Favezelimab + Pembrolizumab for Lymphoma
Trial Summary
What is the purpose of this trial?
This study will evaluate the safety and efficacy of favezelimab (MK-4280) in combination with pembrolizumab (MK-3475) using a non-randomized study design in participants with the following hematological malignancies: * classical Hodgkin lymphoma (cHL) * diffuse large B-cell lymphoma (DLBCL) * indolent non-Hodgkin lymphoma (iNHL) This study will also evaluate the safety and efficacy of pembrolizumab or favezelimab administered as monotherapy in participants with cHL using a 1:1 randomized study design. The study will have 2 phases: a safety lead-in and an efficacy expansion phase. The recommended Phase 2 dose (RP2D) will be determined in the safety lead-in phase by evaluating dose-limiting toxicities. There is no primary hypothesis for this study.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop your current medications. However, you cannot have received certain anticancer therapies, monoclonal antibodies, or live vaccines recently. It's best to discuss your specific medications with the trial team.
What data supports the idea that Favezelimab + Pembrolizumab for Lymphoma is an effective treatment?
The available research shows that Pembrolizumab, one of the drugs in the combination, has shown promising results in certain types of lymphoma, particularly those with specific genetic features similar to Hodgkin Lymphoma. While the results for non-Hodgkin Lymphoma are mixed, some subtypes have responded well in early trials. This suggests that Pembrolizumab, when used in combination with other treatments like Favezelimab, could be effective for certain lymphoma patients. However, more research is needed to confirm its effectiveness in broader lymphoma cases.12345
What safety data is available for Favezelimab + Pembrolizumab treatment?
Pembrolizumab (Keytruda) has been evaluated in various clinical trials and has received FDA approval for the treatment of metastatic melanoma. Common adverse reactions include fatigue, cough, nausea, pruritus, rash, decreased appetite, constipation, arthralgia, and diarrhea. Immune-mediated adverse reactions can include pneumonitis, colitis, hepatitis, hypophysitis, thyroid disorders, and rare cases of type 1 diabetes mellitus. Safety data from trials indicate that pembrolizumab is associated with immune-related adverse events, which are important considerations for its use in cancer treatment.23678
Is the drug Favezelimab + Pembrolizumab a promising treatment for lymphoma?
Yes, the drug Pembrolizumab, which is part of the Favezelimab + Pembrolizumab combination, has shown promising results in treating various cancers, including lymphoma. It has been effective in different types of cancer and has received approval for treating advanced melanoma, indicating its potential as a promising treatment.234910
Eligibility Criteria
This trial is for people with certain blood cancers like Hodgkin's lymphoma and B-cell lymphoma. Participants must be relatively healthy (ECOG performance status of 0 or 1), have measurable disease, and can provide a recent tumor biopsy. They shouldn't have severe leftover side effects from past treatments, active infections, CNS involvement, recent vaccines or immunotherapies, HIV/hepatitis B/C infection, pregnancy/breastfeeding plans within the study period, or a history of LAG-3 antibody treatment.Inclusion Criteria
Exclusion Criteria
Treatment Details
Interventions
- Favezelimab (Monoclonal Antibodies)
- Pembrolizumab (Monoclonal Antibodies)