A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer
Launched by PFIZER · Oct 22, 2020
Trial Information
Current as of May 20, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effectiveness of two medications, encorafenib and cetuximab, either on their own or combined with standard chemotherapy, for treating a specific type of colorectal cancer that has spread to other parts of the body. This cancer must have a particular genetic change called the "BRAF V600E mutation," and patients must not have received any previous treatments for their cancer. Participants will be assigned to one of three treatment groups: one group will receive encorafenib and cetuximab, another group will receive those same medications along with chemotherapy, and the last group will receive chemotherapy alone.
To be eligible for this study, participants should be at least 16 years old, have confirmed stage IV colorectal cancer with the BRAF mutation, and have measurable disease. They should not have received more than one previous treatment for metastatic cancer. Throughout the study, which may last up to three years, the research team will closely monitor how each participant responds to their assigned treatment. It's important to note that the study is currently active but not recruiting new participants.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Safety Lead-In = Male/female ≥ 18 years old
- • Phase 3 and Cohort 3: Male/female ≥ 16 years old (where permitted locally)
- • Histologically or cytologically confirmed Stage IV CRC that contains BRAF V600E mutation
- • Prior systemic treatment in metastatic setting: 0-1 regimens for Safety Lead In; none for Phase 3 and Cohort 3. (Note: Prior adjuvant or neoadjuvant therapy considered metastatic treatment if relapse/metastasis \< 6 month from end of adj/neoadjuvant treatment )
- • Measurable disease (Phase 3 and Cohort 3)/ Measurable or evaluable disease (Safety Lead-in)
- • ECOG PS 0-1
- • Adequate organ function
- Exclusion Criteria:
- • Tumors that are locally confirmed or unknown MSI-H or dMMR unless participant is ineligible to receive immune checkpoint inhibitors due to a pre-existing medical condition
- • Active bacterial or viral infections in 2 weeks prior to starting dosing
- • Symptomatic brain metastases
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
Ann Arbor, Michigan, United States
Rochester, Minnesota, United States
Saint Louis, Missouri, United States
Brussels, , Belgium
Copenhagen, , Denmark
Edmonton, Alberta, Canada
Calgary, Alberta, Canada
Los Angeles, California, United States
New Orleans, Louisiana, United States
New York, New York, United States
Liverpool, New South Wales, Australia
Madrid, , Spain
Valencia, , Spain
Miami Beach, Florida, United States
Zaragoza, , Spain
Portland, Oregon, United States
Nashville, Tennessee, United States
Seattle, Washington, United States
Portland, Oregon, United States
Washington, District Of Columbia, United States
Los Angeles, California, United States
Washington, District Of Columbia, United States
Cleveland, Ohio, United States
Seattle, Washington, United States
Sapporo, Hokkaido, Japan
Nashville, Tennessee, United States
Charlotte, North Carolina, United States
Chicago, Illinois, United States
Miami, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Miami Beach, Florida, United States
Toronto, Ontario, Canada
Los Angeles, California, United States
Richmond, Virginia, United States
Pittsburgh, Pennsylvania, United States
Los Angeles, California, United States
Miami, Florida, United States
Melbourne, Victoria, Australia
Woolloongabba, Queensland, Australia
Phoenix, Arizona, United States
Montreal, Quebec, Canada
Taichung, , Taiwan
Ann Arbor, Michigan, United States
Houston, Texas, United States
Valencia, , Spain
Jacksonville, Florida, United States
Pretoria, , South Africa
Richmond, Virginia, United States
Houston, Texas, United States
