A phase II clinical trial on the combination of dabrafenib and trametinib for BRAF-inhibitor pretreated patients with advanced BRAF V600 mutant melanoma - Combi-Rechallenge

Z Brussel0 sitesMarch 27, 2014

Conditionsadvanced BRAF V600 mutant melanoma MedDRA version: 16.1Level: PTClassification code 10025671Term: Malignant melanoma stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.1Level: PTClassification code 10025670Term: Malignant melanoma stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.1Level: HLTClassification code 10027156Term: Skin melanomas (excl ocular)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.1Level: PTClassification code 10066600Term: Melanoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.1Level: PTClassification code 10027480Term: Metastatic malignant melanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

DrugsTafinlar

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: advanced BRAF V600 mutant melanoma
Sponsor: Z Brussel
Status: Active, not recruiting
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 27, 2014

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Z Brussel

Eligibility Criteria

Inclusion Criteria

•1\. ?18 years of age.
•2\. Signed written informed consent.
•3\. Histologically confirmed cutaneous melanoma that is either Stage IIIC (unresectable) or Stage IV (metastatic), and determined to be BRAF V600E/K mutation\-positive.
•4\. Subjects must have failed at least two prior systemic anti\-cancer treatments for Stage IIIC (unresectable) or Stage IV (metastatic) melanoma that must have included:
•a. Treatment with a BRAF inhibitor (including but not limited to dabrafenib, vemurafenib, and LGX818\) and progression of disease per RECIST, version 1\.1 must have been documented during this treatment.
•b. Treatment with ipilimumab (or an alternative experimental immunotherapy) and progression of disease per immune related response criteria must have been documented during this treatment.
•5\. Documented progression of disease per RECIST, version 1\.1 or per immune related response criteria if the latest systemic therapy administered was ipilimumab, an anti\-PD1 or anti\-PD\-L1 therapy, or any other experimental immunotherapy.
•6\. The presence of at least one measurable lesion per RECIST, version 1\.1
•7\. Interval between the date of the last administration of prior therapy for melanoma and the date of recruitment:
•a. \> 12 weeks following the date of the last administration of a BRAF\-inhibitor;

Exclusion Criteria

•1\. Grade 4 or repetitive grade 3 adverse event(s) related to prior treatment with a BRAF\- and/or MEK inhibitor.
•2\. Prior treatment with a combination of a BRAF inhibitor and a MEK inhibitor (including but not limited to the combination of dabrafenib and trametinib or vemurafenib and cobimetinib, or LGX818 and MEK162\)
•3\. Any contra\-indication for evaluation by whole body CT and MRI of the brain.
•4\. Taken an investigational drug within 28 days or 5 half\-lives (minimum 14 days), whichever is shorter, prior to recruitment.
•5\. Current use of a prohibited medication as described in Section 6 or requires any of these medications during treatment.
•6\. History of another malignancy, including any malignancy with confirmed activating RAS mutation. Note: Prospective RAS testing is not required. However, if the results of previous RAS testing are known, they must be used in assessing eligibility. Exception: Subjects who have been disease\-free for 3 years, (i.e. subjects with second malignancies that are indolent or definitively treated at least 3 years ago) not including malignancy with confirmed activating RAS mutation, or subjects with a history of completely resected non\-melanoma skin cancer.
•7\. Any serious or unstable pre\-existing medical conditions (aside from malignancy exceptions specified above), psychiatric disorders, or other conditions that could interfere with the subject’s safety, obtaining informed consent, or compliance with study procedures.
•8\. Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection (subjects with laboratory evidence of cleared HBV and HCV infection will be permitted).
•9\. Patients with progressive symptoms from active brain metastasis or in need of an increase in corticosteroids dose to control symptoms within 4 weeks prior to recruitment are excluded
•10\. No enzyme inducing anticonvulsants for \= 4 weeks prior to recruitment