Cabozantinib With Nivolumab and Ipilimumab in Rare GU Tumors
PHASE II STUDY OF CABOZANTINIB IN COMINATION WITH NIVOLUMAB AND IPILIMUMAB IN RARE GENITOURINARY TUMORS
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Clinical Trial Information
Trial Contact: Djuro, Victor; Frankos, Marie; Walton, Sherri
Trial Phone: 321.841.7477 ; 321.841.7303 ; 321.841.1907
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IRB No: A031702
Protocol Abbrev: ICONIC-A031702
Principal Investigator: Daniel Ari Landau, MD
Phase: Drug: Phase II
Age Group: Adult
Secondary Protocol No: ICONIC
Treatment: Patients receive cabozantinib PO, QD on days 1-21 of cycles 1-4, nivolumab IV over 30 minutes on day 1 of cycles 1-13 and ipilimumab IV over 90 minutes on day 1 of cycles 1-4. This triple combination therapy is followed by double therapy with cabozantinib PO, QD on days 1-28 and nivolumab IV over 30 minutes on day 1 of each 28 day cycle for the remaining cycles.1 Cycles repeat every 21 days for cycles 1-4 and every 28 days for subsequent cycles for 2 years in the absence of disease progression or unacceptable toxicity.
Therapies Involved: Oncology: 1st line; Oncology: 3rd line/Refractory
ClinicalTrials.gov ID: NCT03866382
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Objective
This phase II trial studies how well the combination of cabozantinib, nivolumab, and ipilimumab work in treating patients with rare genitourinary (GU) tumors that have spread to other places in the body
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Key Eligibility
• Metastatic disease defined as new or progressive lesions on cross-sectional imaging. Patients must have at least:
◦One measurable site of disease as per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1
◦Histologically confirmed diagnosis of metastatic: small cell carcinoma of the bladder; adenocarcinoma of the bladder; squamous cell carcinoma of the bladder; plasmacytoid urothelial carcinoma; any penile cancer; sarcomatoid renal cell carcinoma; sarcomatoid urothelial carcinoma; renal medullary carcinoma or other miscellaneous histologic variants of the urothelial carcinoma, such as, but not limited to micropapillary, giant cell, lipid-rich, clear cell and nested variants, large cell neuroendocrine carcinoma, lymphoepithelioma-like carcinoma and mixed patterns will be considered, as well as small cell neuroendocrine prostate cancer, testicular Sertoli or Leydig cell tumors, and papillary and chromophobe renal cell carcinoma (RCC)
◦2 hematoxylin and eosin (H&E) slides from diagnostic tumor tissue for retrospective central pathology review
• Patients may have received any number of prior anti-cancer treatments or be treatment naive (with the exception of patients with small cell carcinoma of the bladder, whom should have received a platinum-based combination regimen either as neoadjuvant, adjuvant or first-line treatment)
• Patients must be able to swallow oral formulation of the tablets
• Karnofsky performance status >= 70%
. Initial Laboratory Values
