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Checkpoint Inhibitor

Talimogene Laherparepvec + Nivolumab for Skin Cancer and Lymphoma

Q: Are there any adverse effects associated with Talimogene Laherparepvec?

The safety profile of Talimogene Laherparepvec is assessed to be a 2, as this clinical trial falls into Phase 2 and has evidence backing its security yet no data indicating efficacy.

Q: Is this trial the first of its kind?

In 2012, Ono Pharmaceutical Co. Ltd initiated the initial clinical trial of Talimogene Laherparepvec; following this first trail involving 659 participants, Phase 1 &#x26; 2 drug approval was granted. At present time, 49 different countries across 2364 cities are conducting 736 active trials pertaining to Talimogene Laherparepvec.

Q: How many healthcare centers are administering this clinical test in the city?

Currently, this trial is accepting patients from 14 different medical sites. Notably, these locations include Salt Lake City, Creve Coeur and Coral Gables in addition to 11 other clinics. When selecting a clinic for participation it is advised to choose the one closest to you in order to reduce travel needs.

Q: What is the general purpose of Talimogene Laherparepvec?

Talimogene Laherparepvec is typically used to target malignant neoplasms, but it can also be utilized for a range of other medical conditions such as unresectable <a href="https://www.withpower.com/clinical-trials/melanoma">melanoma</a> and metastatic esophageal adenocarcinoma.

Q: What is the total participant count for this clinical evaluation?

Affirmative. The clinicaltrials.gov database currently reflects the fact that this experiment is actively recruiting and was initially posted on September 18th 2017, with a recent edit occurring on November 12th 2022. 68 candidates must be recruited from 14 different medical sites to complete the trial.

Q: Are there any previous investigations that have employed Talimogene Laherparepvec?

Presently, there are 736 trials assessing the efficacy of Talimogene Laherparepvec. Of those studies, 82 have progressed to Phase 3. These clinical research undertakings predominantly take place in Basel, BE; although 40488 separate locations worldwide host these investigations.

Q: Is the research team actively seeking participants for this experiment?

Clinicaltrials.gov confirms that this medical trial, which was initially advertised on September 18th 2017, is currently seeking patients for study enrollment. The last update to the posting occured on November 12th 2022

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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of treatment to time of progression or death, whichever occurs first, assessed at 2 years for reporting.

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 more

Other 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 more

Side effects data

From 2014 Phase 3 trial • 31 Patients • NCT01368276

67%

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%

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

~850

Biospecimen Collection

2004

Completed Phase 2

~1730

Computed Tomography

2017

Completed Phase 2

~2720

Nivolumab

2014

Completed Phase 3

~4750

Positron Emission Mammography

2009

N/A

~40

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,085 Total Patients Enrolled

Ann (Annie) W SilkPrincipal InvestigatorDana-Farber - Harvard Cancer Center LAO

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02978625 — Phase 2

Signet Ring Cell Carcinoma Research Study Groups: Treatment (talimogene laherparepvec, nivolumab)

Signet Ring Cell Carcinoma Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT02978625 — Phase 2

Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02978625 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any adverse effects associated with Talimogene Laherparepvec?

"The safety profile of Talimogene Laherparepvec is assessed to be a 2, as this clinical trial falls into Phase 2 and has evidence backing its security yet no data indicating efficacy."

Answered by AI

Is this trial the first of its kind?

"In 2012, Ono Pharmaceutical Co. Ltd initiated the initial clinical trial of Talimogene Laherparepvec; following this first trail involving 659 participants, Phase 1 & 2 drug approval was granted. At present time, 49 different countries across 2364 cities are conducting 736 active trials pertaining to Talimogene Laherparepvec."

Answered by AI

How many healthcare centers are administering this clinical test in the city?

"Currently, this trial is accepting patients from 14 different medical sites. Notably, these locations include Salt Lake City, Creve Coeur and Coral Gables in addition to 11 other clinics. When selecting a clinic for participation it is advised to choose the one closest to you in order to reduce travel needs."

Answered by AI

What is the general purpose of Talimogene Laherparepvec?

"Talimogene Laherparepvec is typically used to target malignant neoplasms, but it can also be utilized for a range of other medical conditions such as unresectable melanoma and metastatic esophageal adenocarcinoma."

Answered by AI

What is the total participant count for this clinical evaluation?

"Affirmative. The clinicaltrials.gov database currently reflects the fact that this experiment is actively recruiting and was initially posted on September 18th 2017, with a recent edit occurring on November 12th 2022. 68 candidates must be recruited from 14 different medical sites to complete the trial."

Answered by AI

Are there any previous investigations that have employed Talimogene Laherparepvec?

"Presently, there are 736 trials assessing the efficacy of Talimogene Laherparepvec. Of those studies, 82 have progressed to Phase 3. These clinical research undertakings predominantly take place in Basel, BE; although 40488 separate locations worldwide host these investigations."

Answered by AI

Is the research team actively seeking participants for this experiment?

"Clinicaltrials.gov confirms that this medical trial, which was initially advertised on September 18th 2017, is currently seeking patients for study enrollment. The last update to the posting occured on November 12th 2022"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2017. "Talimogene Laherparepvec and Nivolumab in Treating Patients With Refractory Lymphomas or Advanced or Refractory Non-melanoma Skin Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02978625.

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