960 Participants NeededMy employer runs this trial

MK-1045 + Rituximab for Follicular Lymphoma

Recruiting at 25 trial locations
TF
Overseen ByToll Free Number
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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?

MD

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

I have had hepatitis C, but my viral load is now undetectable.
My HIV is well-controlled with medication.
I have untreated, biopsy-proven CD19+ and CD20+ follicular lymphoma, stage II-IV, FLIPI 2-5.
See 3 more

Exclusion Criteria

My follicular lymphoma has changed into a more aggressive type.
I have received a live vaccine in the past 30 days.
I have or had significant central nervous system diseases.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MK-1045 and rituximab or physician's choice of chemotherapy plus rituximab

12 months
Weekly visits for MK-1045, every 4 weeks for rituximab

Follow-up

Participants are monitored for safety and effectiveness after treatment

15 months

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

Group I: Part 2: Physician's Choice of Chemotherapy plus Rituximab (or biosimilar)Experimental Treatment8 Interventions
Group II: Part 2: MK-1045 plus Rituximab (or biosimilar)Experimental Treatment3 Interventions
Group III: Part 1: MK-1045 plus Rituximab (or biosimilar)Experimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

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 profile image

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 ...

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% ...

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; ...