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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04657991




Registration number
NCT04657991
Ethics application status
Date submitted
1/12/2020
Date registered
8/12/2020

Titles & IDs
Public title
A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients With Advanced or Metastatic Melanoma
Scientific title
A PHASE 3, RANDOMIZED, DOUBLE-BLIND STUDY OF ENCORAFENIB AND BINIMETINIB PLUS PEMBROLIZUMAB VERSUS PLACEBO PLUS PEMBROLIZUMAB IN PARTICIPANTS WITH BRAF V600E/K MUTATION-POSITIVE METASTATIC OR UNRESECTABLE LOCALLY ADVANCED MELANOMA
Secondary ID [1] 0 0
STARBOARD
Secondary ID [2] 0 0
C4221016
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Encorafenib
Treatment: Drugs - Binimetinib
Treatment: Drugs - Pembrolizumab

Experimental: Triplet Arm - Encorafenib and Binimetinib in combination with Pembrolizumab

Active comparator: Control Arm - Pembrolizumab


Treatment: Drugs: Encorafenib
Encorafenib

Treatment: Drugs: Binimetinib
Binimetinib

Treatment: Drugs: Pembrolizumab
Pembrolizumab
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety Lead In (SLI): Incidence of Dose Limiting Toxicities (DLTs)
Timepoint [1] 0 0
First 2 Cycles of Treatment (cycles are 21 days)
Primary outcome [2] 0 0
Phase 3: Objective Response (OR) by Blinded Independent Central Review (BICR)
Timepoint [2] 0 0
Time from the date of randomization until documented PD, start of subsequent anticancer therapy, or death due to any cause (approximately every 9 weeks).
Secondary outcome [1] 0 0
Safety Lead in (SLI) and Phase 3: Incidence and severity of Adverse Events (AEs) and changes in clinical laboratory parameters, vital signs, and cardiac assessments.
Timepoint [1] 0 0
Time from first dose of study intervention through 28 days after the last dose of study intervention.
Secondary outcome [2] 0 0
Safety Lead in (SLI) and Phase 3: Objective Response (OR)
Timepoint [2] 0 0
Time from the date after the first dose of first dose (SLI) or the date of randomization (Phase 3) until documented PD, or start of subsequent anticancer therapy (approximately every 9 weeks).
Secondary outcome [3] 0 0
Safety Lead in (SLI) and Phase 3: Disease Control (DC)
Timepoint [3] 0 0
Time from the date after the first dose of first dose (SLI) or the date of randomization (Phase 3) until documented PD, or start of subsequent anticancer therapy (approximately every 9 weeks)
Secondary outcome [4] 0 0
Safety Lead in (SLI) and Phase 3: Time to Response (TTR)
Timepoint [4] 0 0
Time from the date of randomization to the date of first documented response (CR or PR), as determined by investigator assessment per RECIST v1 (approximately every 9 weeks)
Secondary outcome [5] 0 0
Phase 3: Overall Survival (OS)
Timepoint [5] 0 0
Time from the date of randomization to the date of death due to any cause.
Secondary outcome [6] 0 0
Safety Lead In (SLI) and Phase 3: Progression Free Survival (PFS) by Investigator and BICR assessment
Timepoint [6] 0 0
The time from the date of randomization to the date of first documented disease progression, as determined by investigator and BICR assessment per RECIST v1.1, or death due to any cause, whichever occurs first (approximately every 9 weeks)
Secondary outcome [7] 0 0
Phase 3: Duration of Response (DOR)
Timepoint [7] 0 0
Time from date of first documented response (CR or PR) to the date of first documented disease progression, as determined by BICR and investigator assessment per RECIST v1.1, or death due to any cause, whichever occurs first (approximately every 9 weeks)
Secondary outcome [8] 0 0
Safety Lead in (SLI): Plasma concentration-time profiles and Pharmacokinetic (PK) parameter estimates for encorafenib and binimetinib.
Timepoint [8] 0 0
Cycle 2, Day 1
Secondary outcome [9] 0 0
Phase 3: Plasma concentrations of encorafenib and binimetinib.
Timepoint [9] 0 0
Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1 (Each Cycle is 21 days)
Secondary outcome [10] 0 0
Phase 3: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30): change from baseline in the global health status/QoL score.
Timepoint [10] 0 0
Day 1 of every 3 cycles: C4D1, C7D1, C10D1, etc. for the first 24 months and then Day 1 of every 4 cycles after 24 months
Secondary outcome [11] 0 0
Phase 3: Change from baseline in Functional Assessment of Cancer Therapy-Melanoma (FACT-M) subscale score.
Timepoint [11] 0 0
Day 1 of every 3 cycles: C4D1, C7D1, C10D1, etc. for the first 24 months and then Day 1 of every 4 cycles after 24 months
Secondary outcome [12] 0 0
Phase 3: Change from baseline in 5-level EuroQol-5D (EQ-5D-5L) index score and visual analog scale (VAS)
Timepoint [12] 0 0
Day 1 of every 3 cycles: C4D1, C7D1, C10D1, etc. for the first 24 months and then Day 1 of every 4 cycles after 24 months
Secondary outcome [13] 0 0
Phase 3: Change from baseline in Patient Global Impression of Severity (PGIS) score
Timepoint [13] 0 0
Day 1 of every 3 cycles: C4D1, C7D1, C10D1, etc. for the first 24 months and then Day 1 of every 4 cycles after 24 months
Secondary outcome [14] 0 0
Phase 3: Patient Global Impression of Change (PGIC) score
Timepoint [14] 0 0
Day 1 of every 3 cycles: C4D1, C7D1, C10D1, etc. for the first 24 months and then Day 1 of every 4 cycles after 24 months

