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NCT02758717 · ClinicalTrials.gov registry record · Phase 2
Nivolumab and Brentuximab Vedotin in Treating Older Patients With Untreated Hodgkin Lymphoma
A Phase 2 study of Ann Arbor Stage IIB Hodgkin Lymphoma and Ann Arbor Stage IB Hodgkin Lymphoma, sponsored by Academic and Community Cancer Research United.
- Active
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
- 9
- Study locations
NCT02758717: Active Phase 2 study of Ann Arbor Stage IIB Hodgkin Lymphoma and Ann Arbor Stage IB Hodgkin Lymphoma, sponsored by Academic and Community Cancer Research United.
NCT02758717 is a Phase 2 study of Ann Arbor Stage IIB Hodgkin Lymphoma and Ann Arbor Stage IB Hodgkin Lymphoma that is active but no longer recruiting, run by Academic and Community Cancer Research United. The registered enrollment target is 46 participants, below the 279-participant average among 3 other Ann Arbor Stage IIB Hodgkin Lymphoma trials with a reported enrollment target (84% lower). The trial reports 9 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02758717, a Phase 2 study of Ann Arbor Stage IIB Hodgkin Lymphoma and Ann Arbor Stage IB Hodgkin Lymphoma, is active but no longer recruiting, sponsored by Academic and Community Cancer Research United.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
- 9
- Study locations
Study Summary
This phase II trial studies how well nivolumab and brentuximab vedotin work in treating older patients with untreated Hodgkin lymphoma. 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. Biological therapies, such as brentuximab vedotin, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Nivolumab and brentuximab vedotin may work better in treating older patients with untreated Hodgkin lymphoma.
Primary Outcome
The primary endpoint of this trial is the rate (percentage) of overall metabolic response. A metabolic response is defined as a participant who has achieved an objective status of Partial metabolic response (PMR) or Complete metabolic response (CMR) at the end of cycle 8. Response is based on PET/CT based on the revised 2014 Lugano Classification. (PMR: Score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with baseline and
Conditions Studied
Interventions
- BIOLOGICAL Nivolumab
- DRUG Brentuximab Vedotin
Study Locations (9)
California
- Stanford Cancer Institute Palo Alto - Palo Alto
District of Columbia
- MedStar Georgetown University Hospital - Washington D.C.
Georgia
- Emory University Hospital/Winship Cancer Institute - Atlanta
Minnesota
- Mayo Clinic - Rochester
Missouri
- Washington University School of Medicine - St Louis
New Jersey
- Hackensack University Medical Center - Hackensack
New York
- Laura and Isaac Perlmutter Cancer Center at NYU Langone - New York
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2016-05-13 |
| Est. Completion | 2025-09-13 |
| Phase | Phase 2 |
What the registry record for NCT02758717 still lists
NCT02758717 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 279-participant average among 3 other Ann Arbor Stage IIB Hodgkin Lymphoma trials with a reported enrollment target (84% lower).
The record links to 10 conditions, with Ann Arbor Stage IIB Hodgkin Lymphoma appearing as the primary indexed condition, and to 2 interventions - of which Nivolumab is the first listed.
NCT02758717 lists 9 locations in 9 states (California, District of Columbia, Georgia).
Frequently Asked Questions
What is clinical trial NCT02758717 about?
NCT02758717 is a clinical study titled "Nivolumab and Brentuximab Vedotin in Treating Older Patients With Untreated Hodgkin Lymphoma". This phase II trial studies how well nivolumab and brentuximab vedotin work in treating older patients with untreated Hodgkin lymphoma. 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 ...
What is the current status of trial NCT02758717?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2016-05-13. Estimated completion is 2025-09-13.
What conditions does trial NCT02758717 study?
This clinical trial studies the following conditions: Ann Arbor Stage IIB Hodgkin Lymphoma, Ann Arbor Stage IB Hodgkin Lymphoma, Ann Arbor Stage II Hodgkin Lymphoma, Ann Arbor Stage IIA Hodgkin Lymphoma, Ann Arbor Stage III Hodgkin Lymphoma.
What interventions are being tested in trial NCT02758717?
The interventions under investigation include: Nivolumab (BIOLOGICAL), Brentuximab Vedotin (DRUG).
Who is sponsoring clinical trial NCT02758717?
This trial is sponsored by Academic and Community Cancer Research United, which has 42 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02758717 being conducted?
This trial has 9 study locations across California, District of Columbia, Georgia, Minnesota, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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