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

Conditions

• Esophagus Cancer, Adenocarcinoma
• Stomach Cancer, Adenocarcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Rucaparib — DRUG
  Rucaparib tablet
• Ramucirumab — DRUG
  Ramucirumab intravenous solution
• Nivolumab — DRUG
  Nivolumab intravenous solution

Study Details

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.

Key Dates

Start date

Jan 9, 2020

Status verified

Jan 2023

Primary completion

Oct 19, 2022

Completion

Dec 31, 2024

Study Design

Enrollment

34 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Safety Lead In
  * Rucaparib 600 milligrams twice daily * Ramucirumab 8 milligrams per kilogram intravenous every 2 weeks * Nivolumab 480 milligrams intravenous every 4 weeks * Treatment will continue until disease progression, unacceptable toxicity or the patient desires to discontinue this therapy * One dose level decrease of Rucaparib will be planned if toxicity develops in the first 6 patients * 1 cycle= 28 days
• Experimental: Cohort A
  * Rucaparib 600 milligrams twice daily * Ramucirumab 8 milligrams per kilogram intravenous every 2 weeks * Nivolumab 480 milligrams intravenous every 4 weeks * Treatment will continue until disease progression, unacceptable toxicity or the patient desires to discontinue this therapy * 1 cycle= 28 days
• Active Comparator: Cohort B
  * Rucaparib 600 milligrams twice daily * Ramucirumab 8 milligrams per kilogram intravenous every 2 weeks * Treatment will continue until disease progression, unacceptable toxicity or the patient desires to discontinue this therapy * 1 cycle= 28 days

Primary Outcome Measure

Recommended Phase 2 Dose (RP2D) [ Time Frame: Up to 28 days ]

Locations (8)

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