EUCTR2018-001423-40-PTActive, not recruitingPhase 1
A Phase 3, Randomized, Open-label Study of NKTR-214 Combined with Nivolumab Versus Nivolumab in Participants with Previously Untreated Unresectable or Metastatic Melanoma - 17-214-08
Bristol-Myers Squibb International Corporation0 sites1,009 target enrollmentStarted: May 24, 2019Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 1,009
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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: 50
- •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.
Investigators
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