Study of MK-3475 in Participants With Progressive Locally Advanced or Metastatic Carcinoma, Melanoma, or Non-small Cell Lung Carcinoma (P07990/MK-3475-001/KEYNOTE-001)



Status:Recruiting
Conditions:Lung Cancer, Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:5/5/2014
Start Date:March 2011
End Date:July 2016
Contact:Toll Free Number
Phone:1-888-577-8839

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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

This study will be done in 6 parts. In Part A the dose of intravenous (IV) MK-3475 will be
escalated to find the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) 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 safety, tolerability, and
efficacy of the drug in participants with advanced or metastatic MEL and compare every 2
week to every 3 week dosing. Part C of the study will explore the safety, tolerability, and
efficacy of the drug in participants with non-small cell lung carcinoma (NSCLC) that is
locally advanced or metastatic. Part D of the study will explore the low and high doses of
study drug identified in Parts A and B in participants with advanced or metastatic MEL. Part
E (closed with Amendment 7) will explore low, medium, and high doses of study drug in
combination with standard chemotherapy in participants with locally advanced or metastatic
NSCLC. Part F will explore low and high doses of study drug in treatment-naive and
previously-treated participants with NSCLC with programmed cell death 1 ligand (PD-L1) gene
expression. In Parts D and F and some of Part B participants will be randomized to one dose
level. The primary hypotheses are the following: that MK-3475 has acceptable safety and
tolerability; and that MK-3475 shows a clinically meaningful response rate (RR) or
disease-control rate (DCR) in participants with melanoma (ipilimumab-refractory or not),
and a clinically meaningful RR in participants with NSCLC, especially a clinically
meaningful RR in those participants with either cancer, whose tumors express PD-L1.

Part F (NSCLC) is the only part currently enrolling participants.

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.
We found this trial at
18
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