Heidelberg, Victoria, Australia
Mumbai, Maharashtra, India
Odense C, , Denmark
Elche, Alicante, Spain
Helsinki, , Finland
Nagoya, Aichi, Japan
Kashiwa, Chiba, Japan
Chuo Ku, Tokyo, Japan
Herlev, , Denmark
Dresden, , Germany
Madrid, , Spain
Taipei, , Taiwan
Taipei, , Taiwan
Turku, , Finland
Savannah, Georgia, United States
Oulu, , Finland
Taichung, , Taiwan
New York, New York, United States
Sevilla, , Spain
Leuven, , Belgium
Kaohsiung, , Taiwan
Leuven, , Belgium
Seoul, , Korea, Republic Of
Savannah, Georgia, United States
Seoul, , Korea, Republic Of
Barcelona, , Spain
Suita, Osaka, Japan
Hannover, Niedersachsen, Germany
Porto Alegre, Rio Grande Do Sul, Brazil
Pori, , Finland
Incheon, , Korea, Republic Of
Tainan, , Taiwan
Leipzig, Sachsen, Germany
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Auckland, , New Zealand
Bratislava, , Slovakia
Barcelona, , Spain
Melbourne, Victoria, Australia
Madrid, , Spain
Kanazawa, Ishikawa, Japan
Busan, , Korea, Republic Of
Herston, Queensland, Australia
Birmingham, , United Kingdom
Antwerpen, , Belgium
Beijing, Beijing, China
Guangzhou, Guangdong, China
Beijing, , China
Guangzhou, , China
Seoul, , Korea, Republic Of
Berkeley Heights, New Jersey, United States
Saint Louis, Missouri, United States
Los Angeles, California, United States
Orlando, Florida, United States
Osakasayama, Osaka, Japan
Beijing, , China
Charlotte, North Carolina, United States
Praha 5, , Czechia
Matsuyama, Ehime, Japan
Taoyuan, , Taiwan
Berlin, , Germany
Utrecht, , Netherlands
Wexford, Pennsylvania, United States
Eindhoven, Noord Brabant, Netherlands
Camperdown, New South Wales, Australia
Hradec Kralove, , Czechia
Adelaide, South Australia, Australia
Goyang Si, , Korea, Republic Of
Incheon, , Korea, Republic Of
Sutton, Surrey, United Kingdom
Fukuoka, , Japan
London, , United Kingdom
Taipei, , Taiwan
Orlando, Florida, United States
Ivano Frankivsk, , Ukraine
Pune, Maharashtra, India
Zhengzhou, Henan, China
Daegu, , Korea, Republic Of
Columbus, Ohio, United States
Milano, , Italy
Commack, New York, United States
Changsha, Hunan, China
Maastricht, , Netherlands
Richmond, Virginia, United States
Hefei, , China
Los Angeles, California, United States
Seoul, , Korea, Republic Of
Fuzhou, Fujian, China
Charleroi, Hainaut, Belgium
Creve Coeur, Missouri, United States
Tampere, , Finland
Changsha, , China
Beijing, Beijing, China
Pune, Maharashtra, India
Poprad, , Slovakia
Los Angeles, California, United States
Charlotte, North Carolina, United States
Aalborg, , Denmark
Madison, Wisconsin, United States
Brescia, , Italy
Melbourne, Victoria, Australia
Johannesburg, Gauteng, South Africa
Nashville, Tennessee, United States
Shenyang, , China
Plovdiv, , Bulgaria
Changsha, Hunan, China
Savannah, Georgia, United States
Cordoba, , Argentina
Nagaizumi, Shizuoka, Japan
Hannover, Lower Saxony, Germany
Guangzhou, Guangdong, China
Columbus, Ohio, United States
London, , United Kingdom
Milwaukee, Wisconsin, United States
Berlin, , Germany
Yokohama, Kanagawa, Japan
Saint Louis, Missouri, United States
Herlev, , Denmark
Billings, Montana, United States
Tianjin, , China
Koto Ku, Tokyo, Japan
Daegu, , Korea, Republic Of
Basking Ridge, New Jersey, United States
Columbus, Ohio, United States
New Lenox, Illinois, United States
Los Angeles, California, United States
Goyang Si, Gyeonggi Do, Korea, Republic Of
St Leonards, New South Wales, Australia
Olomouc, , Czechia
Saint Peters, Missouri, United States
Gdansk, , Poland
Barretos, Sp, Brazil
Taipei, , Taiwan
Bergen, Hordaland, Norway
Portland, Oregon, United States
Santo Andre, Sp, Brazil
Saransk, Republic Of Mordovia, Russian Federation
Kharkiv, , Ukraine
Padova, , Italy
Kosice, , Slovakia
Clayton, Victoria, Australia
Guangzhou, , China
Concord, North Carolina, United States
Omsk, , Russian Federation
Tainan, , Taiwan
Hamburg, , Germany
Chiba Shi, Chiba, Japan
London, , United Kingdom
São José Do Rio Preto, , Brazil
