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Brief Title: Rucaparib Plus Ramucirumab With or Without Nivolumab in Advanced Gastric and Esophageal Adenocarcinoma
Official Title: A Phase I/II Trial of Rucaparib in Combination With Ramucirumab With or Without Nivolumab in Previously Treated Patients With Advanced Gastric and Esophageal Adenocarcinoma (RiME)
Study ID: NCT03995017
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Chicago Medical Center, Chicago, Illinois, United States
KU Cancer Center, Fairway, Kansas, United States
University of Kansas Cancer Center - CRC, Fairway, Kansas, United States
University of Kansas Cancer Center - West, Kansas City, Kansas, United States
The University of Kansas Cancer Center, Westwood Campus, Kansas City, Kansas, United States
University of Kansas Cancer Center - Overland Park, Overland Park, Kansas, United States
University of Kansas Cancer Center - North, Kansas City, Missouri, United States
University of Kansas Cancer Center - Lee's Summit, Lee's Summit, Missouri, United States
Name: Anwaar Saeed, MD
Affiliation: Kansas University Cancer Center
Role: PRINCIPAL_INVESTIGATOR