Melanoma patients get drug combo before surgery in new trial
NCT ID NCT01972347
First seen Jun 27, 2026 · Last updated Jun 30, 2026 · Updated 2 times
Summary
This phase II trial tests whether giving two targeted drugs (dabrafenib and trametinib) before and after surgery can improve outcomes for people with stage IIIB-C melanoma that has a BRAF V600 mutation. 35 participants will take the drugs for 12 weeks before surgery, then continue for 40 weeks after. The main goal is to see how much the tumor shrinks before surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Dabrafenib and trametinib (targeted therapy drugs)
- What this could lead to
- If successful, this approach could shrink melanoma tumors before surgery, potentially improving surgical outcomes and long-term disease control.
- What could go wrong
- This is a small, early-phase study (35 people) at a single center. Results may not apply to all patients, and side effects from the drugs are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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35 people
The number who actually took part.
- Started
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Oct 2014
- Finished
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Jun 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥18 years * Histologically confirmed AJCC Stage IIIB or IIIC (Tx, T1-4, N1b, N2b, N2c, N3, Mo) cutaneous melanoma or unknown primary determined to be BRAF V600 mutation positive, with sufficient nodal or in-transit disease to enable biopsies prior to surgery.Patients must have disease that is measurable per RECIST version 1.1 * Able to swallow and retain oral medication and must not have any clinically significant gastrointestinal abnormalities that may alter absorption * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 * Adequate baseline organ function * Women of childbearing potential must have a negative serum pregnancy test within 7 days of first dose of study treatment and agree to use effective contraception from 14 days prior to commencing study treatment, throughout the treatment period and for 4 months after the last dose of study treatment * Men with any female partner of childbearing potential must agree to use effective contraception from 14 days prior to commencing study treatment, throughout the treatment period and for 4 months after the last dose of study treatment Exclusion Criteria: * Known mucosal or ocular melanoma or any unresectable in-transit metastases * Evidence of distant metastatic disease on screening evaluation * Prior anti-cancer treatment for melanoma (chemotherapy, immunotherapy, biologic therapy, vaccine therapy, investigational treatment or radiotherapy). Prior surgery for melanoma is allowed. * Taken an investigational drug within 28 days or 5 half-lives, whichever is longer, prior to commencing study treatment. * Current or expected use of a prohibited medication(s) * Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study treatments, their excipients, and/or dimethyl sulfoxide (DMSO) * Known HIV * A history of known glucose-6-phosphate dehydrogenase (G6PD) deficiency * History of another malignancy or a concurrent malignancy except: 1. Patients who have been disease-free for 3 years and have a life expectancy of \> 5 years; 2. Patients with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible, for example cervical cancer in situ, atypical melanocytic hyperplasia or melanoma in situ, multiple primary melanomas. * A history or evidence of cardiovascular risk including any of the following: a. QT interval corrected for heart rate using the Bazett's formula ≥480 msec or ≥ 450 msec for patients with bundle branch block; b. History or evidence of current clinically significant uncontrolled arrhythmias; c. History of acute coronary syndromes (including myocardial infarction or unstable angina), coronary angioplasty, or stenting within 6 months prior to commencement of study treatment; d. History or evidence of current ≥ Class II congestive heart failure; e. Abnormal cardiac valve morphology documented by echocardiogram which in the opinion of the investigator could interfere with the patient's safety. f. Treatment refractory hypertension defined as a blood pressure of systolic \> 140 mm Hg and/or diastolic \> 90 mm Hg which cannot be controlled by anti-hypertensive therapy. * A history or current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR) * Any serious or unstable pre-existing medical conditions (aside from the malignancy exceptions specified above), psychiatric disorders, or other conditions that, in the opinion of the treating clinician, could interfere with the patient's safety, obtaining informed consent, or compliance with study procedures. * Breastfeeding females
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Melanoma Institute Australia
Wollstonecraft, New South Wales, 2065, Australia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New antibody GNR-051 tested for safety in Hard-to-Treat cancers
- Blood test could spot Melanoma's BRAF mutation
- Can a CXCR1/2 blocker boost radiation against cancer that spreads to the brain lining?
- Can a new antibody help the immune system fight Hard-to-Treat tumors?
- Can tumor DNA and immune cells reveal why some cancers resist immunotherapy?
- Can a Two-Drug immune combo shrink melanoma tumors?