Paclitaxel, Pembrolizumab and Olaparib in Previously Treated Advanced Gastric Adenocarcinoma

December 1, 2025 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Phase 2 Study of Paclitaxel, Pembrolizumab and Olaparib in Previously Treated Advanced Gastric Adenocarcinoma

The purpose of this study is to evaluate the safety and clinical activity of paclitaxel plus olaparib and pembrolizumab in patients with previously treated advanced Gastric Cancer (GC).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Sidney Kimmel Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Must have advanced gastric or gastroesophageal cancer.
  • Must have received only one prior line of systemic therapy for advanced disease and experienced disease progression on this regimen..
  • For Cohort 1: Must have the presence of measurable lesion.
  • Must agree to have a biopsy.
  • Life expectancy of greater than 3 months.
  • Patients must have adequate organ and marrow function defined by study - specified laboratory tests.
  • Woman of childbearing potential must have a negative pregnancy test.
  • Must use acceptable form of birth control while on study.
  • Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Require any antineoplastic therapy.
  • Require any other form of systemic or localized antineoplastic therapy.
  • Has received prior therapy with paclitaxel or PARP inhibitor. Previous paclitaxel may be allowed if no progression on or within 6 months of receiving this drug.
  • Hypersensitivity reaction to any paclitaxel, pembrolizumab or related compounds and/or to any of the components.
  • Allergy to dexamethasone, diphenhydramine and famotidine.
  • Is taking a moderate or strong CYP3A inhibitor.
  • Has uncontrolled intercurrent acute or chronic medical illness.
  • Has a known additional malignancy that is progressing and has required active treatment within the past 1 year.
  • Has received prior systemic anti-cancer therapy including investigational agents within 2 weeks prior to study treatment.
  • Has received prior radiotherapy within 2 weeks of start of study treatment.
  • Has received a live vaccine within 30 days prior to the first dose of study drug.
  • Is currently or has participated in another investigational study within 4 weeks prior to receiving study drug.
  • Has an active known or suspected autoimmune disease.
  • Has a diagnosis of immunodeficiency.
  • Prior tissue or organ allograft or allogeneic bone marrow transplantation.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. .
  • Requires daily supplemental oxygen.
  • History of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
  • History of encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent.
  • Infection with HIV or hepatitis B or C at screening.
  • Has uncontrolled infection requiring systemic therapy..
  • Subjects unable to undergo venipuncture and/or tolerate venous access.
  • Has known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial.
  • Woman who are pregnant or breastfeeding.
  • A woman of childbearing potential (WOCBP) who has a positive urine pregnancy test within 72 hours prior to study drug initiation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1 - Measurable Disease
All Participants will receive Paclitaxel, Olaparib and Pembrolizumab.
Drug: Paclitaxel
  1. Patients will receive treatment on Day 1 and 8 starting with cycle 2.
  2. Paclitaxel (80 mg) will be administered IV on days 1 and 8 starting with cycle 2 (every 21 days).
  3. Drug - Paclitaxel - 80mg IV
Other Names:
  • Taxol
Drug: Olaparib
  1. Olaparib will be taken by mouth daily for 3 weeks (every 21 days).
  2. Drug - 100 mg or 300mg
Other Names:
  • Lynparza
Drug: Pembrolizumab
  1. Patients will receive treatment every 21 days.
  2. Pembrolizumab (200 mg) will be administered IV on day 1 (every 21 days).
  3. Drug - 200mg IV
Other Names:
  • MK-3475; Keytruda
Experimental: Arm 2: Cohort 2-Unmeasurable Disease
All Participants will receive Paclitaxel, Olaparib and Pembrolizumab.
Drug: Paclitaxel
  1. Patients will receive treatment on Day 1 and 8 starting with cycle 2.
  2. Paclitaxel (80 mg) will be administered IV on days 1 and 8 starting with cycle 2 (every 21 days).
  3. Drug - Paclitaxel - 80mg IV
Other Names:
  • Taxol
Drug: Olaparib
  1. Olaparib will be taken by mouth daily for 3 weeks (every 21 days).
  2. Drug - 100 mg or 300mg
Other Names:
  • Lynparza
Drug: Pembrolizumab
  1. Patients will receive treatment every 21 days.
  2. Pembrolizumab (200 mg) will be administered IV on day 1 (every 21 days).
  3. Drug - 200mg IV
Other Names:
  • MK-3475; Keytruda

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: 4 years
OS will be measured from the date of first dose until death or end of follow-up. All subjects who receive at least one dose of the 3-drug combination will be included. Subjects who discontinue treatment prior to Cycle 2 will not be included in the analysis. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which that patient was known to be alive. Estimation based on the Kaplan-Meier curve.
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of patients experiencing study drug-related toxicities.
Time Frame: 4 years
Number of participants experiencing drug-related adverse events requiring treatment discontinuation.
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Katherine Bever, MD, Johns Hopkins Medical Institution

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2020

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

December 20, 2019

First Submitted That Met QC Criteria

December 20, 2019

First Posted (Actual)

December 24, 2019

Study Record Updates

Last Update Posted (Estimated)

December 3, 2025

Last Update Submitted That Met QC Criteria

December 1, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • J19135
  • IRB00209006 (Other Identifier: Johns Hopkins Medical Institution)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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