Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06589804
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-06
Brief Title:
Testing the Addition of Anti-Cancer Drug Cetuximab to Standard of Care Treatment Pembrolizumab for Returning or Spreading Head and Neck Cancer After Previous Treatment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Randomized Phase III Trial of Pembrolizumab vs PembrolizumabCetuximab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma With Platinum Refractory Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase III trial compares the effect of adding cetuximab to pembrolizumab versus pembrolizumab alone in treating patients with head and neck squamous cell carcinoma HNSCC that has come back after a period of improvement recurrent andor that has spread from where it first started primary site to other places in the body metastatic Cetuximab is in a class of medications called monoclonal antibodies It binds to a protein called EGFR which is found on some types of tumor cells This may help keep tumor cells from growing Immunotherapy with monoclonal antibodies such as pembrolizumab may help the bodys immune system attack the tumor and may interfere with the ability of tumor cells to grow and spread Giving cetuximab and pembrolizumab together may be more effective at treating patients with recurrent andor metastatic HNSCC than pembrolizumab alone
Detailed Description:
PRIMARY OBJECTIVE
I To assess whether the combination of cetuximab and pembrolizumab arm 2 compared to pembrolizumab alone arm 1 results in improved overall survival OS in subjects with platinum refractory HNSCC
SECONDARY OBJECTIVES
I To compare pembrolizumab cetuximab arm 2 versus vs pembrolizumab alone arm 1 with respect to objective response rate per Response Evaluation Criteria in Solid Tumors RECIST 11
II To compare pembrolizumab cetuximab arm 2 vs pembrolizumab alone arm 1 with respect to progression free survival PFS per RECIST 11
III To evaluate pembrolizumab cetuximab arm 2 vs pembrolizumab alone arm 1 with respect to duration of response DOR per RECIST 11
IV To assess the safety and tolerability of pembrolizumab cetuximab arm 2 vs pembrolizumab alone arm 1
V To assess the patient-reported toxicity using Patient Reported Outcomes version of Common Terminology Criteria for Adverse Events PRO-CTCAE of pembrolizumab cetuximab arm 2 vs pembrolizumab alone arm 1
EXPLORATORY OBJECTIVES
I To identify specific mutational changes that may be indicative of clinical response to pembrolizumab cetuximab and pembrolizumab alone
II To evaluate circulating tumor-derived deoxyribonucleic acid ctDNA kinetics over the course of treatment in response to pembrolizumab cetuximab and pembrolizumab alone
OUTLINE Patients are randomized to 1 of 2 arms
ARM 1 Patients receive pembrolizumab intravenously IV over 30 minutes on day 1 of each cycle Cycles repeat every 42 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity Patients also undergo computed tomography CT positron emission tomography PETCT or magnetic resonance imaging MRI throughout the trial and optionally undergo blood sample collection on study and at disease progression or end of treatment
ARM 2 Patients receive cetuximab IV over 120 minutes on day -14 prior to cycle 1 and then on days 1 15 and 29 of each cycle and pembrolizumab IV over 30 minutes on day 1 of each cycle Cycles repeat every 42 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity Patients also undergo CT PETCT or MRI throughout the trial and optionally undergo blood sample collection on study and at disease progression or end of treatment
After completion of study treatment patients are followed up within 4 weeks and then every 3 andor 6 months for up to 5 years
I To assess whether the combination of cetuximab and pembrolizumab arm 2 compared to pembrolizumab alone arm 1 results in improved overall survival OS in subjects with platinum refractory HNSCC
SECONDARY OBJECTIVES
I To compare pembrolizumab cetuximab arm 2 versus vs pembrolizumab alone arm 1 with respect to objective response rate per Response Evaluation Criteria in Solid Tumors RECIST 11
II To compare pembrolizumab cetuximab arm 2 vs pembrolizumab alone arm 1 with respect to progression free survival PFS per RECIST 11
III To evaluate pembrolizumab cetuximab arm 2 vs pembrolizumab alone arm 1 with respect to duration of response DOR per RECIST 11
IV To assess the safety and tolerability of pembrolizumab cetuximab arm 2 vs pembrolizumab alone arm 1
V To assess the patient-reported toxicity using Patient Reported Outcomes version of Common Terminology Criteria for Adverse Events PRO-CTCAE of pembrolizumab cetuximab arm 2 vs pembrolizumab alone arm 1
EXPLORATORY OBJECTIVES
I To identify specific mutational changes that may be indicative of clinical response to pembrolizumab cetuximab and pembrolizumab alone
II To evaluate circulating tumor-derived deoxyribonucleic acid ctDNA kinetics over the course of treatment in response to pembrolizumab cetuximab and pembrolizumab alone
OUTLINE Patients are randomized to 1 of 2 arms
ARM 1 Patients receive pembrolizumab intravenously IV over 30 minutes on day 1 of each cycle Cycles repeat every 42 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity Patients also undergo computed tomography CT positron emission tomography PETCT or magnetic resonance imaging MRI throughout the trial and optionally undergo blood sample collection on study and at disease progression or end of treatment
ARM 2 Patients receive cetuximab IV over 120 minutes on day -14 prior to cycle 1 and then on days 1 15 and 29 of each cycle and pembrolizumab IV over 30 minutes on day 1 of each cycle Cycles repeat every 42 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity Patients also undergo CT PETCT or MRI throughout the trial and optionally undergo blood sample collection on study and at disease progression or end of treatment
After completion of study treatment patients are followed up within 4 weeks and then every 3 andor 6 months for up to 5 years
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