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

28. října 2026 aktualizováno: Merck Sharp & Dohme LLC

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

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

470

Fáze

  • Fáze 2
  • Fáze 3

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Sekvenční přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Part 1 and Part 2: MK-1045 plus Zilovertamab vedotin (ZV)

Participants 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.
Biologický: MK-1045

Intravenous (IV) administration

Ostatní jména:
  • CN201
Biologický: Zilovertamab vedotin

1.5 or 1.75 mg/kg administered IV

Ostatní jména:
  • MK-2140
Biologický: Rescue Medication - Biological

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

Lék: Rescue Medications - Drug

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).

Jiný: Granulocyte-colony stimulating factor (G-CSF)

Given as prophylaxis as listed in the National comprehensive Cancer Network guidelines.
Aktivní komparátor: Part 2: Physician's Choice of Chemotherapy

Participants 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).
Biologický: Rituximab

375mg/m^2, administered IV

Biologický: Rituximab biosimilar

375 mg/m^2, administered IV

Ostatní jména:
  • TRUXIMA®
  • RUXIENCE®
  • RIABNI®
Biologický: Polatuzumab vedotin

1.8 mg/kg, administered IV

Lék: Bendamustine

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

Biologický: Lenalidomide

25 mg, administered orally

Biologický: Tafasitamab

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

Ostatní jména:
  • Monjuvi

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Part 1A: Number of Participants Who Experience Dose Limiting Toxicity (DLT)
Časové okno: Up to approximately 42 days

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).
Up to approximately 42 days
Part 1A and 1B: Number of Participants Who Experience an Adverse Event (AE)
Časové okno: Up to approximately 53 months

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.
Up to approximately 53 months
Part 1A and 1B: Number of Participants Who Discontinue Study Treatment Due to an AE
Časové okno: Up to approximately 11 months

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.
Up to approximately 11 months
Part 1B: Objective Response Rate (ORR)
Časové okno: Up to approximately 53 months

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.
Up to approximately 53 months
Part 2: Progression Free Survival (PFS)
Časové okno: Up to approximately 53 months

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.
Up to approximately 53 months

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Part 1A: ORR
Časové okno: Up to approximately 53 months

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.
Up to approximately 53 months
Part 1A and 1B: Duration of Response (DOR)
Časové okno: Up to approximately 53 months

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.
Up to approximately 53 months
Part 1A and 1B: Complete Response Rate (CRR)
Časové okno: Up to approximately 53 months

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.
Up to approximately 53 months
Part 1A and 1B: Area Under the Time Concentration Curve (AUC) of MK-1045
Časové okno: Predose and at designated time points post-dose (up to approximately 11 months)

Blood samples will be collected at designated timepoints to estimate the AUC of MK-1045.
Predose and at designated time points post-dose (up to approximately 11 months)
Part 1A and 1B: Maximum Concentration (Cmax) of MK-1045
Časové okno: Predose and at designated time points post-dose (up to approximately 11 months)

Blood samples will be collected at designated timepoints to estimate the Cmax of MK-1045.
Predose and at designated time points post-dose (up to approximately 11 months)
Part 1A and 1B: Minimum Concentration Just Before the Next Dose (Ctrough) of MK-1045
Časové okno: Predose and at designated time points post-dose (up to approximately 11 months)

Blood samples will be collected at designated timepoints to estimate the Ctrough of MK-1045.
Predose and at designated time points post-dose (up to approximately 11 months)
Part 2: Overall Survival (OS)
Časové okno: Up to approximately 53 months

OS is defined as the time from randomization to death due to any cause.
Up to approximately 53 months
Part 2: ORR
Časové okno: Up to approximately 53 months

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.
Up to approximately 53 months
Part 2: Number of Participants Who Experience an AE
Časové okno: Up to approximately 53 months

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.
Up to approximately 53 months
Part 2: Number of Participants Who Discontinue Study Treatment Due to an AE
Časové okno: Up to approximately 11 months

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.
Up to approximately 11 months
Part 2: CRR
Časové okno: Up to approximately 53 months

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.
Up to approximately 53 months
Part 2: DOR
Časové okno: Up to approximately 53 months

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.
Up to approximately 53 months
Part 2: Minimal Residual Disease (MRD) Negativity Rate
Časové okno: Predose and at designated time points post-dose (up to approximately 11 months)

MRD is defined as the percentage of participants reaching MRD negativity by ctDNA clearance at predefined timepoints.
Predose and at designated time points post-dose (up to approximately 11 months)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Merck Sharp & Dohme LLC

Vyšetřovatelé

  • Ředitel studie: Medical Director, Merck Sharpe & Dohme LLC

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

13. prosince 2026

Primární dokončení (Odhadovaný)

13. března 2037

Dokončení studie (Odhadovaný)

13. března 2037

Termíny zápisu do studia

První předloženo

28. října 2026

První předloženo, které splnilo kritéria kontroly kvality

28. října 2026

První zveřejněno (Aktuální)

5. listopadu 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

5. listopadu 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

28. října 2026

Naposledy ověřeno

1. října 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 1045-010
  • 2025 (Grant/smlouva NIH USA)
  • MK-1045-010 (Jiný identifikátor: MSD)
  • 2025-524261-24-00 (Identifikátor registru: EU CT)
  • U1111-1330-0209 (Identifikátor registru: UTN)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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