Paclitaxel, Pembrolizumab and Olaparib in Previously Treated Advanced Gastric Adenocarcinoma

NCT04209686 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: J19135IRB00209006
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Keywords

Paclitaxel; Olaparib; Pembrolizumab; Immunotherapy; Anti-PD-1; PARP inhibitors; Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  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 Outcomes (1)

• The number of patients experiencing study drug-related toxicities.

  4 years

Study Arms (2)

Cohort 1 - Measurable Disease

EXPERIMENTAL

All Participants will receive Paclitaxel, Olaparib and Pembrolizumab.

Drug: Paclitaxel; Drug: Olaparib; Drug: Pembrolizumab

Arm 2: Cohort 2-Unmeasurable Disease

EXPERIMENTAL

All Participants will receive Paclitaxel, Olaparib and Pembrolizumab.

Drug: Paclitaxel; Drug: Olaparib; Drug: Pembrolizumab

Interventions

Paclitaxel 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

Also known as: Taxol

Arm 2: Cohort 2-Unmeasurable Disease; Cohort 1 - Measurable Disease

Olaparib DRUG

1. Olaparib will be taken by mouth daily for 3 weeks (every 21 days). 2. Drug - 100 mg or 300mg

Also known as: Lynparza

Arm 2: Cohort 2-Unmeasurable Disease; Cohort 1 - Measurable Disease

Pembrolizumab 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

Also known as: MK-3475; Keytruda

Arm 2: Cohort 2-Unmeasurable Disease; Cohort 1 - Measurable Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Paclitaxel; olaparib; pembrolizumab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Katherine Bever, MD

  Johns Hopkins Medical Institution

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: December 24, 2019
• Study Start: July 31, 2020
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: December 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)