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Phase I Study of Single Agent MK-3475 in Patients With Progressive Locally Advanced or Metastatic Carcinoma, Melanoma, and Non-Small Cell Lung Carcinoma

Phase 1
18 Years
Open (Enrolling)
Cancer, Solid Tumor

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Trial Information

Phase I Study of Single Agent MK-3475 in Patients With Progressive Locally Advanced or Metastatic Carcinoma, Melanoma, and Non-Small Cell Lung Carcinoma

Inclusion Criteria

Inclusion criteria

- 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.

- 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

- 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 lambrolizumab.

- Other form(s) of antineoplastic therapy anticipated during the period of the study.

- History of pneumonitis or interstitial lung disease.

- Medical condition that requires chronic systemic steroid therapy, or on any other
form of immunosuppressive medication.

- History of acute diverticulitis, intra-abdominal abscess, GI obstruction, abdominal

- 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 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 lambrolizumab 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants experiencing dose-limiting toxicities (DLTs)

Outcome Time Frame:

Cycle 1 (28 days)

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

March 2011

Completion Date:

March 2015

Related Keywords:

  • Cancer, Solid Tumor
  • Melanoma
  • Carcinoma
  • Cancer
  • Advanced cancer
  • Metastatic cancer
  • Metastatic melanoma
  • PD-1
  • PD1
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Melanoma



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