At a glance
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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
In Brief
A Phase 2 clinical trial evaluating Dose Escalation Doublet: Combination of NKTR-214 + nivolumab, Dose Expansion Doublet: Combination of NKTR-214 + nivolumab, and 2 other interventions for Melanoma and 6 related conditions. Completed, enrolled 557 participants across 58 sites in 8 countries.
Detailed Summary
In this four-part study, NKTR-214 was administered in combination with nivolumab and with/without other anticancer therapies. Part 1 considered escalating doublet (NKTR 214 + nivolumab) doses to determine the RP2D. Part 2 considered dose expansion cohorts for the doublet (NKTR 214 + nivolumab ± chemotherapy). Part 3 was schedule-finding for a triplet therapy (NKTR 214 + nivolumab + ipilimumab). Part 4 dose expansion for the triplet (NKTR 214 + nivolumab + ipilimumab) was planned to further assess the efficacy of the RP2D triplet combination at dosing schedules from Part 3.
Study Details
Timeline
Interventions
NKTR 214 + nivolumab at 5 dosage levels.
Select patient cohorts with select tumor types will be dosed with NKTR-214 + nivolumab at the RP2D + other anti-cancer therapies per institution standard.
1L patients with RCC, NSCLC, UCC, and melanoma received NKTR-214 0.006 mg/kg q3w in combination with nivolumab and ipilimumab according to 3 dosing schedules.
Combination of NKTR-214 + nivolumab + ipilimumab was administered at RP2D dose/schedules in select tumor types