Testing the Addition of the Anti-cancer Drug, Cabozantinib, to the Usual Immunotherapy Treatment, Avelumab, in Patients With Metastatic Urothelial Cancer, MAIN-CAV Study

Conditions

• Advanced Bladder Urothelial Carcinoma
• Advanced Renal Pelvis Urothelial Carcinoma
• Advanced Ureter Urothelial Carcinoma
• Advanced Urethral Urothelial Carcinoma
• Metastatic Bladder Urothelial Carcinoma
• Metastatic Renal Pelvis Urothelial Carcinoma
• Metastatic Ureter Urothelial Carcinoma
• Metastatic Urethral Urothelial Carcinoma
• Stage III Bladder Cancer AJCC v8
• Stage III Renal Pelvis Cancer AJCC v8
• Stage III Renal Pelvis and Ureter Cancer AJCC v8
• Stage III Ureter Cancer AJCC v8
• Stage III Urethral Cancer AJCC v8
• Stage IV Bladder Cancer AJCC v8
• Stage IV Renal Pelvis Cancer AJCC v8
• Stage IV Renal Pelvis and Ureter Cancer AJCC v8
• Stage IV Ureter Cancer AJCC v8
• Stage IV Urethral Cancer AJCC v8

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Avelumab — DRUG
  Given IV
• Biospecimen Collection — PROCEDURE
  Undergo collection of blood and urine samples
• Bone Scan — PROCEDURE
  Undergo bone scan
• Cabozantinib S-malate — DRUG
  Given PO
• Computed Tomography — PROCEDURE
  Undergo CT
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Quality-of-Life Assessment — OTHER
  Ancillary studies
• Questionnaire Administration — OTHER
  Ancillary studies

Study Details

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.

Key Dates

Start date

Jun 3, 2022

Status verified

Jun 2026

Primary completion

Jul 15, 2029

Completion

Jul 15, 2029

Study Design

Enrollment

654 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm A (avelumab)
  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.
• Experimental: Arm B (avelumab, cabozantinib)
  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.

Primary Outcome Measure

Overall survival (OS) [ Time Frame: Time from randomization until death due to any cause, assessed up to 5 years ]

Locations (271)

Find similar trials in Phoenix, AZ

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