A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients With Advanced or Metastatic Melanoma
Study Details
Study Description
Brief Summary
The purpose of this study is to learn about the effects of three study medicines (encorafenib, binimetinib, and pembrolizumab) given together for the treatment of melanoma that:
-
is advanced or metastatic (spread to other parts of the body);
-
has a certain type of abnormal gene called "BRAF"; and
-
has not received prior treatment.
All participants in this study will receive pembrolizumab at the study clinic once every 3 weeks as an intravenous (IV) infusion (given directly into a vein). In addition, half of the participants will take encorafenib and binimetinib orally (by mouth) at home every day.
Participants may receive pembrolizumab for up to two years. Those participants taking encorafenib and binimetinib can continue until their melanoma is no longer responding. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Detailed Description
This study will compare the efficacy, safety, and tolerability of encorafenib and binimetinib plus pembrolizumab (Triplet Arm) versus placebo plus pembrolizumab (Control Arm) in participants with metastatic or unresectable locally advanced BRAF V600E/K mutation-positive melanoma. The study will have an open-label safety lead-in (SLI) phase to determine the safety recommend Phase 3 dose (RP3D) and pharmacokinetics (PK) of encorafenib and binimetinib plus pembrolizumab combination therapy prior to initiation of the randomized Phase 3 part of the study. Two dose levels of encorafenib in combination with binimetinib plus pembrolizumab will be explored in parallel. A minimum of 12 evaluable participants will be enrolled per dose level. During the double-blind randomized Phase 3 part of the study, approximately 600 eligible participants will be randomized in a 1:1 ratio to the Triplet Arm (at RP3D determined in the SLI) or Control Arm (approximately 300 participants per arm). Randomization will be stratified by prior systemic adjuvant therapy and stage of disease by AJCC (ED8).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Triplet Arm Encorafenib and Binimetinib in combination with Pembrolizumab |
Drug: Encorafenib
Encorafenib
Other Names:
Drug: Binimetinib
Binimetinib
Other Names:
Drug: Pembrolizumab
Pembrolizumab
Other Names:
|
| Active Comparator: Control Arm Pembrolizumab |
Drug: Pembrolizumab
Pembrolizumab
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Safety Lead In (SLI): Incidence of Dose Limiting Toxicities (DLTs) [First 2 Cycles of Treatment (cycles are 21 days)]
A DLT is defined as any adverse event or laboratory value that is assessed as unrelated to disease, disease progression, intercurrent illness or concomitant medications/therapies occurring within the first 2 cycles of treatment.
- Phase 3: Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) [Time from the date of randomization to the date of first documented disease progression, as determined by BICR assessment per RECIST v1.1, or death due to any cause, whichever occurs first (approximately every 9 weeks for 24 months)]
PFS is defined as the time from the date of randomization to the first date of documented disease progression as determined by BICR assessment per RECIST 1.1 or death due to any cause, whichever occurs first.
Secondary Outcome Measures
- 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. [Time from first dose of study intervention through 28 days after the last dose of study intervention.]
AEs, laboratory parameters, vital signs and cardiac abnormalities will be graded according to the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], version 4.03).
- Safety Lead in (SLI) and Phase 3: Objective Response Rate (ORR) [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).]
ORR is defined as the proportion of participants with a confirmed BOR of either CR or PR, as determined by BICR and investigator assessment per RECIST v1.1
- Safety Lead in (SLI) and Phase 3: Disease Control Rate (DCR) [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)]
DCR is defined as the proportion of participants with a confirmed BOR of CR, PR or SD, as determined by BICR and investigator assessment per RECIST v1.1.
- Safety Lead in (SLI) and Phase 3: Time to Response (TTR) [Time from the date of first dose to the date of first documented response (CR or PR), as determined by investigator assessment per RECIST v1 (approximately every 9 weeks)]
TTR is defined as the time from the date of randomization to the date of first documented response (CR or PR), as determined by BICR and investigator or assessment per RECIST v1.1.
- Phase 3: Overall Survival (OS) [Time from the date of randomization to the date of death due to any cause.]
