NCT03995017

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

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)

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Rucaparib	Rucaparib tablet
DRUG	Ramucirumab	Ramucirumab intravenous solution
DRUG	Nivolumab	Nivolumab intravenous solution

Timeline

• Start date: 2020-01-09
• Primary completion: 2022-10-19
• Completion: 2024-12-01
• First posted: 2019-06-21
• Last updated: 2023-02-01

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study