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Chemotherapy
Immunotherapy + Chemotherapy for Pancreatic Cancer (REVOLUTION Trial)
Phase 1
Waitlist Available
Research Sponsored by Cancer Insight, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant has histologically or cytologically documented diagnosis of pancreatic adenocarcinoma with metastatic disease. Participants with locally advanced disease are not eligible.
Participant must be age 18 years or older.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2.5 years
Awards & highlights
REVOLUTION Trial Summary
This trial is testing different combinations of chemotherapy and immunotherapy to see if they are safe and effective in treating mPDAC.
Who is the study for?
This trial is for adults with metastatic pancreatic adenocarcinoma who haven't had treatment for it. They need to have a certain level of health (ECOG 0 or 1), measurable disease, and no recent chemotherapy or radiotherapy. Prior surgery is okay, but they can't join if they've had specific past treatments like anti-CD40 antibodies (for cohort C) or have active autoimmune diseases.Check my eligibility
What is being tested?
The study tests different combinations of immunotherapy and chemotherapy in three groups: Cohort A gets Nivolumab with Nab-paclitaxel and Gemcitabine; Cohort B adds Hydroxychloroquine; Cohort C tries NG350A. All cohorts receive Ipilimumab too. The goal is to see which combo works best as a first-line treatment.See study design
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs, infusion-related symptoms, fatigue, skin issues, gastrointestinal problems like nausea or diarrhea, potential blood disorders, and an increased risk of infections due to the immune system's response.
REVOLUTION Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My pancreatic cancer has spread beyond the pancreas.
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I am 18 years old or older.
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I can provide a sample of my tumor for the study.
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My last cancer treatment was over 4 months ago, and I haven't had any treatment since my cancer spread.
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I am fully active or restricted in physically strenuous activity but can do light work.
REVOLUTION Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence and severity of adverse events
Secondary outcome measures
Disease control rate (DCR)
Duration of response (DOR)
Objective response rate (ORR)
+3 moreREVOLUTION Trial Design
3Treatment groups
Experimental Treatment
Group I: Cohort C: NG-350A + Ipilimumab + nP/gemExperimental Treatment4 Interventions
Group II: Cohort B: Hydroxychloroquine + Ipilimumab + nP/gemExperimental Treatment4 Interventions
Group III: Cohort A: Nivolumab + Ipilimumab + nP/gemExperimental Treatment4 Interventions
Find a Location
Who is running the clinical trial?
Cancer Insight, LLCLead Sponsor
9 Previous Clinical Trials
535 Total Patients Enrolled
PsiOxus Therapeutics LtdIndustry Sponsor
11 Previous Clinical Trials
745 Total Patients Enrolled
Akamis BioIndustry Sponsor
11 Previous Clinical Trials
745 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My pancreatic cancer has spread beyond the pancreas.I am 18 years old or older.I have not had treatments like chemotherapy for my pancreatic cancer.I have had surgery to remove a tumor.My organs are functioning well.My last cancer treatment was over 4 months ago, and I haven't had any treatment since my cancer spread.I have an autoimmune disease but it's under control or not severe.I can provide a sample of my tumor for the study.I am fully active or restricted in physically strenuous activity but can do light work.I have never received enadenotucirev-based therapy or anti-CD40 antibody treatments.I completed treatment for pancreatic cancer more than 4 months ago.I haven't had active cancer in the last 2 years, except for certain curable types.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A: Nivolumab + Ipilimumab + nP/gem
- Group 2: Cohort B: Hydroxychloroquine + Ipilimumab + nP/gem
- Group 3: Cohort C: NG-350A + Ipilimumab + nP/gem
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.
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