Pumitamig + Ipilimumab for Liver Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the safety of two treatments, Pumitamig (a new potential drug) and Ipilimumab (an immunotherapy), for individuals with advanced or unresectable Hepatocellular Carcinoma (HCC). Researchers aim to assess the effectiveness of these treatments both individually and in combination. The trial is open to those diagnosed with advanced HCC who have not yet received any other treatments. 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 potential drug.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that ipilimumab, often used with other treatments, effectively treats liver cancer, demonstrating strong antitumor activity. It has proven effective and appears safe for patients with hepatocellular carcinoma (HCC).
Data collection for pumitamig is ongoing. Current studies are examining its effects both alone and in combination with ipilimumab. This research aims to understand patient tolerance to pumitamig and identify any potential side effects.
As this trial begins, it primarily focuses on safety and patient tolerance. The main goal is to observe patient reactions and monitor for any unwanted side effects. While some evidence exists from similar treatments, more information will emerge as the trial progresses.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Pumitamig combined with Ipilimumab for liver cancer because this treatment approach targets the immune system in a novel way. Most liver cancer treatments focus on directly attacking the cancer cells, but Pumitamig works by enhancing the body's own immune response, potentially leading to more robust and long-lasting effects. Ipilimumab is an immune checkpoint inhibitor that helps lift the brakes off the immune system, allowing it to recognize and attack cancer cells more effectively. This combination could offer a more powerful alternative to standard therapies, such as targeted therapy and chemotherapy, by providing a boost to the body's natural defenses against cancer.
What evidence suggests that this trial's treatments could be effective for liver cancer?
Research shows that ipilimumab, when combined with other treatments, effectively fights liver cancer, also known as hepatocellular carcinoma (HCC). In this trial, some participants will receive ipilimumab, which has demonstrated potential effectiveness with positive responses in past studies. Pumitamig, a newer treatment, is also being studied to determine if it can enhance ipilimumab's effects. Although information on pumitamig remains limited, researchers are investigating whether this combination can improve outcomes for patients with advanced liver cancer. Early findings are encouraging, but further studies are needed to confirm these results.12356
Who Is on the Research Team?
Bristol-Myers Squibb
Principal Investigator
Bristol-Myers Squibb
Are You a Good Fit for This Trial?
This trial is for individuals with advanced or inoperable liver cancer (Hepatocellular Carcinoma). Specific eligibility criteria are not provided, but typically participants would need to be adults who haven't had treatment before and meet certain health standards.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Pumitamig alone or in combination with Ipilimumab
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for progression-free survival and incidence of anti-drug antibodies
What Are the Treatments Tested in This Trial?
Interventions
- Ipilimumab
- Pumitamig
Trial Overview
The study is testing the safety and how well people can handle Pumitamig on its own or when used with Ipilimumab. It's for those facing their first battle against advanced liver cancer.
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bristol-Myers Squibb
Lead 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
BioNTech SE
Industry Sponsor
Prof. Dr. Ugur Sahin
BioNTech SE
Chief Executive Officer since 2008
MD from University of Cologne
Prof. Özlem Türeci
BioNTech SE
Chief Medical Officer since 2018
MD from Saarland University
Citations
NCT07291076 | A Study to Evaluate the Safety and ...
The purpose of this study is to evaluate the safety and tolerability of Pumitamig alone or in combination with Ipilimumab in participants with first-line ...
2.
trial.medpath.com
trial.medpath.com/news/ceacb878754e4e7d/bristol-myers-squibb-and-biontech-launch-phase-1-2-trial-testing-pumitamig-in-first-line-hepatocellular-carcinomaBristol-Myers Squibb and BioNTech Launch Phase 1/2 Trial ...
The randomized, open-label study will evaluate pumitamig alone or combined with ipilimumab against the standard atezolizumab-bevacizumab ...
A Study to Evaluate the Safety and Tolerability ...
Outcome Measure, Measure Description, Time Frame. Number of participants with adverse events (AEs), Phase 1, Up to approximately 25 weeks.
4.
investors.biontech.de
investors.biontech.de/system/files-encrypted/nasdaq_kms/assets/2025/11/14/4-15-10/BNTX%20Innovation%20Series%20%28R%26D%29%20Day%202025_final_%20website.pdfInnovation Series: R&D Day 2025 - BioNTech
... efficacy of pumitamig in combination with CTx vs. Bevacizumab in combination with CTx in participants with previously untreated ...
Efficacy and Safety of Ipilimumab Plus Anti-PD-1/PD-L1 ...
The combination of nivolumab and ipilimumab has demonstrated significant antitumor activity in first-line treatment for hepatocellular carcinoma ...
BMY and BNTX advance new immunotherapy bet in first- ...
The trial is important because first-line liver cancer remains an area of high unmet need, and any positive signal here could support a new ...
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