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NCT03651271 · ClinicalTrials.gov registry record · Phase 2
Nivolumab With or Without Ipilimumab in Advanced Metastatic Cancer
A Phase 2 study, sponsored by Parker Institute for Cancer Immunotherapy.
- Completed
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
NCT03651271 is a Phase 2 study that has completed, run by Parker Institute for Cancer Immunotherapy. The registered enrollment target is 100 participants.
The verdict
NCT03651271, a Phase 2 study, has completed, sponsored by Parker Institute for Cancer Immunotherapy.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
Study Summary
This is an open-label, exploratory study to evaluate nivolumab with or without ipilimumab based on percentage of tumoral CD8 cells at the time of treatment in participants with varying advanced solid tumors. Participants who have a tumor with ≥ 15% CD8 cells (classified as CD8 high) will receive nivolumab monotherapy, and participants who have a tumor with \< 15% CD8 cells (classified as CD8 low) will receive ipilimumab in combination with nivolumab.
Interventions
- BIOLOGICAL Nivolumab Monotherapy
- BIOLOGICAL Nivolumab and Ipilimumab and Combination for Metastatic Cancer
- BIOLOGICAL Nivolumab and Ipilimumab (3 mg/kg) Combination for Prostate Cancer
- BIOLOGICAL Nivolumab and Ipilimumab (5 mg/kg) Combination for Prostate Cancer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2018-10-17 |
| Est. Completion | 2023-06-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03651271
The ClinicalTrials.gov registry entry for NCT03651271 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Parker Institute for Cancer Immunotherapy, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Nivolumab Monotherapy is the first listed.
NCT03651271 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03651271 about?
NCT03651271 is a clinical study titled "Nivolumab With or Without Ipilimumab in Advanced Metastatic Cancer". This is an open-label, exploratory study to evaluate nivolumab with or without ipilimumab based on percentage of tumoral CD8 cells at the time of treatment in participants with varying advanced solid tumors. Participants who have a tumor with ≥ 15% CD8 cells (classified as CD8 high) will receive niv...
What is the current status of trial NCT03651271?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2018-10-17. Estimated completion is 2023-06-30.
What interventions are being tested in trial NCT03651271?
The interventions under investigation include: Nivolumab Monotherapy (BIOLOGICAL), Nivolumab and Ipilimumab and Combination for Metastatic Cancer (BIOLOGICAL), Nivolumab and Ipilimumab (3 mg/kg) Combination for Prostate Cancer (BIOLOGICAL), Nivolumab and Ipilimumab (5 mg/kg) Combination for Prostate Cancer (BIOLOGICAL).
Who is sponsoring clinical trial NCT03651271?
This trial is sponsored by Parker Institute for Cancer Immunotherapy, which has 5 total clinical trials registered on ClinicalTrials.gov.
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