REVEAL Study of NKTR-262 in Combination With NKTR-214 and Nivolumab in Patients With Locally Advanced / Metastatic Solid Tumor Malignancies

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Nektar Therapeutics
Study ID
NCT03435640
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NKTR-262 — DRUG
    During Phase 1 Doublet: Patients receive escalating doses of NKTR-262 IT (starting dose 0.03 mg) in 3-week treatment cycles. During Phase 1 Doublet (Cohort A), Phase 2 Doublet: Patients were to receive the RP2D of NKTR-262. During Phase 1 Triplet (Cohort B), and Phase 2 Triplet: Patients receive the RP2D of NKTR-262.
  • bempegaldesleukin — DRUG
    During Phase 1 Doublet (Cohort A), and proposed Phase 2 Doublet: Patients receive 0.006 mg/kg bempegaldesleukin administered in 3-week treatment cycles. During Phase 1 Triplet (Cohort B), and proposed Phase 2 Triplet: Patients receive 0.006 mg/kg bempegaldesleukin administered in 3-week treatment cycles.
  • nivolumab — DRUG
    During Phase 1 Triplet (Cohort B), and proposed Phase 2 Triplet: Patients receive a nivolumab flat dose of 360 mg administered in 3-week treatment cycles.

Study Details

Patients received intratumoral (IT) injections of NKTR-262 in 3-week cycles for up to 3 cycles; bempegaldesleukin with or without nivolumab was administered every 3 weeks (q3w), and treatment continued until unacceptable toxicity, death, or disease progression per RECIST 1.1. Based on Phase 1 results of the study, the decision was made not to start the Phase 2 part of the study and the study was terminated.

Key Dates

Start date
Mar 15, 2018
Status verified
Feb 2023
Primary completion
May 9, 2022
Completion
May 9, 2022

Study Design

Enrollment
64 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: NKTR-262 + bempegaldesleukin or + bempegaldesleukin with nivolumab
    Phase 1: NKTR-262 in escalating doses, combined with bempegaldesleukin. The goal of this dose escalation part of the study is to establish a recommended Phase 1b dose for NKTR-262 + bempegaldesleukin with nivolumab, followed by a dose-confirmation cohort.

Primary Outcome Measure

Number of Participants Experiencing Dose-Limiting Toxicities (DLTS) [ Time Frame: The DLT window is 21 days following NKTR-262 single agent administration (Cycle 1) and an additional 9 days when combined with bempeg for staggered dosing administration (Cohorts 1 and 2), or 7 days for the same day administration (Cohort 3 and higher). ]

Locations (14)

FacilityCityStateZIPSite coordinators
HonorHealthScottsdaleArizona85258-
UC San Diego Moores Cancer CenterLa JollaCalifornia92093-
Moffitt Cancer CenterTampaFlorida33612-
Winship Cancer Center, Emory University HospitalAtlantaGeorgia30322-
University of Kansas Research CenterFairwayKansas66205-
Henry Ford Health SystemDetroitMichigan48202-
Masonic Cancer Center, University of MinnesotaMinneapolisMinnesota55455-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Duke University Medical CenterDurhamNorth Carolina27710-
Cleveland ClinicClevelandOhio44195-
Providence Portland Medical CenterPortlandOregon97213-
University of Texas Southwestern Medical CenterDallasTexas75390-
MD Anderson Cancer CenterHoustonTexas77030-
Seattle Cancer Care AllianceSeattleWashington98109-

Find similar trials in Scottsdale, AZ

By condition
Colorectal cancerHead and neck cancerMelanomaKidney cancerBreast cancer
By specialty
OncologyGI oncologyENTSkin cancerDermatologyUrologyBreast oncologyWomen's health
By research site
HonorHealth· Scottsdale, AZUC San Diego Moores Cancer Center· La Jolla, CAMoffitt Cancer Center· Tampa, FLWinship Cancer Center, Emory University Hospital· Atlanta, GAUniversity of Kansas Research Center· Fairway, KSHenry Ford Health System· Detroit, MI

Related Studies