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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.

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.

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.

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I am a male and will either not have sex or use a condom with women who can get pregnant.

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I am 18 years old or older.

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I can take care of myself and am up and about more than half of my waking hours.

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My pancreatic cancer can be measured and is at least 1cm big.

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My pancreatic cancer is advanced and cannot be removed by surgery.

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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:

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My pancreatic cancer is not expected to stop me from completing the study.

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I have no lasting side effects from previous cancer treatments.

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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.

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I have not had radiation to my abdomen recently.

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I have not received a live vaccine recently.

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I am currently taking Coumadin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36-48 months

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

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

Primary study objectives

Maximum Tolerated Dose (MTD)

Secondary study objectives

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

Back pain

Abdominal pain

Rash

Hyperhidrosis

Erythema

Tumour pain

Anxiety

Insomnia

Oropharyngeal pain

Weight decreased

Dyspepsia

Injection site erythema

Musculoskeletal pain

Neck pain

Depression

Anaemia

Vitiligo

Muscle spasms

Dyspnoea

Injection site reaction

Injection site swelling

Disease progression

Injection site pruritus

Cellulitis

Rib fracture

Gastrointestinal haemorrhage

Intestinal obstruction

Metastases to central nervous system

Deep vein thrombosis

Pleural effusion

Dehydration

Infected neoplasm

Metastatic malignant melanoma

Cerebral haemorrhage

Convulsion

Mental status changes

Pulmonary embolism

Atrial fibrillation

100%

80%

60%

40%

20%

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

0 / 16Eligibility criteria met