Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Participants With Advanced Melanoma (P08719/KEYNOTE-002)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: October 8, 2012
Last updated: August 3, 2015
Last verified: August 2015

October 8, 2012
August 3, 2015
November 2012
December 2015   (final data collection date for primary outcome measure)
  • Progression-free-survival (PFS) [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
  • Overall response rate (ORR) at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Progression-free-survival (PFS) [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01704287 on Archive Site
  • Overall response rate (ORR) [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
  • Response Duration [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
  • Disease control rate (DCR) at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Overall survival rate at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Response Duration [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Participants With Advanced Melanoma (P08719/KEYNOTE-002)
Randomized, Phase II Study of MK-3475 Versus Chemotherapy in Patients With Advanced Melanoma
This study is being done to compare survival using pembrolizumab (MK-3475) or standard chemotherapy for participants with advanced melanoma (MEL) who have progressed after prior therapy. Participants will be randomized to receive either low dose pembrolizumab, higher dose pembrolizumab or Investigator-choice chemotherapy. The pembrolizumab dose will be blinded to Investigators and participants. The randomization to either pembrolizumab or Investigator choice chemotherapy will be conducted in open-label fashion. The four standard chemotherapy choices are carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide. Participants on standard chemotherapy who experience disease progression may be eligible to cross-over to treatment with pembrolizumab provided they meet protocol-specified requirements for cross-over.
Not Provided
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Malignant Melanoma
  • Drug: Pembrolizumab
    Pembrolizumab, intravenously (IV) at a dose assigned at randomization
  • Drug: Carboplatin
    Carboplatin per institutional standard.
  • Drug: Paclitaxel
    Paclitaxel per institutional standard.
  • Drug: Dacarbazine
    Dacarbazine per institutional standard.
    Other Name: DTIC
  • Drug: Temozolomide
    Temozolomide per institutional standard.
  • Experimental: Pembrolizumab Low dose
    Intervention: Drug: Pembrolizumab
  • Experimental: Pembrolizumab Higher Dose
    Intervention: Drug: Pembrolizumab
  • Active Comparator: Investigator-Choice Chemotherapy
    Participants on this arm will receive one of 4 possible chemotherapy regimens decided at the treating institution (carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide).
    • Drug: Carboplatin
    • Drug: Paclitaxel
    • Drug: Dacarbazine
    • Drug: Temozolomide
Ribas A, Puzanov I, Dummer R, Schadendorf D, Hamid O, Robert C, Hodi FS, Schachter J, Pavlick AC, Lewis KD, Cranmer LD, Blank CU, O'Day SJ, Ascierto PA, Salama AK, Margolin KA, Loquai C, Eigentler TK, Gangadhar TC, Carlino MS, Agarwala SS, Moschos SJ, Sosman JA, Goldinger SM, Shapira-Frommer R, Gonzalez R, Kirkwood JM, Wolchok JD, Eggermont A, Li XN, Zhou W, Zernhelt AM, Lis J, Ebbinghaus S, Kang SP, Daud A. Pembrolizumab versus investigator-choice chemotherapy for ipilimumab-refractory melanoma (KEYNOTE-002): a randomised, controlled, phase 2 trial. Lancet Oncol. 2015 Aug;16(8):908-18. doi: 10.1016/S1470-2045(15)00083-2. Epub 2015 Jun 23.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
January 2016
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of unresectable Stage III or metastatic MEL not amenable to local therapy
  • Participants must be refractory to ipilimumab
  • Participants with BRAF gene mutant melanoma must have had a prior treatment regimen that included vemurafenib, dabrafenib, or an approved BRAF gene and/or MEK protein inhibitor
  • Must consent to allow correlative studies; must provide a newly obtained tissue/biopsy specimen (or specimen obtained within 60 days of consenting)
  • Radiographically measurable disease
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1

Exclusion criteria:

  • Chemotherapy, radiation therapy, or biological therapy within four weeks prior to the first dose of study drug, or not recovered from the AEs due to cancer therapies administered more than four weeks earlier
  • Disease progression within 24 weeks of last dose of ipilimumab
  • 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
  • Chronic systemic steroid therapy within two weeks before the planned date for first dose randomized treatment or on any other form of immunosuppressive medication
  • Known history of any other than the current malignancy excepting adequately treated basal or squamous cell carcinoma of the skin, superficial bladder cancer, in situ cervical cancer, breast cancer, or other in situ cancers
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents
  • Prior treatment with any other anti-programmed cell death (PD) agent
  • Active infection requiring systemic therapy
  • Known history of Human Immunodeficiency Virus (HIV)
  • Active Hepatitis B or Hepatitis C
  • 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
18 Years and older
Contact information is only displayed when the study is recruiting subjects
Not Provided
Argentina,   Australia,   Germany,   Israel,   Italy,   Netherlands,   Norway,   Spain,   Sweden,   Switzerland,   United States
P08719, MK-3475-002
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP