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NCT01416831 · ClinicalTrials.gov registry record · Phase 2
Comparison of High-dose IL-2 and High-dose IL-2 With Radiation Therapy in Patients With Metastatic Melanoma.
A Phase 2 study of Metastatic Melanoma, sponsored by Providence Health & Services.
- Active
- Registry status
- Phase 2
- Development phase
- 44
- Enrollment target
- 1
- Study location
NCT01416831: Active Phase 2 study of Metastatic Melanoma, sponsored by Providence Health & Services.
NCT01416831 is a Phase 2 study of Metastatic Melanoma that is active but no longer recruiting, run by Providence Health & Services. The registered enrollment target is 44 participants, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (47% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01416831, a Phase 2 study of Metastatic Melanoma, is active but no longer recruiting, sponsored by Providence Health & Services.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 44 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is compare the response rates in patients with metastatic melanoma treated with high-dose IL-2 to patients treated with high-dose IL-2 along with radiation therapy.
Primary Outcome
Determine the best overall tumor response rate of high dose IL-2 versus SBRT + high-dose IL-2 using RECIST v1.1 assessed by CT/MRI, criteria applied to all target and non-target lesions with the exclusion of sites treated with SBRT. For patients who have SBRT after progression on IL-2 monotherapy, the response rate will be recorded, but not counted as a response for the primary objective. Overall response rate (ORR) includes all measurable and non-measurable target lesions except the lesions tr
Conditions Studied
Interventions
- OTHER Radiation therapy and high-dose IL-2
- DRUG High-dose IL-2
Study Locations (1)
Oregon
- Providence Cancer Center - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2011-07-01 |
| Est. Completion | 2025-12 |
| Phase | Phase 2 |
What the registry record for NCT01416831 still lists
NCT01416831 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (47% lower).
The record links to 1 condition, with Metastatic Melanoma appearing as the primary indexed condition, and to 2 interventions - of which Radiation therapy and high-dose IL-2 is the first listed.
NCT01416831 reports a single indexed study location in Oregon.
Frequently Asked Questions
What is clinical trial NCT01416831 about?
NCT01416831 is a clinical study titled "Comparison of High-dose IL-2 and High-dose IL-2 With Radiation Therapy in Patients With Metastatic Melanoma.". The purpose of this study is compare the response rates in patients with metastatic melanoma treated with high-dose IL-2 to patients treated with high-dose IL-2 along with radiation therapy.
What is the current status of trial NCT01416831?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2011-07-01. Estimated completion is 2025-12.
What conditions does trial NCT01416831 study?
This clinical trial studies the following conditions: Metastatic Melanoma.
What interventions are being tested in trial NCT01416831?
The interventions under investigation include: Radiation therapy and high-dose IL-2 (OTHER), High-dose IL-2 (DRUG).
Who is sponsoring clinical trial NCT01416831?
This trial is sponsored by Providence Health & Services, which has 69 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01416831 being conducted?
This trial has 1 study location across Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Metastatic Melanoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01416831's enrollment target sits among peer trials
44 41st of 91 higher than 51 of 91 other Metastatic Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Melanoma 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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