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Neoadjuvant Chemotherapy and Programmed Cell Death Protein 1(PD-1) Inhibition for Head and Neck Cancer Treatment De-escalation (NeoScorch HN)

ConditionsHead and Neck CancerSquamous Cell CarcinomaOral Cavity CancerOropharyngeal CancerLaryngeal CancerSinonasal Squamous Cell CarcinomaHPV (Human Papillomavirus)-Associated CarcinomaSkull Base TumorsHPV 16 Positive Oropharyngeal Tumors (OPC)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Toripalimab + Chemotherapy

    Drug

    Toripalimab is the study drug and will be given via IV in all arms except "Rad+/-Chem : Adjuvant radiation or chemoradiotherapy"

  • Toripalimab

    Drug

    Study drug

  • Chemoradiotherapy or radiation

    Radiation

    In the adjuvant phase, either radiation or chemoradiotherapy is used for treatment

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: Neo + Surg : Neoadjuvant Treatment and surgeryExperimental treatment 1 intervention
Group B: Rad+/-Chem : Adjuvant radiation or chemoradiotherapyExperimental treatment 1 intervention
Group C: Adjuvant (ADJ) treatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Up to 5 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead sponsor

Coherus Oncology, Inc.

Collaborator

Source ClinicalTrials.gov
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