VAY736 + Antineoplastic Agents for Non-Hodgkin's Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment called VAY736, alone or with other medications, for individuals with certain types of non-Hodgkin's lymphoma (NHL), such as diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL). The goal is to assess the safety and effectiveness of this treatment for those whose cancer has returned or did not respond to previous treatments. Individuals who have tried at least two prior treatments for their lymphoma, including one targeting CD20, and still have measurable disease might be suitable candidates for this trial. As a Phase 1 trial, this 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 for this trial?
The trial information does not specify if 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 shows that VAY736, when used alone, may help the body fight certain cancer cells by blocking signals that help these cells survive. This treatment is still being tested, so limited information exists about its safety.
When combined with lenalidomide, more safety information is available. Lenalidomide, approved by the FDA for some types of non-Hodgkin's lymphoma, is generally well-tolerated. Common side effects include tiredness, diarrhea, and low blood counts, while serious side effects are less common.
Since this trial is in an early stage, it primarily focuses on assessing the safety and optimal dose levels of VAY736. Although researchers are still learning about its safety, using it with lenalidomide, which has a known safety record, offers some reassurance in this new setting.12345Why are researchers excited about this trial's treatments?
Researchers are excited about VAY736 for treating non-Hodgkin's lymphoma because it targets the immune system differently from standard treatments like chemotherapy and monoclonal antibodies. VAY736 is an anti-CD40 monoclonal antibody, which means it binds to a specific protein on the surface of B cells, potentially enhancing their ability to fight cancer. Additionally, in one experimental arm, VAY736 is combined with lenalidomide, a drug known to boost the immune response against cancer cells, offering a potentially powerful double-hit strategy. This unique mechanism of action could offer new hope for patients who have not responded to existing therapies.
What evidence suggests that this trial's treatments could be effective for Non-Hodgkin's Lymphoma?
This trial examines VAY736 for its potential to treat various types of non-Hodgkin's lymphoma (NHL), including diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL). Participants in one trial arm will receive VAY736 alone, which targets specific proteins on cancer cells to slow or stop their growth. Early results from previous research suggest that VAY736 alone may effectively manage these cancers.
In another trial arm, participants will receive a combination of VAY736 and lenalidomide, a drug that treats B-cell NHL by boosting the immune system. Lenalidomide has shown success in some NHL cases. Together, VAY736 and lenalidomide could offer a stronger approach to treating these challenging lymphomas.16789Who Is on the Research Team?
Novartis Institutes of Biomedical Research
Principal Investigator
Novartis Institutes of Biomedical Research
Are You a Good Fit for This Trial?
This trial is for adults with certain types of B-cell Non-Hodgkin Lymphoma that have tried at least two prior treatments without success. Participants must be able to undergo biopsies and have a performance status allowing daily activity. Excluded are those with central nervous system lymphoma, severe heart or lung conditions, HIV, active hepatitis infections, or women who could become pregnant and aren't using contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Investigational drug VAY736 was explored alone or in combination with lenalidomide to identify the maximum tolerated dose/recommended dose (MTD/RD) in patients with NHL.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- VAY736
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novartis Pharmaceuticals
Lead Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD
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