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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)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01866319
First received: May 28, 2013
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

This is a three-arm study to evaluate the safety and efficacy of two dosing schedules of pembrolizumab (MK-3475) compared to ipilimumab for the treatment of ipilimumab-naïve participants with unresectable or metastatic melanoma.


Condition Intervention Phase
Melanoma
Drug: Pembrolizumab
Drug: Ipilimumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Controlled, Three-Arm, Phase III Study to Evaluate the Safety and Efficacy of Two Dosing Schedules of MK-3475 Compared to Ipilimumab in Patients With Advanced Melanoma

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Progression-free Survival (PFS) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: Up to 30 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall response rate (ORR) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 645
Study Start Date: August 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pembrolizumab Every 2 Weeks
Participants receive pembrolizumab, 10 mg intravenously (IV), once every 2 weeks for up to 2 years
Drug: Pembrolizumab
Experimental: Pembrolizumab Every 3 Weeks
Participants receive pembrolizumab, 10 mg IV, once every 3 weeks for up to 2 years
Drug: Pembrolizumab
Active Comparator: Ipilimumab
Participants receive ipilimumab, 3 mg/kg IV, once every 3 weeks for a total of 4 doses
Drug: Ipilimumab

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 and male participants 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01866319

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01866319     History of Changes
Other Study ID Numbers: 3475-006, 2012-004907-10
Study First Received: May 28, 2013
Last Updated: August 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
PD-1
PD1

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on November 20, 2014