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Lymphoma, Large B-Cell, DiffusePhase 2/3WaveSpan-010NCT07917754

A Clinical Trial of MK-1045 With Zilovertamab Vedotin in Participants With Diffuse Large B-cell Lymphoma (MK-1045-010)

A Phase 2/3 study testing MK-1045, Zilovertamab vedotin and Rituximab in people with Lymphoma, Large B-Cell, Diffuse and Diffuse Large B-Cell Lymphoma, run by Merck Sharp & Dohme LLC.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

Researchers are looking for new ways to treat relapsed or refractory, diffuse large B-cell lymphoma (R/R DLBCL). Relapsed means the cancer came back after treatment. Refractory means the number of cancer cells in the body did not go down or the cancer did not go away after treatment. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MK-1045, Zilovertamab vedotin and Rituximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
470 participants
Where
No sites listed yet
Study dates
13 Dec 2026to 13 Mar 2037
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has histologically confirmed diagnosis of Diffuse Large B-Cell Lymphoma, not otherwise specified (DLBCL-NOS), by prior biopsy.
  • Part 1 participants: Has relapsed or refractory DLBCL after at least 2 prior systemic DLBCL therapies; Part 2 participants: Has relapsed or refractory DLBCL after at least 1 prior systemic DLBCL therapy.
  • Is ineligible for or progressed after autologous stem cell transplant (ASCT) or chimeric antigen receptor T-cell (CAR-T) therapy.
  • Has locally confirmed cluster of differentiation 19 (CD19) expression in tumor tissue obtained after disease progression on CD19-targeting therapy, if had disease progression after CD19-targeting therapy.
  • Has radiographically measurable DLBCL per Lugano response criteria.
  • Has provided an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.
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  • If human immunodeficiency virus (HIV)-infected, has well-controlled HIV on antiretroviral therapy.
  • If hepatitis B surface antigen (HBsAg)-positive, has undetectable hepatitis B virus (HBV) viral load and received and will continue to receive HBV antiviral therapy.
  • If has a history of hepatitis C virus (HCV) infection, has undetectable HCV viral load.

Who cannot join

  • Has a diagnosis of primary mediastinal B-cell lymphoma.
  • Has received a solid organ transplant.
  • Has a known or suspected history of hemophagocytic lymphohistiocytosis (HLH).
  • Has a rare type of DLBCL.
  • Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
  • Has a history of serious cardiovascular or cerebrovascular diseases.
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  • Has a demyelinating form of Charcot-Marie-Tooth disease.
  • Has ongoing corticosteroid therapy (in dosing exceeding 30 mg daily of prednisone equivalent).
  • Has a known additional malignancy that is progressing or required active treatment in the past 3 years.
  • Has a history or presence of clinically relevant central nervous system (CNS) diseases.
  • Has known active CNS lymphoma or involvement of CNS with DLBCL.
  • Has an active autoimmune disease that required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed.
  • Has an active infection requiring systemic therapy.
  • Has prior allogeneic stem cell transplantation and has acute graph versus host disease (GVHD), ongoing chronic GVHD, or requires systemic immunosuppression for treatment/prophylaxis of GVHD.
  • Has not adequately recovered from surgery or has ongoing surgical complications.
  • Has been found to be primary refractory to monomethyl auristatin E (MMAE)-containing agents

About this study

Official title: A Phase 2/3 Multi-arm, Open-label Study of MK-1045 in Combination With Zilovertamab Vedotin in Participants With Relapsed/Refractory Diffuse Large B-cell Lymphoma

Researchers are looking for new ways to treat relapsed or refractory, diffuse large B-cell lymphoma (R/R DLBCL). Relapsed means the cancer came back after treatment. Refractory means the number of cancer cells in the body did not go down or the cancer did not go away after treatment. Researchers want to learn if MK-1045, an immunotherapy, can treat R/R DLBCL when given with zilovertamab vedotin (ZV), a type of targeted therapy.

