RecruitingPhase 2NCT04069273

Novel SEQUEnced Immunotherapy With Anti-angiogenesis and Chemotherapy in Advanced gastroesophageaL Adenocarcinoma

Phase 2 Study of Novel SEQUEnced Immunotherapy (Pembrolizumab) With Anti-angiogenesis and Chemotherapy in Advanced Gastric and gastroesophageaL Junction (GEJ) Adenocarcinoma

Sponsor

Harry H Yoon

Enrollment

58 participants

Start Date

Dec 1, 2020

Study Type

INTERVENTIONAL

Conditions

Gastric Cancer Gastroesophageal Cancer Adenocarcinoma

Summary

Cohort 1 \[CLOSED\] Study treatment involves two segments: (1) Induction Immunotherapy segment with pembrolizumab monotherapy every 3 weeks until irRECIST PD and (2) Combination Therapy segment. Nab-paclitaxel may be utilized in place of paclitaxel at investigator's discretion for subjects with paclitaxel reactions. Cohort 2 Patients are randomized to Arm A or B. Treatment in both arms includes pembrolizumab + RAM + paclitaxel.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new combination treatment approach — using immunotherapy, anti-angiogenic drugs (medications that cut off blood supply to tumors), and chemotherapy in a specific sequence — for people with advanced cancer of the stomach or the junction between the esophagus and stomach (gastroesophageal adenocarcinoma). **You may be eligible if...** - You are 18 years or older - You have advanced gastroesophageal adenocarcinoma that has not been previously treated - You are in good physical condition (ECOG performance status 0–1) - You have tumor tissue available for testing - You have authorized the release of your personal health information **You may NOT be eligible if...** - You have already received systemic cancer treatment for this cancer - You do not have available tumor tissue for testing - Your general health status is below the required threshold 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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