Study on SBRT/Olaparib Followed by Pembrolizumab/Olaparib in Gastric Cancers

Sponsor: University of Colorado, Denver

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05379972

Provider View

This clinical trial is testing a new treatment approach for patients with advanced gastric and gastroesophageal junction (GEJ) cancers. It combines radiation therapy and the drug olaparib, followed by a combination of olaparib and pembrolizumab, to see if it can improve treatment outcomes.

Patient Parameters

Program Overview

The study aims to evaluate the effectiveness of using olaparib and stereotactic beam radiotherapy (SBRT) initially, followed by a combination of olaparib and pembrolizumab, in patients with metastatic gastric and GEJ cancers who have already received at least one prior therapy. Researchers are also exploring how genetic factors related to DNA repair might influence the response to this treatment.

Description

This clinical trial is designed to test a new treatment strategy for patients with advanced gastric and gastroesophageal junction (GEJ) cancers. The study involves two main phases: first, patients receive a combination of the drug olaparib and a type of targeted radiation therapy called stereotactic beam radiotherapy (SBRT). After this initial treatment, patients will receive a combination of olaparib and another drug called pembrolizumab.

The study is open-label, meaning both the researchers and participants know which treatments are being administered. It is a phase II trial, which means it is focused on assessing the effectiveness and safety of the treatment. The trial will also look at how certain genetic factors related to DNA repair might affect how well the treatment works.

Participants will undergo various tests and procedures, including tumor biopsies, to monitor their response to the treatment. The study will also evaluate the safety of the treatment and any potential side effects.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of metastatic gastric or GEJ adenocarcinoma that can be biopsied.
  • Agree to provide tumor samples for research purposes.
  • Have a tumor that can be treated with radiation in specific areas like the stomach, esophagus, liver, lungs, or other specified locations.
  • Have at least one measurable tumor that will not receive radiation.
  • Have a specific genetic mutation related to DNA repair, identified through testing.
  • Have received at least one prior treatment, including specific chemotherapy drugs.
  • Be in good overall health with an ECOG performance status of 0 or 1.
  • Be able to swallow pills and liquids.
  • Have adequate organ function based on specific lab tests.
  • Women must not be pregnant or breastfeeding and must agree to use contraception.
  • Men must agree to use contraception and not donate sperm during the study.

Exclusion Criteria

  • Have received other cancer treatments or investigational drugs recently.
  • Have had recent radiation therapy or surgery without adequate recovery.
  • Have received a live vaccine recently.
  • Have a diagnosis of immunodeficiency or are on high-dose steroids or immunosuppressive therapy.
  • Have another active cancer requiring treatment.
  • Have active brain metastases or meningitis.
  • Have severe allergies to the study drugs.
  • Have gastrointestinal issues affecting drug absorption.
  • Have an active autoimmune disease requiring treatment.
  • Have a history of lung inflammation requiring steroids.
  • Have an active infection needing treatment.
  • Have a known history of HIV.

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