Active — Not RecruitingPhase 2

Talimogene Laherparepvec and Nivolumab in Treating Patients With Refractory Lymphomas or Advanced or Refractory Non-melanoma Skin Cancers

United States68 participantsStarted 2017-09-27

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients must have histologic or cytologic diagnosis of non-melanoma skin cancer (NMSC) or lymphomas other than B-cell lymphomas; as both of those terms are categories rather than specific diagnoses, specific guidance on eligible tumor types is provided below * PART I (before February 2020 amendment): Included tumor types * T cell and NK cell lymphomas, including, but not limited to: cutaneous T-cell lymphomas (CTCL), mycosis fungoides (MF), Sezary syndrome (SS), peripheral T-cell lymphoma (PTCL), ALK-positive and ALK-negative anaplastic large cell lymphoma (ALCL), and NK-cell lymphomas * Merkel cell carcinoma * Squamous cell carcinoma of the skin, including keratoacanthomas, vulvar squamous carcinoma, and mixed histology tumors, such as basosquamous carcinoma, and squamous cell carcinoma of unknown primary consistent with skin origin * Other non-melanoma skin cancers * Basal cell carcinoma * Malignant sweat gland tumors, including porocarcinoma, hidradenocarcinoma, spiradenocarcinoma, cylindrocarcinoma, microcystic adnexal carcinoma and related entities, squamoid eccrine ductal carcinoma, cutaneous adenoid cystic carcinoma, digital papillary adenocarcinoma, primary cutaneous mucinous carcinoma, endocrine mucin-producing sweat gland carcinoma, primary cutaneous signet ring cell carcinoma, cutaneous apocrine gland carcinoma, and extraocular sebaceous carcinoma * Adnexal carcinoma * Trichilemmal carcinoma * Extramammary Paget…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is in Phase 2 and is no longer enrolling — does that mean there are published or preliminary results from it that might tell us something about how well this combination of talimogene laherparepvec and nivolumab worked for my specific type of cancer?
2Since the trial covers a wide range of rare skin cancers and lymphomas, how does my particular diagnosis compare to the subgroup that seemed to respond best in studies like this one, and is my cancer more likely to fall into the 'refractory' category where standard treatments have already been tried?
3Talimogene laherparepvec is injected directly into tumors — given my situation, do I have tumors that are actually accessible for that kind of injection, and if not, does that change whether a treatment approach like this would even be practical for me?
4Nivolumab works by releasing the brakes on the immune system, which can sometimes cause serious side effects in different organs — given my overall health and any existing conditions I have, how does my doctor weigh that risk against the potential benefit of adding it to the talimogene laherparepvec?
5Before looking at a trial like this one, are there approved standard-of-care treatments I haven't yet tried for my diagnosis that my doctor would recommend exploring first, or is my cancer already considered refractory enough that a combination immunotherapy approach like this would be a reasonable next step to discuss?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Response rate to talimogene laherparepvec alone (Part I)

Timeframe: Up to 1 year

Best overall response rate to talimogene laherparepvec and nivolumab combination therapy (Part II)

Timeframe: Up to 1 year

Trial details

NCT IDNCT02978625

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2027-09-01

View on ClinicalTrials.gov More Anaplastic Large Cell Lymphoma, ALK-Negative trials