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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 below
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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 weeks
Treatment ~ Varies
Follow Up ~up to 2.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2.5 years for reporting.

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 more

REVOLUTION 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

Gemcitabine (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04787991 — Phase 1
Pancreatic Cancer Research Study Groups: Cohort A: Nivolumab + Ipilimumab + nP/gem, Cohort B: Hydroxychloroquine + Ipilimumab + nP/gem, Cohort C: NG-350A + Ipilimumab + nP/gem
Pancreatic Cancer Clinical Trial 2023: Gemcitabine Highlights & Side Effects. Trial Name: NCT04787991 — Phase 1
Gemcitabine (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04787991 — Phase 1
~5 spots leftby Oct 2024