Recruiting
Phase 4

Encorafenib & Binimetinib

Sponsor:

Pfizer

Code:

NCT05203172

Conditions

Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Binimetinib

Encorafenib

Vemurafenib

Ribociclib

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 in 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 were not enrolled in a prior study of encorafenib or binimetinib.

Participants who had enrolled but had stopped receiving the study treatment in a prior study cannot be enrolled in this study. Participants in the FLOTILLA study will receive study treatment 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

Oct, 2026

Completion date

Jun 30, 2032

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

210 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Sub-Study C4221004C

Continued treatment access for participants from the C4221004 (ARRAY CMEK162B2301, COLUMBUS) Encorafenib and Binimetinib study.

Each participant will receive the same study treatment as received in the Parent Study.

experimental: Sub-Study C4221005C

Continued treatment access for participants from the C4221005 (ARRAY CMEK162X2110) Encorafenib and Binimetinib study.

Each participant will receive the same study treatment as received in the Parent Study.

experimental: Sub-Study C4211001C / C4211003C

Continued treatment access for participants from the C4211001 (ARRAY CMEK162×2201) and the C4211003 (ARRAY-162-311, MILO) Binimetinib studies.

Each participant will receive the same study treatment as received in the Parent Study.

experimental: Sub-Study C4221003C / C4221006C / C4221013C

Continued treatment access for participants from the C4221003 (ARRAY-818-103), C4221006 (ARRAY-818-201) and the C4221013 (ARRAY CLGX818X2109) Encorafenib and Binimetinib studies.

Each participant will receive the same study treatment as received in the Parent Study.

experimental: Sub-Study C4221009C / W00090 GE 2 01C

Continued treatment access for participants from the C4221009 (ARRAY-818-302, BEACON) and W00090 GE 2 01 (ANCHOR CRC) Encorafenib, Binimetinib and Cetuximab studies.

Each participant will receive the same study treatment as received in the Parent Study.

experimental: Sub-Study C4221008C

Continued treatment access for participants from the C4221008 (ARRAY-818-202, PHAROS) Encorafenib and Binimetinib study.

Each participant will receive the same study treatment as received in the Parent Study.

experimental: Sub-Study C4221016C / C4221023C

Continued treatment access for participants from the C4221016 (STARBOARD) and C4221023 (PORTSIDE) Encorafenib and Binimetinib studies.

Each participant will receive the same study treatment as received in the Parent Study.

experimental: Sub-Study C4221010C

Continued treatment access for participant from the C4221010 (CLGX818X2101) Encorafenib study.

Each participant will receive the same study treatment as received in the Parent Study.

experimental: Sub-Study C4221015C / C4221022C

Continued treatment access for participants from the C4221015 (BREAKWATER) and C4221022 (SEAMARK) Encorafenib studies.

Each participant will receive the same study treatment as received in the Parent Study.

Interventions

Binimetinib

Binimetinib is administered orally twice a day.

Encorafenib

Encorafenib is administered orally once a day.

Vemurafenib

Vemurafenib is administered orally twice a day.

Ribociclib

Ribociclib is administered orally once a day.

Cetuximab

Cetuximab is administered intravenously (IV) every 2 weeks.

Pembrolizumab

Pembrolizumab is administered intravenously (IV) every 3 weeks. A maximum of 35 administrations will be given, including doses already given in the Parent Study.

Nivolumab

Nivolumab is administered intravenously (IV) every 4 week. A maximum of 24 months of treatment will be given, beginning with the first dose in the Parent Study.

5-Fluorouracil

5-FU is administered intravenously (IV) every 2 weeks.

Leucovorin

Leucovorin is administered intravenously (IV) every 2 weeks. Levo-leucovorin may be given as an alternative for leucovorin.

Oxaliplatin

Oxaliplatin is administered intravenously (IV) every 2 or 3 weeks.

Irinotecan

Irinotecan is administered intravenously (IV) every 2 weeks.

Capecitabine

Capecitabine is administered orally twice a day for 14 consecutive days, followed by 7 days off.

Bevacizumab

Bevacizumab will be administered intravenously (IV), if applicable.

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

Oct 19, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by Pfizer on 2026-10-19. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.