Immunotherapy + Chemotherapy for Pancreatic Cancer

(REVOLUTION Trial)

Recruiting at 6 trial locations

Overseen By George Fisher, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Cancer Insight, LLC

Must not be taking: Enadenotucirev, Anti-CD40 antibody

Disqualifiers: Prior malignancy, Autoimmune disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

45 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is designed to evaluate multiple clinical hypotheses and mechanistically-defined combinations to evaluate the safety and efficacy of first-line chemo-immunotherapy combinations in participants with metastatic pancreatic ductal adenocarcinoma (mPDAC).

Research Team

Parker Institute for Cancer Immunotherapy

Principal Investigator

Parker Institute for Cancer Immunotherapy

Eligibility Criteria

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.

Inclusion Criteria

My pancreatic cancer has spread beyond the pancreas.

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.

Exclusion Criteria

I have not had treatments like chemotherapy for my pancreatic cancer.

I have had surgery to remove a tumor.

I have an autoimmune disease but it's under control or not severe.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants receive immunotherapy in combination with standard chemotherapy to evaluate safety and antitumor activity

12 weeks

Weekly visits (in-person)

Expanded Cohort (Stage 2)

Based on results from Stage 1, participants may continue treatment to further evaluate clinical activity and safety

Variable, up to 2.5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2.5 years

Treatment Details

Interventions

• Gemcitabine
• Ipilimumab
• Nab-paclitaxel
• Nivolumab

Trial Overview 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.

Participant Groups

Group I: Cohort C: NG-350A + Ipilimumab + nP/gem Experimental Treatment 4 Interventions

Group II: Cohort B: Hydroxychloroquine + Ipilimumab + nP/gem Experimental Treatment 4 Interventions

Group III: Cohort A: Nivolumab + Ipilimumab + nP/gem Experimental Treatment 4 Interventions

Gemcitabine is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Gemzar for:

• Pancreatic cancer
• Breast cancer
• Ovarian cancer
• Non-small cell lung cancer

Approved in United States as Gemzar for:

• Pancreatic cancer
• Breast cancer
• Ovarian cancer
• Non-small cell lung cancer

Approved in Canada as Gemzar for:

• Pancreatic cancer
• Breast cancer
• Ovarian cancer
• Non-small cell lung cancer

Approved in Japan as Gemzar for:

• Pancreatic cancer
• Breast cancer
• Ovarian cancer
• Non-small cell lung cancer

Who Is Running the Clinical Trial?

Cancer Insight, LLC

Lead Sponsor

Trials

10

Recruited

520+

Parker Institute for Cancer Immunotherapy

Lead Sponsor

Trials

12

Recruited

460+

PsiOxus Therapeutics Ltd

Industry Sponsor

Trials

12

Recruited

790+

Akamis Bio

Industry Sponsor

Trials

13

Recruited

820+

Bristol-Myers Squibb

Industry Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Cancer Research Institute, New York City

Collaborator

Trials

22

Recruited

1,300+