Estudio del fármaco MK-3475 frente a la quimioterapia de uso común para el tratamiento del melanoma avanzado (cáncer de piel que se ha extendido a otras partes del cuerpo)
- Conditions
- Advanced melanoma (unresectable or metastatic)MedDRA version: 14.1 Level: PT Classification code 10027480 Term: Metastatic malignant melanoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-003030-17-ES
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 540
1)Patient must have a histologically or cytologically confirmed diagnosis of unresectable stage III or metastatic MEL not amenable to local therapy.
?Patient may not have a diagnosis of uveal melanoma.
2)Patiens must be refractory to ipilimumab, defined as:
?Received at least two doses of ipilimumab
?Documented disease progression within 24 weeks of the last dose of ipilimumab. Patients who were re-treated with ipilimumab and patients who were on maintenance ipilimumab will be allowed to enter the trial as long as there is documented PD within 24 weeks of the last treatment date (with ipilimumab).
?Progressive disease will be defined as increase in tumor burden >25% relative to nadir (minimum recorded tumor burden) which is confirmed by repeat assessment (investigator determination based on site radiology reading; SPONSOR will collect CT scans for retrospective analysis) no less than four weeks from the date of the first documented PD. Once PD is confirmed, initial date of PD documentation will be considered as the date of disease progression.
3)Full resolution of ipilimumab related AEs (including irAEs) back to baseline and off steroid treatment for irAEs for at least two weeks.
4)Full resolution of ipilimumab related AEs (including irAEs) back to baseline and off of steroid treatment (>10 mg/day prednisone or equivalent dose) for irAEs for at least two weeks prior to first dose of study drug.
?No history of severe irAEs from ipilimumab CTCAE Grade 4 requiring steroid treatment; CTCAE Grade 3 requiring steroid treatment (>10 mg/day prednisone or equivalent dose) >12 weeks
?Minimum of four weeks (wash out period) from the last dose of ipilimumab
5)Patients must consent to allow correlative studies and should have available tumor tissue (formalin fixed paraffin embedded block or unstained slides). These tumor tissues could be archival or fresh tumor biopsy as part of this trial.
6)Patients with BRAF V600E mutant melanoma must have also been previously treated with a BRAF and/or MEK inhibitor. Patient must have progressive disease after the most recent treatment regimen.
7)Patient must have measurable disease as per RECIST version 1.1 (Appendix 6.1)
Are the trial subjects under 18? yes
Number of subjects for this age range: 30
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 240
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 240
1)Patient who has had chemotherapy, radioactive, or biological cancer therapy within four weeks prior to the first dose of study drug, or who has not recovered to CTCAE Grade 1 or better from the AEs due to cancer therapeutics administered more than four weeks earlier.
?The requirements for prior ipilimumab treatment are listed in Inclusion Criterion 2.
2)Patient is currently participating or has participated in a study of an investigational agent or using an investigational device within 30 days of the first dose of study drug.
3)Patient is expected to require any other form of systemic or localized antineoplastic therapy while on study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method