Encorafenib + Binimetinib Access for Cancer

Recruiting in Palo Alto (17 mi)

+50 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Pfizer

Must be taking: Encorafenib, Binimetinib

Disqualifiers: Not in prior study, others

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial continues the use of cancer medications encorafenib and binimetinib for patients who benefited from them in previous studies. The drugs work by blocking proteins that help cancer cells grow. Encorafenib and binimetinib were first approved for use in combination to treat metastatic melanoma with specific BRAF mutations.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It seems focused on continuing the study medicines from previous trials.

What data supports the effectiveness of the drug combination Encorafenib and Binimetinib for cancer treatment?

Research shows that the combination of Encorafenib and Binimetinib is effective in treating advanced melanoma with a specific gene mutation, improving survival rates and quality of life compared to other treatments. This combination is also being studied for its potential in treating other types of cancer.

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Is the combination of Encorafenib and Binimetinib safe for human use?

The combination of Encorafenib and Binimetinib has been shown to have an acceptable safety profile in patients with certain types of cancer, such as metastatic melanoma and non-small-cell lung cancer. Some side effects like fever and skin sensitivity are less common compared to other similar treatments, which can improve patients' quality of life.

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Eligibility Criteria

The FLOTILLA study is for people with solid tumors who have previously benefited from encorafenib and/or binimetinib in earlier trials. They must be seeing ongoing benefits without severe side effects, as judged by their doctor, and agree to follow specific reproductive guidelines.

Inclusion Criteria

Participants must agree to follow the reproductive criteria as outlined in the applicable Encorafenib/Binimetinib Continuation Sub-Study Protocol

I am benefiting from an encorafenib/binimetinib study without severe side effects.

Exclusion Criteria

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

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive encorafenib and/or binimetinib at the same dose and frequency as in their prior study

Up to 5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Participant Groups

This trial provides continued access to encorafenib and binimetinib, alone or combined with ribociclib or cetuximab, for those previously treated with these drugs. The aim is safety monitoring while allowing participants to keep taking the same doses for up to five years.

Group I: Treatment of Encorafenib & Binimetinib & Ribociclib Experimental Treatment 1 Intervention

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

Group II: Treatment of Encorafenib & Binimetinib & Cetuximab Experimental Treatment 1 Intervention

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

Group III: Encorafenib only Treatment Experimental Treatment 1 Intervention

For those participants receiving encorafenib only treatment in parent studies

Group IV: Encorafenib & Binimetinib Treatment Experimental Treatment 1 Intervention

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

Group V: Binimetinib only treatment Experimental Treatment 1 Intervention

For those participants receiving binimetinib treatment in parent studies

Binimetinib is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Mektovi for:

• Unresectable or metastatic melanoma with a BRAF V600E or V600K mutation

🇪🇺 Approved in European Union as Mektovi for:

• Unresectable or metastatic melanoma with a BRAF V600 mutation

🇨🇦 Approved in Canada as Mektovi for:

• Unresectable or metastatic melanoma with a BRAF V600E or V600K mutation

🇯🇵 Approved in Japan as Mektovi for:

• Unresectable or metastatic melanoma with a BRAF V600 mutation

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

HealthPartners Cancer Research Center Saint Paul, MN

Princess Margaret Cancer Centre Toronto, Canada

Jewish General Hospital Montreal, Canada

MSK Basking Ridge Basking Ridge, NJ

More Trial Locations

Who Is Running the Clinical Trial?

Pfizer Lead Sponsor

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Encorafenib and Binimetinib: First Global Approvals. [2019] Encorafenib (Braftovi™), a BRAF inhibitor, and binimetinib (Mektovi®), a MEK inhibitor, are two orally bioavailable drugs developed by Array BioPharma. In June 2018 they each received their first global approval, in the USA, for use in combination, for patients with unresectable or metastatic melanoma with a BRAFV600E or -V600K mutation as detected by an FDA-approved test. Registration applications for encorafenib and binimetinib for use in combination in the treatment of BRAF-mutation-positive advanced melanoma have also been submitted in the EU, Australia, Switzerland and Japan, with the EMA Committee for Medicinal Products for Human Use adopting a positive opinion in July 2018 towards granting the drugs marketing authorizations in the EU. Encorafenib plus binimetinib combination therapy is also in ongoing phase III clinical development in the treatment of metastatic colorectal cancer. This article summarizes the milestones in the development of encorafenib and binimetinib leading to these first approvals for the treatment of BRAFV600E or -V600K-mutation-positive unresectable or metastatic melanoma.

2. England pubmed.ncbi.nlm.nih.gov

Quality of life in patients with BRAF-mutant melanoma receiving the combination encorafenib plus binimetinib: Results from a multicentre, open-label, randomised, phase III study (COLUMBUS). [2021] In COLUMBUS, treatment with encorafenib plus binimetinib in patients with advanced BRAF-mutant melanoma showed improved progression-free and overall survival with favourable tolerability compared to vemurafenib treatment. Here, results on health-related quality of life (HRQoL) are presented.

3. England pubmed.ncbi.nlm.nih.gov

COLUMBUS 5-year update: a randomized, open-label, phase III trial of encorafenib plus binimetinib versus vemurafenib or encorafenib in patients with BRAF. [2023] Label="WHAT IS THIS SUMMARY ABOUT?" NlmCategory="UNASSIGNED">Here, we summarize the 5-year results from part 1 of the COLUMBUS clinical study, which looked at the combination treatment of encorafenib plus binimetinib in people with a specific type of skin cancer called melanoma. Encorafenib (BRAFTOVI®) and binimetinib (MEKTOVI®) are medicines used to treat a type of melanoma that has a change in the BRAF gene, called advanced or metastatic BRAF V600-mutant melanoma. Participants with advanced or metastatic BRAF V600-mutant melanoma took either encorafenib plus binimetinib together (COMBO group), compared with encorafenib alone (ENCO group) or vemurafenib (ZELBORAF®) alone (VEMU group).

4. United States pubmed.ncbi.nlm.nih.gov

A Phase Ib/II Study of the BRAF Inhibitor Encorafenib Plus the MEK Inhibitor Binimetinib in Patients with BRAFV600E/K -mutant Solid Tumors. [2021] Label="PURPOSE">This open-label, dose-finding phase Ib/II study reports the safety and activity of the first combination use with BRAF inhibitor (BRAFi) encorafenib plus MEK inhibitor (MEKi) binimetinib in patients with BRAF V600E-mutant solid tumors.

5. Italy pubmed.ncbi.nlm.nih.gov

[Long-term efficacy of encorafenib plus binimetinib combined treatment: case report.] [2021] Combination treatment with BRAF plus MEK inhibitors is a standard of care in patients with BRAF-mutant advanced melanoma. In addition to dabrafenib+trametinib and vemurafenib+cobimetinib, a new combination of BRAF and MEK inhibitors, encorafenib and binimetinib, was recently introduced into clinical practice. Encorafenib plus binimetinib achieved similar efficacy to that observed with previously available combinations, but incidence of some toxicities such as pyrexia and photosensitivity, which have a relevant impact on patients quality of life, is lower. In this article, the case of a patient who received encorafenib and binimetinib within the phase 3 trial COLUMBUS is presented and discussed, with a focus on the clinical management during the pandemic caused by SARS-CoV-2 virus.

6. United States pubmed.ncbi.nlm.nih.gov

Phase II, Open-Label Study of Encorafenib Plus Binimetinib in Patients With BRAFV600-Mutant Metastatic Non-Small-Cell Lung Cancer. [2023] Label="PURPOSE">The combination of encorafenib (BRAF inhibitor) plus binimetinib (MEK inhibitor) has demonstrated clinical efficacy with an acceptable safety profile in patients with BRAFV600E/K-mutant metastatic melanoma. We evaluated the efficacy and safety of encorafenib plus binimetinib in patients with BRAFV600E-mutant metastatic non-small-cell lung cancer (NSCLC).

7. England pubmed.ncbi.nlm.nih.gov

The spectrum of cutaneous adverse events during encorafenib and binimetinib treatment in B-rapidly accelerated fibrosarcoma-mutated advanced melanoma. [2019] B-rapidly accelerated fibrosarcoma (BRAF) inhibitor encorafenib alone and in combination with MEK inhibitor binimetinib improves survival in BRAF-mutated melanoma patients. So far, the range of cutaneous adverse events has been characterized only for established BRAF inhibitors (vemurafenib, dabrafenib) and MEK inhibitors (trametinib, cobimetinib).