RecruitingPhase 1Phase 2NCT04592211

Pembrolizumab, Olaparib, Recurrent/Advanced Gastric and Gastro-esophageal Junction(GEJ) Cancer

An Open Label, Single-Arm, Multi-center Phase Ib/II Study to Evaluate the Efficacy of Paclitaxel in Combination With Pembrolizumab and Olaparib as a Second Line Treatment in Immune Checkpoint Inhibitor-experienced Recurrent/Advanced Gastric and Gastro-esophageal Junction(GEJ) Cancer.

Sponsor

Yonsei University

Enrollment

71 participants

Start Date

Oct 1, 2021

Study Type

INTERVENTIONAL

Conditions

Gastric Cancer Stage IV

Summary

Pembrolizumab is a potent humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb) with high specificity of binding to the programmed cell death 1 (PD 1) receptor, thus inhibiting its interaction with programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2). Olaparib is a potent PARP inhibitor (PARP1, 2, and 3) that is being developed as a monotherapy as well as for combination with chemotherapy, ionizing radiation, and other anti-cancer agents including novel agents and immunotherapy. Paclitaxel is widely used in breast, lung and gastric cancer with every 3-week or weekly cycle. Various targeted anticancer agents have been investigated with paclitaxel and combination with ramucirumab, a monoclonal anti-VEGFR2 antibody, was approved as a 2nd line treatment.

Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether combining two drugs — pembrolizumab (an immunotherapy) and olaparib (a targeted drug that affects DNA repair) — can work against advanced or recurrent stomach cancer or cancer at the junction of the stomach and esophagus that has returned after initial treatment. **You may be eligible if...** - You are 19 years or older - You have measurable advanced or recurrent stomach or gastroesophageal junction (GEJ) cancer - Your overall health/functional status is good - Your heart, liver, kidneys, and blood counts are within acceptable ranges - Your life expectancy is at least 3 months - If your cancer is HER2-positive, you must have already received trastuzumab treatment that stopped working **You may NOT be eligible if...** - You received any anti-cancer treatment within the past 2 weeks - You received radiation within the past 2 weeks - You received a live vaccine in the past 30 days - You have an immune system disorder or take high-dose steroids - You are pregnant or may become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGolaparib+pembrolizumab+paclitaxel

olaparib, 100\~200mg, PO, bid, continuous Pembrolizumab 200mg, IV, q 3 weeks Paclitaxel 80mg/m2 IV, Q weekly

Locations(1)

Severance Hospital

Seoul, South Korea

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NCT04592211

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