Pembrolizumab + Chemotherapy Before Surgery for Bladder Cancer

Recruiting in Palo Alto (17 mi)

Overseen byPetros Grivas

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Washington

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial is testing a mix of a drug that helps the immune system and another that targets cancer cells before surgery for a specific type of bladder cancer. It focuses on patients who may not respond well to usual treatments. The treatment helps the body fight cancer and uses drugs to kill or stop cancer cells.

Eligibility Criteria

This trial is for adults with muscle-invasive bladder cancer that looks unusual under the microscope and hasn't spread elsewhere. They must be fit for chemotherapy, surgery to remove the bladder, and willing to provide tissue samples. Participants need functioning major organs, no severe allergies to pembrolizumab or its components, no active hepatitis B/C or HIV, not pregnant or breastfeeding, and agree to use contraception.

Inclusion Criteria

My bladder cancer has not spread, as confirmed by CT or MRI scans.

My bladder cancer is mainly not urothelial type.

My blood clotting time is normal or managed if I'm on blood thinners.

+17 more

Exclusion Criteria

Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial

I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.

I have not had cancer treatment or experimental drugs in the last 4 weeks.

+20 more

Participant Groups

The study tests if combining pembrolizumab (an immune system-boosting drug) with chemotherapy drugs (methotrexate, vinblastine sulfate, doxorubicin hydrochloride, cisplatin) before surgery can better treat patients compared to chemotherapy alone. The goal is to see if this combination helps shrink the cancer more effectively before removing the bladder.

1Treatment groups

Experimental Treatment

Group I: Treatment (pembrolizumab, aMVAC)Experimental Treatment7 Interventions

Patients receive pembrolizumab IV over 30 minutes on day 1 of weeks 0, 3, and 6 and methotrexate IV, vinblastine IV, doxorubicin IV, and cisplatin IV on day 1 of weeks 0, 2, 4, and 6 in the absence of disease progression or unacceptable toxicity. Patients also receive pegfilgrastim SC on day 1 or 2 of weeks 0, 2, 4, and 6 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care radical cystectomy.