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Virus Therapy

T-VEC for Pancreatic Cancer

Phase 1
Waitlist Available
Led By Yvonne M Saenger, MD
Research Sponsored by Yvonne Saenger
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Disease must be refractory to or intolerant of at least first-line chemotherapy which contains 5-fluorouracil or gemcitabine
Males must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential
Must not have
Pancreatic metastases likely to limit the patient's ability to participate in the study for the complete duration
Unresolved toxicity from prior treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36-48 months
Awards & highlights

Summary

This trial is looking at whether or not a certain medication is safe to give to people with pancreatic cancer, and if it is effective in shrinking tumors or preventing their growth.

Who is the study for?
This trial is for adults with advanced or metastatic pancreatic cancer that can't be surgically removed. Participants must have tried at least one chemotherapy, tolerate endoscopy, and have measurable disease. They should not have recent pancreatitis, major surgeries, severe infections, or exposure to live vaccines recently.Check my eligibility
What is being tested?
The study tests different doses of T-VEC given via endoscopy directly into pancreatic tumors to find the safest and most effective dose. It will also assess if T-VEC can shrink tumors or halt their growth over periods of 6 to 24 months.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site, flu-like symptoms such as fever and chills, fatigue, nausea, pain in affected areas. Since T-VEC is a modified virus therapy there's a risk of viral infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My condition did not improve with the first round of chemotherapy using 5-fluorouracil or gemcitabine.
Select...
I am a male and will either not have sex or use a condom with women who can get pregnant.
Select...
I am 18 years old or older.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My pancreatic cancer can be measured and is at least 1cm big.
Select...
My pancreatic cancer is advanced and cannot be removed by surgery.
Select...
I am committed to not having heterosexual intercourse or will use effective birth control.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My pancreatic cancer is not expected to stop me from completing the study.
Select...
I have no lasting side effects from previous cancer treatments.
Select...
I am receiving treatment for an active autoimmune disease.
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I have active herpes skin sores or complications.
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I have been treated with specific therapies before.
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I have had pancreatitis recently or it's still active.
Select...
I have not had radiation to my abdomen recently.
Select...
I have not received a live vaccine recently.
Select...
I am currently taking Coumadin.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36-48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36-48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose (MTD)
Secondary outcome measures
Change in size of injected lesion(s)
Heart rate
Overall survival (OS)
+1 more

Side effects data

From 2014 Phase 3 trial • 437 Patients • NCT00769704
50%
Fatigue
48%
Chills
41%
Pyrexia
36%
Nausea
30%
Influenza like illness
28%
Injection site pain
21%
Vomiting
19%
Diarrhoea
19%
Headache
17%
Arthralgia
17%
Myalgia
16%
Pain
16%
Pain in extremity
12%
Constipation
12%
Oedema peripheral
11%
Cough
10%
Upper respiratory tract infection
10%
Decreased appetite
10%
Dizziness
10%
Pruritus
9%
Back pain
9%
Abdominal pain
9%
Rash
8%
Hyperhidrosis
7%
Erythema
7%
Tumour pain
7%
Anxiety
7%
Insomnia
6%
Oropharyngeal pain
6%
Weight decreased
5%
Dyspepsia
5%
Injection site erythema
5%
Musculoskeletal pain
5%
Neck pain
5%
Depression
5%
Anaemia
5%
Vitiligo
4%
Muscle spasms
4%
Dyspnoea
3%
Injection site reaction
3%
Injection site swelling
3%
Disease progression
2%
Injection site pruritus
2%
Cellulitis
1%
Gastrointestinal haemorrhage
1%
Intestinal obstruction
1%
Rib fracture
1%
Metastases to central nervous system
1%
Deep vein thrombosis
1%
Pleural effusion
1%
Dehydration
1%
Infected neoplasm
1%
Metastatic malignant melanoma
1%
Cerebral haemorrhage
1%
Convulsion
1%
Mental status changes
1%
Pulmonary embolism
1%
Atrial fibrillation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Talimogene Laherparepvec
GM-CSF

Trial Design

1Treatment groups
Experimental Treatment
Group I: T-VecExperimental Treatment1 Intervention
All enrolled patients will receive a test dose of talimogene laherparepvec (10^6 plaque forming units (PFU)/ml) on day 1, followed by treatment doses at escalating concentrations weeks 4, 7, and 10. A biopsy will be obtained during each scheduled endoscopy prior to talimogene laherparepvec injection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Talimogene laherparepvec
2014
Completed Phase 3
~810

Find a Location

Who is running the clinical trial?

Yvonne SaengerLead Sponsor
1 Previous Clinical Trials
6 Total Patients Enrolled
Karie D. Runcie, MDLead Sponsor
AmgenIndustry Sponsor
1,392 Previous Clinical Trials
1,381,111 Total Patients Enrolled

Media Library

Talimogene Laherparepvec (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03086642 — Phase 1
Pancreatic Cancer Research Study Groups: T-Vec
Pancreatic Cancer Clinical Trial 2023: Talimogene Laherparepvec Highlights & Side Effects. Trial Name: NCT03086642 — Phase 1
Talimogene Laherparepvec (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03086642 — Phase 1
~1 spots leftby Jul 2025