Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:23 PM
Ignite Modification Date:
2025-12-24 @ 3:23 PM
NCT ID:
NCT02967692
Eligibility Criteria:
Inclusion criteria 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 Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT02967692
Study Brief:
Protocol Section:
NCT02967692