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NCT01740297 · ClinicalTrials.gov registry record · Phase 1
Ipilimumab With or Without Talimogene Laherparepvec in Unresected Melanoma
A Phase 1 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 1
- Development phase
- 217
- Enrollment target
NCT01740297: Completed Phase 1 study, sponsored by Amgen.
NCT01740297 is a Phase 1 study that has completed, run by Amgen. The registered enrollment target is 217 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (262% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01740297, a Phase 1 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 217 participants
- Enrollment target
Study Summary
Phase 1b of the study will evaluate the safety of talimogene laherparepvec in combination with ipilimumab. Phase 2 is a randomized study that will evaluate the safety and efficacy of talimogene laherparepvec in combination with ipilimumab versus ipilumumab alone.
Primary Outcome
A DLT was defined as any toxicity related to study drug which met any of the following criteria based on Common Terminology Criteria for Adverse Events version 3.0: * treatment-related non-laboratory adverse events (AE) ≥ grade 4 * ≥ grade 4 immune-mediated dermatitis * ≥ grade 4 immune-mediated endocrinopathy (except autoimmune thyroiditis) * ≥ grade 3 immune-mediated enterocolitis * ≥ grade 3 immune-mediated hepatitis (except grade 3 that resolved to grade 1 or baseline within 28 days of onse
Interventions
- DRUG Ipilimumab
- DRUG Talimogene laherparepvec
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 217 participants |
| Start Date | 2013-02-07 |
| Est. Completion | 2021-03-09 |
| Phase | Phase 1 |
What the finished NCT01740297 record still lists
NCT01740297 is an interventional study that assigns participants to a tested intervention. The registered 217 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 (262% higher).
The record links to 0 conditions, and to 2 interventions - of which Ipilimumab is the first listed.
NCT01740297 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01740297 about?
NCT01740297 is a clinical study titled "Ipilimumab With or Without Talimogene Laherparepvec in Unresected Melanoma". Phase 1b of the study will evaluate the safety of talimogene laherparepvec in combination with ipilimumab. Phase 2 is a randomized study that will evaluate the safety and efficacy of talimogene laherparepvec in combination with ipilimumab versus ipilumumab alone.
What is the current status of trial NCT01740297?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 217 participants. The study started on 2013-02-07. Estimated completion is 2021-03-09.
What interventions are being tested in trial NCT01740297?
The interventions under investigation include: Ipilimumab (DRUG), Talimogene laherparepvec (DRUG).
Who is sponsoring clinical trial NCT01740297?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01740297's enrollment target sits among peer trials
217 240th of 2000 higher than 1,758 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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