A Phase 1b/2 Study to Evaluate the Safety and Efficacy of MK-1045 Monotherapy or in Combination With Other Anticancer Agents in Participants With Non-Hodgkin Lymphoma

New immunotherapy MK-1045 tested in advanced Non-Hodgkin Lymphoma

NCT: NCT07519772 · Status: NOT YET RECRUITING · Phase: Phase 2 · Sponsor: Merck Sharp & Dohme LLC · Started: 2026-05-07 · Est. Completion: 2030-10-21

Plain English Summary

A Clinical Study of MK-1045 in People With Non-Hodgkin Lymphoma (MK-1045-008) is a Phase 2 clinical trial sponsored by Merck Sharp & Dohme LLC studying Lymphoma, Non-Hodgkin, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse. This study tests a new immunotherapy drug called MK-1045, alone or with other cancer treatments, for specific types of Non-Hodgkin Lymphoma (NHL). It is for adults with follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL) that has returned or not responded to at least two previous treatments. Participants will receive MK-1045, possibly with other drugs, and will have regular check-ups, blood tests, and scans to monitor their health and cancer. Alternative treatments may include chemotherapy, radiation, stem cell transplant, or other targeted therapies depending on the specific lymphoma type and prior treatments. The trial aims to enroll 200 participants.

Official Summary

Researchers are looking for new ways to treat 2 types of non-Hodgkin lymphoma (NHL) called follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL). FL is a slow-growing type of NHL. DLBCL is a fast-growing type of NHL. NHL is a cancer in the lymphatic system that causes swollen lymph nodes. The lymphatic system is part of the immune system. In this study, researchers want to learn if MK-1045 can treat FL and DLBCL. MK-1045 is a study treatment that is an immunotherapy, which helps the immune system fight cancer. The goals of this study are to learn how safe MK-1045 is and if people tolerate it. Researchers also want to see if FL and DLBCL respond (the cancer gets smaller or goes away) to treatment.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults with confirmed follicular lymphoma or diffuse large B-cell lymphoma. Patients whose cancer has returned or not responded to at least two prior treatments. For DLBCL patients, they must have progressed after or be ineligible for transplant and CAR-T therapy. Individuals with controlled HIV, Hepatitis B, or Hepatitis C infections may be eligible, but specific criteria apply. This trial is studying Lymphoma, Non-Hodgkin, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome of 'Objective Response Rate' means researchers will measure how often the cancer shrinks or disappears in response to MK-1045, indicating its effectiveness. The specific primary outcome measures are: Number of Participants Who Experience an Adverse Event (AE) (Up to approximately 44 months); Number of Participants Who Discontinue Study Treatment Due to an AE (Up to approximately 12 months); Arms 2 and 3: Number of Participants Who Experience Dose Limiting Toxicity (DLT) (Up to approximately 28 Days); Arms 1 and 4: Objective Response Rate (ORR) per Lugano Response Criteria as assessed by Blinded Independent Central review (BICR) (Up to approximately 44 months); Arm 2: ORR per Lugano Response Criteria as assessed by Investigator (Up to approximately 44 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial addresses a critical need for new treatments for relapsed or refractory Non-Hodgkin Lymphoma, particularly for patients who have exhausted standard options. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Lymphoma, Non-Hodgkin, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse, where improved treatment options are needed.

Investor Insight

This Phase 1b/2 trial signals Merck's investment in a potentially novel immunotherapy for a significant cancer market, with an estimated 200 participants, suggesting a competitive landscape for NHL tr Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor if MK-1045 is a suitable option given your treatment history and overall health. Understand the potential side effects and how they will be managed throughout the study. Be prepared for regular clinic visits for drug administration, blood draws, and imaging scans over several years. The trial is being conducted at multiple sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* Has disease that has relapsed (disease progression after remission) or is refractory (failure to achieve complete or partial response) to at least 2 prior systemic lines of therapy.
* Has a histologically confirmed diagnosis of follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL).
* DLBCL participants only: has progressed after or is ineligible for transplant and chimeric antigen receptor T (cell) (CAR-T) therapy.
* Has provided tumor tissue sample (archival or newly obtained, if performed per standard of care).
* Has documented retained expression of cluster of differentiation 19 (CD19) in tumor tissue obtained by biopsy after disease progression on CD19-targeting therapy, if experienced disease progression after prior CD19-targeting therapy.
* Has well-controlled human immunodeficiency virus (HIV) on antiretroviral therapy if has a history of HIV infection.
* Has undetectable hepatitis B virus (HBV) viral load and received and will continue to receive HBV antiviral therapy if hepatitis B surface antigen (HBsAg)-positive.
* Has undetectable hepatitis C virus (HCV) viral load and received HCV antiviral therapy if has a history of HCV infection.
* Has radiographically measurable disease per Lugano Response Criteria.

