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

Summary

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.

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 and Ureter Cancer AJCC v8
• Stage III Renal Pelvis 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 and Ureter Cancer AJCC v8
• Stage IV Renal Pelvis Cancer AJCC v8
• Stage IV Ureter Cancer AJCC v8
• Stage IV Urethral Cancer AJCC v8

Interventions

DRUG

Avelumab

Given IV

PROCEDURE

Biospecimen Collection

Undergo collection of blood and urine samples

PROCEDURE

Bone Scan

Undergo bone scan

DRUG

Cabozantinib S-malate

Given PO

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Shilpa Gupta · Alliance for Clinical Trials in Oncology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-03

Primary Completion

2026-06-15

Completion

2026-06-15

FDA Drug

Yes

Countries

• United States
• Canada

Study Locations