Head and Neck CancerPhase 2(NeoScorch HN)NCT07209189
Neoadjuvant Chemotherapy and Programmed Cell Death Protein 1(PD-1) Inhibition for Head and Neck Cancer Treatment De-escalation (NeoScorch HN)
A Phase 2 study testing Toripalimab + Chemotherapy, Toripalimab and Chemoradiotherapy or radiation in people with Head and Neck Cancer and Squamous Cell Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Squamous Cell Carcinoma, Oral Cavity Cancer
- What is being tested?
- Toripalimab + Chemotherapy, Toripalimab and Chemoradiotherapy or radiation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2026to 1 Dec 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible subjects must have histologically confirmed, locoregionally advanced head and neck or sinonasal, nasolacrimal, or skull base tumors and meet HPV testing requirements as outlined.
- HPV-independent HNSCC (cT2-cT4, N0-N3) with potential for organ preservation using response-adapted 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 (e.g., Isocitrate dehydrogenase 2 (IDH2) mutant), or neuroendocrine sinonasal tumors (e.g., olfactory neuroblastoma) (cT2-cT4, N0-N3).
- HPV16 type only. Patients with non-HPV16 cancers are not eligible. If p16 immunohistohemistry (IHC) positivity is the only result available at enrollment, neoadjuvant therapy may start while HPV nucleic acid testing is pending. Patients found to be HPV non-16 must discontinue study participation.
- At least 8 unstained 5-µm slides must be available. If unavailable, a new biopsy is required unless waived by the PI.
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- Appropriate candidates for curative-intent therapy.
- American Joint Committee on Cancer (AJCC) 7th edition: Stage III-IV, excluding N2c or bulky N2b/c (N3 equivalent) and bulky T4 (≥30cc).
- AJCC 8th edition: Stage I with N1, Stage II, or Stage III, excluding N2 disease, bulky nodal disease (N3 equivalent), or bulky T4 (≥30cc).
- Surgical arm: Candidates must be operable based on upfront imaging/exam. Patients with Grade 1 rENE may proceed to surgery; Grade 2/3 rENE are excluded.
- Measurable disease per RECIST 1.1.
- No prior systemic therapy, radiotherapy, or investigational agents for the current cancer.
- No complete surgical resection within 8 weeks of enrollment (biopsy or excision with residual disease acceptable).
- Eastern Cooperative Oncology Group (ECOG) 0-1 or Karnofsky ≥70%.
- Platelets ≥100,000/µL.
- Absolute Neutrophil Count (ANC) ≥1,500/µL.
- Hemoglobin ≥9 g/dL (without recent transfusion/EPO).
- Aspartate Aminotransferase (AST)/ Alanine Aminotransferase (ALT) <2.5 × ULN.
- Albumin ≥2.5 mg/dL.
- Total bilirubin ≤1.5 × ULN or direct bilirubin ≤ULN if total >1.5 × ULN (Upper Limit of Normal).
- Creatinine clearance ≥60 mL/min (Cockcroft-Gault or measured GFR).
- International Normalized Ratio (INR)/ Prothrombin Time (PT) ≤1.5 × ULN (unless on anticoagulants; must be within therapeutic range).
- Activated Partial Thromboplastin Time (aPTT) ≤1.5 × ULN (unless on anticoagulants; must be within therapeutic range).
- Must sign and understand a study-specific informed consent form.
- Women of childbearing potential (WOCBP): Negative pregnancy test within 72 hours prior to first dose.
- WOCBP must not be breastfeeding and must agree to use highly 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 in addition to highly effective methods.
- Azoospermic men and WOCBP not heterosexually active are exempt from contraception but must still undergo pregnancy testing.
- Counseling on pregnancy prevention is mandatory.
- Highly effective methods (<1% failure rate with consistent use) must be used
Who cannot join
- WOCBP with a positive urine pregnancy test within 72 hours before treatment allocation; if positive or inconclusive, a confirmatory serum pregnancy test is required.
- Pregnant or breastfeeding, or planning to conceive or father a child during the study and for 120 days after the last dose.
- Prior treatment with PD-1, PD-L1, PD-L2 inhibitors, or other agents targeting T-cell receptors (e.g., Cytotoxic T-lymphocyte antigen 4 (CTLA-4), OX40 (Tumor Necrosis Factor Receptor Superfamily Member 4), CD137).
- Prior systemic anti-cancer therapy or radiotherapy for the current cancer. Surgery is allowed if adequately recovered from complications.
- Radiotherapy within 2 weeks of study start. A 1-week washout is permitted for palliative, non-stereotactic radiation (≤2 weeks) to non-Central Nervous System (CNS), non-head and neck disease, provided there are no residual toxicities, no steroid requirement, and no history of radiation pneumonitis.
