At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I Study of MK-3475 Alone in Subjects With Advanced Solid Tumors and in Combination With Platinum-Doublet Chemotherapy or Immunotherapy in Subjects With Advanced Non-Small Cell Lung Cancer/Extensive-Disease Small Cell Lung Cancer.
In Brief
A Phase 1 clinical trial evaluating Pembrolizumab 2 mg/kg, Pembrolizumab 10 mg/kg, and 10 other interventions for Solid Tumor and 2 related conditions. Completed, enrolled 57 participants.
Detailed Summary
This study using pembrolizumab (MK-3475) will be done in 5 parts. In Part A, successive participant cohorts with advanced solid tumors will receive pembrolizumab to assess the safety and tolerability of monotherapy. In Parts B, C, and D, participants with advanced non-small cell lung cancer (NSCLC) will receive pembrolizumab in combination with either cisplatin/pemetrexed or carboplatin/pemetrexed (Part B); with either carboplatin/paclitaxel or carboplatin/nab-paclitaxel (Part C); or with ipilimumab (Part D) by non-random assignment to assess the safety and tolerability of the combination therapy. In Part E, participants with untreated Extensive-disease (ED) Small Cell Lung Cancer (SCLC) will receive pembrolizumab in combination with either cisplatin/etoposide, carboplatin/etoposide, or cisplatin/etoposide with prophylactic use of granulocyte colony-stimulating factor (lasting G-CSF \[pegfilgrastim\]) by non-random assignment to assess the safety and tolerability of the combination therapy.
Study Details
Timeline
Interventions
Administered as an intravenous (IV) infusion on Day 1 of Cycle 1 (28 days), Cycle 2 (14 days), and Cycle 3 (14 days)
Administered as an IV infusion on Day 1 of Cycle 1 (28 days), Cycle 2 (14 days), and Cycle 3 (14 days)
Administered as an IV infusion on Day 1 of each 21-day cycle
Administered as an IV infusion on Day 1 of each 21-day cycle
Administered as an IV infusion on Day 1 of each 21-day cycle
Administered as an IV infusion on Day 1 of each 21-day cycle
Administered as an IV infusion on Day 1 of each 21-day cycle
Administered as an IV infusion on Day 1 of each 21-day cycle
Administered as an IV infusion on Days 1, 8, and 15 of each 21-day cycle
Administered as an IV infusion on Day 1 of every other 21-day cycle (every 42 days)
Administered as an IV infusion on Days 1, 2, and 3 of each 21-day cycle
Administered as a subcutaneous injection on Day 4 of Cycle 1