Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06413095
Status:
COMPLETED
Last Update Posted:
2024-05-14
First Post:
2024-04-01
Brief Title:
PBI-MST-01 NCT04541108 Substudy MSD-03 Intratumoral Microdosing of Pembrolizumab Alone and With MK-0482 or MK-4830 in HNSCC or STS
Sponsor:
Presage Biosciences
Organization:
Presage Biosciences
Study Overview
Official Title:
Pembrolizumab Alone and in Combinations With MK-0482 and MK-4830 Via Intratumoral Injection in Patients With Head and Neck Squamous Cell Carcinoma or Soft Tissue Sarcoma Prior to Planned Surgical Intervention
Status:
COMPLETED
Status Verified Date:
2024-05
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 multi-center open-label Phase 0 substudy designed to evaluate the ability of pembrolizumab alone and in combination with MK-0482 or MK-4830 to elicit pharmacodynamic changes suggestive of antitumor immune activation within the native tumor microenvironment TME following intratumoral microdosing via the CIVO device in patients with surface accessible Head and Neck Squamous Cell Carcinoma HNSCC or Soft Tissue Sarcoma STS lesions who are scheduled for tumor andor regional node dissection as part of their standard treatment
Detailed Description:
The CIVO Microdose Injection Device MID simultaneously delivers multiple drugs and drug combinations up to 8 each in microdose amounts into a single patient tumor and enables comparisons of the resulting biomarker responses that occurred while that tumor was still in the native microenvironment The microdose injection procedure is conducted ahead of the patients scheduled surgical intervention and localized biomarker responses are then evaluated in the injected tumor tissue following surgery This enables assessments of drug-induced changes to the tumor stroma and local immune cells within the unique landscape of each individual patient and their respective tumor genomic profile and immune system functional status CIVO is a research tool used only to assess the responses of tumor cells and other cell populations with the TME following intratumoral administration of drug microdoses it is not a therapeutic device
MK-0482 MK-4830 and pembrolizumab have distinct mechanisms of action MOAs that affect the TME including relief of immune suppression and enhanced T-cell activation Surgery is the standard primary treatment for most patients with STS and surgical intervention of the primary tumor and cervical lymph node dissection may be recommended for patients with HNSCC Dysfunction of the immune system eg immune evasion expression of suppressive immune checkpoint receptors etc plays a major role in the development and progression of HNSCC and STS Therefore in this Phase 0 study the ability of pembrolizumab alone and in combination with MK-0482 or MK-4830 to elicit pharmacodynamic changes suggestive of antitumor immune activation within the native TME in patients with HNSCC or STS will be assessed Pembrolizumab alone and in combination with MK-0482 or MK-4830 will be injected in microdose quantities at tumor sites in HNSCC or STS patients with a surface accessible lesion who are scheduled for tumor andor regional node dissection as part of their standard treatment Injected tumors will be resected as per surgical standard of care following 2 to 4 days in situ exposure Thereafter the CIVO-injected portion of the tissue will be analyzed for localized response at sites of drug exposure in the TME
MK-0482 MK-4830 and pembrolizumab have distinct mechanisms of action MOAs that affect the TME including relief of immune suppression and enhanced T-cell activation Surgery is the standard primary treatment for most patients with STS and surgical intervention of the primary tumor and cervical lymph node dissection may be recommended for patients with HNSCC Dysfunction of the immune system eg immune evasion expression of suppressive immune checkpoint receptors etc plays a major role in the development and progression of HNSCC and STS Therefore in this Phase 0 study the ability of pembrolizumab alone and in combination with MK-0482 or MK-4830 to elicit pharmacodynamic changes suggestive of antitumor immune activation within the native TME in patients with HNSCC or STS will be assessed Pembrolizumab alone and in combination with MK-0482 or MK-4830 will be injected in microdose quantities at tumor sites in HNSCC or STS patients with a surface accessible lesion who are scheduled for tumor andor regional node dissection as part of their standard treatment Injected tumors will be resected as per surgical standard of care following 2 to 4 days in situ exposure Thereafter the CIVO-injected portion of the tissue will be analyzed for localized response at sites of drug exposure in the TME
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 |
|---|---|---|---|
| PBI-MST-01 | OTHER | Presage Biosciences | None |