A Phase 1b/2 Study of Immunotherapy-Based Treatments and Combinations in People With Muscle-Invasive Bladder Cancer

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Full Title

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients with Urothelial Carcinoma (Morpheus-UC)

Purpose

Researchers are assessing different combinations of immunotherapy drugs in people with bladder cancer. The people in this study have bladder cancer that grew into the muscle wall (muscle-invasive bladder cancer or MIBC). They will also be having cystectomy (surgery to remove the bladder).

If you can have the drugs cisplatin and gemcitabine, you will be randomly assigned to get one of these treatments:

  • Atezolizumab, cisplatin, gemcitabine, and tiragolumab
  • Atezolizumab, cisplatin, and gemcitabine

If you cannot have cisplatin due to your health, you will be randomly assigned to get one of these treatments:

  • Atezolizumab
  • Atezolizumab plus tiragolumab

Atezolizumab and tiragolumab are types of immunotherapy (treatments that boost the body’s natural defenses to fight cancer). Researchers think that atezolizumab and tiragolumab could be effective treatments for MIBC. They boost the ability of the immune system to find and kill cancer cells. All of the medications in this study are given intravenously (by vein).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have MIBC that will be removed with surgery.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Samuel Funt’s office at 646-888-4770.

Protocol

23-266

Phase

Phase I/II (phases 1 and 2 combined)

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

ClinicalTrials.gov ID

NCT03869190