Study of Pembrolizumab (MK-3475) Monotherapy in Advanced Solid Tumors and Pembrolizumab Combination Therapy in Advanced Non-small Cell Lung Cancer (MK-3475-011/KEYNOTE-011)
Solid Tumor - Non-small Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Study Type
Study Phase
Phase 1
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: Pembrolizumab Type: Biological
Name: Cisplatin Type: Drug
Name: Pemetrexed Type: Drug
Name: Carboplatin Type: Drug
Name: Paclitaxel Type: Drug
Overall Status
This study using pembrolizumab (MK-3475) will be done in 2 parts. In Part A successive participant cohorts with advanced solid tumors will receive pembrolizumab to assess the safety and tolerability of monotherapy. In Part B participants with advanced non-small cell lung cancer (NSCLC) will receive pembrolizumab in combination with either cisplatin/pemetrexed or carboplatin/paclitaxel by non-random assignment to assess the safety and tolerability of the combination therapy.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 20 Years
Gender: Both
Criteria: Inclusion Criteria:

- In Part A: histological or cytological diagnosis of solid tumor, progressive metastatic disease, or progressive locally advanced disease not amenable to local therapy

- In Part B: histologically- or cytologically-confirmed diagnosis of NSCLC (Stage IIIB/IV)

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

- Adequate organ function

Exclusion criteria:

- Cancer therapy within 4 weeks prior to the first dose of study therapy, or not recovered from the adverse events of agents administered more than 4 weeks prior to the first dose of study therapy.

- Currently participating or has participated in a study with an investigational agent or using an investigational device within 30 days of first dose of study therapy

- Expected to require any other form of antineoplastic therapy while on study

- On chronic systemic steroid therapy within two weeks prior to the first dose of trial treatment or on any other form of immunosuppressive medication
Chiyoda-Ku, Tokyo, Japan
Status: Recruiting
Contact: Japan Call Center - 81-3-6272-1957
Start Date
April 2013
Completion Date
June 2016
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Record processing date processed this data on July 28, 2015 page