00% 0/1 • Serious and Other (Not Including Serious) Adverse Events were evaluated from start of treatment up to 15 months. All-cause mortality was evaluated from start of treatment up to 27 months.
General disorders Meningitis	5.6% 1/18 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated from start of treatment up to 15 months. All-cause mortality was evaluated from start of treatment up to 27 months.	0.00% 0/1 • Serious and Other (Not Including Serious) Adverse Events were evaluated from start of treatment up to 15 months. All-cause mortality was evaluated from start of treatment up to 27 months.
Metabolism and nutrition disorders Failure to thrive	5.6% 1/18 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated from start of treatment up to 15 months. All-cause mortality was evaluated from start of treatment up to 27 months.	0.00% 0/1 • Serious and Other (Not Including Serious) Adverse Events were evaluated from start of treatment up to 15 months. All-cause mortality was evaluated from start of treatment up to 27 months.
Gastrointestinal disorders Mucositis oral	5.6% 1/18 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated from start of treatment up to 15 months. All-cause mortality was evaluated from start of treatment up to 27 months.	0.00% 0/1 • Serious and Other (Not Including Serious) Adverse Events were evaluated from start of treatment up to 15 months. All-cause mortality was evaluated from start of treatment up to 27 months.
Investigations Neutrophil count decreased	5.6% 1/18 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated from start of treatment up to 15 months. All-cause mortality was evaluated from start of treatment up to 27 months.	0.00% 0/1 • Serious and Other (Not Including Serious) Adverse Events were evaluated from start of treatment up to 15 months. All-cause mortality was evaluated from start of treatment up to 27 months.
Gastrointestinal disorders Obstruction gastric	5.6% 1/18 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated from start of treatment up to 15 months. All-cause mortality was evaluated from start of treatment up to 27 months.	0.00% 0/1 • Serious and Other (Not Including Serious) Adverse Events were evaluated from start of treatment up to 15 months. All-cause mortality was evaluated from start of treatment up to 27 months.
Infections and infestations Sepsis	11.1% 2/18 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated from start of treatment up to 15 months. All-cause mortality was evaluated from start of treatment up to 27 months.	0.00% 0/1 • Serious and Other (Not Including Serious) Adverse Events were evaluated from start of treatment up to 15 months. All-cause mortality was evaluated from start of treatment up to 27 months.
Gastrointestinal disorders Small intestinal obstruction	11.1% 2/18 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated from start of treatment up to 15 months. All-cause mortality was evaluated from start of treatment up to 27 months.	0.00% 0/1 • Serious and Other (Not Including Serious) Adverse Events were evaluated from start of treatment up to 15 months. All-cause mortality was evaluated from start of treatment up to 27 months.
Vascular disorders Thromboembolic event	16.7% 3/18 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated from start of treatment up to 15 months. All-cause mortality was evaluated from start of treatment up to 27 months.	0.00% 0/1 • Serious and Other (Not Including Serious) Adverse Events were evaluated from start of treatment up to 15 months. All-cause mortality was evaluated from start of treatment up to 27 months.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	5.6% 1/18 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated from start of treatment up to 15 months. All-cause mortality was evaluated from start of treatment up to 27 months.	0.00% 0/1 • Serious and Other (Not Including Serious) Adverse Events were evaluated from start of treatment up to 15 months. All-cause mortality was evaluated from start of treatment up to 27 months.
Investigations Weight Loss	5.6% 1/18 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated from start of treatment up to 15 months. All-cause mortality was evaluated from start of treatment up to 27 months.	0.00% 0/1 • Serious and Other (Not Including Serious) Adverse Events were evaluated from start of treatment up to 15 months. All-cause mortality was evaluated from start of treatment up to 27 months.