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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
N/A
Open (Enrolling)
Both
Cancer, Solid Tumor

Thank you

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
carcinomatosis.

- 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:

Interventional

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:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

P07990

NCT ID:

NCT01295827

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

Name

Location

Call for Information (Investigational Site 0001) San Antonio, Texas  78229
Call for Information (Investigational Site 0012) Houston, Texas  77030
Call for Information (Investigational Site 0015) Berkeley, California  94704
Call for Information (Investigational Site 0016) West Reading, Pennsylvania  19611
Call for Information (Investigational Site 0004) Scottsdale, Arizona  85259
Call for Information (Investigational Site 0027) Beverly Hills, California  90211
Call for Information (Investigational Site 0010) Los Angeles, California  90025
Call for Information (Investigational Site 0008) San Francisco, California  94115
Call for Information (Investigational Site 0003) Jacksonville, Florida  32224
Call for Information (Investigational Site 0018) Tampa, Florida  33612
Call for Information (Investigational Site 0011) Boston, Massachusetts  02215
Call for Information (Investigational Site 0002) Rochester, Minnesota  55905
Call for Information (Investigational Site 0013) Pittsburgh, Pennsylvania  15232