Cabozantinib + Avelumab for Bladder Cancer

Recruiting in Palo Alto (17 mi)

+308 other locations

Overseen byShilpa Gupta

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This phase III trial compares the effect of adding cabozantinib to avelumab versus avelumab alone in treating patients with urothelial cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib and avelumab together may further shrink the cancer or prevent it from returning/progressing.

Research Team

Shilpa Gupta

Principal Investigator

Alliance for Clinical Trials in Oncology

Eligibility Criteria

Adults with advanced or metastatic urothelial cancer who've had one round of platinum-based chemo can join this trial. They must have stable health, no recent major surgeries, and not be on certain blood thinners or immunosuppressants. Women must test negative for pregnancy and all participants should use birth control to prevent pregnancy during the study.

Inclusion Criteria

Your hemoglobin level is at least 8 grams per deciliter.

The amount of protein in your urine is within a certain range.

I don't have active brain metastases and am stable if previously treated.

See 31 more

Treatment Details

Interventions

Avelumab (Monoclonal Antibody)
Cabozantinib S-malate (Tyrosine Kinase Inhibitor)

Trial OverviewThe MAIN-CAV Study is testing if adding Cabozantinib to Avelumab improves treatment outcomes in metastatic urothelial cancer compared to Avelumab alone. It's a phase III trial where patients are randomly assigned to either receive both drugs or just the immunotherapy drug.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm B (avelumab, cabozantinib)Experimental Treatment8 Interventions

Patients receive avelumab IV over 60 minutes on days 1 and 15 of each cycle and cabozantinib PO daily on days 1-28 of each cycle. Cycles repeat every 28 days for 24 months in the absence of disease progression or unacceptable toxicity. Patients also undergo bone scan at screening and undergo CT or MRI and biospecimen collection throughout the trial. Patients may undergo urine sample collection as clinically indicated.

Group II: Arm A (avelumab)Active Control7 Interventions

Patients receive avelumab IV over 60 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days for 24 months in the absence of disease progression or unacceptable toxicity. Patients also undergo bone scan at screening and undergo CT or MRI and biospecimen collection throughout the trial. Patients may undergo urine sample collection as clinically indicated.

Avelumab is already approved in Japan for the following indications: