Study on Talimogene Laherparepvec and Nivolumab for Treating Resistant Lymphomas or Advanced Non-Melanoma Skin Cancers
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT02978625
This clinical trial is testing a combination of two treatments, talimogene laherparepvec and nivolumab, to see if they can help patients with lymphomas that haven't responded to treatment or advanced non-melanoma skin cancers that have spread or are resistant to treatment.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to find out if using talimogene laherparepvec, a therapy made from living organisms, along with nivolumab, an immunotherapy drug, can better treat lymphomas and non-melanoma skin cancers that are hard to treat. Talimogene laherparepvec may help stop tumor cells from growing by affecting the immune system, while nivolumab may help the immune system attack cancer cells and prevent them from spreading.
Description
The main goal of this study is to see how many patients respond to treatment with talimogene laherparepvec alone. The study also aims to see how well the combination of talimogene laherparepvec and nivolumab works and to identify markers that might predict how the immune system responds to the treatment.
Patients will receive talimogene laherparepvec directly into their tumors and nivolumab through an IV every 21 days for the first cycle, then every 14 days for up to a year, as long as the cancer doesn't progress or side effects aren't too severe. Patients will have CT or PET/CT scans, blood tests, and biopsies during the study.
After finishing the treatment, patients will have follow-up visits every 12 weeks for three years to monitor their health.
Eligibility Criteria
Inclusion Criteria
- Must have a diagnosis of non-melanoma skin cancer or certain types of lymphomas, excluding B-cell lymphomas.
- For patients with T cell and NK cell lymphomas, the cancer must not have responded to standard treatments or the patient must be unable to tolerate them.
- For non-melanoma skin cancers, the cancer must be advanced or resistant to previous treatments.
- Must have at least one tumor that can be injected with the treatment.
- Must have measurable disease, meaning at least one tumor is 10 mm or larger.
- Must be willing to have biopsies of the tumors.
- Must be in relatively good health with a performance status score of 2 or less.
- Must have adequate blood counts and organ function.
- Women of childbearing potential must use effective contraception and have a negative pregnancy test before starting the study.
- Must be able to understand and sign a consent form.
Exclusion Criteria
- Cannot have melanoma, bone sarcomas, soft tissue sarcomas, leukemias, or B-cell lymphomas.
- Cannot have had recent systemic therapy or radiotherapy within three weeks before starting the study.
- Cannot have untreated brain metastases unless they have been treated and are stable.
- Cannot have previously received talimogene laherparepvec or similar therapies.
- Cannot have unresolved side effects from previous cancer treatments.
- Cannot have active autoimmune diseases requiring treatment.
- Cannot have significant immunosuppression or be on high-dose steroids.
- Cannot have active viral infections like hepatitis B, hepatitis C, or HIV.
- Cannot have received a live vaccine within 28 days before starting the study.
- Cannot be pregnant or breastfeeding, and must agree to use contraception during and after the study.
- Cannot have severe allergies to the study drugs.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Los Angeles General Medical Center | 90033 | Los Angeles | California |
| USC / Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| UC Irvine Health/Chao Family Comprehensive Cancer Center | 92868 | Orange | California |
| Keck Medical Center of USC Pasadena | 91105 | Pasadena | California |
| University of California Davis Comprehensive Cancer Center | 95817 | Sacramento | California |
| UCHealth University of Colorado Hospital | 80045 | Aurora | Colorado |
| UM Sylvester Comprehensive Cancer Center at Aventura | 33180 | Aventura | Florida |
| UM Sylvester Comprehensive Cancer Center at Coral Gables | 33146 | Coral Gables | Florida |
| UM Sylvester Comprehensive Cancer Center at Deerfield Beach | 33442 | Deerfield Beach | Florida |
| University of Miami Miller School of Medicine-Sylvester Cancer Center | 33136 | Miami | Florida |
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