Source: https://www.mycancergenome.org/content/clinical_trials/NCT02130466/
Timestamp: 2019-08-25 17:40:00
Document Index: 347213697

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Clinical Trial: NCT02130466 - My Cancer Genome
https://clinicaltrials.gov/show/NCT02130466
A Study of the Safety and Efficacy of <span class="go-doc-concept go-doc-intervention">Pembrolizumab (MK-3475)</span> in Combination With <span class="go-doc-concept go-doc-intervention">Trametinib</span> and <span class="go-doc-concept go-doc-intervention">Dabrafenib</span> in Participants With Advanced <span class="go-doc-concept go-doc-disease">Melanoma</span> (<span class="go-doc-concept go-doc-intervention">MK-3475</span>-022/KEYNOTE-022)
Brief Title: A Study of the Safety and Efficacy of Pembrolizumab (MK-3475) in Combination With Trametinib and Dabrafenib in Participants With Advanced Melanoma (MK-3475-022/KEYNOTE-022)
NCT ID: NCT02130466
ORG ID: 3475-022
Dabrafenib Pembro+D+T (Parts 1, 2, and 3), Placebo+D+T (Part 3), Pembro+D (Parts 1 and 2)
Trametinib Pembro+D+T (Parts 1, 2, and 3), Placebo+D+T (Part 3), Pembro+T (Parts 1 and 2)
This is a 3-part dose-finding and preliminary efficacy study of pembrolizumab (Pembro) +
dabrafenib (D) + trametinib (T) for participants with advanced melanoma. Parts 1 and 2 are
open-label to find and confirm the maximum tolerated dose (MTD)/maximum administered dose
(MAD) for Pembro+D+T. The primary hypothesis (Parts 1 and 2) is that Pembro+D+T is
sufficiently well-tolerated to permit clinical investigation. Part 3 is a double-blind study
of Pembro+D+T versus placebo+D+T. The primary study hypothesis (Part 3 only) is that the
Pembro+D+T improves progression-free survival (PFS) compared with placebo+D+T. Parts 1 and 2
of the study will also explore the MTD/MAD for open-label Pembro+T (for v-raf murine sarcoma
viral oncogene homolog B1 [BRAF] mutation-negative participants) concurrently with the
Pembro+D+T arm; Pembro+D (for BRAF mutation-positive participants) may be initiated in Parts
Pembro+D+T (Parts 1, 2, and 3) Experimental Participants receive pembrolizumab intravenously (IV) on Days 1 and 22 of each 6-week cycle; dabrafenib capsules, 150 mg/day total, orally, in a divided dose (twice per day, or BID) starting on Day 1, through study treatment discontinuation; and trametinib tablets, 2 mg, orally, once daily (QD) starting on Day 1, through study treatment discontinuation. Dabrafenib, Trametinib
Placebo+D+T (Part 3) Placebo Comparator Participants receive placebo IV on Days 1 and 22 of each 6-week cycle; dabrafenib capsules, 150 mg/day total, orally, in a divided dose BID starting on Day 1, through study treatment discontinuation; and trametinib tablets, 2 mg, orally, QD starting on Day 1, through study treatment discontinuation. Dabrafenib, Trametinib
Pembro+T (Parts 1 and 2) Experimental Participants receive pembrolizumab IV on Days 1 and 22 of each 6-week cycle and trametinib tablets, 2 mg, orally, QD starting on Day 1, through study treatment discontinuation. Trametinib
Pembro+D (Parts 1 and 2) Experimental Participants receive pembrolizumab IV on Days 1 and 22 of each 6-week cycle and dabrafenib capsules, 150 mg/day total, orally, in a divided dose BID starting on Day 1, through study treatment discontinuation. Dabrafenib
- Histologically-confirmed diagnosis of advanced (unresectable Stage III) or metastatic
(Stage IV) melanoma excluding uveal, mucosal, or ocular melanoma
- At least 1 measurable lesion as defined by Response Evaluation Criteria in Solid
Tumors Version 1.1 (RECIST 1.1) on imaging studies (computed tomography [CT] or
- BRAF mutation-positive (V600 E or K) tumor, or for Parts 1 and 2 only BRAF
mutation-negative (wild type) tumor with documented progression of >=1 measurable
lesion after prior therapy (if prior therapy was received)
- Anticipated life expectancy of at least 3 months
- Able to swallow and retain oral medication and no clinically significant
- Provide tissue for biomarker analysis from a newly or recently-obtained biopsy
(within 60 days of Study Day 1) of a tumor lesion not previously irradiated
- Female participant of non-childbearing potential or willing to use adequate
contraceptive measures from the Screening Visit (Visit 1) through 120 days after the
last dose of study drug; male participants must agree to use an adequate method of
- Female participants of childbearing potential should have a negative urine or serum
pregnancy test within 72 hours prior to receiving the first dose of study drug
or using an investigational device within 4 weeks of the first dose of study drug
- Prior systemic therapy (for participants who are BRAF mutation-positive), or BRAF
mutation-negative and has received >1 prior systemic therapy for metastatic melanoma
- Prior therapy with compounds targeting the programmed cell death 1(PD-1), PD-1 ligand
1(PD-L1), BRAF, mitogen-activated protein kinase (MEK) or other molecules in the
- BRAF mutation-positive and has received prior therapy with ipilimumab or other
anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) blocking antibodies
- Chemotherapy, radioactive, or biological cancer therapy within 4 weeks prior to the
first dose of study drug, or not recovered from clinically significant adverse events
due to cancer therapeutics administered more than 4 weeks prior to the first dose of
while in this study
- Known history of a hematologic malignancy or of another primary solid tumor, unless
the participant has undergone potentially curative therapy with no evidence of that
disease for 5 years, or underwent successful definitive resection of basal or
squamous cell carcinoma of the skin, superficial bladder cancer, in situ cervical
cancer, in situ breast cancer or other in situ cancers
- Active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Active autoimmune disease, or document history of autoimmune disease, or a syndrome
- On chronic systemic steroid therapy (>10 mg/day prednisone or equivalent) within 2
weeks prior to first dose of study drug or on any other form of immunosuppressive
- Uncorrectable electrolyte abnormalities, long QT syndrome or taking medications known
to prolong the QT interval
- History of prior or current retinal vein occlusion (RVO)
chemically related to the study drugs, their excipients, and/or dimethyl sulfoxide
- Has had an allogeneic tissue/solid organ transplant, prior stem cell or bone marrow
- Received a live vaccine within 30 days prior to first dose of study drug
- Pregnant or breastfeeding or expecting to conceive or father children from the
Screening Visit (Visit 1) through 120 days after last dose of study drug