A study of NKTR-214 combined with Nivolumab vs Nivolumab alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma

Phase 1

Conditions: ntreated unresectable or metastatic melanoma
MedDRA version: 20.0Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2018-001423-40-AT

Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1009

Inclusion Criteria

- Eastern Cooperative Oncology Group (ECOG) performance status of /= 80% (minors ages 12-17 only)
- Histologically confirmed stage III (unresectable) or stage IV melenoma
- Treatment-naive participants (ie, no prior systemic anticancer therapy for unresectable or metastatic melanoma) with the exception of prior adjuvant treatment and/or neoadjuvant treatment for melanoma with approved agents

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 555
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 404

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 could apply.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The purpose of this study is to determine whether an investigational immunotherapy NKTR-214, when combined with nivolumab, is more effective than nivolumab by itself in participants with unresectable or metastatic melanoma that is previously untreated;Secondary Objective: - To evaluate efficacy of NKTR-214 combined with nivolumab and that of nivolumab monotherapy<br>- To evaluate the association between PD-L1 tumor expression on tumor cells (= 1% or < 1%/indeterminate) and efficacy measures<br>including PFS and ORR by BICR and OS. -To evaluate the safety and tolerability of NKTR-214 combined with nivolumab and that of nivolumab monotherapy;Primary end point(s): 1. Overall response rate (ORR) by Blinded Independent central review (BICR) <br>2. Progression-free survival (PFS) by BICR<br>3. Overall survival (OS);Timepoint(s) of evaluation of this end point: 1- Approximately 16 months<br>2- Approximately 22 months<br>3- Up to 59 months

Secondary Outcome Measures