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NCT01103635 · ClinicalTrials.gov registry record · Phase 1
Tremelimumab and CP-870,893 in Patients With Metastatic Melanoma
A Phase 1 study of Recurrent Melanoma and Stage IV Melanoma, sponsored by Abramson Cancer Center at Penn Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT01103635: Completed Phase 1 study of Recurrent Melanoma and Stage IV Melanoma, sponsored by Abramson Cancer Center at Penn Medicine.
NCT01103635 is a Phase 1 study of Recurrent Melanoma and Stage IV Melanoma that has completed, run by Abramson Cancer Center at Penn Medicine. The registered enrollment target is 25 participants, below the 172-participant average among 23 other Recurrent Melanoma trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01103635, a Phase 1 study of Recurrent Melanoma and Stage IV Melanoma, has completed, sponsored by Abramson Cancer Center at Penn Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
RATIONALE: Monoclonal antibodies, such as tremelimumab and CD40 agonist monoclonal antibody CP-870,893, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Giving tremelimumab together with CD 40 agonist monoclonal antibody CP-870, 893 may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of giving tremelimumab together with CD40 agonist monoclonal antibody CP-870,893 in treating patients with metastatic melanoma.
Primary Outcome
Toxicities which occur during later cycles will be monitored and described separately. The MTD is defined as the dose level at which 0-1/6 patients experience DLT in the first 12 week cycle and at least 2/3 or 2/6 patients treated at the next higher dose level (unless MTD is level 4) experience DLT in the first 12 week cycle.
Conditions Studied
Interventions
- OTHER laboratory biomarker analysis
- BIOLOGICAL tremelimumab
- BIOLOGICAL CD40 agonist monoclonal antibody CP-870,893
Study Locations (1)
Pennsylvania
- Abramson Cancer Center of The University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2010-02 |
| Est. Completion | 2016-05-02 |
| Phase | Phase 1 |
What the finished NCT01103635 record still lists
NCT01103635 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 172-participant average among 23 other Recurrent Melanoma trials with a reported enrollment target (85% lower).
The record links to 2 conditions, with Recurrent Melanoma appearing as the primary indexed condition, and to 3 interventions - of which laboratory biomarker analysis is the first listed.
NCT01103635 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01103635 about?
NCT01103635 is a clinical study titled "Tremelimumab and CP-870,893 in Patients With Metastatic Melanoma". RATIONALE: Monoclonal antibodies, such as tremelimumab and CD40 agonist monoclonal antibody CP-870,893, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Giving tr...
What is the current status of trial NCT01103635?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2010-02. Estimated completion is 2016-05-02.
What conditions does trial NCT01103635 study?
This clinical trial studies the following conditions: Recurrent Melanoma, Stage IV Melanoma.
What interventions are being tested in trial NCT01103635?
The interventions under investigation include: laboratory biomarker analysis (OTHER), tremelimumab (BIOLOGICAL), CD40 agonist monoclonal antibody CP-870,893 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01103635?
This trial is sponsored by Abramson Cancer Center at Penn Medicine, which has 402 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01103635 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Recurrent 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 NCT01103635's enrollment target sits among peer trials
25 18th of 23 higher than 5 of 23 other Recurrent Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent 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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