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 sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02983045.
Locations matching your search criteria
United States
Kansas
Westwood
University of Kansas Hospital-Westwood Cancer CenterStatus: Active
Name Not Available
Part 1 enrolled patients with advanced or metastatic melanoma, renal cell carcinoma
(RCC), non-small cell lung cancer (NSCLC), urothelial carcinoma, or triple negative
breast cancer (TNBC) to determine the recommended Phase 2 dose (RP2D) or maximum
tolerated dose (MTD) of NKTR 214 + nivolumab doublet therapy.
Part 2 enrolled patients with advanced or metastatic solid tumor malignancies (including
9 tumor types consisting of the same 5 tumor types as in Part 1, plus hormone receptor
positive human epidermal growth factor receptor 2 [HER 2] negative breast cancer [HR+
HER2- BC], gastric cancer, colorectal carcinoma, and small cell lung cancer [SCLC]) to
assess the efficacy of the RP2D.
Part 3 enrolled patients with advanced or metastatic melanoma, RCC, NSCLC, or urothelial
carcinoma (UCC) in a first-line setting (1L) to assess the safety and tolerability of
NKTR 214 + nivolumab + ipilimumab triplet therapy Three dosing schedules were evaluated
to establish RP2D dosing schedules for Part 4 of the study.
Part 4 planned to enroll patients with advanced or metastatic melanoma, RCC, NSCLC, or
UCC to further assess the efficacy of the RP2D triplet combination at the 3 dosing
schedules from Part 3. Patients were enrolled simultaneously to each tumor cohort.
All patients enrolled in the study were closely monitored for safety, tolerability and
response per RECIST criteria. The primary efficacy endpoint was objective response rate
(ORR) using RECIST 1.1 at the RP2D doublet.