Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer
Launched by PFIZER · Oct 6, 2016
Trial Information
Current as of June 13, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Key Inclusion Criteria:
- • Age ≥ 18 years at time of informed consent
- • Histologically- or cytologically-confirmed CRC that is metastatic
- • Presence of BRAFV600E in tumor tissue as previously determined by a local assay at any time prior to Screening or by the central laboratory
- • Progression of disease after 1 or 2 prior regimens in the metastatic setting
- • Evidence of measurable or evaluable non-measurable disease per RECIST, v1.1
- • Adequate bone marrow, cardiac, kidney and liver function
- • Able to take oral medications
- • Female patients are either postmenopausal for at least 1 year, are surgically sterile for at least 6 weeks, or must agree to take appropriate precautions to avoid pregnancy from screening through follow-up if of childbearing potential
- • Males must agree to take appropriate precautions to avoid fathering a child from screening through follow-up
- Key Exclusion Criteria:
- • Prior treatment with any RAF inhibitor, MEK inhibitor, cetuximab, panitumumab or other epidermal growth factor receptor (EGFR) inhibitors
- • Prior irinotecan hypersensitivity or toxicity that would suggest an inability to tolerate irinotecan 180 mg/m2 every 2 weeks
- • Symptomatic brain metastasis or leptomeningeal disease
- • History or current evidence of retinal vein occlusion or current risk factors for retinal vein occlusion (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes)
- • Known history of acute or chronic pancreatitis
- • History of chronic inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) ≤12 months prior to randomization
- • Uncontrolled blood pressure despite medical treatment
- • Impaired GI function or disease that may significantly alter the absorption of encorafenib or binimetinib (e.g., ulcerative diseases, uncontrolled vomiting, malabsorption syndrome, small bowel resection with decreased intestinal absorption)
- • Concurrent or previous other malignancy within 5 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in-situ of the cervix, or other noninvasive or indolent malignancy
- • History of thromboembolic or cerebrovascular events ≤ 6 months prior to starting study treatment, including transient ischemic attacks, cerebrovascular accidents, deep vein thrombosis or pulmonary emboli
- • Concurrent neuromuscular disorder that is associated with the potential of elevated creatine (phosphor)kinase (CK) (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy)
- • Residual common terminology criteria for adverse events (CTCAE) ≥ Grade 2 toxicity from any prior anticancer therapy, with the exception of Grade 2 alopecia or Grade 2 neuropathy
- • Known history of HIV infection
- • Active hepatitis B or hepatitis C infection
- • Known history of Gilbert's syndrome
- • Known contraindication to receive cetuximab or irinotecan at the planned doses
About Pfizer
Pfizer Inc. is a global leader in biopharmaceutical innovation, dedicated to discovering, developing, and delivering advanced therapies that enhance patient outcomes across a wide range of medical conditions. With a rich history of scientific research and a commitment to quality, Pfizer focuses on areas such as oncology, immunology, cardiology, and rare diseases. The company leverages cutting-edge technology and collaborates with healthcare professionals, regulatory bodies, and academic institutions to conduct rigorous clinical trials that ensure the safety and efficacy of its products. Pfizer's mission is to bring breakthroughs that change patients' lives, exemplifying its commitment to health and wellness worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rochester, Minnesota, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Iowa City, Iowa, United States
Saint Louis, Missouri, United States
