Immunotherapy + Chemotherapy for Pancreatic Cancer

(REVOLUTION Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new treatments for individuals with metastatic pancreatic ductal adenocarcinoma, a type of advanced pancreatic cancer. Researchers aim to determine the safety and effectiveness of combining different drugs, such as chemotherapy and immunotherapy. Participants will receive one of several treatment combinations, including drugs like gemcitabine (a chemotherapy drug) and ipilimumab (an immunotherapy drug). Those with a confirmed case of pancreatic cancer that has spread and who have not received treatment for this advanced stage might be suitable for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive potentially groundbreaking therapies.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, it does mention that participants must not have received prior treatment for metastatic pancreatic cancer, except for certain conditions. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found that the combination of nivolumab, ipilimumab, nab-paclitaxel, and gemcitabine was generally safe for patients with advanced pancreatic cancer. Most side effects were mild and manageable with standard treatments.

Specific safety information for the combination of hydroxychloroquine with ipilimumab, nab-paclitaxel, and gemcitabine is not yet available. However, nab-paclitaxel and gemcitabine have been used together for pancreatic cancer and are usually well-tolerated.

The NG-350A combination represents a newer treatment approach. NG-350A is an experimental drug designed to target cancer cells. Although specific safety data for this combination is not yet available, researchers are closely monitoring for any potential issues.

These treatments are in early trial phases, meaning researchers are still carefully studying them for safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for pancreatic cancer because they combine traditional chemotherapy with innovative immunotherapies. Unlike the standard of care, which typically involves chemotherapy alone, these treatments incorporate drugs like Nivolumab and Ipilimumab that help the immune system target cancer cells more effectively. In particular, Cohort A uses Nivolumab, Cohort B includes Hydroxychloroquine, and Cohort C involves NG-350A, each with unique mechanisms that potentially enhance the body's immune response against pancreatic cancer. This approach aims to improve the effectiveness of treatment and offer hope for better outcomes in a condition known for its aggressive nature and limited treatment options.

What evidence suggests that this trial's treatments could be effective for metastatic pancreatic cancer?

In this trial, participants will join different treatment arms to evaluate the effectiveness of various combinations for advanced pancreatic cancer. One arm will receive nivolumab and ipilimumab with nab-paclitaxel and gemcitabine. Research suggests this combination may be more effective than chemotherapy alone for late-stage pancreatic cancer. Another arm will explore hydroxychloroquine, ipilimumab, nab-paclitaxel, and gemcitabine, aiming to enhance the body's immune response against cancer cells, though less direct evidence supports this approach. Lastly, a separate arm will investigate NG-350A with ipilimumab and chemotherapy, designed to overcome cancer's resistance to treatment. Early research suggests these methods could be helpful, but more studies are needed to confirm this. ^{2 4 5 6 7}

Who Is on the Research Team?

Parker Institute for Cancer Immunotherapy

Principal Investigator

Parker Institute for Cancer Immunotherapy

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9179513/

The Next Frontier in Pancreatic Cancer: Targeting ... In this review, we discuss the evolving landscape of therapeutic targets in PDAC, including selected clinical data from corresponding trials. 2. Immunotherapy.

2. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.70035

Advances in pancreatic cancer early diagnosis, prevention ... For the vast majority of patients diagnosed with metastatic PDAC, the 5-year overall survival rate remains below 10%, and two primary systemic ...

3. dmr.amegroups.org dmr.amegroups.org/article/view/10275/html

Recent advances in immunotherapy for pancreatic cancer This article provides a comprehensive update of various novel immunotherapy approaches to treat pancreatic cancer.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0169409X25001565

Classic versus innovative strategies for immuno-therapy in ... Association between the use of antibiotics and efficacy of gemcitabine plus nab-paclitaxel in advanced pancreatic cancer. Medicine (Baltimore), 99 (39) (2020 ...

5. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT04787991

Platform Trial to Evaluate Immunotherapy Combinations ... This trial is designed to evaluate multiple clinical hypotheses and mechanistically-defined combinations to evaluate the safety and efficacy of ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04787991

Study Details | NCT04787991 | Exploratory Platform Trial to ... This trial is designed to evaluate multiple clinical hypotheses and mechanistically-defined combinations to evaluate the safety and efficacy of first-line chemo ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8606164/

Pancreas Cancer: Therapeutic Trials in Metastatic Disease : Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. ... : Ipilimumab and Gemcitabine for Advanced Pancreatic Cancer: A Phase Ib Study.