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Cancer Vaccine
Immunotherapy for Pancreatic Cancer
Phase 1
Recruiting
Led By Paul Oberstein, MD
Research Sponsored by Amal Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout the study, on average 2.4 years
Awards & highlights
Study Summary
This trial tests a new immunotherapy treatment for pancreatic cancer patients to see if it's safe and effective. Patients receive 3 separate treatments and will be compared to an observational group.
Who is the study for?
This trial is for pancreatic cancer patients with a specific mutation (KRAS G12D/G12V). They must have had surgery and chemotherapy, be in good physical condition, and not show signs of cancer returning. Those who've recently used certain drugs or treatments, have immune deficiencies or active autoimmune diseases, other recent cancers, or haven't recovered from surgery are excluded.Check my eligibility
What is being tested?
The KISIMA-02 study tests an immunotherapy treatment on pancreatic cancer. It includes a protein vaccine (ATP150/152), a viral vector (VSV-GP154), and an immune checkpoint inhibitor (Ezabenlimab). The first part checks safety; the second compares treated patients to those only observed.See study design
What are the potential side effects?
Potential side effects may include typical reactions to vaccines like soreness at injection site, fatigue, flu-like symptoms; for Ezabenlimab: inflammation in organs similar to autoimmune responses, infusion-related reactions and increased risk of infections.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ throughout the study, on average 2.4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout the study, on average 2.4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease-free survival (DFS), defined as the time from randomization until confirmed relapse or death from any cause, whichever occurs earlier.
Secondary outcome measures
Occurrence of dose-limiting toxicity (DLT)
Proportion of patients achieving ctDNA clearance
Proportion of patients experiencing ctDNA non-progression
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Cohort C TreatmentExperimental Treatment4 Interventions
Group II: Cohort BExperimental Treatment4 Interventions
Group III: Cohort AExperimental Treatment3 Interventions
Group IV: Cohort C ObservationalActive Control1 Intervention
Find a Location
Who is running the clinical trial?
Boehringer IngelheimIndustry Sponsor
2,507 Previous Clinical Trials
11,340,822 Total Patients Enrolled
Amal TherapeuticsLead Sponsor
1 Previous Clinical Trials
96 Total Patients Enrolled
Paul Oberstein, MDPrincipal InvestigatorNYU Langone Health
2 Previous Clinical Trials
40 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had surgery to remove my cancer completely and underwent chemotherapy for at least 3 months.I have been diagnosed with an immune system disorder.I am still recovering from pancreatic cancer surgery.I have a blockage in my intestines.I have not had any other cancer in the last 3 years.I haven't had chemotherapy or targeted therapy for my pancreatic cancer within the last 14 or 28 days.I have previously used immunotherapy treatments.My advanced cancer responded to or remained stable after 16 weeks of standard treatment.My cancer has not grown or come back.My doctor expects me to live at least 12 months if my pancreatic cancer was removed, or at least 6 months if it has spread.I am on long-term steroids or other drugs that weaken my immune system.I will start the study treatment within 12 weeks after my last surgery for pancreatic cancer.I am fully active or can carry out light work.My previous tumor samples are available for KRAS testing.I have not taken Tamoxifen in the last month.I have not had radiotherapy within the last 14 or 28 days, depending on my PDAC stage.My pancreatic cancer has a specific KRAS mutation.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort C Observational
- Group 2: Cohort A
- Group 3: Cohort C Treatment
- Group 4: Cohort B
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.
What is the highest recorded enrolment of patients taking part in this trial?
"Affirmative, the details from clinicaltrials.gov verify that this trial is presently welcoming participants. It was initially made public on March 13th 2023 and has since undergone its most recent update on May 4th 2023. The research requires 85 people to enrol at 1 site."
Answered by AI
Is there still a possibility to join this research project?
"Affirmative, the public information on clinicaltrials.gov states that this research project is recruiting participants at present. This trial was originally posted online in March 13th 2023 and last updated in May 4th 2023. The experiment requires 85 patients from one medical facility to take part."
Answered by AI
Does Cohort A have the necessary regulatory clearance to be introduced into marketplaces?
"Our team has assigned Cohort A a safety score of 1, as it is currently in the preliminary stages of its clinical trials with limited evidence to back up efficacy and safety."
Answered by AI
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