A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Completed
Phase 3

Conditions

Melanoma

Treatments

Biological: NKTR-214
Biological: Nivolumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT03635983
17-214-08 (Other Identifier)
CA045-001
2018-001423-40 (EudraCT Number)

Details and patient eligibility

About

The purpose of the study is to test the effectiveness (how well the drug works), safety, and tolerability of the investigational drug called NKTR-214, when combined with nivolumab versus nivolumab given alone in participants with previously untreated melanoma skin cancer that is either unable to be surgically removed or has spread

Enrollment

783 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤1 (adults 18 years or older)/Lansky Performance Score ≥ 80% (minors ages 12-17 only)
  • Histologically confirmed stage III (unresectable) or stage IV melanoma
  • Treatment-naive participants (ie, no prior systemic anticancer therapy for unresectable or metastatic melanoma) with the exception of prior adjuvant and/or neoadjuvant treatment for melanoma with approved agents

Exclusion criteria

  • Active brain metastases or leptomeningeal metastases
  • Uveal melanoma
  • Participants with an active, known or suspected autoimmune disease

Other protocol defined inclusion/exclusion criteria apply

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

783 participants in 2 patient groups

Combination
Experimental group
Description:
NKTR-214 + Nivolumab
Treatment:
Biological: Nivolumab
Biological: NKTR-214
Monotherapy
Experimental group
Description:
Nivolumab
Treatment:
Biological: Nivolumab

Trial documents
1

Trial contacts and locations

167

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Data sourced from clinicaltrials.gov

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