New Orleans, Louisiana, United States
New York, New York, United States
Madrid, , Spain
Valencia, , Spain
Barcelona, , Spain
Madrid, , Spain
Madrid, , Spain
Zaragoza, , Spain
Toronto, Ontario, Canada
Urbana, Illinois, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Scottsdale, Arizona, United States
Sapporo, Hokkaido, Japan
Portland, Oregon, United States
Aurora, Colorado, United States
Chicago, Illinois, United States
Fort Lauderdale, Florida, United States
Los Angeles, California, United States
Los Angeles, California, United States
Newport Beach, California, United States
Madrid, , Spain
Saint Louis, Missouri, United States
Bedford Park, South Australia, Australia
Phoenix, Arizona, United States
Saint Louis, Missouri, United States
Porto Alegre, Rs, Brazil
Bonheiden, , Belgium
Houston, Texas, United States
Valencia, , Spain
Jacksonville, Florida, United States
Phoenix, Arizona, United States
Porto Alegre, Rs, Brazil
Heidelberg, Victoria, Australia
Madrid, , Spain
Nagoya, Aichi, Japan
Chuo Ku, Tokyo, Japan
Taipei, , Taiwan
Taichung, , Taiwan
Sevilla, , Spain
Ottawa, Ontario, Canada
Tainan, , Taiwan
Kaohsiung, , Taiwan
Cleveland, Ohio, United States
Osaka, , Japan
Hannover, Niedersachsen, Germany
Edegem, , Belgium
Nashville, Tennessee, United States
Seoul, , Korea, Republic Of
Boston, Massachusetts, United States
Wien, , Austria
Brno, , Czechia
Dresden, , Germany
Barcelona, , Spain
Melbourne, Victoria, Australia
Kanazawa, Ishikawa, Japan
Busan, , Korea, Republic Of
Saint Louis, Missouri, United States
Seoul, , Korea, Republic Of
Aurora, Colorado, United States
New Haven, Connecticut, United States
Paris, , France
Reims Cedex, , France
Seoul, , Korea, Republic Of
Budapest, , Hungary
Nashville, Tennessee, United States
Budapest, , Hungary
Canton, Ohio, United States
Utrecht, , Netherlands
Hradec Kralove, , Czechia
Incheon, , Korea, Republic Of
Fukuoka, , Japan
Gent, , Belgium
New York, New York, United States
Lyon Cedex 08, , France
Valencia, , Spain
Amsterdam, Noord Holland, Netherlands
Los Angeles, California, United States
London, , United Kingdom
Indianapolis, Indiana, United States
Poznan, , Poland
Creve Coeur, Missouri, United States
Hradec Kralove, , Czechia
London, , United Kingdom
Reus, Tarragona, Spain
Seongnam Si, Gyeonggi Do, Korea, Republic Of
Manchester, , United Kingdom
Burgos, , Spain
Ulm, Baden Wuerttemberg, Germany
Saint Louis, Missouri, United States
Portland, Oregon, United States
Madison, Wisconsin, United States
Villejuif Cedex, , France
Berlin, , Germany
Madrid, , Spain
Pecs, , Hungary
Debrecen, , Hungary
Toronto, Ontario, Canada
Spokane, Washington, United States
Cordoba, , Argentina
Kfar Saba, , Israel
Miami, Florida, United States
London, , United Kingdom
Palma De Mallorca, Baleares, Spain
Peoria, Illinois, United States
Indianapolis, Indiana, United States
Kansas City, Kansas, United States
Essen, Nordrhein Westfalen, Germany
Budapest, , Hungary
Saint Louis, Missouri, United States
Baltimore, Maryland, United States
North Haven, Connecticut, United States
Taoyuan, , Taiwan
Portland, Oregon, United States
Kursk, Kursk Region, Russian Federation
Seoul, , Korea, Republic Of
New Lenox, Illinois, United States
Suwon, Gyeonggi Do, Korea, Republic Of
Edegem, Antwerpen, Belgium
Olomouc, , Czechia
Aurora, Colorado, United States
Saint Peters, Missouri, United States
Liege, , Belgium
Aurora, Colorado, United States
Den Haag, Zuid Holland, Netherlands
Izmir, Bornova, Turkey
Vancouver, British Columbia, Canada
Liege, , Belgium
Sabadell, Barcelona, Spain
Indianapolis, Indiana, United States
Hamburg, , Germany
Taoyuan City, , Taiwan
Edirne, , Turkey
Besancon Cedex, , France
Westwood, Kansas, United States
Barretos, Sao Paulo, Brazil
Westwood, Kansas, United States
Montpellier Cedex 5, , France
Hwasun Gun, Jeollanam Do, Korea, Republic Of
Fairway, Kansas, United States
Kawasaki, Kanagawa, Japan
Temuco, Region De La Araucania, Chile
Chelyabinsk, , Russian Federation
