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A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic Colorectal Cancer (SEAMARK)

Primary Purpose

Metastatic Colorectal Cancer

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Encorafenib
Cetuximab
Pembrolizumab
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring Keynote-D31, BRAF V600E mutation positive, Colon cancer, Rectal cancer, Metastatic colon cancer, Colon cancer BRAF, Rectal cancer BRAF, MSI-H colorectal cancer, MSI-H colon cancer

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Locally confirmed microsatellite instability-high/ deficient mismatch repair (MSI-H/dMMR) stage IV colorectal carcinoma
  • Locally confirmed BRAF V600E mutation in tumor tissue or blood
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Have not received prior systemic regimens for metastatic disease.
  • Measurable disease per RECIST 1.1
  • Adequate organ function

Exclusion Criteria:

  • Colorectal adenocarcinoma that is RAS mutant or for which RAS mutation status is unknown
  • Known active central nervous system metastases and/or carcinomatous meningitis; leptomeningeal disease
  • Immunodeficiency or active autoimmune disease requiring systemic treatment in the past 2 years
  • Presence of acute or chronic pancreatitis
  • Clinically significant cardiovascular diseases (eg, thromboembolic or cerebrovascular accident events ≤ 12 wks prior)
  • Received a live or live-attenuated vaccine within 30 days of planned start of study medication
  • Previous treatment with any selective BRAF inhibitor (eg, encorafenib, dabrafenib, vemurafenib, XL281/BMS-908662) or any epidermal growth factor receptor (EGFR) inhibitor (eg, cetuximab, panitumumab).
  • Previous treatment with an immune checkpoint inhibitor (eg, anti-programmed cell death [PD-1], anti-PD-L1 or anti-PD-L2 agent); or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).

Sites / Locations

  • Mayo Clinic Building - PhoenixRecruiting
  • Mayo Clinic HospitalRecruiting
  • Mayo ClinicRecruiting
  • Keck Hospital of USCRecruiting
  • Keck School of Medicine of USCRecruiting
  • LAC USC Medical CenterRecruiting
  • USC Norris Comprehensive Cancer CenterRecruiting
  • USC/Norris Comprehensive Cancer Center / Investigational Drug ServicesRecruiting
  • USC/Norris Comprehensive Cancer CenterRecruiting
  • Keck Hospital of USC PasadenaRecruiting
  • Mount Sinai Cancer CenterRecruiting
  • University of Miami Hospital and Clinics, Sylvester Cancer CenterRecruiting
  • University of Miami Hospital and Clinics, Sylvester Cancer CenterRecruiting
  • Mayo Clinic Cancer Center Outpatient PharmacyRecruiting
  • Mayo ClinicRecruiting
  • Columbia University Medical CenterRecruiting
  • The West Clinic, PLLC dba West Cancer CenterRecruiting
  • MD Anderson Cancer CenterRecruiting
  • Chris O'Brien LifehouseRecruiting
  • GenesisCare North ShoreRecruiting
  • Gallipoli Medical Research FoundationRecruiting
  • Greenslopes Private HospitalRecruiting
  • Austin HealthRecruiting
  • Peter MacCallum Cancer CentreRecruiting
  • Royal Melbourne HospitalRecruiting
  • Imelda General HospitalRecruiting
  • Institut Jules BordetRecruiting
  • Cliniques universitaires Saint-LucRecruiting
  • UZ GentRecruiting
  • UZ LeuvenRecruiting
  • ZNA MiddelheimRecruiting
  • William Osler Health SystemRecruiting
  • The Ottawa Hospital - General CampusRecruiting
  • Sunnybrook Health Sciences - Odette Cancer CentreRecruiting
  • CIUSSS de l'Est-de-l'Île-de-MontréalRecruiting
  • Saskatoon Cancer CenterRecruiting
  • Fakultni nemocnice Hradec KraloveRecruiting
  • Fakultni nemocnice OlomoucRecruiting
  • Fakultni Thomayerova nemocniceRecruiting
  • Fakultni nemocnice BulovkaRecruiting
  • RigshospitaletRecruiting
  • Herlev and Gentofte HospitalRecruiting
  • Aalborg Universitetshospital, SydRecruiting
  • Vejle SygehusRecruiting
  • Hôpital Européen Georges PompidouRecruiting
  • CHU EstaingRecruiting
  • Centre Hospitalier Universitaire EstaingRecruiting
  • Institut Regional du Cancer de Montpellier - ICM Val d'AurelleRecruiting
  • Institut Régional du Cancer MontpellierRecruiting
  • Hôpital Saint AntoineRecruiting
  • Muenchen Klinik Neuperlach, Klinik fuer Haematologie und OnkologieRecruiting
  • Institut für Klinisch Onkologische ForschungRecruiting
  • Klinikum OldenburgRecruiting
  • Studiengesellschaft BSF UnternehmergesellschaftRecruiting
  • Universitätsklinikum LeipzigRecruiting
  • Onkologische Schwerpunktpraxis KurfuerstendammRecruiting
  • Studiengesellschaft BSF UGRecruiting
  • Facharztzentrum EppendorfRecruiting
  • Policlinico Universitario MonserratoRecruiting
  • Azienda Ospedaliera Universitaria dell'Università "Luigi Vanvitelli" Piazza Luigi Miraglia, 2 NapolRecruiting
  • Ospedale di GuastallaRecruiting
  • IRCCS Casa Sollievo della SofferenzaRecruiting
  • ASST Grande Ospedale Metropolitano NiguardaRecruiting
  • Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'OncologiaRecruiting
  • Azienda USL Toscana Nord Ovest_Ospedale Civile di LivornoRecruiting
  • Azienda Ospedaliero Universitaria PisanaRecruiting
  • Istituto Oncologico Veneto IRCCSRecruiting
  • Fondazione Poliambulanza Istituto OspedalieroRecruiting
  • Istituto Europeo di Oncologia IRCCSRecruiting
  • Arcispedale Santa Maria NuovaRecruiting
  • Maastricht UMC+Recruiting
  • Haaglanden MC - locatie AntoniushoveRecruiting
  • St. Olavs HospitalRecruiting
  • Oslo Universitetssykehus UllevålRecruiting
  • Przychodnia Lekarska KOMEDRecruiting
  • Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. MarkiewiczaRecruiting
  • SPZOZ Wojewodzki Szpital Specjalistyczny nr 4 w BytomiuRecruiting
  • Copernicus Podmiot Leczniczy Sp. z o.o. Wojewodzkie Centrum OnkologiiRecruiting
  • Radomskie Centrum Onkologii im. Bohaterow Radomskiego Czerwca 76Recruiting
  • Fakultna nemocnica s poliklinikou F. D. Roosevelta Banska BystricaRecruiting
  • Onkologicky ustav sv. Alzbety, s.r.o.Recruiting
  • Narodny onkologicky ustavRecruiting
  • Vychodoslovensky onkologicky ustav, a.s.Recruiting
  • CHUS - Hospital Clinico UniversitarioRecruiting
  • Hospital General Universitario de ElcheRecruiting
  • Hospital Universitari Vall d'HebronRecruiting
  • Hospital Clínic de BarcelonaRecruiting
  • Institut Català d'Oncologia - L'HospitaletRecruiting
  • Hospital Universitario Ramón y CajalRecruiting
  • Hospital Universitario 12 de OctubreRecruiting
  • Hospital General Universitario Gregorio MarañonRecruiting
  • Hospital Universitario 12 de OctubreRecruiting
  • Hospital Universitario Virgen Del RocioRecruiting
  • Hospital General Universitario de ValenciaRecruiting
  • Hospital Universitario Miguel ServetRecruiting
  • Karolinska Universitetssjukhuset SolnaRecruiting
  • SödersjukhusetRecruiting
  • Skaraborgs Sjukhus SkövdeRecruiting
  • Aberdeen Royal InfirmaryRecruiting
  • Guy's & St Thomas's NHS Foundation TrustRecruiting
  • Guy's & St Thomas' NHS Foundation TrustRecruiting
  • Heartlands HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A: encorafenib, cetuximab and pembrolizumab

Arm B: pembrolizumab

Arm Description

Participants receive encorafenib orally + cetuximab IV + pembrolizumab IV.

Participants receive pembrolizumab IV.

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS)
PFS per investigator, defined as the time from randomization until PD based on investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause, whichever occurs first:

Secondary Outcome Measures

Incidence of adverse events
Incidence and severity of AEs graded according to the NCI CTCAE v4.03: encorafenib and cetuximab + pembrolizumab (Arm A) vs pembrolizumab (Arm B)
Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death due to any cause: encorafenib and cetuximab + pembrolizumab (Arm A) vs pembrolizumab (Arm B)
Objective Response (OR)
OR is defined as a CR or PR per RECIST version 1.1 recorded from the date of randomization until date of first documentation of PD, death, or start of new anti-cancer therapy: encorafenib and cetuximab + pembrolizumab (Arm A) vs pembrolizumab (Arm B)

Full Information

First Posted
January 19, 2022
Last Updated
October 23, 2023
Sponsor
Pfizer
Collaborators
Merck Sharp & Dohme LLC, Merck KGaA, Darmstadt, Germany, Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT05217446
Brief Title
A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic Colorectal Cancer
Acronym
SEAMARK
Official Title
A PHASE 2, RANDOMIZED, OPEN-LABEL STUDY OF ENCORAFENIB AND CETUXIMAB PLUS PEMBROLIZUMAB VERSUS PEMBROLIZUMAB ALONE IN PARTICIPANTS WITH PREVIOUSLY UNTREATED BRAF V600E-MUTANT, MSI H/DMMR METASTATIC COLORECTAL CANCER
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 11, 2022 (Actual)
Primary Completion Date
March 28, 2026 (Anticipated)
Study Completion Date
March 28, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
Collaborators
Merck Sharp & Dohme LLC, Merck KGaA, Darmstadt, Germany, Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to learn about the effects of three study medicines (encorafenib, cetuximab, and pembrolizumab) given together for the treatment of colorectal cancer that: is metastatic (spread to other parts of the body); has the condition of genetic hypermutability (tendency to mutation) or impaired DNA mismatch repair (MMR) 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 as an intravenous (IV) infusion (given directly into a vein) at the study clinic. In addition, half of the participants will take encorafenib by mouth at home every day and cetuximab by IV infusion at the study clinic. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
Keynote-D31, BRAF V600E mutation positive, Colon cancer, Rectal cancer, Metastatic colon cancer, Colon cancer BRAF, Rectal cancer BRAF, MSI-H colorectal cancer, MSI-H colon cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
This is an open-label, multicenter study of encorafenib and cetuximab plus pembrolizumab (Triplet Arm [Arm A]) versus pembrolizumab alone (Control Arm [Arm B]) as first-line treatment in participants with BRAF inhibitor (BRAF) V600E-mutant and microsatellite instability-high/ deficient mismatch repair (MSI-H/dMMR) mCRC. Randomization will be stratified by ECOG (0 vs 1)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A: encorafenib, cetuximab and pembrolizumab
Arm Type
Experimental
Arm Description
Participants receive encorafenib orally + cetuximab IV + pembrolizumab IV.
Arm Title
Arm B: pembrolizumab
Arm Type
Active Comparator
Arm Description
Participants receive pembrolizumab IV.
Intervention Type
Drug
Intervention Name(s)
Encorafenib
Other Intervention Name(s)
PF-07263896 LGX818 ONO-7702 W0090
Intervention Description
capsule
Intervention Type
Biological
Intervention Name(s)
Cetuximab
Other Intervention Name(s)
Erbitux
Intervention Description
IV
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
Keytruda, Lambrolizumab b MK-3475
Intervention Description
IV
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
PFS per investigator, defined as the time from randomization until PD based on investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause, whichever occurs first:
Time Frame
Duration of study, approximately 45 months
Secondary Outcome Measure Information:
Title
Incidence of adverse events
Description
Incidence and severity of AEs graded according to the NCI CTCAE v4.03: encorafenib and cetuximab + pembrolizumab (Arm A) vs pembrolizumab (Arm B)
Time Frame
Duration of study, approximately 45 months
Title
Overall Survival (OS)
Description
OS is defined as the time from the date of randomization to the date of death due to any cause: encorafenib and cetuximab + pembrolizumab (Arm A) vs pembrolizumab (Arm B)
Time Frame
Duration of study, approximately 45 months
Title
Objective Response (OR)
Description
OR is defined as a CR or PR per RECIST version 1.1 recorded from the date of randomization until date of first documentation of PD, death, or start of new anti-cancer therapy: encorafenib and cetuximab + pembrolizumab (Arm A) vs pembrolizumab (Arm B)
Time Frame
Duration of study, approximately 45 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Locally confirmed microsatellite instability-high/ deficient mismatch repair (MSI-H/dMMR) stage IV colorectal carcinoma Locally confirmed BRAF V600E mutation in tumor tissue or blood Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Have not received prior systemic regimens for metastatic disease. Measurable disease per RECIST 1.1 Adequate organ function Exclusion Criteria: Colorectal adenocarcinoma that is RAS mutant or for which RAS mutation status is unknown Known active central nervous system metastases and/or carcinomatous meningitis; leptomeningeal disease Immunodeficiency or active autoimmune disease requiring systemic treatment in the past 2 years Presence of acute or chronic pancreatitis Clinically significant cardiovascular diseases (eg, thromboembolic or cerebrovascular accident events ≤ 12 wks prior) Received a live or live-attenuated vaccine within 30 days of planned start of study medication Previous treatment with any selective BRAF inhibitor (eg, encorafenib, dabrafenib, vemurafenib, XL281/BMS-908662) or any epidermal growth factor receptor (EGFR) inhibitor (eg, cetuximab, panitumumab). Previous treatment with an immune checkpoint inhibitor (eg, anti-programmed cell death [PD-1], anti-PD-L1 or anti-PD-L2 agent); or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pfizer CT.gov Call Center
Phone
1-800-718-1021
Email
ClinicalTrials.gov_Inquiries@pfizer.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic Building - Phoenix
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Individual Site Status
Recruiting
Facility Name
Keck Hospital of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Name
Keck School of Medicine of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Name
LAC USC Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Name
USC Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Name
USC/Norris Comprehensive Cancer Center / Investigational Drug Services
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Name
USC/Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Name
Keck Hospital of USC Pasadena
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Individual Site Status
Recruiting
Facility Name
Mount Sinai Cancer Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Miami Hospital and Clinics, Sylvester Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Miami Hospital and Clinics, Sylvester Cancer Center
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic Cancer Center Outpatient Pharmacy
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Name
The West Clinic, PLLC dba West Cancer Center
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Individual Site Status
Recruiting
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Chris O'Brien Lifehouse
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Individual Site Status
Recruiting
Facility Name
GenesisCare North Shore
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Individual Site Status
Recruiting
Facility Name
Gallipoli Medical Research Foundation
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4120
Country
Australia
Individual Site Status
Recruiting
Facility Name
Greenslopes Private Hospital
City
Greenslopes
State/Province
Queensland
ZIP/Postal Code
4120
Country
Australia
Individual Site Status
Recruiting
Facility Name
Austin Health
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Individual Site Status
Recruiting
Facility Name
Peter MacCallum Cancer Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Individual Site Status
Recruiting
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Individual Site Status
Recruiting
Facility Name
Imelda General Hospital
City
Bonheiden
State/Province
Antwerpen
ZIP/Postal Code
2820
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Institut Jules Bordet
City
Anderlecht
State/Province
Bruxelles-capitale, Région DE
ZIP/Postal Code
1070
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Cliniques universitaires Saint-Luc
City
Brussels
State/Province
Bruxelles-capitale, Région DE
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UZ Gent
City
Gent
State/Province
Oost-vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UZ Leuven
City
Leuven
State/Province
Vlaams-brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
ZNA Middelheim
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Individual Site Status
Recruiting
Facility Name
William Osler Health System
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6R 3J7
Country
Canada
Individual Site Status
Recruiting
Facility Name
The Ottawa Hospital - General Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Sunnybrook Health Sciences - Odette Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Name
CIUSSS de l'Est-de-l'Île-de-Montréal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
h1t2m4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Saskatoon Cancer Center
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N4H4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Hradec Kralove
City
Hradec Kralove
State/Province
Hradec Králové
ZIP/Postal Code
500 05
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Olomouc
City
Olomouc
State/Province
Olomoucký KRAJ
ZIP/Postal Code
779 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni Thomayerova nemocnice
City
Prague
State/Province
Praha 4
ZIP/Postal Code
14059
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Bulovka
City
Prague
State/Province
Praha 8
ZIP/Postal Code
180 81
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Rigshospitalet
City
Copenhagen
State/Province
Hovedstaden
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Herlev and Gentofte Hospital
City
Copenhagen
State/Province
Hovedstaden
ZIP/Postal Code
2730
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Aalborg Universitetshospital, Syd
City
Aalborg
State/Province
Nordjylland
ZIP/Postal Code
9000
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Vejle Sygehus
City
Vejle
State/Province
Syddanmark
ZIP/Postal Code
7100
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Hôpital Européen Georges Pompidou
City
Paris Cedex 15
State/Province
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Estaing
City
Clermont Ferrand
ZIP/Postal Code
63100
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire Estaing
City
Clermont-Ferrand
ZIP/Postal Code
63100
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Regional du Cancer de Montpellier - ICM Val d'Aurelle
City
Montpellier Cedex 5
ZIP/Postal Code
34298
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Régional du Cancer Montpellier
City
Montpellier
ZIP/Postal Code
34298
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Saint Antoine
City
Paris
ZIP/Postal Code
75571
Country
France
Individual Site Status
Recruiting
Facility Name
Muenchen Klinik Neuperlach, Klinik fuer Haematologie und Onkologie
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81737
Country
Germany
Individual Site Status
Recruiting
Facility Name
Institut für Klinisch Onkologische Forschung
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60488
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum Oldenburg
City
Oldenburg
State/Province
Niedersachsen
ZIP/Postal Code
26133
Country
Germany
Individual Site Status
Recruiting
Facility Name
Studiengesellschaft BSF Unternehmergesellschaft
City
Halle (Saale)
State/Province
Sachsen-anhalt
ZIP/Postal Code
06108
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Leipzig
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Name
Onkologische Schwerpunktpraxis Kurfuerstendamm
City
Berlin
ZIP/Postal Code
10707
Country
Germany
Individual Site Status
Recruiting
Facility Name
Studiengesellschaft BSF UG
City
Halle /Saale
ZIP/Postal Code
06108
Country
Germany
Individual Site Status
Recruiting
Facility Name
Facharztzentrum Eppendorf
City
Hamburg
ZIP/Postal Code
20249
Country
Germany
Individual Site Status
Recruiting
Facility Name
Policlinico Universitario Monserrato
City
Monserrato
State/Province
Cagliari
ZIP/Postal Code
09042
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Universitaria dell'Università "Luigi Vanvitelli" Piazza Luigi Miraglia, 2 Napol
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale di Guastalla
City
Guastalla
State/Province
Emilia-romagna
ZIP/Postal Code
42016
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS Casa Sollievo della Sofferenza
City
San Giovanni Rotondo
State/Province
Foggia
ZIP/Postal Code
71013
Country
Italy
Individual Site Status
Recruiting
Facility Name
ASST Grande Ospedale Metropolitano Niguarda
City
Milan
State/Province
Milano
ZIP/Postal Code
20162
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
City
Candiolo
State/Province
Torino
ZIP/Postal Code
10060
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda USL Toscana Nord Ovest_Ospedale Civile di Livorno
City
Livorno
State/Province
Toscana
ZIP/Postal Code
57124
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto Oncologico Veneto IRCCS
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione Poliambulanza Istituto Ospedaliero
City
Brescia
ZIP/Postal Code
25124
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto Europeo di Oncologia IRCCS
City
Milano
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Recruiting
Facility Name
Arcispedale Santa Maria Nuova
City
Reggio Emilia
ZIP/Postal Code
42123
Country
Italy
Individual Site Status
Recruiting
Facility Name
Maastricht UMC+
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229 HX
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Haaglanden MC - locatie Antoniushove
City
Leidschendam
State/Province
Zuid-holland
ZIP/Postal Code
2262 BA
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
St. Olavs Hospital
City
Trondheim
State/Province
Sør-trøndelag
ZIP/Postal Code
7030
Country
Norway
Individual Site Status
Recruiting
Facility Name
Oslo Universitetssykehus Ullevål
City
Oslo
ZIP/Postal Code
0450
Country
Norway
Individual Site Status
Recruiting
Facility Name
Przychodnia Lekarska KOMED
City
Konin
State/Province
Wielkopolskie
ZIP/Postal Code
62-500
Country
Poland
Individual Site Status
Recruiting
Facility Name
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza
City
Brzozow
ZIP/Postal Code
36-200
Country
Poland
Individual Site Status
Recruiting
Facility Name
SPZOZ Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu
City
Bytom
ZIP/Postal Code
41-902
Country
Poland
Individual Site Status
Recruiting
Facility Name
Copernicus Podmiot Leczniczy Sp. z o.o. Wojewodzkie Centrum Onkologii
City
Gdansk
ZIP/Postal Code
80-219
Country
Poland
Individual Site Status
Recruiting
Facility Name
Radomskie Centrum Onkologii im. Bohaterow Radomskiego Czerwca 76
City
Radom
ZIP/Postal Code
26-600
Country
Poland
Individual Site Status
Recruiting
Facility Name
Fakultna nemocnica s poliklinikou F. D. Roosevelta Banska Bystrica
City
Banska Bystrica
ZIP/Postal Code
975 17
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Onkologicky ustav sv. Alzbety, s.r.o.
City
Bratislava
ZIP/Postal Code
812 50
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Narodny onkologicky ustav
City
Bratislava
ZIP/Postal Code
833 10
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Vychodoslovensky onkologicky ustav, a.s.
City
Kosice
ZIP/Postal Code
04191
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
CHUS - Hospital Clinico Universitario
City
Santiago de Compostela
State/Province
A Coruña [LA Coruña]
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario de Elche
City
Elche
State/Province
Alicante
ZIP/Postal Code
03202
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
State/Province
Barcelona [barcelona]
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
State/Province
Catalunya [cataluña]
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Institut Català d'Oncologia - L'Hospitalet
City
L'Hospitalet de Llobregat
State/Province
Catalunya [cataluña]
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
State/Province
Madrid, Comunidad DE
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
State/Province
Madrid, Comunidad DE
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen Del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Karolinska Universitetssjukhuset Solna
City
Solna
State/Province
Stockholms LÄN [se-01]
ZIP/Postal Code
171 64
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Södersjukhuset
City
Stockholm
State/Province
Stockholms LÄN [se-01]
ZIP/Postal Code
11883
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Skaraborgs Sjukhus Skövde
City
Skövde
ZIP/Postal Code
541 85
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
State/Province
Aberdeen CITY
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Guy's & St Thomas's NHS Foundation Trust
City
London
State/Province
England
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Guy's & St Thomas' NHS Foundation Trust
City
London
State/Province
London, CITY OF
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Heartlands Hospital
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C4221022
Description
To obtain contact information for a study center near you, click here.
URL
https://www.seamarkstudy.com
Description
SEAMARK Study Webpage on PfizerClincialTrials.com

Learn more about this trial

A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic Colorectal Cancer

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