Ignite Creation Date:
2024-05-06 @ 6:30 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05681039
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2022-12-15
Brief Title:
Phase 2 Trial of Neoadjuvant and Adjuvant Tiragolumab Plus Atezolizumab in Patients With Newly Diagnosed PD-L1 CPS Positive Resectable Stage 3-4 Oral Cavity Squamous Cell Carcinoma OCSCC
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase 2 Trial of Neoadjuvant and Adjuvant Tiragolumab Plus Atezolizumab in Patients With Newly Diagnosed PD-L1 CPS Positive Resectable Stage 3-4 Oral Cavity Squamous Cell Carcinoma OCSCC
Status:
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:
To learn if treatment with tiragolumab and atezolizumab before and after standard of care surgery and chemoradiation radiation therapy with or without cisplatincarboplatin can help to control OCSCC that is PD-L1 CPS positive
Detailed Description:
Primary Objectives
To determine the major pathological response rate defined as 10 viable tumor in the resection specimen after two cycles of neoadjuvant atezolizumab and tiragolumab in patients with newly diagnosed local-regionally advanced OCSCC that is PD-L1 CPS 1 Response at the primary site and in nodal disease will be evaluated
Secondary Objectives
To evaluate the safety of two cycles of atezolizumab and tiragolumab in patients with newly diagnosed local-regionally advanced OCSCC as measured by the incidence nature and severity of adverse events with severity measured by CTCAE V5
To evaluate the overall response rate ORR as measured by RECIST11 after two cycles of neoadjuvant atezolizumab and tiragolumab including complete or partial response CRPR
To evaluate the distribution of percent tumor viability in tumor biopsies and resection specimens after two cycles of atezolizumab and tiragolumab
To estimate the 12 18 and 24 month progression-free survival PFS defined as time from enrollment to date of progression or death and overall survival OS defined as time from enrollment to death in the study population
Exploratory Objectives
To investigate changes in the tumor microenvionment before and after two cycles of atezolizumab and tiragolumab as measured by multispectral immunofluorescence and single-cell sequencing
To genetically profile OSCC by use of oral rinse and to measure changes in patient-specific somatic mutations by cfDNA before during and after neoadjuvant immunotherapy
To assess polyfunctionality in peripheral blood CD4 and CD8 T cells after neoadjuvant immunotherapy radiotherapy and adjuvant immunotherapy
To evaluate the symptom severity mean measured by MDASI-HN and its association with the major pathological response
To determine the major pathological response rate defined as 10 viable tumor in the resection specimen after two cycles of neoadjuvant atezolizumab and tiragolumab in patients with newly diagnosed local-regionally advanced OCSCC that is PD-L1 CPS 1 Response at the primary site and in nodal disease will be evaluated
Secondary Objectives
To evaluate the safety of two cycles of atezolizumab and tiragolumab in patients with newly diagnosed local-regionally advanced OCSCC as measured by the incidence nature and severity of adverse events with severity measured by CTCAE V5
To evaluate the overall response rate ORR as measured by RECIST11 after two cycles of neoadjuvant atezolizumab and tiragolumab including complete or partial response CRPR
To evaluate the distribution of percent tumor viability in tumor biopsies and resection specimens after two cycles of atezolizumab and tiragolumab
To estimate the 12 18 and 24 month progression-free survival PFS defined as time from enrollment to date of progression or death and overall survival OS defined as time from enrollment to death in the study population
Exploratory Objectives
To investigate changes in the tumor microenvionment before and after two cycles of atezolizumab and tiragolumab as measured by multispectral immunofluorescence and single-cell sequencing
To genetically profile OSCC by use of oral rinse and to measure changes in patient-specific somatic mutations by cfDNA before during and after neoadjuvant immunotherapy
To assess polyfunctionality in peripheral blood CD4 and CD8 T cells after neoadjuvant immunotherapy radiotherapy and adjuvant immunotherapy
To evaluate the symptom severity mean measured by MDASI-HN and its association with the major pathological response
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 |
|---|---|---|---|
| NCI-2022-10637 | OTHER | NCI-CTRP Clinical Trials Registry | None |