Rucaparib + Nivolumab for Leiomyosarcoma

Recruiting in Palo Alto (17 mi)

+7 other locations

Sujana Movva, MD - MSK Sarcoma Medical ...

Overseen bySujana Movva, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The purpose of this study is to find out whether combining the study drugs rucaparib and nivolumab may be an effective treatment for advanced and/or metastatic LMS, and whether the study treatment works as well as the standard chemotherapy for this type of cancer.

Eligibility Criteria

Adults (18+) with advanced or metastatic Leiomyosarcoma who have had 1-3 prior systemic therapies can join this trial. They must not have used PARP inhibitors or PD-1/PD-L1 antibodies before, and should be recovered from previous treatments' side effects. Participants need functioning major organs, measurable disease, and no active infections or significant heart issues. Women of childbearing potential must test negative for pregnancy and agree to contraception.

Inclusion Criteria

My liver function tests are within the required range.

My LMS cannot be removed by surgery and has spread.

I finished any cancer treatments at least 3 weeks ago, and my side effects are mild.

+11 more

Exclusion Criteria

I do not have any other cancer that needs treatment or could affect this trial.

Subjects expecting to have a child within the projected duration of the trial, starting with the pre-screening or screening visit through 6 months after the last dose of study treatment(s) for women or 7 months for men.

I have a weakened immune system due to conditions like HIV, Hepatitis B/C, or autoimmune diseases.

+8 more

Participant Groups

The study is testing the combination of Rucaparib (a drug that targets cancer cells) and Nivolumab (an immunotherapy) in patients with Leiomyosarcoma to see if it's more effective than standard chemotherapy. Patients will receive both drugs as part of their treatment regimen.

1Treatment groups

Experimental Treatment

Group I: Rucaparib in combination with NivolumabExperimental Treatment2 Interventions

One treatment cycle will consist of 28 days. Patients will receive rucaparib at 600 mg, orally, twice daily, continuously for 28 days. They will receive 480mg of nivolumab intravenously on day 1 of every four-week cycle. This is the recommended phase II dose of the combination therapy. Re-staging scans will be performed every 8 weeks. Treatment will be repeated until the patient develops progressive disease or unacceptable toxicity or for a maximum duration of 26 cycles as long as patients are receiving benefit from treatment, have not had disease progression, met any criteria for study withdrawal and are tolerating therapy.

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

🇺🇸 Approved in United States as Opdivo for: