Paclitaxel, Pembrolizumab and Olaparib in Previously Treated Advanced Gastric Adenocarcinoma

NCT04209686 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: J19135IRB00209006
• Study Type: interventional
• Target: 19
• 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)

  Overall survival is the time from the start of first dose of study drug to death or end of follow-up (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve.

  Up to 27 months

Secondary Outcomes (2)

• Number of Participants Experiencing Grade 3 or Above Study Drug-related Adverse Events (AEs)

  15 months

• Number of Participants Experiencing Immune-related Adverse Events (irAEs)

  15 months

Study Arms (2)

Arm 1: Measurable Disease

EXPERIMENTAL

Drug: Paclitaxel; Drug: Olaparib; Drug: Pembrolizumab

Arm 2: Unmeasurable Disease

EXPERIMENTAL

Drug: Paclitaxel; Drug: Olaparib; Drug: Pembrolizumab

Interventions

Paclitaxel DRUG

Paclitaxel (80mg/m\^2) will be administered IV on days 1 and 8 starting with Cycle 2. Each Cycle is 21 days.

Also known as: Taxol

Arm 1: Measurable Disease; Arm 2: Unmeasurable Disease

Olaparib DRUG

Olaparib (100mg or 300mg) will be administered orally on Days 1-21 of each Cycle. Each Cycle is 21 days.

Also known as: Lynparza

Arm 1: Measurable Disease; Arm 2: Unmeasurable Disease

Pembrolizumab DRUG

Pembrolizumab (200mg) will be administered IV on day 1 of each Cycle. Each Cycle is 21 days.

Also known as: MK-3475; Keytruda

Arm 1: Measurable Disease; Arm 2: Unmeasurable 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

Results Point of Contact

• Title: Katherine Bever, MD
• Organization: SKCCC, Johns Hopkins Medical Institution

kbever1@jhmi.edu

443-287-0966

Study Officials

• Katherine Bever, MD

  Johns Hopkins Medical Institution

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: November 17, 2025
• Study Completion: November 17, 2025
• Last Updated: September 1, 2026
• Results First Posted: September 1, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)