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NCT02570308 · ClinicalTrials.gov registry record · Phase 1
A Study of the Intra-Patient Escalation Dosing Regimen With IMCgp100 in Patients With Advanced Uveal Melanoma
A Phase 1 study, sponsored by Immunocore.
- Completed
- Registry status
- Phase 1
- Development phase
- 146
- Enrollment target
NCT02570308: Completed Phase 1 study, sponsored by Immunocore.
NCT02570308 is a Phase 1 study that has completed, run by Immunocore. The registered enrollment target is 146 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (143% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02570308, a Phase 1 study, has completed, sponsored by Immunocore.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 146 participants
- Enrollment target
Study Summary
IMCgp100-102 is a Phase I/II study of the weekly intra-patient escalation dose regimen with IMCgp100 as a single agent in participants with metastatic uveal melanoma (mUM). According to this regimen, all participants in the trial received 2 weekly doses of IMCgp100 at a dose level below the identified weekly recommended Phase II dose (RP2D-QW) and then a dose escalation commenced at the third weekly dose at C1D15. The Phase I testing of the intra-patient escalation dosing regimen is designed to achieve a higher exposure and maximal plasma concentration of IMCgp100 after doses at Cycle 1 Day 15 (C1D15) and thereafter.
Primary Outcome
Number of participants with a dose limiting toxicity, defined as an adverse event (AE) or abnormal laboratory value assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle of treatment and meets any of the pre-specified criteria.
Interventions
- DRUG IMCgp100
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 146 participants |
| Start Date | 2016-02-29 |
| Est. Completion | 2022-10-17 |
| Phase | Phase 1 |
What the finished NCT02570308 record still lists
NCT02570308 is an interventional study that assigns participants to a tested intervention. The registered 146 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (143% higher).
The record links to 0 conditions, and to 1 intervention - of which IMCgp100 is the first listed.
NCT02570308 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02570308 about?
NCT02570308 is a clinical study titled "A Study of the Intra-Patient Escalation Dosing Regimen With IMCgp100 in Patients With Advanced Uveal Melanoma". IMCgp100-102 is a Phase I/II study of the weekly intra-patient escalation dose regimen with IMCgp100 as a single agent in participants with metastatic uveal melanoma (mUM). According to this regimen, all participants in the trial received 2 weekly doses of IMCgp100 at a dose level below the identifi...
What is the current status of trial NCT02570308?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 146 participants. The study started on 2016-02-29. Estimated completion is 2022-10-17.
What interventions are being tested in trial NCT02570308?
The interventions under investigation include: IMCgp100 (DRUG).
Who is sponsoring clinical trial NCT02570308?
This trial is sponsored by Immunocore, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02570308's enrollment target sits among peer trials
146 391st of 2000 higher than 1,610 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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