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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Merck Sharp & Dohme LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 31, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 20, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 24, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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