- Live or live-attenuated vaccines within 30 days of first study dose (including live Corona Virus Disease (COVID-19) vaccines). Inactivated, Messenger ribonucleic acid (mRNA), and peptide vaccines are allowed.
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- Concurrent treatment with other investigational agents.
- Participation in another investigational drug or device study within 4 weeks before first study dose, unless in follow-up phase only.
- Diagnosis of immunodeficiency, or receiving chronic systemic steroids at doses >10 mg prednisone equivalent daily, or other immunosuppressive therapy within 7 days before study drug.
- Active autoimmune disease requiring systemic treatment in the past 2 years. Physiologic replacement therapy (thyroxine, insulin, low-dose steroids for adrenal or pituitary insufficiency) is allowed.
- History of severe hypersensitivity (≥Grade 3) to Toripalimab, its excipients, or other anti-PD-1 agents.
- Additional active malignancy requiring treatment within 2 years, except basal/squamous cell skin cancers, in situ cancers, low-grade tumors unlikely to affect survival within 3 years, or cancers treated with curative therapy.
- Active CNS metastases or carcinomatous meningitis. Intracranial extension of the primary tumor is allowed. Patients with previously treated brain metastases may enroll if radiologically stable ≥4 weeks, clinically stable, and off steroids ≥14 days before study drug.
- History of pneumonitis or interstitial lung disease requiring steroids, or current pneumonitis/Interstitial Lung Disease (ILD).
- Active infection requiring systemic therapy.
- Known HIV infection.
- Known active Hepatitis B (HBsAg positive) or active Hepatitis C (HCV RNA positive). Patients with cleared or eradicated Hepatitis B (HBV) or HCV are eligible.
- Any condition, therapy, or abnormality that could confound study results, interfere with participation, or be judged by the investigator as not in the participant's best interest.
- Known psychiatric illness or substance abuse that could interfere with study compliance. Stable chronic managed disorders are acceptable.
- History of allogeneic tissue or solid organ transplant.
- Significant cardiovascular disease, including congestive heart failure (NYHA Class III or IV), unstable angina, serious uncontrolled arrhythmia, myocardial infarction within 6 months, or prior myocarditis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Hospital East Baltimore
Baltimore, Maryland, 21287
Zubair Khan, MD, MPH, 410-955-3157, ototrials@live.johnshopkins.edu
Shriya Yanamandra, MS, 4699214065, syanama2@jh.edu
About this study
Official title: Neoadjuvant Chemotherapy and PD-1 Inhibition for Head and Neck Cancer Treatment De-escalation (NeoScorch HN)
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
- Head and Neck Cancer, Squamous Cell Carcinoma, Oral Cavity Cancer, Oropharyngeal Cancer, Laryngeal Cancer, Sinonasal Squamous Cell Carcinoma
- Being tested
- Toripalimab + Chemotherapy, Toripalimab, Chemoradiotherapy or radiation
- Keywords
- head and neck cancer, oral cancer, oropharyngeal cancer, laryngeal cancer, HPV associated, squamous cell carcinoma
- Medical subject headings
- Head and Neck Neoplasms, Carcinoma, Squamous Cell, Mouth Neoplasms, Oropharyngeal Neoplasms, Laryngeal Neoplasms, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toripalimab + ChemotherapyDrug
Also called Cisplatin, Carboplatin, Docetaxel
Toripalimab is the study drug and will be given via IV in all arms except "Rad+/-Chem : Adjuvant radiation or chemoradiotherapy"
ToripalimabDrug
Study drug
Chemoradiotherapy or radiationRadiation
In the adjuvant phase, either radiation or chemoradiotherapy is used for treatment
| Study group | Role | What they receive |
|---|---|---|
| Neo + Surg : Neoadjuvant Treatment and surgery | Experimental | Neoadjuvant Chemotherapy with
* Toripalimab + Cisplatin + Docetaxel OR
* Toripalimab + Carboplatin + Docetaxel Receives: Drug: Toripalimab + Chemotherapy |
| Rad+/-Chem : Adjuvant radiation or chemoradiotherapy | Experimental | Radiation or Chemotherapy will be given after the surgery Receives: Radiation: Chemoradiotherapy or radiation |
| Adjuvant (ADJ) treatment | Experimental | Treated with Toripalimab after adjuvant treatment Receives: Drug: Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Pathological Response (MPR)
The objective is to achieve high-quality or "deep" responses to treatment (measurable pathologic response, MPR) that are sufficient to enable surgical de-escalation (less extensive surgery) or response-adaptive, function-preserving surgery (tailoring the surgical approach to preserve organ structure and function while maintaining oncologic safety).
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start18 Feb 2026
- Primary completion1 Oct 2030 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Sponsor type
- University, hospital or other
- Collaborators
- Coherus Oncology, Inc.
