MedTrace Logo

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

NCT02983045 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 557

Last updated 2023-03-13

Study results available
· View outcomes & findings →

Summary

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.

Conditions

Interventions

DRUG

Dose Escalation Doublet: Combination of NKTR-214 + nivolumab

NKTR 214 + nivolumab at 5 dosage levels.

DRUG

Dose Expansion Doublet: Combination of NKTR-214 + nivolumab

Select patient cohorts with select tumor types will be dosed with NKTR-214 + nivolumab at the RP2D + other anti-cancer therapies per institution standard.

DRUG

Schedule Finding Triplet: Combination of NKTR-214+ nivolumab+ ipilimumab

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.

DRUG

Dose Expansion Triplet: Combination of NKTR-214+ nivolumab+ ipilimumab

Combination of NKTR-214 + nivolumab + ipilimumab was administered at RP2D dose/schedules in select tumor types

Sponsors & Collaborators

Principal Investigators

  • Study Director · Nektar Therapeutics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-19
Primary Completion
2022-04-28
Completion
2022-04-28
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • France
  • Italy
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02983045 on ClinicalTrials.gov