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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT07209189
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Feb 18, 2026
Status verified
Apr 2026
Primary completion
Oct 1, 2030
Completion
Dec 1, 2030

Study Design

Enrollment
75 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Neo + Surg : Neoadjuvant Treatment and surgery
    Neoadjuvant Chemotherapy with * Toripalimab + Cisplatin + Docetaxel OR * Toripalimab + Carboplatin + Docetaxel
  • Experimental: Rad+/-Chem : Adjuvant radiation or chemoradiotherapy
    Radiation or Chemotherapy will be given after the surgery
  • Experimental: Adjuvant (ADJ) treatment
    Treated with Toripalimab after adjuvant treatment

Primary Outcome Measure

Major Pathological Response (MPR) [ Time Frame: Up to 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins Hospital East BaltimoreBaltimoreMaryland21287
Zubair Khan, MD, MPH
[email protected]
410-955-3157
Shriya Yanamandra, MS
[email protected]
4699214065
Nyall London, MD, Ph.D (PRINCIPAL_INVESTIGATOR)

Find similar trials in Baltimore, MD

By condition
Head and neck cancerSkin cancer
By specialty
OncologyENTSkin cancerDermatology
By research site
Johns Hopkins Hospital East Baltimore· Baltimore, MD

Related Studies