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

Conditions

• Gastric Cancer
• HR+/HER2- Breast Cancer
• Melanoma
• Non Small Cell Lung Cancer
• Renal Cell Carcinoma
• Triple Negative Breast Cancer
• Urothelial Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Dose Escalation Doublet: Combination of NKTR-214 + nivolumab — DRUG
  NKTR 214 + nivolumab at 5 dosage levels.
• Dose Expansion Doublet: Combination of NKTR-214 + nivolumab — DRUG
  Select patient cohorts with select tumor types will be dosed with NKTR-214 + nivolumab at the RP2D + other anti-cancer therapies per institution standard.
• Schedule Finding Triplet: Combination of NKTR-214+ nivolumab+ ipilimumab — DRUG
  1L patients with RCC, NSCLC, UCC, and melanoma received NKTR-214 0.006 mg/kg q3w in combination with nivolumab and ipilimumab according to 3 dosing schedules.
• Dose Expansion Triplet: Combination of NKTR-214+ nivolumab+ ipilimumab — DRUG
  Combination of NKTR-214 + nivolumab + ipilimumab was administered at RP2D dose/schedules in select tumor types

Study Details

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 Dates

Start date

Dec 19, 2016

Status verified

Mar 2023

Primary completion

Apr 28, 2022

Completion

Apr 28, 2022

Study Design

Enrollment

557 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Dose Escalation: Combination of NKTR-214 + nivolumab
  NKTR 214 + nivolumab at 5 dosage levels to determine the RP2D Part 1 of RP2D in patients with advanced or metastatic melanoma, RCC, NSCLC, urothelial carcinoma, or TNBC.
• Experimental: Dose Expansion: Combination of NKTR-214 + nivolumab
  NKTR-214+nivolumab in patients with advanced or metastatic solid tumor malignancies to assess the efficacy of the RP2D.
• Experimental: Experimental: Combination of NKTR-214 + nivolumab + ipilimumab
  To assess the safety and tolerability of NKTR 214 + nivolumab + ipilimumab triplet therapy and establish RP2D dosing schedules for Part 4 in patients with advanced or metastatic melanoma, RCC, NSCLC, or UCC in a first-line setting (1L).
• Experimental: Experimental: Dose Expansion of Part 3
  To further assess the RP2D triplet combination dosing schedules from Part 3 in 1L NSCLC and 1L RCC patients.

Primary Outcome Measure

Part 1 Dose Escalation: Incidence of Dose-limiting Toxicity (DLT) During the DLT Evaluation Window [ Time Frame: Includes DLTs that occurred within the DLT window of at least 21 days after the first dose of study treatment (28 days for every 2 weeks dosing; 21 days for every 3 weeks dosing). Patients were counted only once under each preferred term. ]

Locations (22)

Find similar trials in La Jolla, CA

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