Actively Recruiting
Neoadjuvant Chemotherapy and Programmed Cell Death Protein 1(PD-1) Inhibition for Head and Neck Cancer Treatment De-escalation (NeoScorch HN)
Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2026-04-23
75
Participants Needed
1
Research Sites
249 weeks
Total Duration
On this page
Sponsors
S
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
C
Coherus Oncology, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The NeoScorch HN study is a single institution multisite phase II trial including 3 cohorts of 25 patients each for patients with newly diagnosed locoregionally advanced, histologically confirmed, head and neck cancer eligible for curative-intent treatment, who will receive neo-adjuvant chemoimmunotherapy-based treatment as well as standard of care adjuvant treatment. The three cohorts include three different aspects of surgical de-escalation in head and neck cancer. The first cohort includes human papillomavirus independent (HPV-) squamous cell carcinoma of the head and neck. The second cohort includes HPV-associated head and neck cancer with radiographic evidence of extranodal extension in neck lymphadenopathy. The third cohort specifically includes malignancies of the sinonasal cavity and skull base which have a propensity for invasion of the orbit, skull base, and maxilla. Surgical treatment of all three of these cohorts has significant morbidity including swallowing, speech, and vision among others.
CONDITIONS
Official Title
Neoadjuvant Chemotherapy and Programmed Cell Death Protein 1(PD-1) Inhibition for Head and Neck Cancer Treatment De-escalation (NeoScorch HN)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed locoregionally advanced head and neck or sinonasal/skull base tumors
- HPV-independent HNSCC (cT2-cT4, N0-N3) suitable for organ preservation surgery
- HPV-associated HNSCC with radiographic extranodal extension (cT1-cT3 tonsil or lateralized base of tongue, N0-N1, up to 4 nodes with rENE)
- Sinonasal/skull base tumors including specific carcinoma and neuroendocrine types (cT2-cT4, N0-N3)
- HPV16 type only; patients with non-HPV16 cancers must discontinue if identified
- At least 8 unstained 5-µm slides available or new biopsy unless waived
- Candidates appropriate for curative-intent therapy
- AJCC 7th edition Stage III-IV, excluding N2c or bulky N2b/c and bulky T4 (≥30cc)
- AJCC 8th edition Stage I with N1, Stage II, or Stage III, excluding N2 disease and bulky nodal or T4 disease (≥30cc)
- Operable based on imaging/exam; Grade 1 rENE allowed, Grade 2/3 excluded
- Measurable disease per RECIST 1.1
- No prior systemic therapy, radiotherapy, or investigational agents for current cancer
- No complete surgical resection within 8 weeks prior; biopsy or excision with residual disease acceptable
- ECOG performance status 0-1 or Karnofsky ≥70%
- Platelets ≥100,000/µL; ANC ≥1,500/µL; Hemoglobin ≥9 g/dL without recent transfusion/EPO
- AST/ALT <2.5 × ULN; Albumin ≥2.5 mg/dL
- Total bilirubin ≤1.5 × ULN or direct bilirubin ≤ULN if total >1.5 × ULN
- Creatinine clearance ≥60 mL/min
- INR/PT and aPTT ≤1.5 × ULN or within therapeutic range if on anticoagulants
- Signed informed consent
- Women of childbearing potential: negative pregnancy test within 72 hours prior to first dose, not breastfeeding, and agree to use effective contraception during therapy and for 120 days after last dose
- Men must use adequate contraception during treatment and for 120 days after last dose; condom use required
- Azoospermic men and non-heterosexually active women of childbearing potential exempt from contraception but must undergo pregnancy testing
- Counseling on pregnancy prevention and use of highly effective contraception required
You will not qualify if you...
- Women of childbearing potential with positive pregnancy test within 72 hours before treatment
- Pregnant or breastfeeding individuals or those planning conception during study and 120 days after last dose
- Prior treatment with PD-1, PD-L1, PD-L2 inhibitors, or other T-cell targeting agents
- Prior systemic anti-cancer therapy or radiotherapy for current cancer; prior surgery allowed if recovered
- Radiotherapy within 2 weeks of study start, except certain palliative non-CNS radiation with washout
- Live or live-attenuated vaccines within 30 days of first dose
- Concurrent treatment with other investigational agents
- Participation in another investigational study within 4 weeks before first dose unless in follow-up
- Immunodeficiency diagnosis or recent immunosuppressive therapy
- Active autoimmune disease requiring systemic treatment in past 2 years (replacement therapy allowed)
- History of severe hypersensitivity to toripalimab or similar agents
- Additional active malignancy requiring treatment within 2 years, except certain skin or low-grade cancers
- Active CNS metastases or carcinomatous meningitis; stable treated brain metastases allowed
- History or current pneumonitis or interstitial lung disease requiring steroids
- Active infection requiring systemic therapy
- Known HIV infection
- Known active Hepatitis B or C infection; cleared infections allowed
- Conditions or abnormalities that could interfere with participation or study results
- Psychiatric illness or substance abuse interfering with compliance; stable managed disorders allowed
- History of allogeneic tissue or solid organ transplant
- Significant cardiovascular disease including severe heart failure, unstable angina, serious arrhythmia, recent myocardial infarction, or prior myocarditis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Johns Hopkins Hospital East Baltimore
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
Z
Zubair Khan, MBBS, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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