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NCT05977907 · ClinicalTrials.gov registry record · Phase 2
Neoadjuvant Pembrolizumab and IO102-103 for Squamous Cell Carcinoma of the Head and Neck (SCCHN).
A Phase 2 study of Head and Neck Squamous Cell Carcinoma, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 5
- Study locations
NCT05977907: Recruiting Phase 2 study of Head and Neck Squamous Cell Carcinoma, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT05977907 is a Phase 2 study of Head and Neck Squamous Cell Carcinoma that is actively recruiting participants, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 30 participants, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (74% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05977907, a Phase 2 study of Head and Neck Squamous Cell Carcinoma, is actively recruiting participants, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 5
- Study locations
Study Summary
This research is being done to see if it is safe to give investigational combination of study drugs (Pembrolizumab and IO102-103) before surgery to people with surgically resectable (removable) newly diagnosed or recurrent metastatic SCCHN. This will be done by watching participants closely for possible side effects from Pembrolizumab and IO102-103. In addition, participants will be monitored for any delays to their surgery due to the study drugs.
Primary Outcome
To determine rate of pathologic treatment response ≥50% (pTR-2) / immune-related pathologic response criteria (irPRC) ≥ 50% rate to neoadjuvant pembrolizumab plus IO102-IO103 in SCCHN
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG IO102-103
Study Locations (5)
District of Columbia
- Sibley Memorial Hospital - Washington D.C.
Illinois
- Northwestern Memorial Hospital - Chicago
Maryland
- Johns Hopkins University - Baltimore
Oregon
- Providence Cancer Institute - Portland
Pennsylvania
- Thomas Jefferson University Hospital - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-12-14 |
| Est. Completion | 2028-10-16 |
| Phase | Phase 2 |
What NCT05977907 shows while recruiting
NCT05977907 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (74% lower).
The record links to 1 condition, with Head and Neck Squamous Cell Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT05977907 lists 5 locations in 5 states (District of Columbia, Illinois, Maryland).
Frequently Asked Questions
What is clinical trial NCT05977907 about?
NCT05977907 is a clinical study titled "Neoadjuvant Pembrolizumab and IO102-103 for Squamous Cell Carcinoma of the Head and Neck (SCCHN).". This research is being done to see if it is safe to give investigational combination of study drugs (Pembrolizumab and IO102-103) before surgery to people with surgically resectable (removable) newly diagnosed or recurrent metastatic SCCHN. This will be done by watching participants closely for poss...
What is the current status of trial NCT05977907?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2023-12-14. Estimated completion is 2028-10-16.
What conditions does trial NCT05977907 study?
This clinical trial studies the following conditions: Head and Neck Squamous Cell Carcinoma.
What interventions are being tested in trial NCT05977907?
The interventions under investigation include: Pembrolizumab (DRUG), IO102-103 (DRUG).
Who is sponsoring clinical trial NCT05977907?
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 NCT05977907 being conducted?
This trial has 5 study locations across District of Columbia, Illinois, Maryland, Oregon, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05977907's enrollment target sits among peer trials
30 85th of 124 higher than 36 of 124 other Head and Neck Squamous Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Squamous Cell Carcinoma 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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