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

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)

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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