Trial purpose
Cancer treatment
Tumor type
Skin
Age
18+
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 people with 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 (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
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
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