A Study Comparing PF-08634404 and a Drug Combination with Chemotherapy in Adults with Metastatic Colorectal Cancer

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What is this study about?

This study is being conducted to evaluate the effectiveness and safety of a new treatment option for individuals with Metastatic Colorectal Cancer. This type of cancer occurs when cancer that started in the colon or rectum spreads to other parts of the body. The research compares two different treatment approaches. One approach uses the study drug PF-08634404 combined with chemotherapy, which is a type of treatment that uses strong medicines to kill fast-growing cancer cells. The chemotherapy used in this study consists of oxaliplatin, calcium folinate, and fluorouracil, which are administered through intravenous infusion, meaning they are delivered directly into a vein. The other approach uses bevacizumab combined with the same chemotherapy medicines.

Participants in the study will be assigned to one of the two treatment groups through a process called randomization, which is similar to drawing lots to decide which group a person joins. To ensure the results are unbiased, a double-blind method is used, meaning that neither the participants nor the researchers know which specific treatment is being given during the course of the study. The study will monitor how long the cancer remains stable and how long participants live to determine if the new combination is more effective than the current standard treatment.

Who Can Join the Study?

  • You must be 18 years of age or older at the time of the initial evaluation.
  • Women who are able to become pregnant must have a negative pregnancy test within 72 hours before receiving the first dose of the study treatment.
  • You must provide informed consent, which means you agree to participate after being fully explained the details of the study.
  • A doctor must confirm through a tissue sample that you have colorectal adenocarcinoma, which is a specific type of cancer that starts in the cells of the colon or rectum.
  • You must have Stage IV metastatic disease, which means the cancer has spread from its original location to other parts of the body.
  • Your RAS mutation status must be known, which refers to specific changes or “errors” in your DNA within the RAS genes that can affect how cancer grows.
  • You must not have received any prior systemic therapy, meaning you have not taken any medicines (like chemotherapy) that travel through the whole body to treat the spread cancer.
  • You must have an ECOG performance status of 0-1, which is a scale used by doctors to measure how well you can perform daily activities and your overall physical health.
  • You must have at least one measurable lesion, which is a tumor or area of cancer that is large enough for doctors to clearly see and track using medical imaging.
  • You must have tumor tissue available, such as a small piece of the tumor from a biopsy, so it can be tested in a laboratory.
  • You must have adequate hematologic, hepatic, and renal function, meaning your blood counts, liver function, and kidney function must all be working at a healthy level.
  • Your blood counts must be stable without the use of transfusions (extra blood or platelets given to you) or growth factors (medicines used to help your body make more blood cells) for at least 7 days before testing.

Who Cannot Join the Study?

