Rucaparib + Nivolumab for Biliary Tract Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment for biliary tract cancer (BTC) using a combination of two drugs, rucaparib and nivolumab, to determine if they can help patients live longer without their cancer worsening. It targets those who have already undergone a first round of platinum-based chemotherapy and whose cancer remained stable during that treatment. Ideal participants have BTC that cannot be removed or treated with surgery and have had stable disease after chemotherapy. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in BTC treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of rucaparib and nivolumab has been studied for safety in various cancers. Studies suggest this combination can be effective, particularly for certain patient groups. However, safety remains a top priority.
In past studies, using nivolumab and rucaparib together led to side effects such as tiredness, nausea, and changes in liver function. Most patients managed these well, but some experienced more serious effects. These findings come from different cancer studies, and side effects can vary.
The trial available for participation is in a phase where safety is closely monitored. This phase helps researchers assess how well patients manage the treatment. If rucaparib or nivolumab have been approved for other uses, it indicates they are generally safe when used alone. Combining them is newer, so ongoing studies are essential to ensure safety for everyone.
Prospective participants should consult the study team or their doctor to understand potential side effects. This is an important step in deciding whether joining a trial is the right choice.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of Rucaparib and Nivolumab for biliary tract cancer because it brings a fresh approach to treatment. Nivolumab is an immunotherapy that helps the immune system detect and attack cancer cells more effectively, while Rucaparib is a PARP inhibitor that targets cancer cells' ability to repair themselves, enhancing the effects of DNA damage. This combination offers a dual mechanism that could potentially overcome resistance seen in traditional chemotherapy and improve outcomes for patients who have limited options.
What evidence suggests that rucaparib and nivolumab could be effective for biliary tract cancer?
Research has shown that using rucaparib and nivolumab together may help treat certain cancers. In a study on a different type of cancer, this combination led to very positive results, especially in patients who hadn't undergone chemotherapy before. In this trial, participants with advanced biliary tract cancers will receive both rucaparib and nivolumab. Nivolumab helps the immune system fight cancer, while rucaparib prevents cancer cells from repairing themselves. For patients with advanced biliary tract cancers, the outlook is often poor, with survival usually less than a year. The hope is that these two drugs together can help patients live longer. Early results suggest they may be effective when used after initial chemotherapy.12456
Who Is on the Research Team?
Vaibhav Sahai, MBBS, MS
Principal Investigator
Rogel Cancer Center
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Rucaparib 600 mg PO BID days 1-28 and Nivolumab 240 mg IV days 1 and 15
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Nivolumab
- Rucaparib
Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Michigan Rogel Cancer Center
Lead Sponsor
Dana-Farber Cancer Institute
Collaborator
Vanderbilt University Medical Center
Collaborator