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NCT07094685 · ClinicalTrials.gov registry record · Phase 2
Ivonescimab Before Surgery for the Treatment of Resectable Stage II-IV Head and Neck Cancer
A Phase 2 study of Advanced Head and Neck Squamous Cell Carcinoma and Resectable Head and Neck Squamous Cell Carcinoma, sponsored by University of Michigan Rogel Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT07094685: Recruiting Phase 2 study of Advanced Head and Neck Squamous Cell Carcinoma and Resectable Head and Neck Squamous Cell Carcinoma, sponsored by University of Michigan Rogel Cancer Center.
NCT07094685 is a Phase 2 study of Advanced Head and Neck Squamous Cell Carcinoma and Resectable Head and Neck Squamous Cell Carcinoma that is actively recruiting participants, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 28 participants, below the 35-participant average among 5 other Advanced Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (20% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07094685, a Phase 2 study of Advanced Head and Neck Squamous Cell Carcinoma and Resectable Head and Neck Squamous Cell Carcinoma, is actively recruiting participants, sponsored by University of Michigan Rogel Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial tests how well ivonescimab before surgery works in treating patients with stage II-IV head and neck cancer that can be removed by surgery (resectable). Ivonescimab is a bispecific monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A bispecific monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens).
Primary Outcome
The major pathologic response (MPR) rate is defined as the proportion of patients achieving major pathologic response out of all response-evaluable patients. This proportion will be estimated as the number of patients with MPR divided by the total number of patients response-evaluable for pathologic response. This estimate will be presented along with a Wilson score 95% confidence interval.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- PROCEDURE Biopsy Procedure
- BIOLOGICAL Ivonescimab
Study Locations (1)
Michigan
- University of Michigan Comprehensive Cancer Center - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2025-11-18 |
| Est. Completion | 2030-11-01 |
| Phase | Phase 2 |
What NCT07094685 shows while recruiting
NCT07094685 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 35-participant average among 5 other Advanced Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (20% lower).
The record links to 5 conditions, with Advanced Head and Neck Squamous Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT07094685 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT07094685 about?
NCT07094685 is a clinical study titled "Ivonescimab Before Surgery for the Treatment of Resectable Stage II-IV Head and Neck Cancer". This phase II trial tests how well ivonescimab before surgery works in treating patients with stage II-IV head and neck cancer that can be removed by surgery (resectable). Ivonescimab is a bispecific monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A bispeci...
What is the current status of trial NCT07094685?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2025-11-18. Estimated completion is 2030-11-01.
What conditions does trial NCT07094685 study?
This clinical trial studies the following conditions: Advanced Head and Neck Squamous Cell Carcinoma, Resectable Head and Neck Squamous Cell Carcinoma, Stage II Head and Neck Cutaneous Squamous Cell Carcinoma, Stage III Head and Neck Cutaneous Squamous Cell Carcinoma, Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma.
What interventions are being tested in trial NCT07094685?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Biopsy Procedure (PROCEDURE), Ivonescimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT07094685?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07094685 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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