Rucaparib + Ramucirumab +/- Nivolumab for Stomach and Esophageal Cancer
(RiME Trial)

Recruiting in Palo Alto (17 mi)

+13 other locations

Overseen byAnwaar Saeed, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: University of Kansas Medical Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults with advanced gastric or esophageal adenocarcinoma who've had standard chemotherapy but the cancer has progressed. They must have a specific gene alteration, measurable disease, and good organ function. Those with autoimmune diseases, recent steroid treatment, or untreated brain metastases can't join.

Inclusion Criteria

I haven't needed treatment for an autoimmune disease in the last 2 years.

My cancer is in the stomach or where the stomach meets the esophagus.

My HER2 positive cancer has worsened despite previous HER2 targeted treatments.

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Exclusion Criteria

I had skin cancer (not melanoma) treated and currently show no signs of it.

I have not had significant bleeding or coughing up blood in the last 3 months.

I have not had major surgery in the last 8 weeks.

See 23 more

Treatment Details

Interventions

Nivolumab (Checkpoint Inhibitor)
Ramucirumab (Monoclonal Antibodies)
Rucaparib (PARP Inhibitor)

Trial OverviewThe study tests Rucaparib plus Ramucirumab with or without Nivolumab in patients whose cancer didn't respond to initial treatments. It's a two-part trial: Phase 1 finds the best dose; Phase 2 compares how well each drug combination works.

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Group I: Safety Lead InExperimental Treatment3 Interventions

* 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

Group II: Cohort AExperimental Treatment3 Interventions

Group III: Cohort BActive Control2 Interventions

* 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

Ramucirumab is already approved in United States, European Union, Japan for the following indications:

🇺🇸 Approved in United States as Cyramza for: