Clinical Trials Search
Clinical Trial 19480
Cancer Type: Multiple
Study Type: Treatment
NCT#: NCT03435640
Phase: Phase I/II
Prinicipal Investigator: Andrew Brohl
Study Title
The Reveal Study: A Phase 1/2, Open-Label, Multicenter, Dose Escalation And Dose Expansion Study Of Nktr-262 In Combination With Bempegaldesleukin (Nktr-214) And In combination With Bempegaldesleukin (Nktr-214) Plus Nivolumab In Patients With Locally Advanced Or Metastatic Solid Tumor Malignancies
Summary
This is an investigational study of a drug called NKTR-262 that will be given together with a drug called NKTR-214 and also possibly another drug called Opdivo® (nivolumab). NKTR-262, also referred to as "Study Drug A", is an investigational drug. The purpose of this study is to test the safety, tolerability, and effectiveness (how well these drugs work together) of the Study Drug A (NKTR-262) and Study Drug B (NKTR-214) given together ("Doublet therapy"), or of the Study Drug A and Study Drug B given with Study Drug C ( Opdivo®) ("Triplet therapy").
Objective
The Primary Objectives are: To evaluate the safety and tolerability, and define the maximum tolerated dose (MTD) or RP2D of NKTR-262 in combination with NKTR-214 (doublet) and the safety and tolerability of NKTR-262 and NKTR-214 plus nivolumab (triplet). To evaluate the anti-tumor activity of the combination of NKTR-262 plus NKTR-214 (doublet) and the combination of NKTR-262 and NKTR-214 plus nivolumab (triplet) by assessing the objective response rate (ORR) by RECIST 1.1. The Secondary Objectives are: To evaluate the anti-tumor activity of the combination of NKTR-262 plus NKTR-214 (doublet) and the combination of NKTR-262 and NKTR-214 plus nivolumab (triplet) by assessing progression-free survival (PFS) and overall survival (OS). To evaluate the proportion of patients with an abscopal response by RECIST 1.1 assessed 9 weeks after the initiation of treatment of NKTR-262 plus NKTR-214 or NKTR-262 and NKTR-214 plus nivolumab. The Exploratory Objectives are: To evaluate the efficacy of the combination of NKTR-262 and NKTR-214 (doublet) and the combination of NKTR-262, NKTR-214 and nivolumab (triplet) by assessing ORR by immune-related RECIST (irRECIST). To assess the effects of the combination of NKTR-262 and NKTR-214 (doublet) and of the combination of NKTR-262 and NKTR-214 plus nivolumab (triplet) on immune cells in blood and tumor. To characterize the pharmacokinetics (PK) of NKTR-262, NKTR-214 and their metabolites, and nivolumab when administered in combination. To assess the immunogenicity of NKTR-214 and nivolumab when given in combination with NKTR-262. To assess the association between efficacy measures and PD-L1 expression in tumors. To assess the association between anti-tumor activity and immune cells in tumor and blood. To assess the association between efficacy measures and tumor mutational burden (TMB) in tumors and blood. To assess the effect of NKTR-262 on QT/QTc interval using exposure response analysis.
Therapies
Medications
BMS-936558 (Nivolumab); NKTR-214 (Bempegaldesleukin); NKTR-262 (); Nivolumab (Opdivo)
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