A study of NKTR-214 combined with Nivolumab vs Nivolumab alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma
- Conditions
- ntreated unresectable or metastatic melanomaMedDRA version: 20.0Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-001423-40-FI
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1020
- 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
- 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
- Secondary Outcome Measures
Name Time Method