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Alliance A031702

Trial Overview

Official Title

Testing the effectiveness of two immunotherapy drugs (nivolumab and ipilimumab) with one anti-cancer targeted drug (cabozantinib) for rare genitourinary tumors

Study Purpose

To test the good and bad effects of the drugs cabozantinib, nivolumab, and ipilimumab in rare genitourinary cancers that have no standard treatment options.

The doctors hope to learn if the study drugs will stabilize or shrink the cancer.

Diagnosis

Metastatic disease of: Small cell carcinoma of the bladder Adenocarcinoma of the bladder Squamous cell carcinoma of the bladder Plasmacytoid urothelial carcinoma Penile cancer Sarcomatoid renal cell carcinoma

Eligibility

May have received any number of prior anti-cancer treatments with the exception of patients with small cell carcinoma of the bladder.

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Intervention

First 12 weeks:

  • Cabozantinib, pill by mouth once a day, every day
  • Nivolumab, IV, once every 3 weeks
  • Ipilimumab, IV, once every 3 weeks

After 12 weeks:

  • Cabozantinib, pill by mouth, once a day, every day,
  • Nivolumab, IV, once every 4 weeks

For more information, visit ClinicalTrials.gov

Key Participation Requirements
Gender
Male or Female
Age
19 years and older
Enrollment Status
Suspended
Phase
Phase II
Methodist Health System Trial Code
A031702
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