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Randomized, Phase II Study of MK-3475 Versus Chemotherapy in Patients With Advanced Melanoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Malignant Melanoma

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Trial Information

Randomized, Phase II Study of MK-3475 Versus Chemotherapy in Patients With Advanced Melanoma


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression-free-survival (PFS)

Outcome Time Frame:

Up to 24 months

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

P08719

NCT ID:

NCT01704287

Start Date:

November 2012

Completion Date:

January 2016

Related Keywords:

  • Malignant Melanoma
  • PD-1
  • PD1
  • Melanoma

Name

Location

Call for Information (Investigational Site 0024) Chicago, Illinois  60612
Call for Information (Investigational Site 0007) Tucson, Arizona  85719
Call for Information (Investigational Site 0061) Beverly Hills, California  90211
Call for Information (Investigational Site 0018) Los Angeles, California  90025
Call for Information (Investigational Site 0034) Los Angeles, California  90024
Call for Information (Investigational Site 0016) Aurora, Colorado  80045
Call for Information (Investigational Site 0021) Washington, District of Columbia  20010
Call for Information (Investigational Site 0017) Ft. Lauderdale, Florida  33308
Call for Information (Investigational Site 0053) Miami Beach, Florida  33140
Call for Information (Investigational Site 0028) Iowa City, Iowa  52242
Call for Information (Investigational Site 0031) Baltimore, Maryland  21237
Call for Information (Investigational Site 0019) Boston, Massachusetts  02215
Call for Information (Investigational Site 0068) Boston, Massachusetts  02114
Call for Information (Investigational Site 0032) Hackensack, New Jersey  07601
Call for Information (Investigational Site 0027) New Brunswick, New Jersey  08901
Call for Information (Investigational Site 0029) Chapel Hill, North Carolina  27599
Call for Information (Investigational Site 0036) Durham, North Carolina  27710
Call for Information (Investigational Site 0001) Bethlehem, Pennsylvania  18105
Call for Information (Investigational Site 0012) Philadelphia, Pennsylvania  19104
Call for Information (Investigational Site 0038) Philadelphia, Pennsylvania  19107
Call for Information (Investigational Site 0046) Pittsburgh, Pennsylvania  15232
Call for Information (Investigational Site 0033) Nashville, Tennessee  37232
Call for Information (Investigational Site 0060) Houston, Texas  77030
Call for Information (Investigational Site 0025) Seattle, Washington  98109