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NCT05280314 · ClinicalTrials.gov registry record · Phase 2
Phase II Trial of Neoadjuvant and Adjuvant IO102-IO103 and Pembrolizumab KEYTRUDA® in Patients With Resectable Tumors
A Phase 2 study of Melanoma and Squamous Cell Carcinoma of Head and Neck, sponsored by IO Biotech.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 15
- Study locations
NCT05280314: Recruiting Phase 2 study of Melanoma and Squamous Cell Carcinoma of Head and Neck, sponsored by IO Biotech.
NCT05280314 is a Phase 2 study of Melanoma and Squamous Cell Carcinoma of Head and Neck that is actively recruiting participants, run by IO Biotech. The registered enrollment target is 60 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (92% lower). The trial reports 15 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05280314, a Phase 2 study of Melanoma and Squamous Cell Carcinoma of Head and Neck, is actively recruiting participants, sponsored by IO Biotech.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 15
- Study locations
Study Summary
This is a multicenter, multi-arm trial evaluating anti-tumor activity, safety, and immune infiltration of IO102-IO103 in combination with pembrolizumab KEYTRUDA® as neoadjuvant and post-surgery treatment. This proof-of-concept trial will include patients with resectable tumors in at least 2 indications.
Primary Outcome
Major pathologic response, defined as pathologic complete response (pCR) (0% residual viable tumor) or near pCR (≤10% residual viable tumor)
Conditions Studied
Interventions
- DRUG IO102-IO103
- DRUG Pembrolizumab KEYTRUDA®
Study Locations (15)
Other
- Aarhus University Hospital - Aarhus
- Copenhagen University Hospital Herlev - Copenhagen
- CHRU Lille - Lille
- Hôpital Ambroise-Paré - Paris
- Institut Gustave Roussy - Paris
- Universitätsklinikum Essen & Research Alliance Ruhr - Essen
- Universität Heidelberg, Medizinische Fakultät - Heidelberg
- Hospital Universitario Quirón Dexeus - Barcelona
- Hospital Universitario Ramón y Cajal - Madrid
- Hospital Clínico Universitario de Valencia -INCLIVA - Valencia
Connecticut
- Yale - New Haven
Massachusetts
- Dana Farber Cancer Institute - Boston
Virginia
- Massey Cancer Center - Richmond
New South Wales
- Melanoma Institute Australia The Uiniversity of Sydney, and Royal North Shore Hospital - Sydney
Victoria
- Peter MacCallum Cancer Centre - Melbourne
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-12-21 |
| Est. Completion | 2027-01 |
| Phase | Phase 2 |
What NCT05280314 shows while recruiting
NCT05280314 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (92% lower).
The record links to 2 conditions, with Melanoma appearing as the primary indexed condition, and to 2 interventions - of which IO102-IO103 is the first listed.
NCT05280314 lists 15 locations in 6 states (Other, Connecticut, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT05280314 about?
NCT05280314 is a clinical study titled "Phase II Trial of Neoadjuvant and Adjuvant IO102-IO103 and Pembrolizumab KEYTRUDA® in Patients With Resectable Tumors". This is a multicenter, multi-arm trial evaluating anti-tumor activity, safety, and immune infiltration of IO102-IO103 in combination with pembrolizumab KEYTRUDA® as neoadjuvant and post-surgery treatment. This proof-of-concept trial will include patients with resectable tumors in at least 2 indicati...
What is the current status of trial NCT05280314?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2023-12-21. Estimated completion is 2027-01.
What conditions does trial NCT05280314 study?
This clinical trial studies the following conditions: Melanoma, Squamous Cell Carcinoma of Head and Neck.
What interventions are being tested in trial NCT05280314?
The interventions under investigation include: IO102-IO103 (DRUG), Pembrolizumab KEYTRUDA® (DRUG).
Who is sponsoring clinical trial NCT05280314?
This trial is sponsored by IO Biotech, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05280314 being conducted?
This trial has 15 study locations across Connecticut, Massachusetts, Virginia, New South Wales, Victoria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05280314's enrollment target sits among peer trials
60 152nd of 266 higher than 112 of 266 other Melanoma trials
participants (enrollment target), bucketed by value
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