Study of safety and efficacy of PDR001 in combination with dabrafenib and trametinib in patients with advanced melanoma

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223604

Enrollment

Registered

2017-07-31

Start date

2017-07-25

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

melanoma

Interventions

PDR001 in combination with dabrafenib and trametinib or placebo in combination with dabrafenib and trametinib

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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 - 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

Exclusion criteria

Exclusion criteria: Parts 2 & 3: Biomarker cohort & double-blind, randomized, placebo-controlled part - Subjects with uveal or mucosal melanoma - Clinically active cerebral melanoma metastasis - Prior systemic anti-cancer treatment for unresectable or metastatic melanoma - Prior loco-regional treatment for unresectable or metastatic melanoma in the last 6 month - Prior neoadjuvant and/or adjuvant therapy for melanoma completed less than 6 months - Radiation therapy within 4 weeks prior to start of study treatment - Active, known, suspected or a documented history of autoimmune disease

Design outcomes

Primary

Measure	Time frame
Part 2: Biomarker cohort - To evaluate changes in PD-L1 levels and CD8+ cells upon treatment with PDR001 in combination with dabrafenib and trametinib Part 3: Double-blind, randomized, placebo-controlled part - To compare the anti-tumor activity of PDR001 in combination with dabrafenib and trametinib versus placebo plus dabrafenib and trametinib as measured by PFS per investigator assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.	—

Measure

Time frame

Part 2: Biomarker cohort - To evaluate changes in PD-L1 levels and CD8+ cells upon treatment with PDR001 in combination with dabrafenib and trametinib Part 3: Double-blind, randomized, placebo-controlled part - To compare the anti-tumor activity of PDR001 in combination with dabrafenib and trametinib versus placebo plus dabrafenib and trametinib as measured by PFS per investigator assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

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Countries

Asia except Japan, Europe, Japan, North America, Oceania

Contacts

Public ContactKyosuke Yamauchi

Novartis Pharma. K.K.

rinshoshiken.toroku2@novartis.com+81-120-003-293

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026