Rucaparib + Nivolumab for Biliary Tract Cancer

Recruiting at 2 trial locations

Overseen By Vaibhav Sahai, MBBS, MS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Michigan Rogel Cancer Center

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Immunodeficiency, Transplantation, Active infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

32 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests if using rucaparib and nivolumab together can help patients with Biliary Tract Cancer live longer. Rucaparib stops cancer cells from repairing themselves, and nivolumab boosts the immune system to fight the cancer.

Research Team

Vaibhav Sahai, MBBS, MS

Principal Investigator

Rogel Cancer Center

Eligibility Criteria

This trial is for adults with advanced biliary tract cancer who've had platinum-based chemotherapy but can't have surgery or other curative treatments. They must be in good physical condition, not have certain other cancers or serious medical issues, and agree to use effective contraception.

Inclusion Criteria

I finished chemotherapy over 6 months ago before starting platinum-based treatment for advanced disease.

I have tissue samples from previous procedures stored.

I am fully active or can carry out light work.

Exclusion Criteria

I have an autoimmune disease that affects my organs or requires immunosuppressive therapy.

I have another active cancer besides non-melanoma skin cancer or cervical carcinoma in situ.

I do not have any current, uncontrolled infections.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Rucaparib 600 mg PO BID days 1-28 and Nivolumab 240 mg IV days 1 and 15

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to two years

Treatment Details

Interventions

• Nivolumab
• Rucaparib

Trial Overview The study tests if rucaparib combined with nivolumab improves survival for patients after first-line platinum chemotherapy. It's for those whose disease hasn't worsened during initial treatment and who meet specific health criteria.

Participant Groups

Group I: Rucaparib and Nivolumab Experimental Treatment 2 Interventions

Rucaparib 600 mg PO BID days 1-28 Nivolumab 240 mg IV days 1 and 15

Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:

Approved in United States as Opdivo for:

• Advanced or metastatic gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma
• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Hepatocellular carcinoma
• Esophageal squamous cell carcinoma

Approved in European Union as Opdivo for:

• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma

Approved in Canada as Opdivo for:

• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma

Approved in Switzerland as Opdivo for:

• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma

Who Is Running the Clinical Trial?

University of Michigan Rogel Cancer Center

Lead Sponsor

Trials

303

Recruited

20,700+

Dana-Farber Cancer Institute

Collaborator

Trials

1,128

Recruited

382,000+

Vanderbilt University Medical Center

Collaborator

Trials

922

Recruited

939,000+