Ignite Creation Date:
2024-05-05 @ 11:16 PM
Last Modification Date:
2024-10-26 @ 10:31 AM
Study NCT ID:
NCT01295827
Status:
COMPLETED
Last Update Posted:
2019-12-13
First Post:
2011-02-10
Brief Title:
Study of Pembrolizumab MK-3475 in Participants With Progressive Locally Advanced or Metastatic Carcinoma Melanoma or Non-small Cell Lung Carcinoma P07990MK-3475-001KEYNOTE-001
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KEYNOTE-001
Brief Summary:
The present study has 5 parts In Parts A and A1 the dose of intravenous IV pembrolizumab MK-3475 will be escalated from 1 to 10 mgkg to determine 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 by evaluating the Dose Limiting Toxicities DLTs Following completion of the dose escalation additional patients will be enrolled in Part A2 to further define pharmacokinetic characteristics Part B of the study will investigate the safety tolerability and efficacy of pembrolizumab 2 mgkg and 10 mgkg in participants with advanced or metastatic MEL and compare every 2 week dosing Q2W to every 3 week dosing Q3W Part C of the study will investigate the safety tolerability and efficacy of pembrolizumab administered at 10 mgkg Q3W in participants with non-small cell lung carcinoma NSCLC that is locally advanced or metastatic Part D of the study will investigate the low and high doses of study drug identified in Parts A and B 2 mgkg and 10 mgkg administered Q3W in participants with advanced or metastatic MEL Part E closed with Amendment 7 was planned to investigate low medium and high doses of pembrolizumab in combination with standard chemotherapy in participants with locally advanced or metastatic NSCLC Part F will investigate low and high doses of pembrolizumab 2 mgkg and 10 mgkg administered Q2W or Q3W in treatment-naive and previously-treated participants with NSCLC with programmed cell death 1 ligand PD-L1 gene expression The primary hypotheses are the following that pembrolizumab will have acceptable safety and tolerability that pembrolizumab will show a clinically meaningful response rate RR or disease-control rate DCR in participants with melanoma ipilimumab-refractory or not and NSCLC and that pembrolizumab will show a more clinically meaningful RR in participants with either cancer whose tumors express PD-L1
Detailed Description:
Per protocol all participants who were receiving study intervention or in survival follow-up could enroll in the extension study KEYNOTE-587 NCT03486873 which would allow further study participation after the Primary Completion Date cut-off Thus all efficacy outcome measures except for survival Overall Survival OS were to be followed up to the Interim Database cut-off of 18-Sept-2018 and the primary safety analyses except for the DLT analysis and Overall Survival were to be followed up to the study Primary Completion Date Final Database cut-off of 05-Nov-2018
Five participants did not have end of study assessments completed by the Primary Completion Date cut-off and were subsequently followed up to the Study Completion Date 11-Dec-2018 End of treatment and end of study assessments are missing for these 5 and the status was noted as unknown as of the Primary Completion Date cut-off Per protocol any safety information after the Primary Completion Date cut-off Final Database cut-off of 05-Nov-2018 would not be included in the safety analysis but reported by the Investigator to the Sponsor via the Sponsor Communication Form and filed in the electronic Trial Master File
Five participants did not have end of study assessments completed by the Primary Completion Date cut-off and were subsequently followed up to the Study Completion Date 11-Dec-2018 End of treatment and end of study assessments are missing for these 5 and the status was noted as unknown as of the Primary Completion Date cut-off Per protocol any safety information after the Primary Completion Date cut-off Final Database cut-off of 05-Nov-2018 would not be included in the safety analysis but reported by the Investigator to the Sponsor via the Sponsor Communication Form and filed in the electronic Trial Master File
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MK-3475-001 | OTHER | None | None |
| 2011-002371-42 | EUDRACT_NUMBER | None | None |
| P07990 | OTHER | None | None |
| KEYNOTE-001 | OTHER | Merck | None |