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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

Must not have

Excluded tumor types: Melanoma, Bone sarcomas, Soft tissue sarcomas, Leukemias, Myeloid sarcoma, leukemia cutis, chloroma, Hodgkin's lymphoma, B cell lymphoma

Untreated central nervous system (CNS) involvement

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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

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My skin cancer is advanced or not responding to treatment.

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

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I have a skin or under-skin lesion that can be injected.

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My disease can be seen on scans or felt by a doctor.

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I am willing to have multiple biopsies of my cancer lesions.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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My brain or spinal cord cancer has not been treated.

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I have been treated with a herpes virus-based therapy before.

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I do not have another cancer that would interfere with this treatment.

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I have an active autoimmune disease.

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I am not pregnant, breastfeeding, nor planning to become pregnant soon.

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I do not have any unmanaged ongoing illnesses.

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I have previously received a viral-based tumor vaccine.

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I do not have active hepatitis B, hepatitis C, or HIV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Response rate to talimogene laherparepvec alone (Part I)

Secondary study objectives

Durable response rate

Incidence of adverse events

Response rate by cancer type

+2 more

Other study objectives

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 more

Side effects data

From 2014 Phase 3 trial • 31 Patients • NCT01368276

18%

Pyrexia

18%

Chills

14%

Diarrhoea

14%

Back pain

11%

Dizziness

11%

Upper respiratory tract infection

11%

Vomiting

11%

Oedema peripheral

11%

Vitiligo

11%

Abdominal pain

11%

Fatigue

11%

Skin irritation

Abdominal discomfort

Injection site pain

Myalgia

Nausea

Headache

Ear pain

Oropharyngeal pain

Tumour pain

Pruritus

Pneumonia

Metastatic malignant melanoma

Haemangioma of liver

Disease progression

Vasculitis

Cough

Lipoma

Hypovolaemic shock

Clavicle fracture

Influenza like illness

Lung neoplasm malignant

Cardiac arrest

Dyspnoea

Respiratory failure

Renal failure

Restrictive cardiomyopathy

Pleural effusion

Ecchymosis

Hyperhidrosis

100%

80%

60%

40%

20%

Study treatment Arm

Talimogene Laherparepvec

GM-CSF

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~630

Biopsy

2014

Completed Phase 4

~1090