Study of MK-3475 in Participants With Progressively Locally Advanced or Metastatic Carcinomas & Melanoma (P07990/MK-3475-001 AM2)
Diagnosis: Cutaneous Skin Cancer
NCT ID: NCT01295827
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-385
In Part A of this study, the dose of intravenous (IV) MK-3475 will be escalated to find the maximum tolerated dose (MTD) for participants with a histologically or cytologically confirmed diagnosis of any type of carcinoma or melanoma (MEL). Part B of the study will explore the efficacy of the drug at the MTD in participants with advanced or metastatic MEL.
Beth-Israel Deaconess Medical Center, Dana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital
Frank Stephen Hodi, MD,
Dana-Farber Cancer Institute
Daniel Cho, MD,
Beth Israel Deaconess Medical Center
Donald Lawrence, MD,
Massachusetts General Hospital
Dana-Farber Cancer Institute:
Kimberly MacNeill, 617-632-3743,
Beth-Israel Deaconess Medical Center:
Cancer Trials Call Center, 617-667-3060
Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100
- In Part A: Histological or cytological diagnosis of MEL or any type of carcinoma,
progressive metastatic disease, or progressive locally advanced disease not amenable
to local therapy. In Part B of the study, only histological diagnoses of metastatic
MEL with progressively locally advanced or metastatic disease are eligible for
- Failure of established standard medical anti-cancer therapies for a given tumor type
or intolerance to such therapy.
- In Part B of the study, MEL must be measurable by imaging.
- Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)
- Adequate organ function.
- Chemotherapy, radioactive, or biological cancer therapy within 4 weeks prior to the
first dose of study therapy, or not recovered to Common Terminology Criteria for
Adverse Events (CTCAE) Grade 1 or better from the adverse events caused by therapy
administered more than 4 weeks prior to first dose.
- Participation in a study of an investigational agent or using an investigational
device within 30 days of administration of MK-3475.
- Other form(s) of antineoplastic therapy anticipated during the period of the study.
- Chronic systemic steroid therapy, or on any other form of immunosuppressive
- Chronic anti-coagulation treatment with warfarin.
- History of a hematologic malignancy, primary brain tumor, sarcoma, or another primary
solid tumor, unless no evidence of that disease for 5 years.
- Active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Previous severe hypersensitivity reaction to another monoclonal antibody (mAb).
- Active autoimmune disease or a documented history of autoimmune disease, except
vitiligo or resolved childhood asthma/atopy.
- Prior therapy with an anti-programmed cell death (PD)-1 or an antibody targeting
other immuno-regulatory receptors or mechanisms (with exception of ipilimumab in
study Part B).
- Active infection requiring therapy.
- Positive for Human Immunodeficiency Virus (HIV), Hepatitis B (Hepatitis B Surface
Antigen [HBsAg] reactive), or Hepatitis C virus (Hepatitis C Virus Ribonucleic Acid
[HCV RNA] (qualitative) is detected).
- Regular use of illicit drugs or a recent history (within the last year) of substance
abuse (including alcohol).
- Symptomatic ascites or pleural effusion.
- Participant is pregnant or breastfeeding, or expecting to conceive or father children
within the projected duration of the study.