  • Having a specific genetic change in the tumor called a BRAF V600E mutation.
  • Having serious heart problems within the last 6 months, such as unstable angina (chest pain that is unpredictable), a myocardial infarction (heart attack), irregular heartbeats like arrhythmia, or congestive heart failure (a condition where the heart cannot pump enough blood).
  • Having a heart rhythm abnormality on an ECG (an electrical test of the heart) known as a QTcF interval longer than 480 msec.
  • Having serious liver disease such as decompensated liver cirrhosis (advanced scarring of the liver that prevents it from working properly).
  • Having nephrotic syndrome (a kidney disorder that causes the body to pass too much protein in the urine).
  • Having uncontrolled high blood pressure (hypertension) or a hypertensive crisis (a sudden, severe increase in blood pressure).
  • Having experienced blood clots in the arteries or veins, such as a thromboembolic event.
  • Having active autoimmune diseases (conditions where the immune system attacks healthy cells) that required treatment with systemic drugs, such as corticosteroids or immunosuppressants, within the last 2 years.
  • Having ILD pneumonitis (inflammation of the lung tissue that is not caused by an infection) that was treated with steroids or is currently being managed with medicine.
  • Having unresolved side effects from previous cancer treatments that have not improved to a mild or no-symptom level, except for alopecia (hair loss).
  • Having significant neuropathy (nerve damage that causes numbness or tingling), especially if caused by a previous medicine called oxaliplatin.
  • Having a history of stomach or intestinal issues in the last 6 months, such as esophageal varices (swollen veins in the food pipe), ulcers, gastrointestinal perforation (a hole in the stomach or intestines), or gastrointestinal bleeding.
  • Having another type of cancer within the last 3 years, unless it was a very low-risk type.
  • Having an allergy or hypersensitivity to any of the ingredients used in the study medicines.
  • Having MSI-high or dMMR colorectal cancer, which are specific biological markers in certain tumors.
  • Having active cancer that has spread to the Central Nervous System (the brain or spinal cord), unless the brain cancer has been treated and is stable.
  • Having a DPD deficiency (a condition where the body lacks an enzyme needed to break down certain chemotherapy drugs).
  • Having a high risk of bleeding or a fistula (an abnormal connection between two organs or between an organ and the skin) due to the location or size of the tumor.
  • Having undergone major surgery or experienced severe trauma within the last 4 weeks.
  • Having a history of receiving an organ transplant or a stem cell transplant.
  • Having severe bleeding or hemorrhage events within the last 28 days.
  • Having an active infection, such as HIV, Hepatitis B (HBV), Hepatitis C (HCV), or Tuberculosis (TB), unless the infection is well-controlled with medicine.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Krankenhaus Nordwest GmbH Frankfurt Germany
Istituto Oncologico Veneto Padua Italy
Asklepios Kliniken Hamburg GmbH Hamburg Germany
Istituto Europeo Di Oncologia S.r.l. Milan Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Centre Hospitalier Universitaire De Poitiers Poitiers France
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
Algemeen Ziekenhuis Delta Roeselare Belgium
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Grand Hopital De Charleroi Charleroi Belgium
AZ Sint-Lucas & Volkskliniek Gent Belgium
Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego W Opolu Samodzielny Publiczny Zaklad Opieki Zdrowotnej Opole Poland
Pratia Hematologia Sp. z o.o. Katowice Poland
Pia Fondazione Di Culto E Religione Card G Panico Tricase Italy
Odense University Hospital Odense Denmark
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Hospital Clinic De Barcelona Barcelona Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Universidade De Santiago De Compostela Santiago De Compostela Spain
Aalborg University Hospital Aalborg Denmark
Pratia S.A. Skorzewo Poland
Muenchen Klinik gGmbH Munich Germany
Rigshospitalet Copenhagen Denmark
Netherlands Cancer Institute Amsterdam The Netherlands
Hopital Beaujon Clichy France
Hopital Huriez Lille France
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Uzmofhyjvqxoenrxtbklu Evzmx Aoo Essen Germany
Ifmqnxif Cczbsq Djcisqjhvdcydited L'hospitalet De Llobregat Spain
Aktlittfer Pvtajyiw Hrkhengf Dx Pbnbj Paris France
Hwzncfpl Vtko dgpwwuiq Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
07.04.2026
Denmark Denmark
Not yet recruiting
07.04.2026
France France
Not yet recruiting
07.04.2026
Germany Germany
Not yet recruiting
07.04.2026
Italy Italy
Not yet recruiting
07.04.2026
Poland Poland
Recruiting
07.04.2026
Spain Spain
Recruiting
07.04.2026
The Netherlands The Netherlands
Not yet recruiting
07.04.2026

Trial locations

PF-08634404 is an experimental drug being tested to see if it can help treat metastatic colorectal cancer when used alongside chemotherapy.

Oxaliplatin is a type of chemotherapy drug used to help stop the growth of cancer cells.

Calcium folinate is a substance used in this study to help the chemotherapy work more effectively.

Fluorouracil is a common chemotherapy medication used to treat various types of cancer.

Bevacizumab is a medication used in this study to target and block certain proteins that help cancer tumors grow and develop new blood supplies.

Metastatic Colorectal Cancer – This is a type of cancer that starts in the cells of the colon or rectum. The disease occurs when abnormal cells grow uncontrollably in the digestive tract. As the condition progresses, these cancer cells can break away from the original site. They travel through the bloodstream or the lymphatic system to reach other parts of the body. Once they reach new organs, they form new growths known as secondary tumors.

Trial ID:
2025-523521-18-00
Protocol code:
C6461003
NCT ID:
NCT07222800
Trial Phase:
Therapeutic confirmatory (Phase III)

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