Ankara, , Turkey
Bursa, , Turkey
Brzozow, , Poland
Passo Fundo, Rs, Brazil
Seoul, , Korea, Republic Of
Yokohama, Kanagawa, Japan
Duarte, California, United States
Be'er Sheva, , Israel
Kashiwa Shi, Chiba, Japan
Fountain Valley, California, United States
Los Angeles, California, United States
Petah Tikva, , Israel
Sao Jose Do Rio Preto, Sp, Brazil
Hannover, Niedersachsen, Germany
Budapest, , Hungary
Fukuoka, , Japan
Tuebingen, Baden Wuerttemberg, Germany
Los Angeles, California, United States
Ashkelon, , Israel
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Los Angeles, California, United States
Orange, California, United States
Aurora, Colorado, United States
New Haven, Connecticut, United States
New Haven, Connecticut, United States
Coral Gables, Florida, United States
Fort Lauderdale, Florida, United States
Fort Lauderdale, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Bloomington, Illinois, United States
Galesburg, Illinois, United States
Orland Park, Illinois, United States
Ottawa, Illinois, United States
Peoria, Illinois, United States
Indianapolis, Indiana, United States
Indianapolis, Indiana, United States
New Albany, Indiana, United States
Prairie Village, Kansas, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Commack, New York, United States
New York, New York, United States
Portland, Oregon, United States
Temple, Texas, United States
Temple, Texas, United States
Spokane Valley, Washington, United States
Spokane, Washington, United States
Spokane, Washington, United States
Spokane, Washington, United States
Pergamino, Buenos Aires, Argentina
Santa Rosa, La Pampa, Argentina
San Miguel De Tucumán, Tucumán, Argentina
La Rioja, , Argentina
Darlinghurst, New South Wales (Nsw), Australia
Darlinghurst, New South Wales (Nsw), Australia
Parramatta, New South Wales (Nsw), Australia
Sydney, New South Wales (Nsw), Australia
South Brisbane, Queensland, Australia
Adelaide, South Australia, Australia
Woodville South, South Australia, Australia
Clayton, Victoria, Australia
Wels, Oberoesterreich, Austria
Wels, Oberoesterreich, Austria
Wels, Oberoesterreich, Austria
Wels, Oberoesterreich, Austria
Wels, Oberoesterreich, Austria
Wels, Oberoesterreich, Austria
Wien, , Austria
Wien, , Austria
Wien, , Austria
Libramont Chevigny, Luxembourg, Belgium
Brugge, West Vlaanderen, Belgium
Charleroi, , Belgium
Leuven, , Belgium
Roeselaere, , Belgium
Verviers, , Belgium
Salvador, Bahia, Brazil
Salvador, Bahia, Brazil
Cachoeiro De Itapemirim, Es, Brazil
Cachoeiro De Itapemirim, Es, Brazil
Cachoeiro De Itapemirim, Es, Brazil
Belo Horizonte, Minas Gerais, Brazil
Belo Horizonte, Minas Gerais, Brazil
Caxias Do Sul, Rs, Brazil
Lajeado, Rs, Brazil
Lajeado, Rs, Brazil
Passo Fundo, Rs, Brazil
Passo Fundo, Rs, Brazil
Pelotas, Rs, Brazil
Pelotas, Rs, Brazil
Pelotas, Rs, Brazil
Pelotas, Rs, Brazil
Pelotas, Rs, Brazil
Porto Alegre, Rs, Brazil
Porto Alegre, Rs, Brazil
Porto Alegre, Rs, Brazil
Porto Alegre, Rs, Brazil
Porto Alegre, Rs, Brazil
Barretos, Sao Paulo, Brazil
Barretos, Sao Paulo, Brazil
Itajai, Sc, Brazil
Santo Andre, Sp, Brazil
Sorocaba, Sp, Brazil
Sorocaba, Sp, Brazil
Sorocaba, Sp, Brazil
Sorocaba, Sp, Brazil
São Paulo, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
Vancouver, British Columbia, Canada
Montreal, Quebec, Canada
Vina Del Mar, V Region Valparaiso, Chile
Brno, , Czechia
Hradec Kralove, , Czechia
Hradec Kralove, , Czechia
Hradec Kralove, , Czechia
Hradec Kralove, , Czechia
Hradec Kralove, , Czechia
Olomouc, , Czechia
Olomouc, , Czechia
Odense C, , Denmark
Brest Cedex, , France
Ecully, , France
Nantes Cedex, , France
Paris Cedex 12, , France
Paris Cedex 12, , France
Saint Jeand De Vedas, , France
Toulouse Cedex 9, , France
Toulouse Cedex 9, , France
Toulouse, , France
Muenchen, Bayern, Germany
Muenchen, Bayern, Germany
Falkensee, Brandenburg, Germany
Essen, Nordrhein Westfalen, Germany
Essen, Nordrhein Westfalen, Germany
Essen, Nordrhein Westfalen, Germany
