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NCT02304458 · ClinicalTrials.gov registry record · Phase 1
Nivolumab With or Without Ipilimumab in Treating Younger Patients With Recurrent or Refractory Solid Tumors or Sarcomas
A Phase 1 study of Metastatic Melanoma and Recurrent Malignant Solid Neoplasm, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 140
- Enrollment target
- 20
- Study locations
NCT02304458: Completed Phase 1 study of Metastatic Melanoma and Recurrent Malignant Solid Neoplasm, sponsored by National Cancer Institute (NCI).
NCT02304458 is a Phase 1 study of Metastatic Melanoma and Recurrent Malignant Solid Neoplasm that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 140 participants, above the 82-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (71% higher). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02304458, a Phase 1 study of Metastatic Melanoma and Recurrent Malignant Solid Neoplasm, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 140 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase I/II trial studies the side effects and best dose of nivolumab when given with or without ipilimumab to see how well they work in treating younger patients with solid tumors or sarcomas that have come back (recurrent) or do not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether nivolumab works better alone or with ipilimumab in treating patients with recurrent or refractory solid tumors or sarcomas.
Primary Outcome
The frequency (%) of patients experiencing a dose limiting toxicity at least possibly attributable to nivolumab as a single agent or in combination with ipilimumab by study part and dose level.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Nivolumab
- BIOLOGICAL Ipilimumab
- OTHER Pharmacological Study
Study Locations (20)
California
- Children's Hospital Los Angeles - Los Angeles
- Children's Hospital of Orange County - Orange
- Lucile Packard Children's Hospital Stanford University - Palo Alto
- UCSF Medical Center-Mission Bay - San Francisco
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
- Children's Hospital of Pittsburgh of UPMC - Pittsburgh
Alabama
- Children's Hospital of Alabama - Birmingham
Colorado
- Children's Hospital Colorado - Aurora
District of Columbia
- Children's National Medical Center - Washington D.C.
Georgia
- Children's Healthcare of Atlanta - Egleston - Atlanta
Illinois
- Lurie Children's Hospital-Chicago - Chicago
Indiana
- Riley Hospital for Children - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2015-03-30 |
| Est. Completion | 2023-03-31 |
| Phase | Phase 1 |
What the finished NCT02304458 record still lists
NCT02304458 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, above the 82-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (71% higher).
The record links to 10 conditions, with Metastatic Melanoma appearing as the primary indexed condition, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT02304458 names 20 study sites across 16 states, led by California, Pennsylvania, Alabama.
Frequently Asked Questions
What is clinical trial NCT02304458 about?
NCT02304458 is a clinical study titled "Nivolumab With or Without Ipilimumab in Treating Younger Patients With Recurrent or Refractory Solid Tumors or Sarcomas". This phase I/II trial studies the side effects and best dose of nivolumab when given with or without ipilimumab to see how well they work in treating younger patients with solid tumors or sarcomas that have come back (recurrent) or do not respond to treatment (refractory). Immunotherapy with monoclo...
What is the current status of trial NCT02304458?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 140 participants. The study started on 2015-03-30. Estimated completion is 2023-03-31.
What conditions does trial NCT02304458 study?
This clinical trial studies the following conditions: Metastatic Melanoma, Recurrent Malignant Solid Neoplasm, Recurrent Melanoma, Recurrent Osteosarcoma, Recurrent Non-Hodgkin Lymphoma.
What interventions are being tested in trial NCT02304458?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Nivolumab (BIOLOGICAL), Ipilimumab (BIOLOGICAL), Pharmacological Study (OTHER).
Who is sponsoring clinical trial NCT02304458?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02304458 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, District of Columbia, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02304458's enrollment target sits among peer trials
140 14th of 91 higher than 78 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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