Study of MK-3475 Versus Chemotherapy in Participants With Advanced Melanoma (P08719/MK-3475-002) - Full Text View

Purpose

This study is being done to compare survival using 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 MK-3475, higher dose MK-3475, or Investigator-choice chemotherapy. The MK-3475 dose will be blinded to Investigators and participants. The randomization to either MK-3475 or Investigator choice chemotherapy will be conducted in open-label fashion. The five standard chemotherapy choices are carboplatin + paclitaxel, carboplatin alone, paclitaxel alone, dacarbazine, or temozolomide.

Condition	Intervention	Phase
Malignant Melanoma	Drug: MK-3475 Drug: Carboplatin Drug: Paclitaxel Drug: Dacarbazine Drug: Temozolomide	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Randomized, Phase II Study of MK-3475 Versus Chemotherapy in Patients With Advanced Melanoma

Resource links provided by NLM:

MedlinePlus related topics: Melanoma

Drug Information available for: Dacarbazine Paclitaxel Carboplatin Temozolomide

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	510
Study Start Date:	November 2012
Estimated Study Completion Date:	January 2016
Estimated Primary Completion Date:	March 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: MK-3475 Low dose	Drug: MK-3475 MK-3475, intravenously (IV) at a dose assigned at randomization
Experimental: MK-3475 Higher Dose	Drug: MK-3475 MK-3475, intravenously (IV) at a dose assigned at randomization
Active Comparator: Investigator-Choice Chemotherapy Participants on this arm will receive one of 5 possible chemotherapy regimens decided at the treating institution (carboplatin + paclitaxel, carboplatin alone, paclitaxel alone, dacarbazine, or temozolomide).	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.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically or cytologically confirmed diagnosis of unresectable Stage III or metastatic MEL not amenable to local therapy
Participants must have progressive disease after the most recent treatment regimen
Must consent to allow correlative studies and should have available tumor tissue
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
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01704287

Contacts

Contact: Toll Free Number

1-888-577-8839

Show 26 Study Locations

Sponsors and Collaborators

Merck

More Information

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT01704287 History of Changes
Other Study ID Numbers:	P08719, MK-3475-002
Study First Received:	October 8, 2012
Last Updated:	April 15, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

PD-1
PD1

Additional relevant MeSH terms:

Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Dacarbazine
Temozolomide
Carboplatin

Paclitaxel
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 16, 2013