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NCT02762006 · ClinicalTrials.gov registry record · Phase 1
Neoadjuvant MEDI 4736 +/- Tremelimumab in Locally Advanced Renal Cell Carcinoma
A Phase 1 study of Renal Cell Carcinoma and Kidney Cancer, sponsored by Moshe Ornstein.
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
- 2
- Study locations
NCT02762006: Completed Phase 1 study of Renal Cell Carcinoma and Kidney Cancer, sponsored by Moshe Ornstein.
NCT02762006 is a Phase 1 study of Renal Cell Carcinoma and Kidney Cancer that has completed, run by Moshe Ornstein. The registered enrollment target is 29 participants, below the 243-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (88% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02762006, a Phase 1 study of Renal Cell Carcinoma and Kidney Cancer, has completed, sponsored by Moshe Ornstein.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to investigate the safety and feasibility of administering investigational drugs (meaning not Food and Drug Administration (FDA)-approved for kidney cancer) prior to surgical treatment for kidney cancer. The first drug is called MEDI4736, and the second drug is called tremelimumab. Both of these drugs work by attaching to certain proteins on immune cells with the goal of stimulating an immune response against cancer cells. This is a phase 1 trial, with the primary goal of identifying if this treatment is safe and possible side effects when given prior to surgery for kidney cancer.
Primary Outcome
Dose-limiting toxicities (DLTs) will be evaluated from the first dose of drug through the first adjuvant dose of durvalumab. Grading of DLTs will follow the guidelines provided in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Conditions Studied
Interventions
- DRUG Durvalumab
- DRUG Tremelimumab
Study Locations (2)
Minnesota
- University of Minnesota - Minneapolis
Ohio
- Cleveland Clinic, Case Comprehensive Cancer Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2016-12-20 |
| Est. Completion | 2020-11-06 |
| Phase | Phase 1 |
What the finished NCT02762006 record still lists
NCT02762006 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 243-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (88% lower).
The record links to 2 conditions, with Renal Cell Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Durvalumab is the first listed.
NCT02762006 reports a single indexed study location in Minnesota, Ohio.
Frequently Asked Questions
What is clinical trial NCT02762006 about?
NCT02762006 is a clinical study titled "Neoadjuvant MEDI 4736 +/- Tremelimumab in Locally Advanced Renal Cell Carcinoma". The purpose of this study is to investigate the safety and feasibility of administering investigational drugs (meaning not Food and Drug Administration (FDA)-approved for kidney cancer) prior to surgical treatment for kidney cancer. The first drug is called MEDI4736, and the second drug is called tr...
What is the current status of trial NCT02762006?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2016-12-20. Estimated completion is 2020-11-06.
What conditions does trial NCT02762006 study?
This clinical trial studies the following conditions: Renal Cell Carcinoma, Kidney Cancer.
What interventions are being tested in trial NCT02762006?
The interventions under investigation include: Durvalumab (DRUG), Tremelimumab (DRUG).
Who is sponsoring clinical trial NCT02762006?
This trial is sponsored by Moshe Ornstein, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02762006 being conducted?
This trial has 2 study locations across Minnesota, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Renal Cell Carcinoma
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 NCT02762006's enrollment target sits among peer trials
29 97th of 121 higher than 25 of 121 other Renal Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Renal Cell Carcinoma 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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