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NCT02553642 · ClinicalTrials.gov registry record · Phase 2
Relationship Between Tumor Mutation Burden and Predicted Neo-antigen Burden in Patients With Advanced Melanoma or Bladder Cancer Treated With Nivolumab or Nivolumab Plus Ipilimumab (CA209-260)
A Phase 2 study of Melanoma and Bladder Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 81
- Enrollment target
- 5
- Study locations
NCT02553642: Completed Phase 2 study of Melanoma and Bladder Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
NCT02553642 is a Phase 2 study of Melanoma and Bladder Cancer that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 81 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (89% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02553642, a Phase 2 study of Melanoma and Bladder Cancer, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 81 participants
- Enrollment target
- 5
- Study locations
Study Summary
The purpose of this study is to investigate the characteristics of tumors in patients treated with nivolumab and to identify features that help to predict a good or bad response to this drug.
Primary Outcome
Primary clinical endpoint was proportion of patients who achieve a confirmed objective response rate (per RECIST 1.1) to nivolumab monotherapy in bladder cancer patients progressing on initial nivolumab monotherapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG Nivolumab plus Ipilimumab
Study Locations (5)
New York
- Memorial Sloan Kettering Westchester - Harrison
- Memorial Sloan Kettering Cancer Center - New York
Connecticut
- University of Connecticut Health Center - Farmington
New Jersey
- Memorial Sloan Kettering Monmouth - Middletown
Pennsylvania
- Lehigh Valley Health Network - Allentown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2015-09-14 |
| Est. Completion | 2024-04-29 |
| Phase | Phase 2 |
What the finished NCT02553642 record still lists
NCT02553642 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (89% lower).
The record links to 2 conditions, with Melanoma appearing as the primary indexed condition, and to 2 interventions - of which Nivolumab is the first listed.
NCT02553642 lists 5 locations in 4 states (New York, Connecticut, New Jersey).
Frequently Asked Questions
What is clinical trial NCT02553642 about?
NCT02553642 is a clinical study titled "Relationship Between Tumor Mutation Burden and Predicted Neo-antigen Burden in Patients With Advanced Melanoma or Bladder Cancer Treated With Nivolumab or Nivolumab Plus Ipilimumab (CA209-260)". The purpose of this study is to investigate the characteristics of tumors in patients treated with nivolumab and to identify features that help to predict a good or bad response to this drug.
What is the current status of trial NCT02553642?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 81 participants. The study started on 2015-09-14. Estimated completion is 2024-04-29.
What conditions does trial NCT02553642 study?
This clinical trial studies the following conditions: Melanoma, Bladder Cancer.
What interventions are being tested in trial NCT02553642?
The interventions under investigation include: Nivolumab (DRUG), Nivolumab plus Ipilimumab (DRUG).
Who is sponsoring clinical trial NCT02553642?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02553642 being conducted?
This trial has 5 study locations across Connecticut, New Jersey, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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