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Rucaparib Plus Ramucirumab With or Without Nivolumab in Advanced Gastric and Esophageal Adenocarcinoma

NCT03995017 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2023-02-01

No results posted yet for this study

Summary

The study population is advanced gastric, gastroesophageal, and esophageal adenocarcinoma participants who have failed upfront standard of care chemotherapy. The goal is to demonstrate that Rucaparib plus Ramucirumab with or without Nivolumab has a higher response rate than what has been reported for Ramucirumab in previously treated patients. Trial will be a phase 1/2 trial. The Phase 1 portion will determine the recommended Phase 2 treatment dose for the combination of Rucaparib plus Ramucirumab and Nivolumab and enroll approximately 6-9 participants. The Phase 2 portion of the study will involve 52 participants allocated between two treatment groups comparing Rucaparib plus Ramucirumab with or without Nivolumab. The participants will be selected based on the results of a screening HRD gene panel.

Conditions

  • Esophagus Cancer, Adenocarcinoma
  • Stomach Cancer, Adenocarcinoma

Interventions

DRUG

Rucaparib

Rucaparib tablet

DRUG

Ramucirumab

Ramucirumab intravenous solution

DRUG

Nivolumab

Nivolumab intravenous solution

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Clovis Oncology, Inc.

    collaborator INDUSTRY

  • University of Kansas Medical Center

    lead OTHER

Principal Investigators

  • Anwaar Saeed, MD · Kansas University Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-09
Primary Completion
2022-10-19
Completion
2024-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03995017 on ClinicalTrials.gov