Brzozow, , Poland
Shanghai, Shanghai, China
Jinan, Shandong, China
Beijing, Beijing, China
Fort Lauderdale, Florida, United States
Panagyurishte, Pazardzhik, Bulgaria
Plovdiv, , Bulgaria
Lajeado, Rio Grande Do Sul, Brazil
Orenburg, , Russian Federation
Plantation, Florida, United States
St. Petersburg, , Russian Federation
Santo Andre, Sp, Brazil
Montvale, New Jersey, United States
Cordoba, , Argentina
Harrison, New York, United States
Middletown, New Jersey, United States
Florham Park, New Jersey, United States
New Delhi, Delhi, India
London, Ontario, Canada
Pushkin, Saint Petersburg, Russian Federation
Yaroslavl, , Russian Federation
San Giovanni Rotondo, Foggia, Italy
Wuhan, Hubei, China
Shanghai, Shanghai, China
Maastricht, Limburg, Netherlands
Orland Park, Illinois, United States
Hamburg, , Germany
Hamburg, , Germany
Oslo, , Norway
Oldenburg, , Germany
Uniondale, New York, United States
Wilrijk, , Belgium
Nanning, Guangxi, China
Milan, Milano, Italy
Chongqing, Chongqing, China
Jeonnam, , Korea, Republic Of
Charlotte, North Carolina, United States
Charlotte, North Carolina, United States
Monroe, North Carolina, United States
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Chicago, Illinois, United States
Chicago, Illinois, United States
Flossmoor, Illinois, United States
Harvey, Illinois, United States
Tinley Park, Illinois, United States
Florissant, Missouri, United States
Rochester, Minnesota, United States
Chelyabinsk, , Russian Federation
Amsterdam, , Netherlands
Shenyang, Liaoning, China
Plovdiv, , Bulgaria
Kyiv, , Ukraine
Portland, Oregon, United States
Portland, Oregon, United States
Port Elizabeth, Eastern Cape, South Africa
Saint Petersburg, , Russian Federation
Saint Petersburg, , Russian Federation
Chongqing, Chongqing, China
Kortrijk, West Vlaanderen, Belgium
Nanjing, Jiangsu, China
Scottsdale, Arizona, United States
Dnipro, , Ukraine
Gabrovo, , Bulgaria
Västerås, , Sweden
Plantation, Florida, United States
Hefei, Anhui, China
Ina Machi, Saitama, Japan
New Delhi, Delhi, India
Kaluga, , Russian Federation
Córdoba, , Argentina
Copenhagen, Region Hovedstaden, Denmark
London, , United Kingdom
Takatsuki, Osaka, Japan
Tokyo, , Japan
Pittsburgh, Pennsylvania, United States
Kharkiv, , Ukraine
St Leonards, New South Wales, Australia
Saint Petersburg, , Russian Federation
New York, New York, United States
Saint Petersburg, , Russian Federation
Ivano Frankivsk, , Ukraine
Praha 8, , Czechia
Concord, North Carolina, United States
Banska Bystrica, , Slovakia
Jaipur, Rajasthan, India
Gilly, Hainaut, Belgium
Phoenix, Arizona, United States
Beverly Hills, California, United States
Pasadena, California, United States
Torrance, California, United States
Aventura, Florida, United States
Coral Gables, Florida, United States
Savannah, Georgia, United States
Savannah, Georgia, United States
New Orleans, Louisiana, United States
Billings, Montana, United States
Omaha, Nebraska, United States
Omaha, Nebraska, United States
Papillion, Nebraska, United States
Babylon, New York, United States
Bronx, New York, United States
New York, New York, United States
Patchogue, New York, United States
Port Jefferson Station, New York, United States
Riverhead, New York, United States
Charlotte, North Carolina, United States
Charlotte, North Carolina, United States
Charlotte, North Carolina, United States
Columbus, Ohio, United States
Oklahoma City, Oklahoma, United States
Portland, Oregon, United States
Jefferson Hills, Pennsylvania, United States
Monroeville, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Clarksville, Tennessee, United States
Franklin, Tennessee, United States
Gallatin, Tennessee, United States
Germantown, Tennessee, United States
Hendersonville, Tennessee, United States
Hermitage, Tennessee, United States
La Vergne, Tennessee, United States
Lebanon, Tennessee, United States
Memphis, Tennessee, United States
