KEYNOTE-001

Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built.

Official title

Phase I Study of Single Agent Pembrolizumab (MK-3475) in Patients With Progressive Locally Advanced or Metastatic Carcinoma, Melanoma, and Non-Small Cell Lung Carcinoma (KEYNOTE 001)

Phase

Phase 1

Status

Completed

Conditions

Cancer, Solid Tumor

Interventions

Pembrolizumab

Arms

• Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A) · Experimental
• Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A) · Experimental
• Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1) · Experimental
• Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2) · Experimental
• Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2) · Experimental
• Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2) · Experimental
• MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D) · Experimental
• MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D) · Experimental
• MEL: Pembrolizumab 10 mg/kg Q2W (Part B) · Experimental
• NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F) · Experimental
• NSCLC: Pembrolizumab 10 mg/kg Q3W (Parts C+F) · Experimental
• NSCLC: Pembrolizumab 10 mg/kg Q2W (Part F) · Experimental
• NSCLC: Pembrolizumab 2 mg/kg Q3W (Part E-Not Enrolled) · Experimental
• NSCLC: Pembrolizumab 5 mg/kg Q3W (Part E-Not Enrolled) · Experimental
• NSCLC: Pembrolizumab 10 mg/kg Q3W (Part E-Not Enrolled) · Experimental

Enrollment

1,260

Primary outcomes

• Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v.4.0) in Participants With Solid Tumors (Parts A and A1)
• Number of Participants Who Experienced an Adverse Event (AE)
• Overall Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Integrated Radiology and Oncology (IRO): Melanoma Participants (Parts B Plus D)
• ORR According to RECIST 1.1 as Assessed by Independent Review Committee (IRC): Non-Small Cell Lung Cancer (NSCLC) Participants (Parts C Plus F)

Sponsor

Merck Sharp & Dohme LLC

Start

Mar 4, 2011

Primary completion

Nov 5, 2018

Results posted

Yes

Registry record

NCT01295827 · updated Dec 13, 2019

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