Paclitaxel, Pembrolizumab and Olaparib in Previously Treated Advanced Gastric Adenocarcinoma

NCT ID: NCT04209686

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-31
• Study Completion Date: 2028-09-01

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).

Conditions

Advanced Gastric Adenocarcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1 - Measurable Disease

All Participants will receive Paclitaxel, Olaparib and Pembrolizumab.

Group Type: EXPERIMENTAL

Paclitaxel

Intervention Type: DRUG

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

Olaparib

Intervention Type: DRUG

1. Olaparib will be taken by mouth daily for 3 weeks (every 21 days).

2. Drug - 100 mg or 300mg

Pembrolizumab

Intervention Type: DRUG

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

Arm 2: Cohort 2-Unmeasurable Disease

All Participants will receive Paclitaxel, Olaparib and Pembrolizumab.

Group Type: EXPERIMENTAL

Paclitaxel

Intervention Type: DRUG

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

Olaparib

Intervention Type: DRUG

1. Olaparib will be taken by mouth daily for 3 weeks (every 21 days).

2. Drug - 100 mg or 300mg

Pembrolizumab

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Olaparib

1. Olaparib will be taken by mouth daily for 3 weeks (every 21 days).

2. Drug - 100 mg or 300mg

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Taxol; Lynparza; MK-3475; Keytruda

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katherine Bever, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Medical Institution

Locations

Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

J19135

Identifier Type: -

Identifier Source: org_study_id

IRB00209006

Identifier Type: OTHER

Identifier Source: secondary_id