Talazoparib + Avelumab for Kidney Cancer

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen byRitesh Kotecha, 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 see whether the combination of avelumab and talazoparib can be an effective treatment for metastatic renal cell carcinoma.

Eligibility Criteria

Inclusion Criteria

You have a specific genetic alteration called VHL, which can be identified through a special genetic testing method.

Women of childbearing potential must have negative serum pregnancy testing at screening and agree to use medically accepted methods of contraception during the study and for a specified duration after the last dose of the study treatment

Willingness and ability to comply with trial protocol

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Exclusion Criteria

Investigator site staff members directly involved in study conduct, including their family members, or patients who are Pfizer members, including their family members, who are directly involved in study conduct

You have difficulty swallowing capsules, are allergic to talazoparib, have trouble absorbing nutrients from food, or have a condition that affects how your body absorbs things from your intestines.

You have had a serious blood vessel disease within 6 months before starting the treatment.

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Treatment Details

Interventions

Avelumab (Monoclonal Antibodies)
Talazoparib (PARP Inhibitor)

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Talazoparib and Avelumab (VHL-deficiency) (Closed to Accrual)Experimental Treatment2 Interventions

All patients will receive combination treatment at the previously established recommended phase II dose, 800 mg avelumab every 2 weeks with 1 mg talazoparib daily, in 28-day cycles.

Group II: Talazoparib and Avelumab (FH- or SDH-deficiency)Experimental Treatment2 Interventions

All patients will receive combination treatment at the previously established recommended phase II dose, 800 mg avelumab every 2 weeks with 1 mg talazoparib daily, in 28-day cycles.

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

🇪🇺 Approved in European Union as Bavencio for: