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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36-48 months
Awards & highlights
Study 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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36-48 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36-48 months
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 moreSide effects data
From 2014 Phase 3 trial • 437 Patients • NCT0076970450%
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
1,370 Previous Clinical Trials
1,377,679 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had major surgery recently.My condition did not improve with the first round of chemotherapy using 5-fluorouracil or gemcitabine.I am a male and will either not have sex or use a condom with women who can get pregnant.My pancreatic cancer is not expected to stop me from completing the study.I have not had any other cancer besides skin cancer in the last 3 years.I have no lasting side effects from previous cancer treatments.I am receiving treatment for an active autoimmune disease.I have active herpes skin sores or complications.I have been treated with specific therapies before.I have been diagnosed with specific infections or illnesses.I have had pancreatitis recently or it's still active.I am 18 years old or older.I can take care of myself and am up and about more than half of my waking hours.My pancreatic cancer can be measured and is at least 1cm big.My organs and bone marrow are working well.I am considered fit for multiple endoscopy procedures by a specialist.You have a weakened immune system that can cause serious health problems.I haven't had any severe infections recently.My pancreatic cancer is advanced and cannot be removed by surgery.You are not willing to reduce contact with people who are at a greater risk for complications caused by HSV-1.I am committed to not having heterosexual intercourse or will use effective birth control.I have not had chemotherapy or radiotherapy recently.I have not had radiation to my abdomen recently.My pancreatic cancer is cystic, possibly with many small cysts.I have not received a live vaccine recently.I am currently taking Coumadin.
Research Study Groups:
This trial has the following groups:- Group 1: T-Vec
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you please provide an overview of prior investigations regarding Talimogene laherparepvec?
"Presently, 22 research trials are assessing Talimogene laherparepvec with none currently in phase 3. Although most of these studies take place at a Santa Monica, California location, 242 clinical trial sites have studied this drug."
Answered by AI
Is this experimental research the inaugural effort of its kind?
"Currently, 22 clinical trials for Talimogene laherparepvec are operational in 93 cities and 16 countries. The earliest trial of its kind took place in 2015 under Amgen's sponsorship; this involved a cohort of 30 participants across two phases to receive drug approval. Since then, 13 studies have been finalized."
Answered by AI
Does Talimogene laherparepvec present any imminent risks to individuals?
"Due to the fact that Talimogene laherparepvec is currently in the first stage of clinical trials, there isn't a large amount of evidence supporting its safety and efficacy. As such, it received score of 1 on our scale from 1-3."
Answered by AI
Are there any openings for volunteers in this experiment?
"As per the details on clinicaltrials.gov, this medical study is not actively recruiting patients at present. The trial was first posted in November 2017 and last updated in late 2022. However, there are numerous other research projects currently enrolling participants across 722 sites."
Answered by AI
What is the aggregate size of the cohort participating in this clinical trial?
"Unfortunately, this investigation is not currently enrolling participants. While the trial was first published on November 16th 2017 and last edited on November 29th 2022, there are a multitude of other trials for cancer of pancreas (700) and Talimogene laherparepvec (22)."
Answered by AI
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