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A Phase 1/2, Open-Label, Multicenter Study of the Combination of NKTR-214 and Nivolumab or the Combination of NKTR-214, Nivolumab and Other Anti-Cancer Therapies in Patients with Select Locally Advanced or Metastatic Solid Tumor Malignancies
This study is to determine first, the recommended Phase 2 dose of NKTR-214 when administered in combination with nivolumab, and then, the clinical benefit, safety, and tolerability of combining NKTR-214 with nivolumab in select patients with melanoma, renal cell carcinoma or non-small cell lung cancer. Both drugs target the immune system and may act synergistically to promote anti-cancer effects.
The Primary Objectives are: - To evaluate the safety and tolerability, and define the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of NKTR-214 in combination with nivolumab. - To evaluate the efficacy of NKTR-214 in combination with nivolumab by assessing the objective response rate (ORR) by RECIST 1.1 at the RP2D. The SecondaryOobjectives are: - To evaluate the efficacy of NKTR-214 in combination with nivolumab by assessing overall survival (OS) and progression-free survival (PFS). The Exploratory Objectives are: - To evaluate the efficacy of NKTR-214 in combination with nivolumab by assessing immune-related RECIST (irRECIST) at the RP2D. - To assess the immunological effects, and to accommodate disease-specific pharmacodynamics markers such as lactate dehydrogenase (LDH) (e.g., in melanoma), of NKTR-214 when administered in combination with nivolumab. - To characterize the pharmacokinetics (PK) of nivolumab and NKTR-214 and metabolites. - To assess the development of anti-drug antibodies against NKTR-214 and nivolumab when administered in combination. - To assess the association between efficacy measures and PD-L1 expression in tumors.