Murfreesboro, Tennessee, United States
Nashville, Tennessee, United States
Nashville, Tennessee, United States
Nashville, Tennessee, United States
Nashville, Tennessee, United States
Nashville, Tennessee, United States
Nashville, Tennessee, United States
Smyrna, Tennessee, United States
Richmond, Virginia, United States
San Miguel De Tucumán, Tucumán, Argentina
Tucuman, Tucumán, Argentina
Ciudad Autónoma De Buenos Aires, , Argentina
Mount Kuring Gai, New South Wales, Australia
Newtown, New South Wales, Australia
St Leonards, New South Wales, Australia
Brussels, Bruxelles Capitale, Région De, Belgium
Brussels, Bruxelles Capitale, Région De, Belgium
Verviers, Liège, Belgium
Liège, , Belgium
Rio De Janeiro, Rj, Brazil
Rio De Janeiro, Rj, Brazil
Blumenau, Santa Catarina, Brazil
Itajaí, Santa Catarina, Brazil
Santo André, Sp, Brazil
Barretos, São Paulo, Brazil
Sao Jose Do Rio Preto, São Paulo, Brazil
São José Do Rio Preto, São Paulo, Brazil
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Kingston, Ontario, Canada
Laval, Quebec, Canada
Fuzhou, Fujian, China
Qingdao, Shandong, China
Chengdu, Sichuan, China
Kunming, Yunnan, China
Hangzhou, Zhejiang, China
Shanghai, , China
Brno, Brno Město, Czechia
Hradec Kralove, Hradec Králové, Czechia
Prague, Praha 4, Czechia
Aalborg, Nordjylland, Denmark
Vejle, Syddanmark, Denmark
Vejle, Syddanmark, Denmark
Helsinki, Nyland, Finland
Tampere, Pirkanmaa, Finland
Muenchen, Bayern, Germany
Frankfurt, Hessen, Germany
Berlin Charlottenburg, , Germany
Berlin, , Germany
Berlin, , Germany
Dresden, , Germany
Thane, Maharashtra, India
Jaipur, Rajasthan, India
Monserrato (Ca), Cagliari, Italy
Candiolo, Torino, Italy
Orbassano, Torino, Italy
Napoli, , Italy
Reggio Emilia, , Italy
Kawasaki, Kanagawa, Japan
Nagoya, Nagoya, Aichi, Japan
Osaka Shi, Osaka, Japan
Hidaka City, Saitama, Japan
Osaka, , Japan
Daegu, Taegu Kwangyǒkshi, Korea, Republic Of
Jeonnam, , Korea, Republic Of
Monterrey, Nuevo Leon, Mexico
Oaxaca, , Mexico
Amsterdam, Noord Holland, Netherlands
Den Haag, Zuid Holland, Netherlands
Den Haag, , Netherlands
Leidschendam, , Netherlands
Tauranga, Bay Of Plenty, New Zealand
Stavanger, Rogaland, Norway
Trondheim, Sør Trøndelag, Norway
Kristiansand, Vest Agder, Norway
Oslo, , Norway
Konin, Wielkopolskie, Poland
Brzozow, , Poland
Bytom, , Poland
Gdansk, , Poland
Bytom, śląskie, Poland
Nalchik, Kabardino Balkarian Republic, Russian Federation
Moscow, , Russian Federation
Ufa, , Russian Federation
Yaroslavl, , Russian Federation
Yaroslav, , Russian Federation
Bratislava, , Slovakia
Rondebosch, Cape Town, South Africa
Pretoria, Gauteng, South Africa
Cape Town, Western Cape, South Africa
Cape Town, Western Cape, South Africa
Santiago De Compostela, A Coruña, Spain
Hospitalet De Llobregat, Barcelona, Spain
Solna, Stockholms Län [Se 01], Sweden
Uppsala, Uppsala Län [Se 03], Sweden
Umeå, Västerbottens Län [Se 24], Sweden
Göteborg, Västra Götalands Län [Se14], Sweden
Pliuty Village, Kyiv Region, Obuhovskiy District, Ukraine
Ivano Frankivsk, , Ukraine
Kryvyi Rih, , Ukraine
Kyiv, , Ukraine
Zaporizhzhia, , Ukraine
Newcastle Upon Tyne, High Heaton, United Kingdom
Oxford, , United Kingdom
Charleroi, Hainaut, Belgium
Parktown, Johannesburg, Gauteng, South Africa
Jinan, Shandong, China
Copenhagen, Hovedstaden, Denmark
Daegu, Taegu Kwangyǒkshi, Korea, Republic Of
Cleveland, Ohio, United States
Sao Paulo, Sp, Brazil
São Paulo, Sp, Brazil
Hefei, Anhui, China
Leidschendam, Zuid Holland, Netherlands
Auckland, , New Zealand
Santo Andre, Sp, Brazil
Blumenau, Santa Catarina, Brazil
Sevilla, Andalucía, Spain
Columbus, Ohio, United States
Richmond, Virginia, United States
Santo Andre, Sp, Brazil
Parktown, Gauteng, South Africa
Johannesburg, , South Africa
Santo Andre, Sp, Brazil
Calgary, Alberta, Canada
Padova, Veneto, Italy
Calgary, Alberta, Canada
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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