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Encorafenib Pill · 1 trial · 3 indications
Investigators will estimate the rate of disease relapse after neoadjuvant therapy based on pathologic complete response status and postoperative adjuvant therapy within each arm.
| Arm | Type | Description |
|---|---|---|
| Surveillance | ACTIVE_COMPARATOR | Participants will receive 24 weeks of neoadjuvant encorafenib and binimetinib and then proceed to planned resection. If participants have pathologic complete response they will receive adjuvant treatment for 24 weeks. Imaging will be conducted every 12 weeks for at least one year after surgery, and every 24 weeks for at least two years post-surgery. |
| Encorafenib and Binimetinib after Pathologic Complete Response | EXPERIMENTAL | Participants will receive 24 weeks of neoadjuvant encorafenib and binimetinib and then proceed to planned resection. If participants have pathologic complete response they will continue to receive encorafenib and binimetinib for 24 more weeks. Imaging will be conducted every 12 weeks for at least one year after surgery, and every 24 weeks for at least two years post-surgery. |
| Encorafenib and Binimetinib after Non-Pathologic Complete Response | EXPERIMENTAL | Participants will receive 24 weeks of neoadjuvant encorafenib and binimetinib and then proceed to planned resection. If participants have non-pathologic complete response they will continue to receive encorafenib and binimetinib for 24 more weeks. Imaging will be conducted every 12 weeks for at least one year after surgery, and every 24 weeks for at least two years post-surgery. |
| Nivolumab after Non-Pathologic Complete Response | EXPERIMENTAL | Participants will receive 24 weeks of neoadjuvant encorafenib and binimetinib and then proceed to planned resection. If participants have non-pathologic complete response they will receive nivolumab for 24 weeks. Imaging will be conducted every 12 weeks for at least one year after surgery, and every 24 weeks for at least two years post-surgery. |
| Name | Type | Description |
|---|---|---|
| Encorafenib Pill | DRUG | Encorafenib 450 mg will be administered orally once per day in continuous 28-day cycles |
| Binimetinib Pill | DRUG | Binimetinib 45 mg will be administered orally twice per day in continuous 28-day cycles |
| Nivolumab | DRUG | Nivolumab will be administered at a dose of 480 mg IV infusion over 30 minutes every 4 weeks. |
Inclusion Criteria: * Age ≥ 18 years at the time of informed consent * Histologically confirmed diagnosis of melanoma. Any primary or unknown origin is permitted. * Melanoma must have a BRAFV600 mutation (using a CLIA-validated assay), either stage III (B/C/D) or Stage IV (AJCC 8th edition). * ECOG...
Encorafenib pill is being studied as adjuvant therapy for Stage III melanoma, including patients with BRAF V600 mutations. The Phase 1 trial evaluates treatment based on pathologic response after neoadjuvant encorafenib and binimetinib. It is an investigational small molecule and is not approved for this use.
Encorafenib pill targets BRAF, a kinase in the MAPK signaling pathway. It acts as an inhibitor of BRAF, including the V600 mutant form. By inhibiting BRAF, the drug aims to block signals that drive melanoma cell growth. This mechanism underlies its study in BRAF V600 mutation-positive melanoma.
Encorafenib pill is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer is the company responsible for the clinical development of this BRAF inhibitor. The asset is being investigated in a company-sponsored trial for melanoma.
Encorafenib pill is in Phase 1 clinical development. The ongoing trial is an early Phase 1 study, and the drug is investigational. It has not been approved by the FDA for the treatment of melanoma or any other indication.
Encorafenib pill is being evaluated in the clinical trial NCT04741997, titled "Adjuvant Therapy Based on Pathologic Response After Neoadjuvant Encorafenib Binimetinib in Melanoma." The trial is recruiting approximately 50 participants in the United States and includes patients with Stage III or Stage IV melanoma and BRAF V600 mutations.