A Dose Escalation and Cohort Expansion Study of NKTR-214 in Combination With Nivolumab and Other Anti-Cancer Therapies in Patients With Select Advanced Solid Tumors
Completed · Phase 1/Phase 2
Conditions studied: Melanoma, Renal Cell Carcinoma, Non Small Cell Lung Cancer, Urothelial Carcinoma, Triple Negative Breast Cancer, HR+/HER2- Breast Cancer, Gastric Cancer
In brief
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.
Key facts
- Study ID
- NCT02983045
- Run by
- Nektar Therapeutics
- People needed
- 557
- Starts
- 2016-12-19
- Expected to finish
- 2022-04-28
- Last updated by the study team
- 2023-03-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- UCLA — Los Angeles, California, United States
- Stanford Cancer Institute — Stanford, California, United States
- University of Colorado, Denver — Denver, Colorado, United States
- Yale School of Medicine — New Haven, Connecticut, United States
- University of Florida — Gainesville, Florida, United States
- Orlando Health Inc. — Orlando, Florida, United States
- Emory University Hospital — Atlanta, Georgia, United States
- Loyola University Medical Center, Chicago — Maywood, Illinois, United States
- Indiana University Health Melvin & Bren Simon Cancer Center — Indianapolis, Indiana, United States
- University of Kansas Cancer Center — Kansas City, Kansas, United States
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
- Henry Ford Hospital — Detroit, Michigan, United States
- Washington University School of Medicine in St. Louis — St Louis, Missouri, United States
- Roswell Park Cancer Institute — Buffalo, New York, United States
- New York University Langone Medical Center - NYU Cancer Institute — New York, New York, United States
- Memorial Sloan-Kettering Cancer Center — New York, New York, United States
- Providence Portland Medical Center — Portland, Oregon, United States
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
- Inova Fairfax Hospital — Fairfax, Virginia, United States
- Virginia Cancer Specialists, PC — Fairfax, Virginia, United States
- Seattle Cancer Care Alliance — Seattle, Washington, United States
- Antwerp University Hospital — Edegem, Belgium
- Vzw Az Groeninge — Kortrijk, Belgium
- UZ Leuven — Leuven, Belgium
- UCSD, Moores Cancer Center — La Jolla, California, United States
Full record on ClinicalTrials.gov
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