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A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer

Status
Active
Cancer Type
Colon/Rectal Cancer
Trial Phase
Phase III
Eligibility
16 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT04607421
Protocol IDs
C4221015 (primary)
NCI-2021-01687
2020-001288-99
Study Sponsor
Pfizer Inc

Summary

The purpose of this study is to evaluate two study medicines (encorafenib plus cetuximab)
taken alone or together with standard chemotherapy for the potential treatment of colorectal
cancer that:

- has spread to other parts of the body (metastatic);

- has a certain type of abnormal gene called "BRAF"; and

- has not received prior treatment.

Participants in this study will receive one of the following study treatments:

- Encorafenib plus cetuximab: These participants will receive encorafenib by mouth at home
every day and cetuximab once every two weeks by intravenous (IV) infusion (an injection
into the vein) at the study clinic.

- Encorafenib plus cetuximab with chemotherapy: These participants will receive
encorafenib and cetuximab in the way described in the bullet above. Additionally, they
will receive standard chemotherapy by IV infusion and oral treatment at home.

- Chemotherapy alone: These participants will receive chemotherapy, the standard treatment
for this condition, by IV infusion at the study clinics and oral treatment at home.

The study team will monitor how each participant responds to the study treatment for up to
about 3 years.

Objectives

The purpose of the study is to evaluate whether encorafenib plus cetuximab (EC), alone or in
combination with chemotherapy, can improve clinical outcomes relative to current standard
of-care chemotherapy in participants with previously untreated BRAF V600E-mutant mCRC. Since
encorafenib has not previously been combined with chemotherapy, the tolerability and PK of EC
in combination with mFOLFOX6 and in combination with FOLFIRI will be evaluated in separate
cohorts in the safety lead-in portion of the trial in order to identify which chemotherapy
combination is to be used in the Phase 3 portion of the study.

Eligibility

  1. Safety Lead-In = Male/female = 18 years old
  2. Phase 3: Male/female = 16 years old (where permitted locally)
  3. Histologically or cytologically confirmed Stage IV CRC that contains BRAF V600E mutation
  4. Prior systemic treatment in metastatic setting
  5. SLI: 0-1 regimens
  6. Phase 3: None
  7. Prior adjuvant or neoadjuvant therapy considered metastatic treatment if relapse/metastasis < 6 month from end of adj/neoadjuvant treatment
  8. Measurable disease (Phase 3)/ Measurable or evaluable disease (Safety Lead-in)
  9. ECOG PS 0-1
  10. Adequate organ function
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
Georgia CORE

 

Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.