Ficerafusp Alfa, Pembrolizumab, and Stereotactic Body Radiotherapy (SBRT) for Head and Neck Squamous Cell Carcinoma (HNSCC)

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT07552558
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hypofractionated Stereotactic Body Radiotherapy (SBRT) — RADIATION
    1-3 fractions given over 1 week as assigned in phase I and as determined to be the maximum tolerated dose (MTD) in phase II
  • Pembrolizumab — BIOLOGICAL
    200 mg intravenously (IV) given on Day 1 or Days 1 and 22 as assigned in phase I and as determined to be the maximum tolerated dose (MTD) in phase II.
  • Ficerafusp alfa — DRUG
    750mg intravenously (IV) on Days 1, 8, 15, and 22.

Study Details

The study is an open-label phase I/II clinical trial. The study will enroll patients to receive neoadjuvant SBRT plus 1 or 2 doses of neoadjuvant pembrolizumab with concurrent ficerafusp alfa (4 doses) prior to definitive surgical resection for high-risk, locoregionally advanced HPV-negative head and neck squamous cell carcinoma (HNSCC). Approximately 6 weeks after end of SBRT, patients will undergo standard of care (SOC) surgical resection followed by SOC adjuvant chemoradiation per National Comprehensive Cancer Network (NCCN) guidelines. Adjuvant therapy is not part of this study and therefore is not dictated by study protocol.

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2033

Study Design

Enrollment
45 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 Dose Level 1: Dose De-Escalation Neoadjuvant SBRT and pembrolizumab plus ficerafusp alfa
    Treatment during the Phase 1 Level 1 consists of Stereotactic Body Radiotherapy (SBRT) at 8 Gy x 3 fractions over one week (given on Days 1, 3, and 5), 2 doses of neoadjuvant pembrolizumab at 200 mg (given on D1 and D22), and 4 weekly doses of ficerafusp alfa at 750 mg (given on D1, D8, D15, and D22). Six weeks after end of SBRT, patients will undergo standard of care (SOC) surgical resection, or biopsy for patients who do not undergo resection, followed by standard of care (SOC) adjuvant chemoradiation per National Comprehensive Cancer Network (NCCN) guidelines.
  • Experimental: Phase 1 Dose Level -1: Dose De-Escalation Neoadjuvant SBRT and pembrolizumab plus ficerafusp alfa
    Treatment during the Phase 1 Level -1 consists of Stereotactic Body Radiotherapy (SBRT) at 8 Gy x 3 fractions over one week (given on Days 1, 3, and 5), 1 dose of neoadjuvant pembrolizumab at 200 mg (given on D1), and 4 weekly doses of ficerafusp alfa at 750 mg (given on D1, D8, D15, and D22). Six weeks after end of SBRT, patients will undergo standard of care (SOC) surgical resection, or biopsy for patients who do not undergo resection, followed by standard of care (SOC) adjuvant chemoradiation per National Comprehensive Cancer Network (NCCN) guidelines.
  • Experimental: Phase 1 Dose Level -2: Dose De-Escalation Neoadjuvant SBRT and pembrolizumab plus ficerafusp alfa
    Treatment during the Phase 1 Level -2 consists of Stereotactic Body Radiotherapy (SBRT) at 8 Gy x 3 fractions over one week (given on Days 1 and 4), 1 dose of neoadjuvant pembrolizumab at 200 mg (given on D1), and 4 weekly doses of ficerafusp alfa at 750 mg (given on D1, D8, D15, and D22). Six weeks after end of SBRT, patients will undergo standard of care (SOC) surgical resection, or biopsy for patients who do not undergo resection, followed by standard of care (SOC) adjuvant chemoradiation per National Comprehensive Cancer Network (NCCN) guidelines.
  • Experimental: Phase 1 Dose Level -3: Dose De-Escalation Neoadjuvant SBRT and pembrolizumab plus ficerafusp alfa
    Treatment during the Phase 1 Level -3 consists of Stereotactic Body Radiotherapy (SBRT) at 8 Gy x 3 fractions over one week (given on Day 1), 1 dose of neoadjuvant pembrolizumab at 200 mg (given on D1), and 4 weekly doses of ficerafusp alfa at 750 mg (given on D1, D8, D15, and D22). Six weeks after end of SBRT, patients will undergo standard of care (SOC) surgical resection, or biopsy for patients who do not undergo resection, followed by standard of care (SOC) adjuvant chemoradiation per National Comprehensive Cancer Network (NCCN) guidelines.
  • Experimental: Phase 2: Maximum Tolerable Dose (MTD) Neoadjuvant SBRT and pembrolizumab plus ficerafusp alfa
    Treatment consists of SBRT beginning on D1 at the dose and number of fractions established in phase I, neoadjuvant pembrolizumab 200 mg at the number of doses established in phase I, and 4 weekly doses of ficerafusp alfa 750 mg (given on D1, D8, D15, and D22). Six weeks after end of SBRT, patients will undergo standard of care (SOC) surgical resection, or biopsy for patients who do not undergo resection, followed by standard of care (SOC) adjuvant chemoradiation per National Comprehensive Cancer Network (NCCN) guidelines.

Primary Outcome Measure

Phase I only: Maximum tolerated dose (MTD) of SBRT in combination with pembrolizumab plus ficerafusp alfa [ Time Frame: From start of treatment until date of surgery (total estimated time of 7 weeks) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Sana Karam, MD, PhD
[email protected]
314-362-9700
Sidharth Puram, MD, PhD
[email protected]
314-362-9700
Sana Karam, MD, PhD (PRINCIPAL_INVESTIGATOR)
Sidharth Puram, MD, PhD (PRINCIPAL_INVESTIGATOR)
Douglas R Adkins, MD (SUB_INVESTIGATOR)
Anthony J Apicelli, MD, PhD (SUB_INVESTIGATOR)
Christine Auberle, MD (SUB_INVESTIGATOR)
Jennifer De Los Santos, MD (SUB_INVESTIGATOR)
Hiram Gay, MD (SUB_INVESTIGATOR)
Lannis Hall, MD, MPH (SUB_INVESTIGATOR)
Yao Hao, PhD (SUB_INVESTIGATOR)
R Alex Harbison, MD, MS (SUB_INVESTIGATOR)
Ryan S Jackson, MD (SUB_INVESTIGATOR)
Brendan J Knapp, MD (SUB_INVESTIGATOR)
Esther Lu, PhD (SUB_INVESTIGATOR)
Daniel Miller, MD, PhD (SUB_INVESTIGATOR)
Peter Oppelt, MD (SUB_INVESTIGATOR)
Patrick Pipkorn, MD (SUB_INVESTIGATOR)
Nikhil Rammohan, MD, PhD (SUB_INVESTIGATOR)
Jason T Rich, MD (SUB_INVESTIGATOR)
Robert D Siegel, MD (SUB_INVESTIGATOR)
Wade L Thorstad, MD (SUB_INVESTIGATOR)
Gregory R Vlacich, MD, PhD (SUB_INVESTIGATOR)
Jesse Zaretsky, MD, PhD (SUB_INVESTIGATOR)
Paul Zolkind, MD (SUB_INVESTIGATOR)

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By condition
Head and neck cancer
By specialty
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By research site
Washington University School of Medicine· St Louis, MO

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