- Responsible party
- Sponsor
- Investigators
- Nyall R London, MD, Ph.D, Principal investigator, Otolaryngology - Broadway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07209189
- Sponsor's protocol ID
- J2537
- Other IDs
- IRB00490896
- Acronym
- (NeoScorch HN)
- Status last verified
- Apr 2026
- First submitted
- 30 Sep 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Chemotherapy and PD-1 Inhibition for Head and Neck Cancer Treatment De-escalation (NeoScorch HN)
- ClinicalTrials.gov ID
- NCT07209189
- Acronym / sponsor ID
- (NeoScorch HN) / J2537
- Conditions
- Head and Neck Cancer, Squamous Cell Carcinoma, Oral Cavity Cancer, Oropharyngeal Cancer, Laryngeal Cancer, Sinonasal Squamous Cell Carcinoma
- Keywords
- head and neck cancer, oral cancer, oropharyngeal cancer, laryngeal cancer, HPV associated, squamous cell carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Coherus Oncology, Inc.
- Study start
- 18 Feb 2026 (actual)
- Primary completion
- 1 Oct 2030 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 6 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neo + Surg : Neoadjuvant Treatment and surgery | Experimental | Drug: Toripalimab + ChemotherapyNeoadjuvant Chemotherapy with * Toripalimab + Cisplatin + Docetaxel OR * Toripalimab + Carboplatin + Docetaxel |
| Rad+/-Chem : Adjuvant radiation or chemoradiotherapy | Experimental | Radiation: Chemoradiotherapy or radiationRadiation or Chemotherapy will be given after the surgery |
| Adjuvant (ADJ) treatment | Experimental | Drug: ToripalimabTreated with Toripalimab after adjuvant treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- Eligible subjects must have histologically confirmed, locoregionally advanced head and neck or sinonasal, nasolacrimal, or skull base tumors and meet HPV testing requirements as outlined.
- HPV-independent HNSCC (cT2-cT4, N0-N3) with potential for organ preservation using response-adapted 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 (e.g., Isocitrate dehydrogenase 2 (IDH2) mutant), or neuroendocrine sinonasal tumors (e.g., olfactory neuroblastoma) (cT2-cT4, N0-N3).
- HPV16 type only. Patients with non-HPV16 cancers are not eligible. If p16 immunohistohemistry (IHC) positivity is the only result available at enrollment, neoadjuvant therapy may start while HPV nucleic acid testing is pending. Patients found to be HPV non-16 must discontinue study participation.
Key exclusion criteria (21 listed)
- WOCBP with a positive urine pregnancy test within 72 hours before treatment allocation; if positive or inconclusive, a confirmatory serum pregnancy test is required.
- Pregnant or breastfeeding, or planning to conceive or father a child during the study and for 120 days after the last dose.
- Prior treatment with PD-1, PD-L1, PD-L2 inhibitors, or other agents targeting T-cell receptors (e.g., Cytotoxic T-lymphocyte antigen 4 (CTLA-4), OX40 (Tumor Necrosis Factor Receptor Superfamily Member 4), CD137).
- Prior systemic anti-cancer therapy or radiotherapy for the current cancer. Surgery is allowed if adequately recovered from complications.
- Radiotherapy within 2 weeks of study start. A 1-week washout is permitted for palliative, non-stereotactic radiation (≤2 weeks) to non-Central Nervous System (CNS), non-head and neck disease, provided there are no residual toxicities, no steroid requirement, and no history of radiation pneumonitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toripalimab + ChemotherapyAlso: Cisplatin, Carboplatin, DocetaxelToripalimab is the study drug and will be given via IV in all arms except "Rad+/-Chem : Adjuvant radiation or chemoradiotherapy" | Drug | Neo + Surg : Neoadjuvant Treatment and surgery |
| ToripalimabStudy drug | Drug | Adjuvant (ADJ) treatment |
| Chemoradiotherapy or radiationIn the adjuvant phase, either radiation or chemoradiotherapy is used for treatment | Radiation | Rad+/-Chem : Adjuvant radiation or chemoradiotherapy |
Primary outcome
Major Pathological Response (MPR)
Time frame: Up to 5 years
The objective is to achieve high-quality or "deep" responses to treatment (measurable pathologic response, MPR) that are sufficient to enable surgical de-escalation (less extensive surgery) or response-adaptive, function-preserving surgery (tailoring the surgical approach to preserve organ structure and function while maintaining oncologic safety).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nyall R London, MD, Ph.D principal investigator
Otolaryngology - Broadway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Toripalimab + Chemotherapy, Toripalimab and Chemoradiotherapy or radiation in people with Head and Neck Cancer and Squamous Cell Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zubair Khan, MBBS, MPH (4109553157, ototrials@live.johnshopkins.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Pathological Response (MPR) (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.