A Pilot Study to Evaluate the Safety of Neoadjuvant Nivolumab Alone or in Combination With Ipilimumab for Cisplatin-Ineligible Patients With Muscle Invasive Bladder Cancer (CA209-9DJ)

NCT03520491 Phase 2 ACTIVE_NOT_RECRUITING

The purpose of this study is to test if immunotherapy with nivolumab alone or in combination with ipilimumab is safe and does not delay the planned bladder cancer surgery. The investigators want to see if treatment with these drugs prior to surgery may decrease the size of the bladder cancer and thus could help make the surgery more successful.

Details

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	52
Start date	2018-04-25
Completion	2027-01

Conditions

• Bladder Cancer

Interventions

• Nivolumab
• Ipilimumab
• Radical cystectomy

Primary outcomes

• number of patients who proceed to radical cystectomy and pelvic lymph node dissection (RC-PLND) — within 60 days after completion of neoadjuvant nivolumab or nivolumab in combination with ipilimumab for cisplatin-ineligible MIBC, without delays due to treatment-related toxicities or progressive disease

Countries

United States