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* Has received a solid organ transplant.
* Had or has clinically relevant central nervous system (CNS) diseases.
* Has a history of serious cardiovascular or cerebrovascular diseases.
* Had prior allogenic stem cell transplantation with acute graft-versus-host-disease (GVHD); has ongoing evidence of chronic GVHD manifesting as skin involvement, diarrhea, or increased serum bilirubin; or requires systemic immunosuppression for GVHD.
* Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
* Has received a live or live-attenuated vaccine within 30 days of randomization.
* Has received prior CAR-T therapy within 3 months before the first dose of the study intervention.
* Has a known additional malignancy that is progressing or required active treatment within the past 2 years.
* Has known active CNS lymphoma or involvement.
* Has active autoimmune disease that required systemic treatment in the past 2 years.
* Has active infection requiring systemic therapy.
* Has a history of severe bleeding disorders.
* Has not recovered from major surgery or has ongoing surgical complications.
* Has diagnosis of primary mediastinal B-cell lymphoma.

Frequently Asked Questions

What is clinical trial NCT07519772?

NCT07519772 is a Phase 2 INTERVENTIONAL study titled "A Clinical Study of MK-1045 in People With Non-Hodgkin Lymphoma (MK-1045-008)." It is currently not yet recruiting and is sponsored by Merck Sharp & Dohme LLC. The trial targets enrollment of 200 participants.

What conditions does NCT07519772 study?

This trial investigates treatments for Lymphoma, Non-Hodgkin, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse. The primary condition under study is Lymphoma, Non-Hodgkin.

What treatments are being tested in NCT07519772?

The interventions being studied include: MK-1045 (BIOLOGICAL). Intravenous (IV) Infusion or Subcutaneous (SC) injection

What does Phase 2 mean for NCT07519772?

Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.

What is the current status of NCT07519772?

This trial is currently "Not Yet Recruiting." It started on 2026-05-07. The estimated completion date is 2030-10-21.

Who is sponsoring NCT07519772?

NCT07519772 is sponsored by Merck Sharp & Dohme LLC. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT07519772?

The trial aims to enroll 200 participants. The trial has not yet started recruiting.

How is NCT07519772 designed?

This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.

What are the primary outcomes being measured in NCT07519772?

The primary outcome measures are: Number of Participants Who Experience an Adverse Event (AE) (Up to approximately 44 months); Number of Participants Who Discontinue Study Treatment Due to an AE (Up to approximately 12 months); Arms 2 and 3: Number of Participants Who Experience Dose Limiting Toxicity (DLT) (Up to approximately 28 Days); Arms 1 and 4: Objective Response Rate (ORR) per Lugano Response Criteria as assessed by Blinded Independent Central review (BICR) (Up to approximately 44 months); Arm 2: ORR per Lugano Response Criteria as assessed by Investigator (Up to approximately 44 months). These are the main endpoints researchers use to determine whether the treatment is effective.

Where can I find official information about NCT07519772?

The official record for NCT07519772 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07519772. This government database provides the most up-to-date and detailed information about the trial.

What is NCT07519772 testing in simple terms?

This study tests a new immunotherapy drug called MK-1045, alone or with other cancer treatments, for specific types of Non-Hodgkin Lymphoma (NHL). It is for adults with follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL) that has returned or not responded to at least two previous treatments.

Why is this trial significant?

This trial addresses a critical need for new treatments for relapsed or refractory Non-Hodgkin Lymphoma, particularly for patients who have exhausted standard options.

What are the potential risks of participating in NCT07519772?

Common side effects may include fatigue, nausea, diarrhea, and low blood cell counts. More serious risks could involve severe allergic reactions, infections, or effects on the heart or lungs. The study will closely monitor for and manage any adverse events that occur during treatment. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT07519772?

Ask your doctor if MK-1045 is a suitable option given your treatment history and overall health. Understand the potential side effects and how they will be managed throughout the study. Be prepared for regular clinic visits for drug administration, blood draws, and imaging scans over several years. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT07519772 signal from an investment perspective?

This Phase 1b/2 trial signals Merck's investment in a potentially novel immunotherapy for a significant cancer market, with an estimated 200 participants, suggesting a competitive landscape for NHL tr This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.

What happens if the treatment in this trial doesn't work?

Participants will receive MK-1045, possibly with other drugs, and will have regular check-ups, blood tests, and scans to monitor their health and cancer. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.