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NCT05162976 · ClinicalTrials.gov registry record · Phase 1
CC-486 and Nivolumab for the Treatment of Hodgkin Lymphoma Refractory to PD-1 Therapy or Relapsed
A Phase 1 study of Recurrent Classic Hodgkin Lymphoma and Refractory Classic Hodgkin Lymphoma, sponsored by City of Hope Medical Center.
- Active
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
- 1
- Study location
NCT05162976: Active Phase 1 study of Recurrent Classic Hodgkin Lymphoma and Refractory Classic Hodgkin Lymphoma, sponsored by City of Hope Medical Center.
NCT05162976 is a Phase 1 study of Recurrent Classic Hodgkin Lymphoma and Refractory Classic Hodgkin Lymphoma that is active but no longer recruiting, run by City of Hope Medical Center. The registered enrollment target is 33 participants, below the 81-participant average among 3 other Recurrent Classic Hodgkin Lymphoma trials with a reported enrollment target (59% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05162976, a Phase 1 study of Recurrent Classic Hodgkin Lymphoma and Refractory Classic Hodgkin Lymphoma, is active but no longer recruiting, sponsored by City of Hope Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial tests the safety and best dose of CC-486 (an oral form of azacitidine) when given together with nivolumab in treating patients with Hodgkin lymphoma that does not respond (refractory) to PD1-based immunotherapy or has come back (relapsed). CC-486 is in a class of medications called demethylation agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving CC-486 in combination with nivolumab may render nivolumab more effective.
Primary Outcome
Toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (\[CTCAE\], version 5.0).
Conditions Studied
Interventions
- BIOLOGICAL Nivolumab
- DRUG Oral Azacitidine
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2022-01-03 |
| Est. Completion | 2026-05-12 |
| Phase | Phase 1 |
What the registry record for NCT05162976 still lists
NCT05162976 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 81-participant average among 3 other Recurrent Classic Hodgkin Lymphoma trials with a reported enrollment target (59% lower).
The record links to 2 conditions, with Recurrent Classic Hodgkin Lymphoma appearing as the primary indexed condition, and to 2 interventions - of which Nivolumab is the first listed.
NCT05162976 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05162976 about?
NCT05162976 is a clinical study titled "CC-486 and Nivolumab for the Treatment of Hodgkin Lymphoma Refractory to PD-1 Therapy or Relapsed". This phase I trial tests the safety and best dose of CC-486 (an oral form of azacitidine) when given together with nivolumab in treating patients with Hodgkin lymphoma that does not respond (refractory) to PD1-based immunotherapy or has come back (relapsed). CC-486 is in a class of medications calle...
What is the current status of trial NCT05162976?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2022-01-03. Estimated completion is 2026-05-12.
What conditions does trial NCT05162976 study?
This clinical trial studies the following conditions: Recurrent Classic Hodgkin Lymphoma, Refractory Classic Hodgkin Lymphoma.
What interventions are being tested in trial NCT05162976?
The interventions under investigation include: Nivolumab (BIOLOGICAL), Oral Azacitidine (DRUG).
Who is sponsoring clinical trial NCT05162976?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05162976 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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