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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 carcinomaEligibility
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
Trial Location(s)
Gender
Male or Female
Age
19 years and older
Enrollment Status
Recruiting
Phase
Phase II
Methodist Health System Trial Code
A031702