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Closed (no longer recruiting)Last updated: 6 October 2023

ARRAY 165-112: This Phase I trial is evaluating how safe and effective combining to targeted therapies (binimetinib and encorafenib) is in adolescents with BRAF V600-mutant advanced or metastatic melanomaA Multicenter, Open-label Phase 1b Study of the Combination of Binimetinib and Encorafenib in Adolescent Patients With Unresectable or Metastatic BRAF V600-mutant Melanoma

Clinical summary

Summary

This is an open-label, non-randomised trial with two phases. The first phase, the Safety Run-In Phase, is to determine the recommended dose for the second phase, the Expansion Phase. Binimetinib will be taken twice daily (orally) and encorafenib will be taken once daily (orally). Dose levels by patient body surface area for binimetinib and encorafenib tablets/capsules are specified in the protocol.

Conditions

This trial is treating patients with melanoma.

Cancer

Skin Cancers Skin

Age

People12 - 17

Phase

I

Trial Acronym

ARRAY 165-112

More information

Trial Identifiers

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Commercial Sponsor

Pfizer

Scientific Title

A Multicenter, Open-label Phase 1b Study of the Combination of Binimetinib and Encorafenib in Adolescent Patients With Unresectable or Metastatic BRAF V600-mutant Melanoma

Eligibility

Inclusion

  • You are able to swallow medication by mouth.
  • Your cancer has not spread to other parts of the body.
  • 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.

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