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NCT07209189 · ClinicalTrials.gov registry record · Phase 2
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 of Head and Neck Cancer and Squamous Cell Carcinoma, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 75
- Enrollment target
- 1
- Study location
NCT07209189: Recruiting Phase 2 study of Head and Neck Cancer and Squamous Cell Carcinoma, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT07209189 is a Phase 2 study of Head and Neck Cancer and Squamous Cell Carcinoma that is actively recruiting participants, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 75 participants, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07209189, a Phase 2 study of Head and Neck Cancer and Squamous Cell Carcinoma, is actively recruiting participants, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 75 participants
- Enrollment target
- 1
- Study location
Study 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 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.
Primary Outcome
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).
Conditions Studied
Interventions
- DRUG Toripalimab
- DRUG Toripalimab + Chemotherapy
- RADIATION Chemoradiotherapy or radiation
Study Locations (1)
Maryland
- Johns Hopkins Hospital East Baltimore - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2026-03-04 |
| Est. Completion | 2030-12-01 |
| Phase | Phase 2 |
What NCT07209189 shows while recruiting
NCT07209189 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (71% lower).
The record links to 9 conditions, with Head and Neck Cancer appearing as the primary indexed condition, and to 3 interventions - of which Toripalimab is the first listed.
NCT07209189 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT07209189 about?
NCT07209189 is a clinical study titled "Neoadjuvant Chemotherapy and Programmed Cell Death Protein 1(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 chemoimmunot...
What is the current status of trial NCT07209189?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2026-03-04. Estimated completion is 2030-12-01.
What conditions does trial NCT07209189 study?
This clinical trial studies the following conditions: Head and Neck Cancer, Squamous Cell Carcinoma, Oropharyngeal Cancer, Oral Cavity Cancer, Laryngeal Cancer.
What interventions are being tested in trial NCT07209189?
The interventions under investigation include: Toripalimab (DRUG), Toripalimab + Chemotherapy (DRUG), Chemoradiotherapy or radiation (RADIATION).
Who is sponsoring clinical trial NCT07209189?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07209189 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07209189's enrollment target sits among peer trials
75 100th of 250 higher than 149 of 250 other Head and Neck Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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