Cancer Melanoma
Conditions
Interventions
Completion of questionnaires, physical examination, ECG, blood draw, CT or MRI
scan, intravenous administration of MK3475.
Sponsors
Merck Sharp & Dohme (MSD)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Patient must have a histologically confirmed diagnosis of unresectable stage III or metastatic MEL not amenable to local therapy. * Patient may not have a diagnosis of uveal or ocular melanoma.;* Patients who have not received prior systemic treatment (excluding adjuvant or neoadjuvant therapy) for MEL (first line) or who have received one prior systemic treatment (excluding adjuvant or neoadjuvant therapy) for MEL (second line) are both eligible. However, the enrollment of either first line or second line patients will be limited to approximately 387 patients (60% of the total patients). After this limit is reached for either of the groups, only patients from the other group will be enrolled.;* Patients must have testing for a BRAF mutation prior to study entry. Patients with BRAF V600E mutant melanoma may have received prior BRAF inhibitor therapy as first-line systemic therapy and be eligible for this study as second line treatment. At the discretion of the investigator, patients with BRAF V600E mutant melanoma who have NOT received a BRAF inhibitor are also eligible for this study as first line treatment if they meet the following additional criteria: * LDH 18 months, post hysterectomy/oophorectomy, or surgically sterilized, must be willing to use either 2 adequate barrier methods or a barrier method plus a hormonal method of contraception to prevent pregnancy or to abstain from heterosexual activity throughout the study, starting with Visit 1 through 120 days after the last dose of study therapy. Approved contraceptive methods include 2 of the following barrier methods or one barrier method combined with a hormonal contraceptive: intra uterine device, diaphragm with spermicide, cervi
Exclusion criteria
Exclusion criteria: 1) Patient had prior treatment with IPI or other anti-CTLA-4 agent, any anti-PD-1, anti-PD-L1, or anti- PD-L2 agent.;2) 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.;3) 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.;4) Patient is expected to require any other form of systemic or localized antineoplastic therapy while on study.;5) Patient is on any systemic corticosteroid therapy within one week before the planned date for first dose of randomized treatment or on any other form of immunosuppressive medication.;6) Patient has a history of a malignancy (other than the disease under treatment in the study) within 5 years prior to first study drug administration. This should exclude adequately treated Stage 1 or Stage 2 basal/squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or other in situ cancers. Shorter intervals can be considered after discussion with Sponsor.;7) Patient has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by MRI for at least four weeks prior to the first dose of study drug), have no evidence of new or enlarging brain metastases and are off systemic steroids for at least two weeks.;8) Patient previously had a severe hypersensitivity reaction to treatment with another mAb.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following evaluations will be performed throughout the course of the study (see flowchart, 1.7 of protocol for more details): - Tumor resonse assessments by physical examination, and tumor imaging by CT or MRI - Anti-MK3475 antibodies (MK3475 patients only) - PK measurements (PK peak/trough) - ECOG performance status - Tumor biopsies - EORTC QLQ-C30 / EuroQol EQ-5D - Health Economic Assessment | — |
Countries
Netherlands
Outcome results
None listed