OS is defined as the time from the date of randomization to the date of death due to any cause
- Phase 3: Progression Free Survival (PFS) by Investigator [The time from the date of randomization to the date of first documented disease progression, as determined by investigator assessment per RECIST v1.1, or death due to any cause, whichever occurs first (approximately every 9 weeks)]
PFS by investigator is defined as the time from the date of randomization to the first date of documented disease progression as determined by investigator assessment per RECIST 1.1 or death due to any cause, whichever occurs first.
- Phase 3: Duration of Response (DOR) [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)]
DOR is defined as the time from the date of first documented response to the date of first documented disease progression, as determined by BICR and investigator assessment or death due to any cause, whichever occurs first.
- Phase 3: Progression Free Survival 2 (PFS2) [The time from the date of randomization to the date of discontinuation of next-line treatment after first objective disease progression by investigator assessment per RECIST v1.1 (approximately every 9 weeks)]
PFS2 is defined as the time from the date of randomization to the date of discontinuation of next-line treatment after first objective disease progression by investigator assessment per RECIST v1.1
- Safety Lead in (SLI): Plasma concentration-time profiles and Pharmacokinetic (PK) parameter estimates for encorafenib and binimetinib. [Cycle 2, Day 1]
To measure plasma concentrations of encorafenib and its metabolite (LHY746), and binimetinib and its metabolite (AR00426032)
- Phase 3: Plasma concentrations of encorafenib and binimetinib. [Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1 (Each Cycle is 21 days)]
To measure the plasma concentrations of encorafenib and its metabolite (LHY746), and binimetinib and its metabolite (AR00426032)
- 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. [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]
EORTC QLQ-30 includes 5 functional scales (physical, role, emotional, cognitive and social functioning), 3 symptom scales (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial impact) and a global health status/Quality of Life scale
- Phase 3: Change from baseline in Functional Assessment of Cancer Therapy-Melanoma (FACT-M) subscale score. [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]
The FACT-M is a melanoma-specific quality of life questionnaire that is composed of items from the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire, melanoma-specific items, and items related to melanoma surgery
- Phase 3: Change from baseline in 5-level EuroQol-5D (EQ-5D-5L) index score and visual analog scale (VAS) [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]
The EQ-5D-5L is a standardized measure of health utility that provides a single index value of health status and contains 1 item for each of 5 dimensions of HRQoL (ie, mobility, self-care, usual activities, pain or discomfort, and anxiety or depression).
- Phase 3: Change from baseline in Patient Global Impression of Severity (PGIS) score [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]
The PGIS is a single 1-item questionnaire designed to assess participant's overall impression of disease severity at a given point in time by using a 4-point Likert scale that ranges from (1) = "none (no symptoms)" to (4) = "severe".
- Phase 3: Patient Global Impression of Change (PGIC) score [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]
The PGIC is a single-item questionnaire designed to assess the participant's overall sense of whether there has been a change since starting treatment as rated on a 5-point Likert scale anchored by (1) "much better" to (5) "much worse", with (4) = "no change"
Eligibility Criteria
Criteria
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.
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Histologically confirmed unresectable (Stage IIIB, IIIC, or IIID) or metastatic (Stage
- 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.
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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).
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Have not received prior first-line systemic therapy for metastatic or unresectable locally advanced melanoma.
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Adequate bone marrow function, hepatic and renal function.
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Capable of giving signed informed consent.
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.
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Mucosal or ocular melanoma.
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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).
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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).
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Unable to swallow, retain, and absorb oral medications.
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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.
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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.
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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.
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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.
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Participants who previously received and subsequently discontinued encorafenib and/or binimetinib and/or anti-PD-1/-L1 due to severe toxicity.
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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).
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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.
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Pregnant, confirmed by a positive β-hCG laboratory test result, or is breastfeeding (lactating).