The goals of this trial are to learn:

  • About the safety of MK-1045 and ZV and if participants tolerate them together. To tolerate these drugs together means that participants will receive the trial medicines unless they need to stop them due to health problems
  • About the number of participants whose cancer responds (gets smaller or goes away) to treatment with MK-1045 and ZV
  • If participants who receive MK-1045 and ZV live longer without the cancer growing or spreading compared to participants who receive standard treatments
Being tested
MK-1045, Zilovertamab vedotin, Rituximab, Rituximab biosimilar, Polatuzumab vedotin
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MK-1045Biological

    Also called CN201

    Intravenous (IV) administration

  • Zilovertamab vedotinBiological

    Also called MK-2140

    1.5 or 1.75 mg/kg administered IV

  • RituximabBiological

    375mg/m^2, administered IV

  • Rituximab biosimilarBiological

    Also called TRUXIMA®, RUXIENCE®, RIABNI®

    375 mg/m^2, administered IV

  • Polatuzumab vedotinBiological

    1.8 mg/kg, administered IV

  • BendamustineDrug

    90 mg/m^2, administered IV for 2 consecutive days

  • LenalidomideBiological

    25 mg, administered orally

  • TafasitamabBiological

    Also called Monjuvi

    12 mg/kg, administered IV, on Days 1, 4, 8, 15, and 22 for Cycle 1; Days 1, 8, 15, and 22 for Cycles 2 and 3; Days 1 and 15 for Cycles 4 to 12 (each Cycle is 28 days). After Cycle 12, administered once every 2 weeks

  • Rescue Medication - BiologicalBiological

    Participants may receive Tocilizumab (or biosimilar) after administration of MK-1045 in the event of cytokine release syndrome

  • Rescue Medications - DrugDrug

    Participants may receive the following rescue medications before administration of MK-1045: acetaminophen (or similar), diphenhydramine (or similar antihistamine), dexamethasone, Varicellazoster/herpes simplex virus prophylaxis (acyclovir, valacyclovir, famiciclovir), and pneumocystis jirovecii pneumonia prophylaxis (trimethoprim/sulfamethoxazole, dapsone, atovaquone, pentamidine).

  • Granulocyte-colony stimulating factor (G-CSF)Other

    Given as prophylaxis as listed in the National comprehensive Cancer Network guidelines.

Study groups in NCT07917754
Study groupRoleWhat they receive
Part 1 and Part 2: MK-1045 plus Zilovertamab vedotin (ZV)ExperimentalParticipants will receive escalating doses (2 to 120mg) of MK-1045 (or in Part 2, a dose of MK-1045 determined by Part 1) via intravenous infusion (IV) once weekly (q1w) for 48 weeks plus 1.5 or 1.75 mg/kg ZV via IV infusion once every 3 weeks (q3w) for 18 weeks. Participants may continue to receive MK-1045 once every 2 weeks (q2w) after 3 months if a Complete Response (CR) is achieved.
Receives: Biological: MK-1045; Biological: Zilovertamab vedotin; Biological: Rescue Medication - Biological; Drug: Rescue Medications - Drug; Other: Granulocyte-colony stimulating factor (G-CSF)
Part 2: Physician's Choice of ChemotherapyActive comparatorParticipants will receive physician's choice of: 12 mg/kg tafasitamab per labeling instructions plus 25mg lenalidomide once daily (qd) from Days 1-21 of each cycle (each cycle is 28 days) for up to 12 cycles followed by 12 mg/kg tafasitamab monotherapy q2w if stable OR 1.8 mg/kg polatuzumab vedotin plus 90 mg/m^2 bendamustine and 375 mg/m^2 rituximab (or biosimilar) q3w for 6 cycles (each cycle is 21 days).
Receives: Biological: Rituximab; Biological: Rituximab biosimilar; Biological: Polatuzumab vedotin; Drug: Bendamustine; Biological: Lenalidomide; Biological: Tafasitamab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1A: Number of Participants Who Experience Dose Limiting Toxicity (DLT)

    The following events, if considered drug related by the Investigator, will be considered a DLT: Grade (Gr) 5 toxicity; Gr 4 nonhematologic toxicity; Gr 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia; Gr 4 thrombocytopenia of any duration; Gr 3 thrombocytopenia associated with any Gr2 or higher bleeding; Nonhematologic AEs ≥Gr 3 with exceptions; Gr 3 or Gr 4 non-hematologic laboratory values if requires medical intervention, leads to hospitalization, or persists for >72 hours; Gr 3 of 4 febrile neutropenia; Treatment-related toxicities that lead to discontinuation of study treatment or results in receiving incomplete planned doses of study treatment during DLT evaluation window (up to approximately 42 days).

