Talimogene Laherparepvec + Nivolumab for Skin Cancer and Lymphoma

Recruiting at 37 trial locations

Overseen By Janice M. Mehnert

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Research Team

Ann (Annie) W Silk

Principal Investigator

Dana-Farber - Harvard Cancer Center LAO

Eligibility Criteria

This trial is for adults with advanced or treatment-resistant non-melanoma skin cancers or lymphomas, excluding B-cell types. Participants must have measurable disease and at least one lesion suitable for injection. They should be in relatively good health (ECOG <=2), not pregnant, willing to use contraception, able to undergo biopsies, and have no significant immunosuppression or certain viral infections.

Inclusion Criteria

My cancer is non-melanoma skin cancer or a non-B-cell lymphoma.

My skin cancer is advanced or not responding to treatment.

I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

My cancer is not melanoma, sarcoma, leukemia, or lymphoma.

I haven't had any cancer treatment in the last 3 weeks.

I still have side effects from previous cancer treatments.

Treatment Details

Interventions

• Nivolumab (Checkpoint Inhibitor)
• Talimogene Laherparepvec (Virus Therapy)

Trial Overview The study tests talimogene laherparepvec plus nivolumab against refractory lymphomas and advanced skin cancers. Talimogene uses modified viruses to stimulate the immune system while nivolumab blocks cancer's defenses against immune cells. The combination aims to enhance the body's ability to fight cancer.

Participant Groups

Group I: Treatment (talimogene laherparepvec, nivolumab) Experimental Treatment 7 Interventions

Patients receive talimogene laherparepvec IT and nivolumab IV over 30 minutes on day 1. Cycles repeat every 21 days for cycle 1 then every 14 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients undergo, CT scan or PET/CT on study. Patients also undergo blood sample collection and biopsies on study.

Nivolumab is already approved in Canada, Switzerland for the following indications:

Approved in Canada as Opdivo for:

• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma

Approved in Switzerland as Opdivo for:

• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+