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New treatment option for Melanoma Stage III
Official title Adjuvant Therapy Based on Pathologic Response After Neoadjuvant Encorafenib Binimetinib in Melanoma
ClinicalTrials.gov ID: NCT04741997
What this study is testing
What is Encorafenib Pill?
Encorafenib Pill is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for melanoma stage iii.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to assess rate of disease relapse and hazard rate of disease relapse after neoadjuvant therapy based on the statuses of pathologic complete response or non-pathologic complete response, and postoperative adjuvant therapy.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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 performance status ≤ 2
- Adequate laboratory parameters as well:
You likely can't join if
- Participants may have received prior therapy with BRAF and/or a MEK inhibitor if it was completed at least 6 months prior to study enrollment...
- Participants must not have had adverse events related to encorafenib and/or binimetinib specifically, that required discontinuation of one or both...
- Participants who have had major surgery or radiotherapy ≤ 14 days prior to start of study treatment or who have not recovered from side effects of...
- Participants must be willing to avoid consuming grapefruit, pomegranates, star fruits, Seville oranges or products containing the juice during the...
- Uncontrolled or symptomatic brain metastases or leptomeningeal carcinomatosis that are not stable, require steroids, are potentially life-threatening...
- Impaired cardiovascular function as below:
See the full eligibility 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 performance status ≤ 2
- Adequate laboratory parameters as well:
- a. Hemoglobin ≥ 8 g/dL.
- b. Platelets ≥ 75 × 109/L;
- c. AST and ALT ≤ 2.5 × ULN; in participants with liver metastases ≤ 5 × ULN;
- d. Total bilirubin ≤ 1.5 × ULN and \ 1.5 × ULN with indirect bilirubin \< 1.5 × ULN;
- e. Serum creatinine ≤ 2.0 × ULN
- Female participants of childbearing potential as described in protocol, must have a negative serum or urine β-HCG test result. Female participants of childbearing potential must agree to use methods of contraception...
- Participants may have received prior therapy with BRAF and/or a MEK inhibitor if it was completed at least 6 months prior to study enrollment. Patients who had prior disease progression while on BRAF/MEK inhibitor...
- Participants must not have had adverse events related to encorafenib and/or binimetinib specifically, that required discontinuation of one or both drugs due to toxicity.
- Participants who have had major surgery or radiotherapy ≤ 14 days prior to start of study treatment or who have not recovered from side effects of such procedure.
- Participants must be willing to avoid consuming grapefruit, pomegranates, star fruits, Seville oranges or products containing the juice during the study while they are taking encorafenib/binimetinib.
- Uncontrolled or symptomatic brain metastases or leptomeningeal carcinomatosis that are not stable, require steroids, are potentially life-threatening or have required radiation within 28 days prior to starting study...
- Impaired cardiovascular function as below:
- a. Congestive heart failure requiring treatment (New York Heart Association Grade ≥ 3);
- b. presence of uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia
- c. Baseline QTcF interval ≥ 500 ms.
- Known history of retinal vein occlusion (RVO)
- Current use of a prohibited medication (including herbal medications, supplements, or foods), as described in protocol, or use of a prohibited medication ≤ 1 week prior to the start of study treatment.
- Participants with a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) does not have the potential to interfere with the safety or how well it works assessment...
- Participants with known human immunodeficiency virus (HIV)-infection are eligible providing they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test and within...
- Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants with HCV infection who are currently on treatment must have an undetectable HCV viral load prior to...
- Pregnancy or breast feeding.
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.