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Closed (no longer recruiting)Last updated: 7 February 2024

This phase III trial is trying to determine how well an investigational drug (NKTR-214) works when combined with an immunotherapy drug (Nivolumab) for the treatment of previously untreated melanoma skin cancer that is either unable to be surgically removed or has spreadA Phase 3, Randomized, Open-label Study of NKTR-214 Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Unresectable or Metastatic Melanoma

Clinical summary

Summary

This is a randomised trial, in which patients will either receive NKTR-214 + Nivolumab or Nivolumab alone (as a monotherapy) at specified doses on specified days of treatment.

Conditions

This trial is treating patients with melanoma.

Cancer

Skin Cancers Skin

Age

People12+

Phase

III

More information

Trial Identifiers

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Trial sponsor

Bristol-Myers Squibb (BMS)

Scientific Title

A Phase 3, Randomized, Open-label Study of NKTR-214 Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Unresectable or Metastatic Melanoma

Eligibility

Inclusion

  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤1 (adults 18 years or older)/Lansky Performance Score ≥ 80% (minors ages 12-17 only)
  • Histologically confirmed stage III (unresectable) or stage IV melanoma
  • 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

Exclusion

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

Other protocol defined inclusion/exclusion criteria apply

Inclusion

  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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