TerminatedPhase 1/2

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

Stopped: Based on the overall results from the Phase 1 part of the study the sponsor decided to end the study. The decision was not due to safety reasons.

United States64 participantsStarted 2018-03-15

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Key Inclusion Criteria: * Histologically confirmed diagnosis of a locally advanced (not amenable to curative therapy such as surgical resection) metastatic cancer of the following histologies: melanoma (MEL), Merkel cell carcinoma (MCC), triple-negative breast cancer (TNBC), renal cell carcinoma (RCC), colorectal cancer, head and neck squamous cell carcinoma (HNSCC), or sarcoma. * Life expectancy \> 12 weeks as determined by the Investigator. * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. * Measurable disease per RECIST 1.1. * Patients enrolled in Cohorts 1-10, Cohort A, Cohort B and Phase 2 Doublet must be refractory to all therapies known to confer clinical benefit to their disease. * Fresh tumor tissue available for cellular characterization and programmed cell death protein 1 (PD-L1) status. * Injected lesions (up to two) must be between 20 mm and 90 mm in diameter for IT injection; lesions must be accessible for baseline and on-treatment biopsies. Any liver lesion targeted for injection must not exceed 50 mm at the time of injection. * Demonstrated adequate organ function within 14 days of Cycle 1 Day 1 (C1D1). Key Exclusion Criteria: * Use of an investigational agent or an investigational device within 21 days before administration of first dose of study drug(s). * Patients treated with prior interleukin-2 (IL-2). * Patients who have been previously treated with a toll-like receptor (TLR) agonist (excluding topical agents) and patients who hav…

What they're measuring

Number of Participants Experiencing Dose-Limiting Toxicities (DLTS)

Timeframe: 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).

Objective Response Rate (ORR) Per RECIST 1.1 in Cohort A and Cohort B at Recommended Phase 2 Dose (RP2D)

Timeframe: From Cycle 1 Day 1 to 100 days after the last dose of study drug or the date for new anti-cancer therapy, whichever is earlier.

Trial details

NCT IDNCT03435640

SponsorNektar Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-05-09

Results submitted2022-11-30

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