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Paclitaxel, Pembrolizumab and Olaparib in Previously Treated Advanced Gastric Adenocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04209686
Recruitment Status : Recruiting
First Posted : December 24, 2019
Last Update Posted : March 8, 2023
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Advanced Gastric Adenocarcinoma Drug: Paclitaxel Drug: Olaparib Drug: Pembrolizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Paclitaxel, Pembrolizumab and Olaparib in Previously Treated Advanced Gastric Adenocarcinoma
Actual Study Start Date : July 31, 2020
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: All Participants
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 Name: Taxol

Drug: Olaparib
  1. Olaparib will be taken by mouth daily for 3 weeks (every 21 days).
  2. Drug - 100 mg or 300mg
Other Name: 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 Name: MK-3475; Keytruda

Primary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: 4 years ]
    OS will be measured from the time of drug administration at Cycle 1, Day 1 until death due to any cause. 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.

Secondary Outcome Measures :
  1. The number of patients experiencing study drug-related toxicities. [ Time Frame: 4 years ]
    Number of patients experiencing study drug-related adverse adverse events Grade 3 or higher as defined by CTCAE v5.0.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 and progressed on only one prior line of systemic therapy for advanced disease.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04209686

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Contact: Trish Brothers, RN 410-614-3644 GIClinicalTrials@jhmi.edu
Contact: Sheila Linden, RN 410-614-4397 slinden2@jhmi.edu

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United States, Maryland
Sidney Kimmel Comprehensive Cancer Center Recruiting
Baltimore, Maryland, United States, 21231
Contact: Trish Brothers, RN    410-614-3644    GIClinicalTrials@jhmi.edu   
Contact: Sheila Linden, RN    410-614-4397    slinden2@jhmi.edu   
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Merck Sharp & Dohme LLC
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Principal Investigator: Katherine Bever, MD Johns Hopkins Medical Institution
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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT04209686    
Other Study ID Numbers: J19135
IRB00209006 ( Other Identifier: Johns Hopkins Medical Institution )
First Posted: December 24, 2019    Key Record Dates
Last Update Posted: March 8, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
PARP inhibitors
Gastric Cancer
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors