Cytoreductive treatment of dabrafenib combined with trametinib to allow complete surgical resection in patients with BRAF mutated, prior unresectable stage III or IV melanoma - Presurgical MAPK inhibition in stage III-IV melanoma, REDUCTOR

ederlands Kanker Instituut0 个研究点目标入组 25 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•1. Patients have provided signed informed consent.
•2. Patients have unresectable stage III melanoma (documented and based on MSD) or stage IV melanoma with <= 3 resectable metastases/organ site.
•3. Patients have pathologically confirmed BRAF mutation-positive (V600E/K) melanoma as determined via in-house testing with a BRAF mutation assay.
•4. Patients are treatment naïve for unresectable melanoma.
•5. Patients for whom the intended operation is considered to offer a chance of cure or substantial palliation.
•6. Patients have evaluable disease by CT/MRI or PET with <= 3 metastases/organ sites.
•7. Patients are >=18 years of age.
•8. Patients are able to swallow and retain oral medication.
•9. Women with child-bearing potential and men with reproductive potential must be willing to practice acceptable methods of birth control during the study.
•10. Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to the first dose of study treatment.
•11. Patients have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
•12. Patients must have adequate organ function as defined in the protocol. Treatment with transfusion, growth factors to meet eligibility criteria will not be allowed.

•1. Patients with known ocular or primary mucosal melanoma.
•2. Patients who used any investigational anti-cancer or other drug within 28 days or 5 half-lives, whichever is longer, preceding the first dose of dabrafenib + trametinib.
•3. Patients who currently use a prohibited medication or are expected to require any of these medications during treatment with dabrafenib and trametinib.
•4. Patients who had any major surgery, radiotherapy, or immunotherapy within the last 4 weeks.
•5. Patients with active gastrointestinal disease or other condition that will interfere significantly with the absorption of drugs.
•6. Patients with a history of glucose-6-phosphate dehydrogenase (G6PD) deficiency.
•7. Patients with a history of other malignancy. Subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible
•8. Patients with a history of alcohol or drug abuse within 6 months prior to screening.
•9. Patients with psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol, or unwillingness or inability to follow the procedures required in the protocol.
•10. Patients with the cardiac abnormalities as defined in the protocol.
•11. Pregnant or lactating female.
•12. Patients with CNS metastases.

发起方

ederlands Kanker Instituut