Cabozantinib and Nivolumab With or Without Ipilimumab May Be Effective in Genitourinary Cancers
Cabozantinib and nivolumab (CaboNivo) with or without ipilimumab (Ipi) demonstrated manageable safety profiles and durable clinical activity.
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Cabozantinib and nivolumab (CaboNivo) with or without ipilimumab (Ipi) demonstrated manageable safety profiles and durable clinical activity in patients with metastatic urothelial carcinoma (mUC) and other genitourinary (GU) malignancies, according to the final results of a study presented at the European Society for Medical Oncology (ESMO) 2017 Congress in Spain.1
For this dose determining phase 1 trial (ClinicalTrials.gov Identifier: NCT02496208), researchers enrolled 42 patients with mUC/GU malignancies and evaluated 7 doses in 2 parts. Patients in part 1 received CaboNivo and part 2 received CaboNivoIpi. Primary outcomes for the study were to determine the dose-limiting toxicity (DLT) and recommended phase 2 dose (RP2D). The median follow-up was 13.4 months.
Overall, 67% of patients experienced grade 3 to 4 adverse events (AEs). AEs were reported primarily in CaboNivo patients and included hypophosphatemia, neutropenia, fatigue, elevated lipase, diarrhea, hypertension, dehydration, thrombocytopenia, proteinuria, and leukopenia. Patients receiving CaboNivoIpi experienced hypophosphatemia, hypertension, fatigue, nausea, lymphopenia, and elevated lipase.
One report of grade 3 immune-related AEs occurred in each part; aseptic meningitis in part 1 and colitis in part 2.
No DLTs or grade 5 AEs were reported.
The RP2D was Cabo 40 mg/Nivo 3 mg/kg for CaboNivo, and Cabo 40 mg/Nivo 3 mg/Ipi 1 mg/kg for CaboNivoIpi.
The objective response rate was 35%, with 11 patients achieving partial response and 3 patients achieving complete response. The median duration of response was 7.1 months (95% CI, 5.1-not reached), median progression-free survival was 5.5 months (95% CI, 4.5-12.8), and median overall survival was not reached.
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Overall survival was 83.3% and 64.3% at 6 and 12 months, respectively.
Read more of Cancer Therapy Advisor's coverage of the European Society of Medical Oncology (ESMO) 2017 Congress by visiting the conference page.
- Nadal R, Mortazavi A, Stein M, et al. Final results of a phase I study of cabozantinib (cabo) plus nivolumab (nivo) and cabonivo plus ipilimumab (Ipi) in patients (pts) with metastatic urothelial carcinoma (mUC) and other genitourinary (GU) malignancies. Presented at: European Society for Medical