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

This phase III trial is evaluating the addition of PDR001 biological therapy to two chemotherapy drugs (Dabrafenib and Trametinib) in patients with previously untreated metastatic BRAF V600 mutant melanomaA Randomized, Double-blind, Placebo-controlled, Phase III Study Comparing the Combination of PDR001, Dabrafenib and Trametinib Versus Placebo, Dabrafenib and Trametinib in Previously Untreated Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma

Clinical summary

Summary

This trial will evaluate the safety and efficacy of the combination of an anti-PD-1 antibody (PDR001), a BRAF inhibitor (dabrafenib) and a MEK inhibitor (trametinib) in unresectable or metastatic BRAF V600 mutant melanoma. It will be conducted across two arms and the investigational arm will be divided into three parts, including - Part 1: Safety run-in, up to 18 evaluable patients with previously untreated unresectable or metastatic BRAF V600 mutated melanoma will be enrolled and treated at different dose levels to determine the recommended Phase 3 regimen of PDR001 in combination with dabrafenib and trametinib. Part 2: Biomarker cohort, approximately 20 patients with previously unresectable or metastatic BRAF V600 mutated melanoma will be enrolled to describe changes in the immune microenvironment and biomarker modulations Part 3: Randomized double blind, approximately 500 patients with previously untreated unresectable and metastatic BRAF V600 mutated melanoma will be enrolled to compare the anti-tumor activity of PDR001 in combination with dabrafenib and trametinib versus placebo plus dabrafenib and trametinib.

Conditions

This trial is treating patients with BRAF V600 mutant melanoma.

Cancer

Skin Cancers Skin

Age

People18+

Phase

III

More information

Trial Identifiers

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Trial sponsor

Novartis Pharmaceuticals

Scientific Title

A Randomized, Double-blind, Placebo-controlled, Phase III Study Comparing the Combination of PDR001, Dabrafenib and Trametinib Versus Placebo, Dabrafenib and Trametinib in Previously Untreated Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma

Eligibility

Inclusion

Part 1: Safety run-in

  • Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation
  • Aspartate transaminase (AST) < 2.5× ULN and Alanine transaminase (ALT) < 2.5× ULN
  • Measurable disease according to RECIST 1.1
  • ECOG performance status ≤ 1

Part 2: Biomarker cohort

  • Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation
  • At least two cutaneous or subcutaneous or nodal lesions for tumor sample collection
  • Measurable disease according to RECIST 1.1
  • ECOG performance status ≤ 2

Part 3: Double-blind, randomized, placebo-controlled part

  • Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation
  • ECOG performance status ≤ 2
  • Measurable disease according to RECIST 1.1

Exclusion

Part 1: Safety run-in

  • Subjects with uveal or mucosal melanoma
  • Any history of CNS metastases
  • Prior systemic anti-cancer treatment for unresectable or metastatic melanoma
  • Neoadjuvant and/or adjuvant therapy for melanoma completed less than 6 months prior to enrollmen
  • Radiation therapy within 4 weeks prior to start of study treatment
  • Active autoimmune disease, and/or history of autoimmune disease(s) that required treatment

Parts 2 & 3: Biomarker cohort & double-blind, randomized, placebo-controlled part

  • Subjects with uveal or mucosal melanoma
  • Prior systemic anti-cancer treatment for unresectable or metastatic melanoma
  • Neoadjuvant and/or adjuvant therapy for melanoma completed less than 6 months prior to enrollment
  • Radiation therapy within 4 weeks prior to start of study treatment
  • Clinically active cerebral melanoma metastasis.
  • Active autoimmune disease, and/or history of autoimmune disease(s) that required treatment

Other protocol-defined Inclusion/Exclusion may apply.

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • 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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