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Banner-University Medical Center Tucson | Tucson | Arizona | United States | 85719 |
| 2 | The University of Arizona Cancer Center - North Campus | Tucson | Arizona | United States | 85719 |
| 3 | The University of Arizona Cancer Center-North Campus | Tucson | Arizona | United States | 85719 |
| 4 | UCLA - Hematology/Oncology - Administrative Office | Los Angeles | California | United States | 90024 |
| 5 | Ronald Reagan UCLA Medical Center Drug Information Center , Dept. of Pharmaceutical Services (Drug | Los Angeles | California | United States | 90095 |
| 6 | Ronald Reagan UCLA Medical Center, Drug Information Center, Dept. of Pharmaceutical Services (Main O | Los Angeles | California | United States | 90095 |
| 7 | UCLA Hematology/Oncology - Westwood (Building 100) | Los Angeles | California | United States | 90095 |
| 8 | UCHealth Sue Anschutz-Rodgers Eye Center | Aurora | Colorado | United States | 80045 |
| 9 | University of Colorado Denver CTO/CTRC | Aurora | Colorado | United States | 80045 |
| 10 | University of Colorado Hospital - Anschutz Cancer Pavilion (ACP) | Aurora | Colorado | United States | 80045 |
| 11 | University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP) | Aurora | Colorado | United States | 80045 |
| 12 | University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP) | Aurora | Colorado | United States | 80045 |
| 13 | Florida Cancer Specialists | Cape Coral | Florida | United States | 33909 |
| 14 | Florida Cancer Specialists | Fort Myers | Florida | United States | 33901 |
| 15 | AdventHealth Hematology and Oncology | Orlando | Florida | United States | 32804 |
| 16 | AdventHealth Orlando Infusion Center | Orlando | Florida | United States | 32804 |
| 17 | AdventHealth Orlando, Investigational Drug Services | Orlando | Florida | United States | 32804 |
| 18 | Advocate Medical Group-Park Ridge, Luther Lane-Oncology | Park Ridge | Illinois | United States | 60068 |
| 19 | The University of Kansas Cancer Center | Westwood | Kansas | United States | 66205 |
| 20 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 21 | Ophthalmic Consultants of Boston Inc (OCB) | Boston | Massachusetts | United States | 02114 |
| 22 | Revive Research Institute, Inc. | Farmington Hills | Michigan | United States | 48334 |
| 23 | Michigan Health Professionals | Farmington Hills | Michigan | United States | 48344 |
| 24 | St. Vincent Healthcare | Billings | Montana | United States | 59101 |
| 25 | St. Vincent Frontier Cancer Center | Billings | Montana | United States | 59102 |
| 26 | University of Cincinnati Medical Center | Cincinnati | Ohio | United States | 45219 |
| 27 | University of Cincinnati Medical Center | West Chester | Ohio | United States | 45069 |
| 28 | University of Tennessee Medical Center | Knoxville | Tennessee | United States | 37920 |
| 29 | Sarah Cannon Research Institute | Nashville | Tennessee | United States | 37203 |
| 30 | Tennessee Oncology, PLLC | Nashville | Tennessee | United States | 37203 |
| 31 | Texas Oncology - Carrollton | Carrollton | Texas | United States | 75010 |
| 32 | North Dallas Eye Associates | Flower Mound | Texas | United States | 75028 |
| 33 | Texas Oncology - Flower Mound | Flower Mound | Texas | United States | 75028 |
| 34 | Baylor Clinic | Houston | Texas | United States | 77030 |
| 35 | Baylor College of Medicine Medical Center | Houston | Texas | United States | 77030 |
