An Investigational Immunotherapy Study of NKTR-214 and Nivolumab vs Nivolumab alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma

Phase 1

• Conditions: ntreated unresectable or metastatic melanoma; MedDRA version: 20.0 Level: LLT Classification code 10027481 Term: Metastatic melanoma System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-001423-40-GB
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-03
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 1020

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
Are the trial subjects under 18? yes
Number of subjects for this age range: 51
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 561
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 408

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified