Immunochemotherapy for Bladder Cancer

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen byPooja Ghatalia, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Fox Chase Cancer Center

Stay on Your Current Meds

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial tests a combination of chemotherapy and immune therapy for patients with muscle invasive bladder cancer. It aims to help these patients keep their bladders and improve their quality of life by effectively targeting and killing cancer cells while boosting the immune system.

Eligibility Criteria

This trial is for adults with muscle invasive bladder cancer (MIBC) without prior chemotherapy or radiation for urothelial carcinoma, no autoimmune diseases, and not on significant immunosuppressive medications. Participants must have normal organ function, no evidence of metastasis or lymph node positive disease unless biopsy-proven negative, and a good performance status.

Inclusion Criteria

There is evidence that the cancer has invaded the muscle layer of the organ.

Your cancer is at a specific stage called T2 or T3 and has not spread to nearby lymph nodes or other parts of the body.

Male or female patients ≥18 years

+8 more

Exclusion Criteria

You have had chemotherapy or radiation for urothelial carcinoma within the past year, or you have had immunotherapy for non-muscle invasive bladder cancer.

You have a type of cancer called small cell histology.

You have a history of certain autoimmune diseases like rheumatoid arthritis or lupus.

+10 more

Participant Groups

The study tests neoadjuvant accelerated methotrexate/vinblastine/adriamycin/cisplatin (AMVAC) combined with nivolumab in MIBC patients. Those responding well may preserve their bladders and enter active surveillance instead of undergoing radical surgery.

1Treatment groups

Experimental Treatment

Group I: AMVAC + nivolumabExperimental Treatment1 Intervention

This will be a single-arm, open-label, multicenter phase 2 study of neoadjuvant nivolumab with AMVAC. Approximately 70 evaluable patients will be enrolled into this study. Eligible patients will be those with diagnosis of muscle invasive urothelial carcinoma of the bladder who are cT2 or cT3 but not clinical N1 at diagnosis. Clinical stage is confirmed by transurethral resection of bladder tumor (TURBT#1).