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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2.5 years

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

0 / 5Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are recruitment efforts still ongoing for this clinical exploration?

"This medical trial is no longer accepting applications. It was initially posted on August 9th 2021 and the page has been updated as recently as October 25th 2022. For those seeking alternative studies, there are 778 trials for neoplasm metastasis presently recruiting participants, with 1875 clinical tests looking to add patients in Cohort A and B of Ipilimumab research."

Answered by AI

Has the FDA sanctioned Ipilimumab (Cohort A and B) for therapeutic use?

"Ipilimumab (Cohort A and B) has limited data supporting its efficacy and safety, earning it a rating of 1 on our assessment scale."

Answered by AI

Are there any prior experiments concerning Ipilimumab that have been conducted in Cohort A and B?

"In 1997, the City of Hope Comprehensive Cancer Center began researching ipilimumab (Cohort A and B). Since then, there have been 2315 completed studies. Right now, 1875 clinical trials are in progress with a significant portion based out of Houston, Texas."

Answered by AI

How extensive is the participation in this experiment?

"At present, this medical trial is not accepting patients. Originally posted on 8/9/2021 and last updated 25th of October 2022; if you are looking for alternative studies, 778 trials focused on neoplasm metastasis and 1875 tribulations involving Ipilimumab (Cohort A & B) are presently enrolling participants."

Answered by AI

What common ailments does Ipilimumab (Cohort A and B) address?

"Ipilimumab is an approved form of treatment for metastatic bladder cancer, urinary bladder issues, and small cell lung cancer (SCLC) in both Cohort A and B."

Answered by AI

Are there multiple sites in the United States deploying this clinical trial?

"Patients may enroll in this trial at M.D Anderson Cancer Centre, University of California San Francisco and University of California Los Angeles as well other seven locations across the nation."

Answered by AI