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Checkpoint Inhibitor
Talimogene Laherparepvec + Nivolumab for Skin Cancer and Lymphoma
Phase 2
Waitlist Available
Led By Ann (Annie) W Silk
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have histologic or cytologic diagnosis of non-melanoma skin cancer (NMSC) or lymphomas other than B-cell lymphomas
Patients with non-melanoma skin cancers (NMSC) must have advanced or refractory tumors
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 2 years
Awards & highlights
Study Summary
This trial is testing talimogene laherparepvec and nivolumab to see if they're effective treatments for patients with refractory lymphomas or advanced non-melanoma skin cancers.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects include typical reactions from biological therapies like flu-like symptoms, fatigue, skin reactions at the injection site, as well as more serious immune-related issues such as inflammation of organs due to nivolumab.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is non-melanoma skin cancer or a non-B-cell lymphoma.
Select...
My skin cancer is advanced or not responding to treatment.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
I have a skin or under-skin lesion that can be injected.
Select...
My disease can be seen on scans or felt by a doctor.
Select...
I am willing to have multiple biopsies of my cancer lesions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from start of treatment to time of progression or death, whichever occurs first, assessed at 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of treatment to time of progression or death, whichever occurs first, assessed at 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Best overall response rate to talimogene laherparepvec and nivolumab combination therapy (Part II)
Response rate to talimogene laherparepvec alone (Part I)
Secondary outcome measures
Durable response rate
Frequency of curative surgery (unresectable lesion becomes resectable)
Incidence of adverse events
+5 moreOther outcome measures
Biomarker analysis of %PD-L1, flow cytometry for HVEM, NECTIN1/2, and IDO, tryptophan and L-kynurenine, cytokine levels, Nanostring, number of non-synonymous mutations, and % T-cell receptor (TCR) clonality
Biomarker analysis of herpes simplex virus (HSV) status, Merkel cell polyomavirus status, and PD-L1 status
Biomarker analysis of necrosis and Nanostring
+1 moreSide effects data
From 2014 Phase 3 trial • 31 Patients • NCT0136827667%
Cough
67%
Fatigue
33%
Injection site mass
33%
Influenza like illness
33%
Dyspnoea
33%
Flushing
33%
Chills
33%
Ecchymosis
33%
Urticaria
33%
Diarrhoea
33%
Nausea
33%
Vomiting
33%
Oedema peripheral
33%
Pyrexia
33%
Folliculitis
33%
Oral herpes
33%
Pneumonia
33%
Upper respiratory tract infection
33%
Lipoma
33%
Haemoptysis
33%
Hypopnoea
33%
Oropharyngeal pain
33%
Blood blister
33%
Hyperhidrosis
33%
Night sweats
33%
Pruritus
100%
80%
60%
40%
20%
0%
Study treatment Arm
GM-CSF
Talimogene Laherparepvec
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (talimogene laherparepvec, nivolumab)Experimental Treatment7 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Talimogene Laherparepvec
2008
Completed Phase 3
~640
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1720
Computed Tomography
2017
Completed Phase 2
~2720
Nivolumab
2014
Completed Phase 3
~4750
Positron Emission Mammography
2009
N/A
~40
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,717 Previous Clinical Trials
40,953,296 Total Patients Enrolled
Ann (Annie) W SilkPrincipal InvestigatorDana-Farber - Harvard Cancer Center LAO
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I do not have another cancer that would interfere with this treatment.I have an active autoimmune disease.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.My brain or spinal cord cancer has not been treated.I have been treated with a herpes virus-based therapy before.My T cell or NK cell lymphoma has not responded to or I cannot tolerate standard treatments.I am not pregnant, breastfeeding, nor planning to become pregnant soon.I have a skin or under-skin lesion that can be injected.My disease can be seen on scans or felt by a doctor.I do not have any unmanaged ongoing illnesses.You have had a bad reaction to talimogene laherparepvec or nivolumab before.I am willing to have multiple biopsies of my cancer lesions.I have previously received a viral-based tumor vaccine.I do not have active hepatitis B, hepatitis C, or HIV.I am using effective birth control during the trial due to risk of fetal harm from the treatments.You have a weakened immune system that could cause health problems.You have a current outbreak of herpes on your skin or have had serious issues from herpes in the past.Your blood test results need to be within certain ranges.My cancer is a rare skin type or specifically listed here.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (talimogene laherparepvec, nivolumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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