Essen, Nordrhein Westfalen, Germany
Essen, Nordrhein Westfalen, Germany
Essen, Nordrhein Westfalen, Germany
Essen, Nordrhein Westfalen, Germany
Moenchengladbach, Nordrhein Westfalen, Germany
Moenchengladbach, Nordrhein Westfalen, Germany
Moenchengladbach, Nordrhein Westfalen, Germany
Neuss, Nordrhein Westfalen, Germany
Bochum, North Rhine Westfalia, Germany
Worms, Rheinland Pfalz, Germany
Worms, Rheinland Pfalz, Germany
Worms, Rheinland Pfalz, Germany
Worms, Rheinland Pfalz, Germany
Worms, Rheinland Pfalz, Germany
Hamburg, , Germany
Hamburg, , Germany
Hamburg, , Germany
Hamburg, , Germany
Hamburg, , Germany
Zalaegerszeg, Zala, Hungary
Pecs, , Hungary
Tel Aviv, Nap, Israel
Bnei Brak, , Israel
Jerusalem, , Israel
Jerusalem, , Israel
Jerusalem, , Israel
Jerusalem, , Israel
Kfar Saba, , Israel
Kfar Saba, , Israel
Petah Tikva, , Israel
Tel Hashomer, , Israel
Torrette Di Ancona, Ancona, Italy
Treviglio, Bergamo, Italy
Bergamo, Bg, Italy
Bergamo, Bg, Italy
Bergamo, Bg, Italy
Monserrato, Cagliari, Italy
Monserrato, Cagliari, Italy
Monserrato, Cagliari, Italy
Cremona, Cr, Italy
Cremona, Cr, Italy
Cremona, Cr, Italy
Rozzano, Milano, Italy
Rozzano (Mi), Milan, Italy
Milano, Mi, Italy
Milano, Mi, Italy
Milano, Mi, Italy
Milano, Mi, Italy
Milano, Mi, Italy
Padova, Pd, Italy
Padova, Pd, Italy
Padova, Pd, Italy
Padova, Pd, Italy
Bologna, , Italy
Cagliari, , Italy
Cagliari, , Italy
Firenze, , Italy
Firenze, , Italy
Milano, , Italy
Milano, , Italy
Milano, , Italy
Milano, , Italy
Modena, , Italy
Modena, , Italy
Modena, , Italy
Modena, , Italy
Napoli, , Italy
Napoli, , Italy
Napoli, , Italy
Pisa, , Italy
Pisa, , Italy
Pisa, , Italy
Pisa, , Italy
Roma, , Italy
Roma, , Italy
Roma, , Italy
Nagoya, Aichi, Japan
Yokohama, Kanagawa, Japan
Suita, Osaka, Japan
Anyang, Gyeonggido, Korea, Republic Of
Seoul, , Korea, Republic Of
Delegacion Cuauhtemoc, Ciudad De Mexico, Mexico
Ciudad De Mexico, Cuauhtemoc, Mexico
Arnhem, Gelderland, Netherlands
Velp, Gelderland, Netherlands
Maastricht, Limburg, Netherlands
Amsterdam, Noord Holland, Netherlands
Lommedalen, , Norway
Oslo, , Norway
Oslo, , Norway
Oslo, , Norway
Elblag, , Poland
Krakow, , Poland
Otwock, , Poland
Poznan, , Poland
Warszawa, , Poland
Warszawa, , Poland
Warszawa, , Poland
Warszawa, , Poland
Warszawa, , Poland
Moscow, , Russian Federation
Moscow, , Russian Federation
Obninsk, , Russian Federation
Sankt Petersburg, , Russian Federation
Jaen, Andalucia, Spain
Jaen, Andalucia, Spain
L'hospitalet De Llobregat, Barcelona, Spain
Cordoba, Cordona, Spain
Madrid, Madrid, Communidad Delaware, Spain
Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Cordoba, , Spain
Madrid, , Spain
Madrid, , Spain
Valencia, , Spain
Zaragoza, , Spain
Changhua City, Changhua County, Taiwan
Izmir, Bornova, Turkey
Izmir, Izmir, Karsiyaka, Turkey
Istanbul, Kadikoy, Turkey
Malatya, , Turkey
Dnipropetrovsk, Dnipropetrovska Oblast', Ukraine
Dnipropetrovsk, Dnipropetrovska Oblast', Ukraine
Dnipropetrovsk, Dnipropetrovska Oblast', Ukraine
Kyiv, Kyivska Oblast', Ukraine
Kyiv, Kyivska Oblast', Ukraine
Kyiv, Kyivska Oblast, Ukraine
Kyiv, Kyivska Oblast, Ukraine
Kyiv, Kyivska Oblast, Ukraine
Vinnytsia, Vinnyts'ka Oblast', Ukraine
Uzhgorod, Zakarpats'ka Oblast', Ukraine
Uzhgorod, Zakarpats'ka Oblast', Ukraine
Uzhhorod, Zakarpatska Oblast, Ukraine
Uzhhorod, Zakarpatska Oblast, Ukraine
Aberdeen, Aberdeenshire Scotland, United Kingdom
Windsor, Berkshire, United Kingdom
Glasglow, Glasglow City, Scotland, United Kingdom
Birmingham, West Midlands, United Kingdom
London, , United Kingdom
Basking Ridge, New Jersey, United States
New York, New York, United States
Salvador, Bahia, Brazil
Firenze, , Italy
Firenze, , Italy
Ciudad De Mexico, Cuauhtemoc, Mexico
Istanbul, Kadikoy, Turkey
Bursa, , Turkey
Budapest, , Hungary
Patients applied
Trial Officials
Pfizer CT.gov Call Center
Study Director
Pfizer
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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