NG-641 + Nivolumab for Advanced Cancer
(NEBULA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment combination of NG-641 (an experimental treatment) and nivolumab (an immunotherapy drug) for individuals with advanced epithelial cancers that have spread or are unresponsive to standard treatments. The primary aim is to ensure the safety of this combination and determine the optimal dose for future studies. It suits those with advanced epithelial cancer that has recurred or is unresponsive to current treatments and who have a tumor that can be safely biopsied. 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 this new treatment.
Do I have to stop taking my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications, but certain treatments like antiviral agents, some vaccines, and specific cancer therapies must be stopped before starting the trial. It's best to discuss your current medications with the trial team to see if any adjustments are needed.
Is there any evidence suggesting that NG-641 in combination with Nivolumab is likely to be safe for humans?
Research shows that NG-641, when combined with nivolumab, has promising early safety results. In earlier studies, patients tolerated this combination well, with no unexpected side effects. Although NG-641 remains in early testing, these initial findings suggest it is generally safe. Nivolumab, a drug approved by the FDA for other cancers, supports this safety evidence, as its side effects are well-known and usually manageable. This trial aims to further investigate the safety of NG-641 when combined with nivolumab for treating advanced cancers.12345
Why are researchers excited about this study treatment for advanced cancer?
Unlike the standard treatments for advanced cancer, which often include chemotherapy or other traditional immunotherapies, NG-641 combined with Nivolumab offers a novel approach. NG-641 is a unique oncolytic virus that specifically targets and destroys cancer cells while also boosting the body's immune response against the tumor. Researchers are excited about this combination because it not only enhances the direct attack on cancer cells but also works alongside Nivolumab, a checkpoint inhibitor, to prevent cancer cells from evading the immune system. This dual action could potentially lead to more effective and sustained tumor reduction compared to current options.
What evidence suggests that NG-641 in combination with nivolumab could be effective for advanced cancer?
Research has shown that NG-641, when combined with nivolumab, may help treat advanced epithelial tumors. In this trial, participants will receive NG-641, a virus designed to target tumors and enhance the immune system's ability to attack cancer cells, alongside nivolumab. Patients who have tried this combination generally tolerated it well, with some showing positive safety results. Nivolumab is already known to aid the immune system by blocking a protein that prevents immune cells from attacking tumors. Together, NG-641 and nivolumab aim to further boost this immune response. While more research is needed, these early findings suggest potential effectiveness for individuals with advanced cancer.12567
Who Is on the Research Team?
Christian Ottensmeier, MD
Principal Investigator
Clatterbridge Cancer Centre
Are You a Good Fit for This Trial?
Adults over 18 with advanced epithelial cancer that's resistant to standard treatments or without treatment options. They must have a life expectancy of at least 6 months, good organ function, and be able to follow study procedures. Exclusions include severe bleeding risks, recent other cancer therapies, certain vaccinations close to trial start, active severe infections or autoimmune diseases.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 1a Part A Treatment
One cycle (28 days) of NG-641 on Days 1, 3, and 5 and nivolumab on Day 15, followed by nivolumab every 4 weeks
Phase 1a Part B Treatment
NG-641 on Days 1, 3, and 5 and nivolumab on Day 15 in each of up to eight 28-day cycles
Phase 1b Treatment
Further investigation of the efficacy and safety of the selected dose regimen in up to three tumour types
Follow-up
Participants are monitored every 8 weeks until 12 months from first dose for disease status, overall survival, further cancer therapy, and best response
What Are the Treatments Tested in This Trial?
Interventions
- NG-641 in combination with Nivolumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
PsiOxus Therapeutics Ltd
Lead Sponsor
Akamis Bio
Lead Sponsor
Bristol-Myers Squibb
Industry Sponsor
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