Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06159621
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2023-11-16
Brief Title:
CD40 Agonist and PD-1 Inhibitor in HNSCC
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
NeoadjuvantPhase 1 Study of CD40 Agonist LVGN7409 and PD-1 Inhibitor LVGN3616 in Patients With Resectable HPV-negative Mucosal HeadNeck Squamous Cell Carcinoma HNSCC
Status:
RECRUITING
Status Verified Date:
2024-09
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:
Prospective open-label phase 1 study of CD40 agonist LVGN7409 and PD-1 inhibition LVGN3616 in patients with resectable Human Papillomavirus HPV-negative mucosal headneck squamous cell carcinoma HNSCC This protocol proposes to study the safety and immunological effects of LVGN7409 a CD40 agonistic antibody when administered in combination with PD-1 inhibition prior to surgical resection
Detailed Description:
This will be a prospective open-label window of opportunity study of LVGN7409 and LVGN3616 in resectable HPV-negative HNSCC with co-primary endpoints of safety and T cell infiltration and secondary endpoint of anti-tumor efficacy
Doses of LVGN7409 and LVGN3616 are based on safety experience in prior and ongoing clinical trials Dose escalation will not be conducted in this trial The study is divided into the following treatment cohorts
I Arm A PD1 LVGN3616 300mg II Arm B PD1 LVGN3616 300mg CD40 LVGN7409 1mgkg
Pre-Surgery and Surgery
1 Patients with potentially resectable HPV-negative HNSCC will be identified by HN surgeons and study coordinator clinic screening Consent and enrollment will take place in HN Surgery clinic by study investigators andor the study coordinator
2 Patients will need baseline non-Fine needle aspirate FNA tumor biopsy either during standard of care exam under anesthesia EUA or via ultrasound-guided needle biopsy prior archival non-FNA biopsy is acceptable as long as obtained within 6 months of screening
3 Patients will be assigned in an alternating fashion to Arm A PD1 or Arm B PD1CD40 At a separate infusion visit after enrollment patients in arm A or arm B will receive a single administration of LVGN3616 or LVGN3616 and LVGN7409 respectively In case of patient drop-out after screeningconsent and before drug administration that slot will be assigned to the next available patient
4 Patients will be included in the primary endpoint calculations safety if they receive study drug However any patients unable to undergo planned surgery within 6 weeks will not contribute to the post-treatment immunologic sample analysis and this slot will be filled by a subsequent patient in order to achieve the goal of 10 paired samples in each arm The maximum number of patients that can be replaced is 5
5 After 2 weeks allowable range 6-42 days patients will undergo planned surgical resection Repeat imaging is not required
6 Blood collection will occur on the day of drug administration prior to administration 24-48 hours after administration 1 week -1 day after administration and on day of planned surgery
Post-Surgery
1 Guideline-based standard of care post-surgical adjuvant therapies as indicated based on pathological features on surgical resection will occur as part of routine clinical care
2 Post-operative visits will occur every 3 months -4 weeks after surgery up to 1 year which will serve as End of trial EOT visit and final Adverse Event AE assessment The following will be performed during each of these visits
1 Physical exam
2 Laboratory monitoring
3 AE assessment
4 Concomitant medication review
Doses of LVGN7409 and LVGN3616 are based on safety experience in prior and ongoing clinical trials Dose escalation will not be conducted in this trial The study is divided into the following treatment cohorts
I Arm A PD1 LVGN3616 300mg II Arm B PD1 LVGN3616 300mg CD40 LVGN7409 1mgkg
Pre-Surgery and Surgery
1 Patients with potentially resectable HPV-negative HNSCC will be identified by HN surgeons and study coordinator clinic screening Consent and enrollment will take place in HN Surgery clinic by study investigators andor the study coordinator
2 Patients will need baseline non-Fine needle aspirate FNA tumor biopsy either during standard of care exam under anesthesia EUA or via ultrasound-guided needle biopsy prior archival non-FNA biopsy is acceptable as long as obtained within 6 months of screening
3 Patients will be assigned in an alternating fashion to Arm A PD1 or Arm B PD1CD40 At a separate infusion visit after enrollment patients in arm A or arm B will receive a single administration of LVGN3616 or LVGN3616 and LVGN7409 respectively In case of patient drop-out after screeningconsent and before drug administration that slot will be assigned to the next available patient
4 Patients will be included in the primary endpoint calculations safety if they receive study drug However any patients unable to undergo planned surgery within 6 weeks will not contribute to the post-treatment immunologic sample analysis and this slot will be filled by a subsequent patient in order to achieve the goal of 10 paired samples in each arm The maximum number of patients that can be replaced is 5
5 After 2 weeks allowable range 6-42 days patients will undergo planned surgical resection Repeat imaging is not required
6 Blood collection will occur on the day of drug administration prior to administration 24-48 hours after administration 1 week -1 day after administration and on day of planned surgery
Post-Surgery
1 Guideline-based standard of care post-surgical adjuvant therapies as indicated based on pathological features on surgical resection will occur as part of routine clinical care
2 Post-operative visits will occur every 3 months -4 weeks after surgery up to 1 year which will serve as End of trial EOT visit and final Adverse Event AE assessment The following will be performed during each of these visits
1 Physical exam
2 Laboratory monitoring
3 AE assessment
4 Concomitant medication review
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