A Phase 1/2, Open-label, Multicenter Study of The Combination of Bempegaldesleuklin (NKTR-214) and Nivolumab or The Combination of Bempegaldesleuklin (NKTR-214), Nivolumab, and Other Anti-Cancer Therapies in Patients with Select Locally Advanced or Metastatic Solid Tumor Malignancies
MD Anderson Study Status
Combination of NKTR-214 + nivolumab, Combination of NKTR-214 + nivolumab + ipilimumab
In this four-part study, NKTR-214 will be administered in combination with nivolumab in Part 1, in combination with nivolumab with or without various chemotherapies in Part 2, and with nivolumab and ipilimumab in Parts 3 & 4. In Part 1, the Recommended Phase 2 Dose (RP2D) of NKTR-214 in combination with nivolumab will be determined. In Part 2, NKTR-214 with nivolumab at the RP2D will be evaluated as first-line therapy and/or as second or third line therapy in select patients with Melanoma, Renal Cell Carcinoma (RCC), Non-Small Cell Lung Cancer (NSCLC), Urothelial Carcinoma (UC), metastatic Breast Cancer (mBC) and Colorectal Cancer (CRC). In addition, in Part 2, the RP2D of NKTR-214 with nivolumab and various chemotherapies and regimens in select cohorts of NSCLC patients will be determined. In Part 3, several different regimens of the triplet combination of NKTR-214 plus nivolumab and ipilimumab will be evaluated in select patients with RCC, NSCLC, Melanoma, and UC. In Part 4, the safety and efficacy of the triplet combination will be evaluated further in select patients with RCC, NSCLC, Melanoma and UC.
Information and next steps
Melanoma, Renal Cell Carcinoma, Non Small Cell Lung Cancer, Urothelial Carcinoma, Metastatic Breast Cancer, Colorectal Cancer
Melanoma Medical Oncology
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