Eligibility
Key inclusion criteria
* Male or female participants = 18 years at the time of informed consent.
* Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
* Histologically confirmed unresectable (Stage IIIB, IIIC, or IIID) or metastatic (Stage IV) cutaneous melanoma, according to the AJCC 8th edition.
* Presence of at least 1 measurable lesion as detected by radiological and/or photographic methods according to RECIST v1.1.
* ECOG performance status 0 or 1.
* Documented evidence of a BRAF V600E or V600K mutation in melanoma tumor tissue as previously determined by either PCR or NGS-based local laboratory assay (eg, US FDA-approved test, CE-marked [European conformity] in vitro diagnostic in EU countries, or equivalent), obtained during the course of normal clinical care, in a CLIA- or similarly certified laboratory.
* Submission of adequate tumor tissue (archival or newly obtained; block or slides to the sponsor central laboratory(ies) during the screening period and prior to enrollment (SLI)/randomization (Phase 3).
* Have not received prior first-line systemic therapy for metastatic or unresectable locally advanced melanoma.
* Adequate bone marrow function, hepatic and renal function.
* Capable of giving signed informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

* Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study (including, but not limited to, a participant who is rapidly progressing or has clinically significant tumor related symptoms, in the judgment of the investigator).
* Mucosal or ocular melanoma.
* Diagnosis of immunodeficiency or an active autoimmune disease that required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
* Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear IgA dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).
* Unable to swallow, retain, and absorb oral medications.
* Impairment of GI function or disease which may significantly alter the absorption of oral study intervention (eg, uncontrolled nausea, vomiting or diarrhea, malabsorption syndrome, including malabsorption syndrome secondary to prior GI surgery).
* Clinically significant cardiovascular diseases,
* History of thromboembolic or cerebrovascular events = 12 weeks prior to enrollment (SLI)/randomization (Phase 3). Examples include transient ischemic attacks, cerebrovascular accidents, hemodynamically significant (ie, massive or sub-massive) deep vein thrombosis or pulmonary emboli.
* History or current evidence of RVO or current risk factors for RVO (eg, uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes)
* Concurrent neuromuscular disorder that is associated with the potential of elevated CK (eg, inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy).
* Current noninfectious pneumonitis or history of noninfectious pneumonitis requiring steroids, or history of radiation pnuemonitis
* Evidence of HBV or HCV infection.
* Known history of a positive test for HIV or known AIDS.
* Any active infection requiring systemic therapeutic treatment within 2 weeks prior to enrollment (SLI)/ randomization (Phase 3).
* Participants with prior or current symptomatic brain metastasis, leptomeningeal disease or other active CNS metastases.
* Concurrent or previous other malignancy within 2 years of study entry, except curatively treated basal or squamous cell skin cancer, prostate intraepithelial neoplasm, carcinoma in-situ of the cervix, Bowen's disease and Gleason = 6 prostate cancer. Participants with a history of other curatively treated cancers must be reviewed with the sponsor or designee prior to entering the study.
* Participants who previously received and subsequently discontinued encorafenib and/or binimetinib and/or anti-PD-1/-L1 due to severe toxicity.
* For participants in the SLI only: Current use or anticipated need for food or drugs that are known moderate or strong CYP3A4 inhibitors during screening and through the DLT-evaluation period
* Participant has not recovered to Grade = 1 from toxic effects of prior therapy and/or complications from prior surgical intervention before enrollment (SLI)/ randomization (Phase 3).
* Receipt of protocol defined medications or treatments outside of required intervals before enrollment (SLI)/randomization (Phase 3):
* Previous administration with an investigational drug = 6 months prior to enrollment (SLI)/randomization (Phase 3).
* Known sensitivity or contraindication to any component of study intervention (encorafenib, binimetinib and pembrolizumab), or their excipients.
* Pregnant, confirmed by a positive ß-hCG laboratory test result, or is breastfeeding (lactating).
* Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/01/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
Accrual to date
Final
257
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
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Texas
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Utah
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RÍO Negro
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Santa FE
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Rouen
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Saint-Etienne Cedex 2
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Villejuif
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Bayern
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Murcia
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Cordoba
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Jaen
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Lleida
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Málaga
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Sevilla
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Valencia
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Spain
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Zaragoza
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Switzerland
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Winterthur
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Switzerland
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Zürich Flughafen
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Turkey
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I?stanbul
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Turkey
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Ankara
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Ukraine
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KYIV Region, Obukhiv District
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Ukraine
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Dnipro
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Ukraine
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Khmelnytskyi
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Ukraine
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Kyiv
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Ukraine
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Lviv
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Ukraine
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M. Kharkiv
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Ukraine
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Zaporizhzhia
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United Kingdom
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Nottinghamshire
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United Kingdom
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London
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United Kingdom
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Nottingham
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United Kingdom
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Swansea

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04657991