| 36 | Baylor College of Medicine | Houston | Texas | United States | 77030 |
| 37 | CHI St. Luke's Health Baylor College of Medicine Medical Center | Houston | Texas | United States | 77030 |
| 38 | Harris Health System - Ben Taub Hospital | Houston | Texas | United States | 77030 |
| 39 | Harris Health System - Smith Clinic | Houston | Texas | United States | 77054 |
| 40 | Dan Brown O.D. | Paris | Texas | United States | 75460 |
| 41 | Texas Oncology-Paris | Paris | Texas | United States | 75460 |
| 42 | Baylor Scott & White Medical Center - Temple | Temple | Texas | United States | 76508 |
| 43 | Utah Cancer Specialists | American Fork | Utah | United States | 84003 |
| 44 | Utah Cancer Specialists | Bountiful | Utah | United States | 84010 |
| 45 | Utah Cancer Specialists | Layton | Utah | United States | 84041 |
| 46 | Utah Cancer Specialists | Murray | Utah | United States | 84157 |
| 47 | Utah Cancer Specialists | Ogden | Utah | United States | 84405 |
| 48 | Utah Cancer Specialists | Provo | Utah | United States | 84604 |
| 49 | Utah Cancer Specialists | Salt Lake City | Utah | United States | 84102 |
| 50 | Utah Cancer Specialists | Salt Lake City | Utah | United States | 84106 |
| 51 | Utah Cancer Specialists | West Jordan | Utah | United States | 84088 |
| 52 | Utah Cancer Specialists | West Valley City | Utah | United States | 84119 |
| 53 | Clinica Viedma S. A | Viedma | RÍO Negro | Argentina | 8500 |
| 54 | Complex Oncology Center - Plovdiv EOOD | Plovdiv | Bulgaria | 4004 | |
| 55 | Complex Oncology Center-Ruse EOOD | Ruse | Bulgaria | 7002 | |
| 56 | Medical Center Nadezhda Clinical EOOD | Sofia | Bulgaria | 1373 | |
| 57 | Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda EAD | Sofia | Bulgaria | 1407 | |
| 58 | Elbe Kliniken Stade-Buxtehude, Klinikum Buxtehude | Buxtehude | Niedersachsen | Germany | 21614 |
| 59 | SRH Wald-Klinikum Gera | Gera | Thüringen | Germany | 07548 |
| 60 | Helios Klinikum Erfurt | Erfurt | Germany | 99089 | |
| 61 | Universitätsklinikum Essen (AöR) | Essen | Germany | 45147 | |
| 62 | Pécsi Tudományegyetem Klinikai Központ | Pécs | Baranya | Hungary | 7632 |
| 63 | Semmelweis Egyetem | Budapest | Hungary | 1085 | |
| 64 | Orszagos Onkologiai Intezet | Budapest | Hungary | 1122 | |
| 65 | Debreceni Egyetem Klinikai Központ | Debrecen | Hungary | 4032 | |
| 66 | Szent-Gyorgyi Albert Klinikai Kozpont | Szeged | Hungary | 6720 | |
| 67 | Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház | Szolnok | Hungary | 5004 | |
| 68 | Fondazione IRCCS Istituto Nazionale dei Tumori | Milano | MI | Italy | 20133 |
| 69 | Istituto Dermopatico dell'Immacolata (IDI-IRCCS) | Roma | RM | Italy | 00167 |
| 70 | A.O.U.S. Policlinico "Le Scotte" | Siena | SI | Italy | 53100 |
| 71 | Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia | Candiolo | Torino | Italy | 10060 |
| 72 | Istituto Europeo di Oncologia IRCCS | Milano | Italy | 20141 | |
| 73 | Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" | Napoli | Italy | 80131 | |
| 74 | Istituto Oncologico Veneto IOV - IRCCS | Padova | Italy | 35128 | |
| 75 | AO di Perugia - Ospedale S. Maria della Misericordia, S.C Oncologia Medica | Perugia | Italy | 06132 | |
| 76 | Istituto Nazionale Tumori Regina Elena | Roma | Italy | 00144 | |
| 77 | New Zealand Clinical Research (Christchurch) | Christchurch | Canterbury | New Zealand | 8011 |
| 78 | Palmerston North Hospital | Palmerston North | Manawatu | New Zealand | 4414 |
| 79 | Auckland City Hospital | Auckland | New Zealand | 1023 | |
