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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)

Study acronym: (NeoScorch HN)
StatusRecruiting
PhasePhase 2
Started2026-02-18
View on ClinicalTrials.gov ↗

Amendment history

2026-04-21
minor
Study Status v9
Start date2026-03-04→2026-02-18
2026-03-05
minor
Study Status v8
Re-verified, no change to tracked fields
2026-02-24
minor
Study Status v7
Start date2026-02-24→2026-03-04
2026-02-24
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v6
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2026-02-15→confirmed 2026-02-24
Study sites0→1
2026-01-30
minor
Study Status v5
Start date2026-01-15→2026-02-15
Show 4 earlier versions
2025-12-10
minor
Study Status v4
Start date2025-12-01→2026-01-15
2025-11-17
minor
Study Status v3
Start date2025-11-01→2025-12-01
2025-10-22
minor
Study Status v2
Start date2025-10-25→2025-11-01
2025-10-06
minor
Study Status, Study Description, Eligibility v1
Eligibility criteriarevised
[...] y. Patients with non-HPV16 cancers are not eligible. If p16 immunohistochemistyimmunohistohemistry (IHC) positivity is the only result available at enrollment [...]
2025-09-30
minor
Original filing
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.
Trial Details
NCT Number NCT07209189
Lead Sponsor Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators: Coherus Oncology, Inc.
Conditions Head and Neck Cancer, Squamous Cell Carcinoma, Oral Cavity Cancer, Oropharyngeal Cancer, Laryngeal Cancer, Sinonasal Squamous Cell Carcinoma, HPV (Human Papillomavirus)-Associated Carcinoma, Skull Base Tumors +1 more
Enrollment 75 participants
Start Date 2026-02-18
Primary Completion 2030-10-01 (estimated)
Study Completion 2030-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-04-23