Actively Recruiting
Neoadjuvant Chemotherapy and 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
8 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
Researchers are evaluating neoadjuvant chemoimmunotherapy combined with standard adjuvant treatment in patients with newly diagnosed locoregionally advanced head and neck cancers, including HPV-independent and HPV-associated squamous cell carcinoma, as well as sinonasal and skull base tumors. This phase II trial aims to study surgical de-escalation approaches to reduce treatment-related morbidity affecting swallowing, speech, and vision. The study is conducted by the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins and includes three cohorts of 25 patients each with specific tumor characteristics. Participants receive neoadjuvant treatment involving Toripalimab combined with chemotherapy drugs such as Cisplatin and Docetaxel or Carboplatin and Docetaxel. After surgery, patients undergo adjuvant radiation or chemoradiotherapy as part of standard care. Following adjuvant treatment, Toripalimab is administered again. The trial investigates these treatments and surgical approaches across the three cohorts, assessing their impact on the tumors and patient outcomes. During the study, patients are monitored for major pathological response over up to 5 years. Evaluations include imaging and clinical exams to confirm eligibility and disease status, including HPV testing and measurable tumor assessment. Safety and treatment adherence are tracked through laboratory tests and clinical criteria. Participants are followed through neoadjuvant therapy, surgery, adjuvant treatment, and long-term monitoring to assess treatment effects and disease response.
CONDITIONS
Brief 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, nasolacrimal, or skull base tumors meeting HPV testing requirements
- HPV-independent HNSCC (cT2-cT4, N0-N3) eligible 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 sinonasal carcinomas, HPV-associated sinonasal cancer, sinonasal undifferentiated carcinoma, or neuroendocrine sinonasal tumors (cT2-cT4, N0-N3)
- HPV16 type only; patients with non-HPV16 cancers excluded
- At least 8 unstained 5-µm slides available or new biopsy required
- Suitable 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, bulky nodal disease, or bulky T4 (≥30cc)
- Operable based on imaging/exam; Grade 1 rENE allowed for surgery; Grade 2/3 rENE 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 of enrollment
- ECOG 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 ≤1.5 × ULN (within therapeutic range if on anticoagulants)
- aPTT ≤1.5 × ULN (within therapeutic range if on anticoagulants)
- Signed informed consent
- Women of childbearing potential with negative pregnancy test, not breastfeeding, and using effective contraception during and 120 days after treatment
- Men using adequate contraception during and 120 days after treatment; condom use required
- Azoospermic men and non-heterosexually active WOCBP exempt from contraception but must undergo pregnancy testing
- Mandatory pregnancy prevention counseling
- Use of highly effective contraception (failure rate <1% with consistent use)
You will not qualify if you...
- Positive pregnancy test in women of childbearing potential within 72 hours before treatment
- Pregnant, breastfeeding, or planning to conceive or father a child during study and 120 days after
- Prior treatment with PD-1, PD-L1, PD-L2 inhibitors or other agents targeting T-cell receptors
- Prior systemic anti-cancer therapy or radiotherapy for current cancer
- Radiotherapy within 2 weeks of study start, except specific palliative cases
- 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 or recent immunosuppressive therapy
- Active autoimmune disease requiring systemic treatment in past 2 years
- Severe hypersensitivity to Toripalimab or similar agents
- Additional active malignancy requiring treatment within 2 years, with some exceptions
- Active CNS metastases or carcinomatous meningitis
- History or current pneumonitis or interstitial lung disease requiring steroids
- Active infection needing systemic therapy
- Known HIV infection
- Known active Hepatitis B or C; cleared/eradicated patients eligible
- Conditions or therapies interfering with study participation
- Known psychiatric illness or substance abuse interfering with compliance
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration as per neoadjuvant chemotherapy schedule
Participants receive neoadjuvant chemotherapy combined with Toripalimab before surgery.
Visits as required for chemotherapy and Toripalimab administration
Duration - Single day for surgery and immediate post-operative care
Participants undergo surgery following the neoadjuvant treatment phase.
1 visit (in-person) for surgery and immediate care
Duration - Duration as per radiation or chemoradiotherapy schedule
Participants receive radiation or chemoradiotherapy after surgery as adjuvant treatment.
Visits according to radiation or chemoradiotherapy treatment schedule
Duration - Duration as per adjuvant Toripalimab treatment schedule
Participants receive Toripalimab treatment following adjuvant radiation or chemoradiotherapy.
Visits as required for Toripalimab administration
Duration - Up to 5 years
Participants are monitored for outcomes including Major Pathological Response for up to 5 years after treatment.
Periodic follow-up visits as scheduled
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
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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