OncoMatch/Clinical Trials/NCT06366451
PBI-MST-01 (NCT04541108) Substudy AZN-05: Intratumoral Microdosing of Rilvegostomig, Volrustomig, Sabestomig, and AZD9592 in HNSCC
Is NCT06366451 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies multiple treatments for head and neck squamous cell carcinoma.
Treatment: Rilvegostomig · Volrustomig · Sabestomig · AZD9592 · Pembrolizumab · AZD9592 + Rilvegostomig · AZD9592 + Volrustomig · AZD9592 + Sabestomig · AZD9592 + Pembrolizumab — This is a multi-center, open-label, Phase 0 substudy designed to evaluate the localized pharmacodynamics (PD) of rilvegostomig, volrustomig, sabestomig, and AZD9592 within the tumor microenvironment (TME) when administered intratumorally in microdose quantities via the CIVO device in patients presenting with Head and Neck Squamous Cell Carcinoma (HNSCC) with a surface accessible lesion, who are scheduled for tumor and/or regional node dissection as part of their standard treatment. PD effects due to injected investigational agents, either as single agents or as AZD9592 drug combinations with the evaluated biologics, will be compared to those elicited by pembrolizumab alone, which will also be injected in microdose quantities via the CIVO device.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: immune-mediated therapy (anti-CTLA-4, anti-PD-1, anti-PD-L1, anti-PD-L2)
Prior exposure to immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies within the last 5 years.
Cannot have received: antibody-drug conjugate
Exception: containing a chemotherapeutic agent that inhibits topoisomerase 1 activity or with another EGFR and/or MET targeted ADC
Previous treatment with another ADC containing a chemotherapeutic agent that inhibits topoisomerase 1 activity or with another epidermal growth factor receptor (EGFR) and/or mesenchymal-epithelial transition factor (c-MET) targeted ADC.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UC Davis · Sacramento, California
- Montefiore Medical Center · The Bronx, New York
- University of North Carolina · Chapel Hill, North Carolina
- Oregon Health & Science University (OHSU) · Portland, Oregon
- University of Pennsylvania · Philadelphia, Pennsylvania
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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