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NCT02978625 · ClinicalTrials.gov registry record · Phase 2
Talimogene Laherparepvec and Nivolumab in Treating Patients With Refractory Lymphomas or Advanced or Refractory Non-melanoma Skin Cancers
A Phase 2 study of Anaplastic Large Cell Lymphoma, ALK-Positive and Anaplastic Large Cell Lymphoma, ALK-negative, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 68
- Enrollment target
- 20
- Study locations
NCT02978625: Active Phase 2 study of Anaplastic Large Cell Lymphoma, ALK-Positive and Anaplastic Large Cell Lymphoma, ALK-negative, sponsored by National Cancer Institute (NCI).
NCT02978625 is a Phase 2 study of Anaplastic Large Cell Lymphoma, ALK-Positive and Anaplastic Large Cell Lymphoma, ALK-negative that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 68 participants, above the 53-participant average among 4 other Anaplastic Large Cell Lymphoma, ALK-Positive trials with a reported enrollment target (28% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02978625, a Phase 2 study of Anaplastic Large Cell Lymphoma, ALK-Positive and Anaplastic Large Cell Lymphoma, ALK-negative, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 68 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial studies how well talimogene laherparepvec and nivolumab work in treating patients with lymphomas that do not responded to treatment (refractory) or non-melanoma skin cancers that have spread to other places in the body (advanced) or do not responded to treatment. Biological therapies, such as talimogene laherparepvec, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop tumor cells from growing. 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 talimogene laherparepvec and nivolumab may work better compared to usual treatments in treating patients with lymphomas or non-melanoma skin cancers.
Primary Outcome
Will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy Procedure
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Nivolumab
Study Locations (20)
Florida
- UM Sylvester Comprehensive Cancer Center at Aventura - Aventura
- UM Sylvester Comprehensive Cancer Center at Coral Gables - Coral Gables
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach - Deerfield Beach
- University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
- UM Sylvester Comprehensive Cancer Center at Kendall - Miami
- UM Sylvester Comprehensive Cancer Center at Plantation - Plantation
California
- Los Angeles General Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
- Keck Medical Center of USC Pasadena - Pasadena
- University of California Davis Comprehensive Cancer Center - Sacramento
Kansas
- University of Kansas Clinical Research Center - Fairway
- University of Kansas Cancer Center-Overland Park - Overland Park
- University of Kansas Hospital-Indian Creek Campus - Overland Park
- University of Kansas Hospital-Westwood Cancer Center - Westwood
Massachusetts
- Massachusetts General Hospital Cancer Center - Boston
- Dana-Farber Cancer Institute - Boston
Colorado
- UCHealth University of Colorado Hospital - Aurora
Illinois
- Northwestern University - Chicago
Maryland
- Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2017-09-27 |
| Est. Completion | 2027-09-01 |
| Phase | Phase 2 |
What the registry record for NCT02978625 still lists
NCT02978625 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, above the 53-participant average among 4 other Anaplastic Large Cell Lymphoma, ALK-Positive trials with a reported enrollment target (28% higher).
The record links to 10 conditions, with Anaplastic Large Cell Lymphoma, ALK-Positive appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT02978625 names 20 study sites across 7 states, led by Florida, California, Kansas.
Frequently Asked Questions
What is clinical trial NCT02978625 about?
NCT02978625 is a clinical study titled "Talimogene Laherparepvec and Nivolumab in Treating Patients With Refractory Lymphomas or Advanced or Refractory Non-melanoma Skin Cancers". This phase II trial studies how well talimogene laherparepvec and nivolumab work in treating patients with lymphomas that do not responded to treatment (refractory) or non-melanoma skin cancers that have spread to other places in the body (advanced) or do not responded to treatment. Biological thera...
What is the current status of trial NCT02978625?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2017-09-27. Estimated completion is 2027-09-01.
What conditions does trial NCT02978625 study?
This clinical trial studies the following conditions: Anaplastic Large Cell Lymphoma, ALK-Positive, Anaplastic Large Cell Lymphoma, ALK-negative, Extramammary Paget Disease, Apocrine Carcinoma, Carcinoma Arising From Cylindroma.
What interventions are being tested in trial NCT02978625?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy Procedure (PROCEDURE), Laboratory Biomarker Analysis (OTHER), Nivolumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT02978625?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02978625 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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