Status:
COMPLETED
Study to Evaluate the Safety and Efficacy of Two Different Dosing Schedules of Pembrolizumab (MK-3475) Compared to Ipilimumab in Participants With Advanced Melanoma (MK-3475-006/KEYNOTE-006)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will evaluate the safety and efficacy of 2 different dosing schedules of pembrolizumab (MK-3475), every 2 weeks (Q2W) and every 3 weeks (Q3W), and compare the 2 schedules to treatment with ...
Detailed Description
Participants assigned to a primary course of pembrolizumab can receive up to 24 months of treatment. Participants with Stable Disease (SD) or better will then proceed to Post Treatment Follow-up. All ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically-confirmed diagnosis of unresectable Stage III or metastatic melanoma not amenable to local therapy (excluding uveal or ocular melanoma)
- At least one measurable lesion
- No prior systemic treatment (excluding adjuvant or neoadjuvant therapy) for melanoma (first line) or one prior systemic treatment (excluding adjuvant or neoadjuvant therapy) for melanoma (second line)
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Archived tissue sample or new biopsy sample
- Female participants of childbearing potential must agree to use effective contraception from Visit 1 to 120 days after the last dose of study drug; male participants must agree to use an adequate method of contraception starting with the first dose of study drug through 120 days after the last dose of study drug
- Exclusion criteria:
- Prior treatment with ipilimumab or other anti-cytotoxic T-Lymphocyte Antigen 4 (CTLA-4) agent or any anti-programmed cell death (PD-1 or PD-L2) agent
- Chemotherapy, radioactive, or biological cancer therapy within four weeks prior to the first dose of study drug, or not recovered from adverse events caused by cancer therapeutics administered more than four weeks earlier
- 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
- Expected to require any other form of systemic or localized antineoplastic therapy while on study
- On any systemic steroid therapy within one week before the planned date for first dose of randomized treatment or on any other form of immunosuppressive medication
- History of a malignancy (other than the disease under treatment in the study) within 5 years prior to first study drug administration, excluding 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.
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis; participants with previously treated brain metastases are eligible
- Severe hypersensitivity reaction to treatment with another monoclonal antibody
- Active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents
- Active infection requiring systemic therapy
- Known history of Human Immunodeficiency Virus (HIV)
- Known history of or positive for Hepatitis B or C
- Known psychiatric or substance abuse disorder
- Regular user (including recreational use) of illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol)
- Pregnant or breastfeeding, or expecting to conceive, or father children within the projected duration of the study
- Received a live vaccine within 30 days prior to first dose of study drug
Exclusion
Key Trial Info
Start Date :
August 28 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 3 2019
Estimated Enrollment :
834 Patients enrolled
Trial Details
Trial ID
NCT01866319
Start Date
August 28 2013
End Date
June 3 2019
Last Update
June 2 2020
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