    Measured: Up to approximately 42 days

  2. Part 1A and 1B: Number of Participants Who Experience an Adverse Event (AE)

    An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.

    Measured: Up to approximately 53 months

  3. Part 1A and 1B: Number of Participants Who Discontinue Study Treatment Due to an AE

    An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.

    Measured: Up to approximately 11 months

  4. Part 1B: Objective Response Rate (ORR)

    ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 50% decrease in the sum of diameters of target lesions) per Lugano response criteria. The percentage of participants who experience CR or PR as assessed by physician investigator will be presented.

    Measured: Up to approximately 53 months

  5. Part 2: Progression Free Survival (PFS)

    PFS is defined as the time from randomization to the first documented disease progression per Lugano response criteria by Blinded Independent Central Review (BICR) or death due to any cause, whichever occurs first.

    Measured: Up to approximately 53 months

Secondary outcomes (13)

  1. Part 1A: ORR

    ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 50% decrease in the sum of diameters of target lesions) per Lugano response criteria. The percentage of participants who experience CR or PR as assessed by physician investigator will be presented.

    Measured: Up to approximately 53 months

  2. Part 1A and 1B: Duration of Response (DOR)

    For participants who demonstrate a CR or PR per Lugano response criteria as assessed by physician investigator. DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.

    Measured: Up to approximately 53 months

  3. Part 1A and 1B: Complete Response Rate (CRR)

    For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) per Lugano response criteria. CR rate is defined as the percentage of participants who experience a CR. The CR rate as assessed by physician investigator will be presented.

    Measured: Up to approximately 53 months

  4. Part 1A and 1B: Area Under the Time Concentration Curve (AUC) of MK-1045

    Blood samples will be collected at designated timepoints to estimate the AUC of MK-1045.

    Measured: Predose and at designated time points post-dose (up to approximately 11 months)

  5. Part 1A and 1B: Maximum Concentration (Cmax) of MK-1045

    Blood samples will be collected at designated timepoints to estimate the Cmax of MK-1045.

    Measured: Predose and at designated time points post-dose (up to approximately 11 months)

  6. Part 1A and 1B: Minimum Concentration Just Before the Next Dose (Ctrough) of MK-1045

    Blood samples will be collected at designated timepoints to estimate the Ctrough of MK-1045.

    Measured: Predose and at designated time points post-dose (up to approximately 11 months)

  7. Part 2: Overall Survival (OS)

    OS is defined as the time from randomization to death due to any cause.

    Measured: Up to approximately 53 months

  8. Part 2: ORR

    ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 50% decrease in the sum of diameters of target lesions) per Lugano response criteria. The percentage of participants who experience CR or PR as assessed by BICR will be presented.

    Measured: Up to approximately 53 months

  9. Part 2: Number of Participants Who Experience an AE

    An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.

    Measured: Up to approximately 53 months

  10. Part 2: Number of Participants Who Discontinue Study Treatment Due to an AE

    An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.

    Measured: Up to approximately 11 months

  11. Part 2: CRR

    For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) per Lugano response criteria. CR rate is defined as the percentage of participants who experience a CR. The CR rate as assessed by BICR will be presented.

    Measured: Up to approximately 53 months

  12. Part 2: DOR

    For participants who demonstrate a CR or PR per Lugano response criteria as assessed by BICR. DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.

    Measured: Up to approximately 53 months

  13. Part 2: Minimal Residual Disease (MRD) Negativity Rate

    MRD is defined as the percentage of participants reaching MRD negativity by ctDNA clearance at predefined timepoints.

    Measured: Predose and at designated time points post-dose (up to approximately 11 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2026
  2. Study start13 Dec 2026 (estimated)
  3. Primary completion13 Mar 2037 (estimated)
  4. Study completion13 Mar 2037 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
470 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07917754
Sponsor's protocol ID
1045-010
Other IDs
MK-1045-010, 2025-524261-24-00, U1111-1330-0209, 2025
Acronym
WaveSpan-010
Status last verified
Oct 2026
First submitted
28 Oct 2026
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing MK-1045, Zilovertamab vedotin and Rituximab in people with Lymphoma, Large B-Cell, Diffuse and Diffuse Large B-Cell Lymphoma, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1A: Number of Participants Who Experience Dose Limiting Toxicity (DLT) (time frame: Up to approximately 42 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07917754.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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