Phase I Study of Single Agent MK-3475 in Patients With Progressive Locally Advanced or Metastatic Carcinoma, Melanoma, and Non-Small Cell Lung Carcinoma
Rochester, Minn., Jacksonville, Fla., Phoenix/Scottsdale, Ariz.
Trial status: Open for Enrollment
Why is this study being done?
Part F (NSCLC) is the only part currently enrolling participants.
Who is eligible to participate?
Inclusion criteria (Part F is the only part currently enrolling participants).
- 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 Parts B and D of the study, histological or cytological diagnoses of metastatic MEL with progressive locally advanced or metastatic disease. In Parts C and F, histological or cytological diagnosis of NSCLC. In Part F, participants with Stage IV NSCLC without prior systemic therapy may be eligible.
- Failure of established standard medical anti-cancer therapies for a given tumor type or intolerance to such therapy.
- In Parts B, C, D, or F of the study, MEL or NSCLC must be measurable by imaging.
- In Part F of the study, NSCLC with PD-L1 gene expression.
- Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
- Adequate organ function.
Exclusion criteria (Part F is the only part currently enrolling participants)
- 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, with the exception of participants in the follow-up phase.
- Other form(s) of antineoplastic therapy anticipated during the period of the study.
- History of pneumonitis requiring treatment with steroids, or has a history of interstitial lung disease.
- Medical condition that requires chronic systemic steroid therapy, or on any other form of immunosuppressive medication, excepting use of inhaled steroids.
- History of acute diverticulitis, intra-abdominal abscess, GI obstruction, abdominal carcinomatosis.
- History of a hematologic malignancy, malignant primary brain tumor, malignant sarcoma, or another malignant 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 or syndrome that requires systemic steroids or immunosuppressive agents, except vitiligo or resolved childhood asthma/atopy.
- Prior therapy with another anti-programmed cell death (PD)-1 agent or previously enrolled in any MK-3475 trial.
- 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.