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NCT03850691 · ClinicalTrials.gov registry record · Phase 2
Radiation and Combination Immunotherapy for Melanoma
A Phase 2 study of Metastatic Melanoma, sponsored by Masonic Cancer Center, University of Minnesota.
- Completed
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
- 1
- Study location
NCT03850691: Completed Phase 2 study of Metastatic Melanoma, sponsored by Masonic Cancer Center, University of Minnesota.
NCT03850691 is a Phase 2 study of Metastatic Melanoma that has completed, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 4 participants, below the 84-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03850691, a Phase 2 study of Metastatic Melanoma, has completed, sponsored by Masonic Cancer Center, University of Minnesota.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 4 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase 2 study designed to evaluate the combination of checkpoint blockade and aldesleukin (IL-2) therapy after a course of standard of care palliative radiation in the management of unresectable metastatic melanoma. To be eligible, a patient must have a minimum of 3 (preferably \>5) radiographically distinct, measurable (\>1.5 cm) lesions based on RECIST 1.1. Metastatic cutaneous melanoma must be refractory to standard immunotherapy drugs, molecular targeted agents and/or chemotherapy. Patients with ocular melanoma subtypes may enroll in this study without prior therapy, as there is no standard front-line therapy for this subset of patients.
Primary Outcome
Determine the objective response rate (ORR). The ORR will be presented as the proportion of patients who achieved complete response (CR) or partial response (PR). In general, categorical data measurements will be summarized as counts and percentages (or proportions). The disease control rate (DCR) will be presented as the proportion of patients with CR, PR, or stable disease. The best overall response (BOR) will be measured as the maximum change from baseline in the sum of the longest diameter f
Conditions Studied
Interventions
- DRUG Aldesleukin: All Patients
- DRUG Nivolumab: Cohort 1 (Cutaneous)
- DRUG Nivolumab: Cohort 2 (Ocular)
- DRUG Ipilimumab: Cohort 2 (Ocular)
Study Locations (1)
Minnesota
- University of Minnesota Masonic Cancer Center - Burnsville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2019-05-28 |
| Est. Completion | 2022-12-12 |
| Phase | Phase 2 |
What the finished NCT03850691 record still lists
NCT03850691 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 84-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Metastatic Melanoma appearing as the primary indexed condition, and to 4 interventions - of which Aldesleukin: All Patients is the first listed.
NCT03850691 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT03850691 about?
NCT03850691 is a clinical study titled "Radiation and Combination Immunotherapy for Melanoma". This is a Phase 2 study designed to evaluate the combination of checkpoint blockade and aldesleukin (IL-2) therapy after a course of standard of care palliative radiation in the management of unresectable metastatic melanoma. To be eligible, a patient must have a minimum of 3 (preferably \>5) radiog...
What is the current status of trial NCT03850691?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2019-05-28. Estimated completion is 2022-12-12.
What conditions does trial NCT03850691 study?
This clinical trial studies the following conditions: Metastatic Melanoma.
What interventions are being tested in trial NCT03850691?
The interventions under investigation include: Aldesleukin: All Patients (DRUG), Nivolumab: Cohort 1 (Cutaneous) (DRUG), Nivolumab: Cohort 2 (Ocular) (DRUG), Ipilimumab: Cohort 2 (Ocular) (DRUG).
Who is sponsoring clinical trial NCT03850691?
This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03850691 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT03850691's enrollment target sits among peer trials
4 91st of 91 higher than 1 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.
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