Recruiting

Encorafenib & Binimetinib

Sponsor:

Pfizer

Code:

NCT05203172

Conditions

Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Binimetinib only treatment

Encorafenib only Treatment

Encorafenib & Binimetinib Treatment

Treatment of Encorafenib & Binimetinib & Ribociclib

Treatment of Encorafenib & Binimetinib & Cetuximab

Study Details

Brief summary:

The purpose of this clinical trial (called the FLOTILLA study) is to give continued access to the study medicines, as well as safety follow-up, for participants in prior clinical trials of encorafenib and/or binimetinib.

All participants who took part in earlier encorafenib and/or binimetinib studies may participate the FLOTILLA study if they are still benefiting from the use of the study medicines. This will be determined by the study doctor. People may not participate in the FLOTILLA study if they have not enrolled in a prior study of encorafenib or binimetinib.

Participants that had enrolled but had stopped receiving the study treatment in a prior study cannot enrolled in this study. Participants in the FLOTILLA study will receive encorafenib and/or binimetinib at the same dose and frequency as in their prior study, for up to about 5 years.

Conditions

Solid Tumors

Study ID

NCT05203172

Start date

Jul 5, 2022

Status verified date

Apr, 2026

Completion date

Jul 31, 2029

Anticipated

Primary completion date

Jul 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Any participant who is receiving study intervention and deriving clinical benefit (as determined by the principal investigator) in an encorafenib/binimetinib Parent Study, with no ongoing NCI CTCAE version 4.03 Grade ≥3 or intolerable Grade 2 AEs considered to be related to study treatment.
  • Participants must agree to follow the reproductive criteria as outlined in the applicable Encorafenib/Binimetinib Continuation Sub-Study Protocol.

Exclusion Criteria:

  • Any medical reason that, in the opinion of the investigator or sponsor, precludes the participant from inclusion in the study.

Study Design

Enrollment

46 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Binimetinib only treatment

For those participants receiving binimetinib treatment in parent studies

experimental: Encorafenib only Treatment

For those participants receiving encorafenib only treatment in parent studies

experimental: Encorafenib & Binimetinib Treatment

For those participants receiving encorafenib \& binimetinib treatment in parent studies.

experimental: Treatment of Encorafenib & Binimetinib & Ribociclib

For those participants receiving treatment of encorafenib \& binimetinib \& ribociclib in parent studies

experimental: Treatment of Encorafenib & Binimetinib & Cetuximab

For those participants receiving treatment of encorafenib \& binimetinib \& cetuximab in parent studies

Interventions

Binimetinib only treatment

Binimetinib will be administered at the same dose level (15 mg to 45 mg) as that received in the Parent Studies C4211001 and C4211003 with water irrespective of food, continuously, starting on Day 1.

Encorafenib only Treatment

Encorafenib will be self-administered at the same dose level as that received in the C4221010 Parent Study.

Encorafenib & Binimetinib Treatment

Encorafenib will be administered on a 300 mg QD schedule and binimetinib will be administered on a 45 mg BID schedule, both orally as a flat fixed dose. Cetuximab will be administered at either 400 mg/m2 or 500 mg/m2 IV every 2 weeks on Days 1 and 15 of every cycle.

Treatment of Encorafenib & Binimetinib & Ribociclib

Encorafenib capsule and ribociclib capsules or tablets will be co-administered orally QD with binimetinib tablets BID. The study drugs will be administered as a flat-fixed dose, and not by body weight or body surface area.

Treatment of Encorafenib & Binimetinib & Cetuximab

Encorafenib will be administered on a 300 mg QD schedule and binimetinib will be administered on a 45 mg BID schedule, both orally as a flat fixed dose. Cetuximab will be administered at either 400 mg/m2 or 500 mg/m2 IV every 2 weeks on Days 1 and 15 of every cycle.

Primary outcome measure

  • Number of participants with adverse events leading to permanent discontinuation of study intervention [ Time Frame: Baseline up to approximately 5 years ]
  • Number serious adverse events reported for all participants [ Time Frame: Baseline up to approximately 5 years ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

1-800-718-1021ClinicalTrials.gov_Inquiries@pfizer.com

Locations

St. Joseph's Hospital and Medical Center

Recruiting

Phoenix, Arizona, United States, 85004

St. Joseph's Hospital and Medical Center

Recruiting

Phoenix, Arizona, United States, 85013

Emory University Hospital Midtown

Recruiting

Atlanta, Georgia, United States, 30308

Emory University Hospital

Recruiting

Atlanta, Georgia, United States, 30322

Investigational Drug Service Emory University Clinic

Recruiting

Atlanta, Georgia, United States, 30322

Winship Cancer Institute of Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

HealthPartners Cancer Research Center

Recruiting

Saint Paul, Minnesota, United States, 55101

Regions Hospital Pharmacy

Recruiting

Saint Paul, Minnesota, United States, 55101

Siteman Cancer Center

Recruiting

St Louis, Missouri, United States, 63108

Barnes-Jewish Hospital

Recruiting

St Louis, Missouri, United States, 63110

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Washington University

Recruiting

St Louis, Missouri, United States, 63110

Duke Cancer Center

Recruiting

Durham, North Carolina, United States, 27710

Investigational Chemotherapy Service

Recruiting

Durham, North Carolina, United States, 27710

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1E2

More Information

Sponsor

Pfizer

Last update posted

Apr 7, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Pfizer on 2026-04-07.