A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Aone inParticipants 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-IT
• Lead Sponsor: BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-08
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• 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 and/or neoadjuvant treatment for melanoma with approved
agents
Are the trial subjects under 18? yes
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 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