A phase I study of the doublet and triplet combination in patients with GU malignancies was conducted and the recommended phase II dose for the triplet is being used in this study. This provides a strong rationale for combining cabozantinib with immune checkpoint inhibitors, such as nivolumab alone or in combination with ipilimumab. Peripheral blood mononuclear cells from patients in a phase II study of monotherapy cabozantinib for advanced urothelial carcinoma and a separate cohort of rare bladder cancers demonstrated an increase in T-regulatory cells, showing that cabozantinib has immunomodulatory properties. Investigators have seen preliminary responses to this triple combination in rare GU tumors.
In this phase II trial (Alliance A031702 ICONIC), Alliance investigators aim to study the role of combination nivolumab, ipilimumab, and cabozantinib in the rare histological variants of the GU tract, including rare bladder tumors including adenocarcinoma, squamous cell carcinoma, and small cell carcinoma variants of urothelial carcinoma including plasmacytoid, sarcomatoid, and others rare renal tumors including sarcomatoid renal cell carcinoma and renal medullary carcinoma and penile cancers. Therefore, treatment information is obtained from case reports, retrospective studies and small-size (often incomplete) clinical trials. These tumors occur so infrequently that large randomized clinical trials to develop optimal effective therapies are logistically difficult. Rare GU cancers are cancers of aberrant histology occurring in the GU tract including kidney, bladder, ureters, and penis. Giving cabozantinib s-malate, nivolumab, and ipilimumab may work better in treating patients with rare GU cancers that have no treatment options compared to giving cabozantinib s-malate, nivolumab, or ipilimumab alone. Immunotherapy with monoclonal antibodies, specifically checkpoint inhibitors, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The Alliance trial looks at how well cabozantinib s-malate, nivolumab, and ipilimumab work together in treating patients with rare genitourinary (GU) cancers that have spread to other places in the body. Alliance Trial Examines Effectiveness of THE COMBINATION OF Two Immunotherapy Drugs with An Anti-cancer Targeted Drug for Rare Genitourinary TumorsĪlliance A031702 - A phase II study of ipilimumab, cabozantinib, and nivolumab in rare genitourinary cancers (ICONIC)
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