Study on Talimogene Laherparepvec and Nivolumab for Treating Resistant Lymphomas or Advanced Non-Melanoma Skin Cancers

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT02978625

Provider View

This clinical trial is exploring the effectiveness of combining two treatments, talimogene laherparepvec and nivolumab, for patients with lymphomas that haven't responded to treatment or advanced non-melanoma skin cancers. The study aims to see if this combination can better control these cancers compared to standard treatments.

Patient Parameters

Program Overview

This phase II study is testing how well two treatments, talimogene laherparepvec and nivolumab, work together in patients with lymphomas that haven't responded to treatment or non-melanoma skin cancers that have spread or haven't responded to treatment. Talimogene laherparepvec is a biological therapy that uses substances from living organisms to help the immune system fight cancer. Nivolumab is an immunotherapy that helps the immune system attack cancer cells. The study will compare this combination to usual treatments to see if it works better.

Description

The main goal of this study is to find out 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 well 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 and any changes in their cancer.

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, or the patient must be unable to tolerate, or have refused all standard treatments.
  • For non-melanoma skin cancers, the cancer must be advanced or not responding to treatment, defined by specific criteria such as tumor size or spread.
  • 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 have a performance status that allows for daily activities with some restrictions.
  • Must meet specific blood count and organ function criteria.
  • 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, Hodgkin's lymphoma, or B cell lymphoma.
  • Cannot have had recent systemic therapy or radiotherapy.
  • Cannot have untreated brain metastases unless they are stable after treatment.
  • Cannot have previously received talimogene laherparepvec or similar therapies.
  • Cannot have unresolved side effects from previous cancer treatments.
  • Cannot have a second primary cancer that affects treatment safety or study procedures.
  • Cannot have active autoimmune diseases requiring treatment.
  • Cannot have significant immunosuppression or be on high-dose steroids.
  • Cannot have active herpetic skin lesions or require regular antiviral treatment.
  • Cannot have active hepatitis B, hepatitis C, or HIV infections.
  • Cannot have received a live vaccine recently.
  • Cannot be pregnant or breastfeeding, and must agree to use contraception to prevent pregnancy and viral transmission during and after the study.
  • Cannot have severe allergies to the study drugs or similar treatments.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.