A Phase II Study of Ipilimumab, Cabozantinib, and Nivolumab in Rare Genitourinary Cancers (ICONIC)

Protocol: Alliance – A031702

SCHEMA A031702

Please Note: Below is partial eligibility, for full eligibility requirement’s, please contact GHCI Research Department at (810) 762-8181, (810) 762-8079 and/or (810)762-8038. Thank you!

Eligibility:

1. Metastatic disease defined as new or progressive lesions on cross-sectional imaging or bone scan. Patients must have at least:  a.One measurable site of disease as per RECIST v1.1 b.  One bone lesion on bone scan (tec99 or NaF PET/CT, CT or MRI) for the bone-only cohort  c. Histologically confirmed diagnosis of one of the following metastatic cohorts: Small cell/neuroendocrine carcinoma of the bladder, Adenocarcinoma of the bladder, or urachal adenocarcinoma or bladder/urethra clear cell adenocarcinoma, Squamous cell carcinoma of the bladder, Plasmacytoid urothelia carcinoma,  Any penile cancer, Sarcomatoid renal cell carcinoma, Sarcomatoid urothelial carcinoma, Renal medullary carcinoma, Renal collecting duct carcinoma, Bone only urothelial carcinoma or other non-prostate GU tumor, Urethra carcinoma, Other miscellaneous histologic variants of the urothelial carcinoma.
2. Patients may have received up to 2 systemic anti-cancer treatments or be treatment naïve. Patients with small cell carcinoma should have received a platinum-based combination regimen either as neoadjuvant, adjuvant or first-line
   treatment). Patients in the bone-only cohort may be urothelial carcinoma histology but must receive standard cisplatin-based chemotherapy (if cisplatineligible).
3. Must be at least 18 years of age.
4. Patients must be able to swallow oral formulation of the tablets.
5. Karnofsky performance status ≥80%.
6. Prior treatment with MET or VEGFR inhibitors is allowed. However, prior cabozantinib will not be allowed. Also, patients that have received both prior MET or VEGF and prior PD-1/PD-L1/CTLA-4 (sequentially or in combination) are also not allowed.
7. Prior treatment with any therapy on the PD-1/PD-L1 axis or anti- CTLA4/CTLA-4 inhibitors is allowed, either in the perioperative or in the metastatic setting. However, patients that have received both prior MET or VEGF and prior PD-1/PDL1/CTLA-4 (sequentially or in combination) are not allowed.
8. The patient has received no cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (e.g., cytokines or antibodies) within 2 weeks before the first dose of study treatment.
9. The patient has received no radiation therapy.
10. The patient has received no radionuclide treatment within 6 weeks of the first dose of study treatment.
11. The patient has received no prior treatment with a small molecule kinase inhibitor within 14 days or five half-lives of the compound or active metabolites, whichever is longer, before the first dose of study treatment.
12. The patient has received no prior treatment with hormonal therapy within 14 days or five half-lives of the compound or active metabolites, whichever is longer, before the first dose of study treatment. Subjects receiving Gonadotropin-releasing hormone (GnRH) agonists and antagonists are allowed to participate.
13. The patient has not received any other type of investigational agent within 14 days before the first dose of study treatment.