| 80 | Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu | Poznan | Poland | 60-780 | |
| 81 | Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy | Warszawa | Poland | 02-781 | |
| 82 | Private Medical Institution "Euromedservice" | Pushkin | Saint-petersburg | Russian Federation | 196603 |
| 83 | Ars Medika Center, LLC | Kaliningrad | Russian Federation | ||
| 84 | BIH of Omsk Region "Clinical Oncological Dispensary" | Omsk | Russian Federation | 644046 | |
| 85 | Eurocityclinic LLC | St.Petersburg | Russian Federation | 197022 | |
| 86 | SAHI Republican Clinical Oncology Dispensary of the Ministry of Health of Bashkortostan Republic | Ufa | Russian Federation | 450054 | |
| 87 | POKO Poprad, s.r.o. | Poprad | Slovakia | 058 01 | |
| 88 | ICO-Badalona Hospital Germans Trias i Pujol | Badalona | Barcelona | Spain | 08916 |
| 89 | Hospital Universitario Marqués de Valdecilla | Santander | Cantabria | Spain | 39008 |
| 90 | Hospital Universitario Puerta de Hierro Majadahonda | Majadahonda | Madrid | Spain | 28222 |
| 91 | Hospital Clinico Universitario Virgen de la Arrixaca | El Palmar | Murcia | Spain | 30120 |
| 92 | Complejo Hospitalario De Navarra | Pamplona | Navarra | Spain | 31008 |
| 93 | CHUAC-Hospital Teresa Herrera | A Coruña | Spain | 15006 | |
| 94 | Hospital Universitari Vall D'Hebron, Servicio de Oncología Médica | Barcelona | Spain | 08035 | |
| 95 | Hospital Clinic Barcelona | Barcelona | Spain | 08036 | |
| 96 | Hospital Universitario Reina Sofía | Cordoba | Spain | 14004 | |
| 97 | Complejo Hospitalario de Jaen | Jaen | Spain | 23007 | |
| 98 | Hospital Universitario Arnau de Vilanova | Lleida | Spain | 25198 | |
| 99 | Hospital General Universitario Gregorio Marañón | Madrid | Spain | 28007 | |
| 100 | Hospital Universitario Ramón y Cajal | Madrid | Spain | 28034 | |
| 101 | Hospital Regional Universitario de Malaga - Hospital Civil | Málaga | Spain | 29011 | |
| 102 | Hospital Universitario Virgen Macarena | Sevilla | Spain | 41009 | |
| 103 | Hospital Universitario Virgen del Rocio | Sevilla | Spain | 41013 | |
| 104 | Fundacion Instituto Valenciano de Oncologia | Valencia | Spain | 46009 | |
| 105 | Medical and diagnostic center of MedX-Ray International Group Limited Liability Company Israeli | Pliuty Village | KYIV Region, Obukhiv District | Ukraine | 08720 |
| 106 | Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council | Dnipro | Ukraine | 49102 | |
| 107 | Municipal non-profit enterprise Khmelnytsky regional antitumor center of Khmelnytsky regional | Khmelnytskyi | Ukraine | 29009 | |
| 108 | Municipal non-profit enterprise "Kyiv City Clinical Hospital No. 2" of the executive body of the | Kyiv | Ukraine | 02094 | |
| 109 | National Cancer Institute | Kyiv | Ukraine | 03022 | |
| 110 | Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Oncological Regional Therapeutica | Lviv | Ukraine | 79031 | |
| 111 | Derzhavna ustanova Instytut zahalnoi ta nevidkladnoi khirurhii im.V.T.Zaitseva Natsionalnoi akademii | M. Kharkiv | Ukraine | 61103 | |
| 112 | Komunalne nekomertsiine pidpryiemstvo Kharkivskoi oblasnoi rady "Oblasnyi klinichnyi spetsializovan | M. Kharkiv | Ukraine | 61166 | |
| 113 | Municipal non-profit enterprise "Zaporizhzhia Regional Antitumor Center" Zaporizhzhya Regional Counc | Zaporizhzhia | Ukraine | 69040 |
Sponsors and Collaborators
- Pfizer
- Merck Sharp & Dohme LLC
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- C4221016
- STARBOARD
- 2020-004850-31
- KEYNOTE-B80