A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma



Status:Recruiting
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/29/2019
Start Date:February 17, 2017
End Date:July 11, 2023
Contact:Novartis Pharmaceuticals
Email:novartis.email@novartis.com
Phone:1-888-669-6682

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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

To evaluate the safety and efficacy of the combination of an anti-PD-1 antibody
(Spartalizumab (PDR001)), a BRAF inhibitor (dabrafenib) and a MEK inhibitor (trametinib) in
unresectable or metastatic BRAF V600 mutant melanoma


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

- 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

- 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:

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

- 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

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

Other protocol-defined Inclusion/Exclusion may apply.
We found this trial at
23
sites
Orange, California 92868
Principal Investigator: John P. Fruehauf
Phone: 714-456-5048
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Aurora, Colorado 80045
Principal Investigator: Theresa Medina
Phone: 720-848-7135
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Boston, Massachusetts 02114
Principal Investigator: Ryan Sullivan
Phone: 617-724-3173
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Caba, Buenos Aires
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Columbia, Missouri 65211
(573) 882-2121
Principal Investigator: Puja Nistala
Phone: 573-882-4979
University of Missouri T he University of Missouri was founded in 1839 in Columbia, Mo.,...
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Principal Investigator: Jade Homsi
Phone: 214-648-1929
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Fayetteville, Arkansas 72703
Principal Investigator: J. Thaddeus Beck
Phone: 479-587-1700
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Hackensack, New Jersey 07601
Principal Investigator: Andrew L. Pecora
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Houston, TX
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Knoxville, Tennessee 37920
Principal Investigator: Timothy J Panella
Phone: 865-305-5483
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2360 West Joppa Road
Lutherville, Maryland 21093
Principal Investigator: William Sharfman
Phone: 410-583-2983
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New York, New York 10016
Principal Investigator: Melissa Wilson
Phone: 929-455-2435
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New York, New York 10029
Principal Investigator: Philip Friedlander
Phone: 212-824-7324
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Omaha, Nebraska 68114
Principal Investigator: Ralph Hauke
Phone: 402-691-6972
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Pittsburgh, Pennsylvania 15232
Principal Investigator: John M. Kirkwood
Phone: 412-647-8587
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Portland, Oregon 97239
Principal Investigator: Matthew Taylor
Phone: 503-418-1208
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Salt Lake City, Utah 84106
Principal Investigator: DiSean Kendall
Phone: 801-270-2239 ext. 234
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16918 Dove Canyon Road
San Diego, California 92024
Principal Investigator: Edward McClay
Phone: 760-747-8935
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45 Castro Street
San Francisco, California 94114
(415) 600-6000
Principal Investigator: Kevin B. Kim
Phone: 415-600-3472
California Pacific Medical Center California Pacific Medical Center is one of the largest private, not-for-profit,...
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1635 Divisadero Street
San Francisco, California 94143
Principal Investigator: Adil Daud
Phone: 415-514-5630
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Stanford, California 94305
Principal Investigator: Sunil Arani Reddy
Phone: 650-725-9810
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Tampa, Florida 33612
Principal Investigator: Nikhil Khushalani
Phone: 813-745-6440
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Westwood, Kansas 66205
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