Rucaparib + Nivolumab for Biliary Tract Cancer
Recruiting at 2 trial locations
VS
Overseen ByVaibhav Sahai, MBBS, MS
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Michigan Rogel Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
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.
See 9 more
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.
See 8 more
Treatment Details
Interventions
- Nivolumab
- Rucaparib
Trial OverviewThe 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
1Treatment groups
Experimental Treatment
Group I: Rucaparib and NivolumabExperimental Treatment2 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
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Michigan Rogel Cancer Center
Lead Sponsor
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303
Recruited
20,700+
Dana-Farber Cancer Institute
Collaborator
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1,128
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382,000+
Vanderbilt University Medical Center
Collaborator
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939,000+
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