Continued access to encorafenib and binimetinib for previous trial participants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The FLOTILLA study aims to provide ongoing access to the medications encorafenib and binimetinib for participants who have previously benefited from these treatments in earlier clinical trials. This open-label continuation study allows eligible participants to receive the same dosage and frequency of the medications for up to five years, ensuring safety follow-up and monitoring. Participants must have been part of prior studies involving these drugs and must still be experiencing clinical benefits as determined by their study doctor.

Why it matters

Who can join: the full rules

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.

Where it's running

• St. Joseph's Hospital and Medical Center
  Phoenix, Arizona, United States Recruiting
• St. Joseph's Hospital and Medical Center
  Phoenix, Arizona, United States Recruiting
• Emory University Hospital Midtown
  Atlanta, Georgia, United States Recruiting
• Emory University Hospital
  Atlanta, Georgia, United States Recruiting
• Investigational Drug Service Emory University Clinic
  Atlanta, Georgia, United States Recruiting
• Winship Cancer Institute of Emory University
  Atlanta, Georgia, United States Recruiting

+27 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.