Ignite Creation Date:
2024-05-06 @ 7:40 AM
Last Modification Date:
2024-10-26 @ 11:50 AM
Study NCT ID:
NCT02574598
Status:
COMPLETED
Last Update Posted:
2021-01-06
First Post:
2015-10-09
Brief Title:
MK-3475 in Combination With Docetaxel vs Docetaxel Alone in Non-Small Cell Lung Cancer Patients
Sponsor:
Instituto Nacional de Cancerologia de Mexico
Organization:
Instituto Nacional de Cancerologia de Mexico
Study Overview
Official Title:
A Randomized Crossover Phase II Clinical Trial of MK-3475 in Combination With Docetaxel Versus Docetaxel Alone in Patients With Non-Small Cell Lung Cancer NSCLC Previously Treated
Status:
COMPLETED
Status Verified Date:
2020-12
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:
None
Brief Summary:
This is a phase II open-label randomized clinical trial of MK-3475 Pembrolizumab on previously treated non-small cell lung cancer NSCLC patients This drug has shown to allow partial response according to the immune-related response criteria and the response evaluation criteria in solid tumors RECIST The main endpoint is to compare the overall response rate ORR of MK-3475 with docetaxel or docetaxel alone in patients with advanced NSCLC
Detailed Description:
MK-3475 MK-3475 is an IgG4 monoclonal antibody to PD1 which received a breakthrough therapy designation for advanced melanoma from the FDA in January 2013 Preliminary results from the NSCLC cohort of a phase I dose expansion trial of MK-3475 were presented at the 2013 World Conference on Lung Cancer meeting MK-3475 was administered intravenously every three weeks and continued until disease progression based upon immune related response criteria irRC or unacceptable toxicity IrRC take into account the potential for different patterns of response that can be seen with immunotherapy Of the 38 patients with previously treated advanced NSCLC evaluable for efficacy 9 24 percent achieved at least partial response by irRC Standard oncology criteria for response Response Evaluation Criteria In Solid Tumors RECIST were available for 33 of these patients with at least a partial response in seven patients 21 percent Median overall survival was 51 weeks Therapy was well tolerated with one case of pneumonitis grade 2 and one case of pulmonary edema grade 3 reported Tumor PDL1 expression assessed with a different assay than that used for the trials evaluating Nivolumab and MPDL3280A antibody used undisclosed was available for 33 of the patients who had irRC assessments and 29 of those with standard oncology RECIST assessment Of the 9 patients with PDL1 positivity and irRC response data 6 achieved at least partial response 67 percent of the 7 patients with PDL1 positivity and standard oncology response data 4 achieved response 57 percent Of note 1 of 24 patients with PDL1 negativity achieved response by irRC 2 of 22 patients with PDL1 negativity had response by standard oncology criteria RECIST
Based upon these results a randomized phase II trial comparing MK-3475 to standard salvage docetaxel in patients with advanced NSCLC has been launched NCT01905657 however there is no study in which the synergistic activity of Docetaxel MK-3475 were evaluated this could open the possibility of using this drug concurrently with Docetaxel as standard therapy in patients with progression of the disease despite a double platinum-based regimen
Measure the expression levels of PD1PD-L1PD-L2 subpopulations tumor cells of patients with NSCLC who come to the clinic of the National Cancer Institute and relevant way associating their role forecast and its potential as a biomarker relating the PD-L1 levels with clinicopathologic characteristics of the patients studied
Based upon these results a randomized phase II trial comparing MK-3475 to standard salvage docetaxel in patients with advanced NSCLC has been launched NCT01905657 however there is no study in which the synergistic activity of Docetaxel MK-3475 were evaluated this could open the possibility of using this drug concurrently with Docetaxel as standard therapy in patients with progression of the disease despite a double platinum-based regimen
Measure the expression levels of PD1PD-L1PD-L2 subpopulations tumor cells of patients with NSCLC who come to the clinic of the National Cancer Institute and relevant way associating their role forecast and its potential as a biomarker relating the PD-L1 levels with clinicopathologic characteristics of the patients studied
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| INCAN014033ICI | OTHER | National Cancer Institute of Mexico | None |