What is the mechanism of action of this treatment?

BRAF inhibitors, such as Encorafenib, and MEK inhibitors, like Binimetinib, target specific proteins in the MAPK/ERK signaling pathway, which is often overactive in various solid tumors due to mutations. BRAF inhibitors block the activity of the mutated BRAF protein, thereby reducing tumor cell proliferation. MEK inhibitors work downstream of BRAF, further inhibiting the pathway and preventing cancer cell growth. This dual inhibition is crucial for patients with solid tumors as it can lead to more effective suppression of tumor growth and potentially improve survival outcomes.

What side effects are associated with this type of intervention?

The most common side effects of treatments for solid tumors using BRAF inhibitors like encorafenib and MEK inhibitors like binimetinib include increased γ-glutamyltransferase, increased blood creatine phosphokinase, hypertension, palmar-plantar erythrodysaesthesia syndrome, myalgia, and arthralgia. These treatments can also lead to severe skin reactions, fatigue, and gastrointestinal issues such as constipation and vomiting. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for solid tumors involving BRAF and MEK inhibitors. For instance, Dabrafenib (a BRAF inhibitor) and Trametinib (a MEK inhibitor) have been approved for the treatment of BRAF V600E-mutated melanoma. These drugs work by targeting specific mutations in the BRAF gene, which are common in various solid tumors. Similarly, Encorafenib and Binimetinib are being studied for their efficacy in treating BRAF V600-mutant melanoma, showing promise in ongoing clinical trials.

What other types of research exist?

Promising alternatives to Encorafenib and Binimetinib for solid tumors include: 1) Dabrafenib (BRAF inhibitor) and Trametinib (MEK inhibitor), which have shown efficacy in BRAF V600E-mutated tumors. 2) Chimeric Antigen Receptor (CAR) T-cell therapies, such as idecabtagene vicleucel and ciltacabtagene autoleucel, targeting specific tumor antigens. 3) Bispecific T-cell engagers (BiTEs) like teclistamab and AMG 701, which engage T-cells to target tumor cells. 4) Novel agents targeting cereblon (CELMoDs) like iberdomide and CC92480. These alternatives offer new mechanisms of action and have demonstrated promising results in clinical trials.

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Kinase Inhibitor

Encorafenib + Binimetinib Access for Cancer

Phase 4

Recruiting

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant receiving study intervention and deriving clinical benefit in an encorafenib/binimetinib Parent Study, with no ongoing NCI CTCAE version 4.03 Grade ≥3 or intolerable Grade 2 AEs related to study treatment

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not specified here, common side effects of cancer treatments like encorafenib and binimetinib can include fatigue, skin reactions, nausea, diarrhea, liver issues and increased risk of bleeding. Each person's experience may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

5Treatment groups

Experimental Treatment

Group I: Treatment of Encorafenib & Binimetinib & RibociclibExperimental Treatment1 Intervention

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

Group II: Treatment of Encorafenib & Binimetinib & CetuximabExperimental Treatment1 Intervention

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

Group III: Encorafenib only TreatmentExperimental Treatment1 Intervention

For those participants receiving encorafenib only treatment in parent studies

Group IV: Encorafenib & Binimetinib TreatmentExperimental Treatment1 Intervention

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

Group V: Binimetinib only treatmentExperimental Treatment1 Intervention

For those participants receiving binimetinib treatment in parent studies

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

BRAF inhibitors, such as Encorafenib, and MEK inhibitors, like Binimetinib, target specific proteins in the MAPK/ERK signaling pathway, which is often overactive in various solid tumors due to mutations. BRAF inhibitors block the activity of the mutated BRAF protein, thereby reducing tumor cell proliferation. MEK inhibitors work downstream of BRAF, further inhibiting the pathway and preventing cancer cell growth. This dual inhibition is crucial for patients with solid tumors as it can lead to more effective suppression of tumor growth and potentially improve survival outcomes.

Breast Cancer Resistance to Cyclin-Dependent Kinases 4/6 Inhibitors: Intricacy of the Molecular Mechanisms.Overall survival in patients with BRAF-mutant melanoma receiving encorafenib plus binimetinib versus vemurafenib or encorafenib (COLUMBUS): a multicentre, open-label, randomised, phase 3 trial.