MK-1045 + Rituximab for Follicular Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment approach for individuals with follicular lymphoma, a type of blood cancer. Researchers aim to determine if combining rituximab, a standard treatment, with a new immunotherapy drug called MK-1045 is effective and safe. They seek to discover if this combination can help the cancer disappear and prevent it from worsening compared to standard treatments. The trial seeks participants with untreated follicular lymphoma that is detectable on scans. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to significant advancements in cancer treatment.
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, if you are on certain treatments like systemic steroids or have active infections requiring treatment, you may not be eligible to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that most people can generally handle the combination of MK-1045 and rituximab with ease. In one study, patients taking these treatments together experienced encouraging results. Safety reports suggest that most people can use this combination without major problems. However, some side effects might occur, as with any treatment. The study aims to understand how well people tolerate these medicines when used together. So far, evidence indicates that this treatment is safe for many patients, but ongoing trials continue to collect more information.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about MK-1045 combined with Rituximab for treating follicular lymphoma because it offers a novel approach compared to standard treatments like chemotherapy combined with Rituximab. MK-1045 is an investigational treatment that targets specific pathways in cancer cells, potentially enhancing the effectiveness of Rituximab. Unlike traditional chemotherapy, which can affect both healthy and cancerous cells, MK-1045 is designed to more precisely target the cancer, possibly reducing side effects. This targeted action could lead to improved outcomes and better quality of life for patients.
What evidence suggests that this trial's treatments could be effective for follicular lymphoma?
Research shows that combining MK-1045 with rituximab might help treat follicular lymphoma. In this trial, participants will receive MK-1045 and rituximab in different treatment arms. Previous studies of similar treatments have shown high success rates. For example, a treatment that combined rituximab with another immune therapy achieved a 96% success rate, with 87% of patients showing no signs of the disease. Additionally, studies indicate that therapies based on rituximab can lead to extended periods where the cancer does not worsen. MK-1045 is a type of immune therapy designed to help the body's immune system find and destroy cancer cells. The goal is that adding MK-1045 to rituximab will lead to better results for patients with follicular lymphoma.13467
Who Is on the Research Team?
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Are You a Good Fit for This Trial?
This trial is for adults with previously untreated follicular lymphoma that tests positive for CD19 and CD20 markers, has spread beyond one area (stage II-IV), and can be measured on scans. People with well-controlled HIV or hepatitis B/C may join if their infections are under control.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive MK-1045 and rituximab or physician's choice of chemotherapy plus rituximab
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- MK-1045
- Rituximab
Trial Overview
The study compares a new immunotherapy drug called MK-1045 combined with rituximab to standard treatments like rituximab plus chemotherapy drugs (such as cyclophosphamide, vincristine, prednisone/prednisolone, doxorubicin, or bendamustine) in people with follicular lymphoma.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Participants will receive physician's choice of: 90 mg/m\^2 bendamustine on Days 1 and 2 of each 4-week cycle for up to 6 cycles (up to approximately 6 months) plus 375 mg/m\^2 rituximab (or biosimilar) Q4W for up to approximately 6 months OR 750 mg/m\^2 cyclophosphamide, 50 mg/m\^2 doxorubicin, and 1.4 mg/m\^2 vincristine on day 1 of each 3-week cycle (Q3W) and 100 mg/m\^2 prednisone (or prednisolone) once daily on days 1 through 5 Q3W for up to 6 cycles (up to approximately 4 months) plus 375 mg/m\^2 rituximab (or biosimilar) Q3W for up to approximately 4 months OR 750 mg/m\^2 cyclophosphamide and 1.4 mg/m\^2 vincristine Q3W and 40 mg/day prednisone (or prednisolone) once daily on days 1 through 5 of each 3-week cycle for up to 6 cycles (up to approximately 4 months) plus 375 mg/m\^2 rituximab (or biosimilar) Q3W for up to approximately 6 months.
Participants will receive MK-1045 QW at the dose determined in Part 1 for up to approximately 12 months. Participants will also receive 375 mg/m\^2 rituximab (or biosimilar) Q4W for up to approximately 6 months.
Participants will receive escalating doses of MK-1045 (from 2 mg to 90 mg) once weekly (QW) for up to approximately 12 months. Participants will also receive 375 mg/m\^2 rituximab (or biosimilar) once every 4 weeks (Q4W) for up to approximately 6 months.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Sharp & Dohme LLC
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University
Citations
NCT07634471 | A Clinical Trial of MK-1045 and Rituximab ...
-1045 is a type of treatment called immunotherapy. Prognostic Index (FLIPI) score of 2-5. Has radiographically measurable disease per the Lugano Response ...
Six-Year Results From RELEVANCE: Lenalidomide Plus ...
Six-year overall survival was estimated to be 89% in both groups. Overall response after progression was 61% and 59%, and 5-year estimated survival rate after ...
3.
hematologyadvisor.com
hematologyadvisor.com/reports/epcoritamab-rituximab-effective-high-tumor-burden-follicular-lymphoma/Epcoritamab Plus Rituximab Effective in High-Tumor ...
The 1-year progression-free survival rate was 97%. The 1-year duration of response rate and the 1-year overall survival rate were both 100%. “ ...
A Clinical Trial of MK-1045 and Rituximab in People With ...
A standard (usual) treatment for FL includes a targeted therapy called rituximab and chemotherapy. In this study, researchers want to learn if giving a study ...
A Clinical Trial of MK-1045 and Rituximab in People With ...
If people who receive MK-1045 and rituximab live longer without their cancer getting worse compared to those who receive standard treatment ( ...
Safety and Efficacy of Ibrutinib in Combination with Rituximab ...
The best ORR (CR/PR) was 95.8% (95% CI: 85.7 – 99.5%) and CRR was 83.3% (95% CI: 69.8 – 92.5%). Among the 46 evaluable patients, the CRR at 120 weeks was 63.0% ...
7.
hematologyadvisor.com
hematologyadvisor.com/news/combined-with-chemotherapy-obinutuzumab-vs-rituximab-for-untreated-fl/Obinutuzumab vs Rituximab Efficacy, Safety in ...
Patients receiving obinutuzumab showed improvements in 5-years PFS compared with patients receiving rituximab (hazard ratio, 0.76; P =.0043; ...
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