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Virus Therapy
Oncolytic Virus Therapy for Pancreatic Cancer
Phase 1 & 2
Recruiting
Research Sponsored by Lokon Pharma AB
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient must be eligible for standard of care treatment with gemcitabine +nab-paclitaxel
Patient is not eligible for a complete surgical resection of their disease as evaluated by a radiologist and/or surgeon
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights
Study Summary
This trial is testing a virus that has been modified to attack cancer cells and also stimulate the immune system to help kill cancer cells. The virus will be injected into the tumor and the patient will also receive standard care treatment.
Who is the study for?
Adults diagnosed with pancreatic ductal adenocarcinoma, not eligible for surgery, can join this trial. They must be fit for standard chemotherapy and able to undergo sedation for injections. Women of childbearing age need a negative pregnancy test and must use contraception. Exclusions include pregnant or breastfeeding women, recent biologic therapy users, those with certain illnesses or high-dose steroid treatment, and individuals with other cancers within the last two years.Check my eligibility
What is being tested?
The trial is testing LOAd703, an oncolytic virus modified to boost the immune system against cancer cells when injected into tumors. It's given alongside standard chemo drugs gemcitabine and nab-paclitaxel, with or without atezolizumab (an anti-cancer antibody). The goal is to shrink tumors and improve survival in pancreatic cancer patients.See study design
What are the potential side effects?
Possible side effects include fever after injection due to immune response activation. There may also be typical chemotherapy-related side effects like fatigue, nausea, low blood counts leading to increased infection risk; plus potential reactions related to atezolizumab such as organ inflammation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am eligible for treatment with gemcitabine and nab-paclitaxel.
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My cancer cannot be completely removed by surgery.
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I am not pregnant and agree to use birth control during the study.
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My liver tests are within normal limits.
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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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I have been diagnosed with pancreatic cancer.
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My kidney function is within the required range.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patient with dose-limiting toxicities (DLTs) as evaluated accordingly to CTCAE 4.0
Secondary outcome measures
Overall Response Rate
Overall Survival
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm 2: Intratumoral LOAd703 + atezolizumabExperimental Treatment4 Interventions
Patients will receive gemcitabine intravenously at a dose of 1000mg/m2 + nab-paclitaxel 125 mg/m2 as per hospital standards. One cycle will be one dose of gemcitabine +nab-paclitaxel given on days 1, 8, and 15 of a 28 day cycle. LOAd703 will be given every other week for 6 doses starting on day 15 of the first cycle of chemotherapy. There is an option for an additional 6 doses if patients benefit from treatment. A fixed dose of atezolizumab 1680 mg will be given every 4 weeks on day 1 of each chemotherapy cycle.
Patients will be assigned to the following LOAd703 doses:
Dose level 1: 1 X 10^11 viral particles per treatment Dose level 2: 5 X 10^11 viral particles per treatment
Group II: Arm 1 Intratumoral LOAd703Experimental Treatment3 Interventions
Patients will receive gemcitabine intravenously at a dose of 1000mg/m2 + nab-paclitaxel 125 mg/m2 as per hospital standards. One cycle will be one dose of gemcitabine +nab-paclitaxel given on days 1, 8, and 15 of a 28 day cycle. LOAd703 will be given every other week for 6 doses starting on day 15 of the first cycle of chemotherapy. There is an option for an additional 6 doses if patients benefit from treatment.
The following LOAd703 doses will be evaluated:
Dose level 1: 5 X 10^10 viral particles per treatment Dose level 2: 1 X 10^11 viral particles per treatment Dose level 3: 5 X 10^11 viral particles per treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
delolimogene mupadenorepvec
2020
Completed Phase 2
~30
Gemcitabine
FDA approved
Atezolizumab
FDA approved
Paclitaxel
FDA approved
Find a Location
Who is running the clinical trial?
Lokon Pharma ABLead Sponsor
2 Previous Clinical Trials
72 Total Patients Enrolled
Angelica Loskog, PhDStudy ChairLokon Pharma AB
3 Previous Clinical Trials
87 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not on any treatments that could interfere with the study, such as high dose steroids or certain immune system targeting drugs.I haven't taken strong immune system drugs like alemtuzumab or rapamycin in the last 3 weeks.I have a noticeable amount of fluid in my abdomen.I have had cancer spread to the lining of my brain and spinal cord.I have had a stem cell or organ transplant in the past.I am eligible for treatment with gemcitabine and nab-paclitaxel.I haven't taken any immune-boosting drugs in the last 4 weeks or longer.I have not had a recent heart attack, stroke, severe heart failure, or uncontrolled heart rhythm problems.I haven't had an adenovirus-based COVID-19 vaccine in the last 3 months.My cancer cannot be completely removed by surgery.I am not pregnant and agree to use birth control during the study.My liver tests are within normal limits.I have a history of specific lung conditions but not due to radiation treatment.I am 18 years old or older.I can be sedated for medical procedures.I have not had biologic therapy in the last 21 days.I do not have active hepatitis B or C, HIV, or tuberculosis.You have a certain level of white blood cells, red blood cells, and platelets in your blood, and your blood clotting time is within a normal range.I haven't had major surgery in the last 4 weeks and don't expect to need any during the study.You have a current autoimmune disease, immune deficiency, or a history of Guillain-Barre syndrome.You are allergic to CHO cell products or any part of the atezolizumab medication.My cancer has a low number of tumors, and one can be biopsied.I have not received any live vaccines in the last 4 weeks and will not during or for 5 months after my atezolizumab treatment.You have had serious allergic reactions to certain types of medications in the past.I can take care of myself and am up and about more than half of my waking hours.I have not had any cancer except for skin, prostate, or cervical cancer in the last 2 years.I have been diagnosed with pancreatic cancer.I frequently need procedures to remove excess fluid from my body.My kidney function is within the required range.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1 Intratumoral LOAd703
- Group 2: Arm 2: Intratumoral LOAd703 + atezolizumab
Awards:
This trial has 3 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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 elaborate on the research conducted with regard to Arm 2: Intratumoral LOAd703 + atezolizumab?
"As of present, 1405 studies for Arm 2: Intratumoral LOAd703 + atezolizumab are in running. Of those trials, 368 have progressed to Phase 3 and are concentrated mainly around Shanghai. However, there is over seventy thousand sites offering this treatment globally."
Answered by AI
Does this research endeavor have openings for new participants?
"According to clinicaltrials.gov, this trial is still actively recruiting patients after its initial posting on November 1st 2016 and subsequent update on September 16th 2022."
Answered by AI
What sort of medical applications is Arm 2: Intratumoral LOAd703 + atezolizumab typically administered for?
"Arm 2 of this trial focuses on the administration of Intratumoral LOAd703 plus atezolizumab to treat neoplasm metastasis, as well as conditions like locally advanced non-small cell lung cancer, urothelial carcinoma of the ureter and mucosal bladder cancer."
Answered by AI
How many people have enrolled in this medical experiment?
"Indeed, records on clinicaltrials.gov confirm that this research is actively seeking volunteers. This trial was initially published on November 1st 2016 and the most recent update occurred in September 16th 2022. The study requires 55 individuals to be recruited from 2 hospitals or clinics."
Answered by AI
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