NCT07917754Toborzás még nem indult2/3. fázis
A Clinical Trial of MK-1045 With Zilovertamab Vedotin in Participants With Diffuse Large B-cell Lymphoma (MK-1045-010)
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. nov. 5.
Rövid összefoglaló (regiszter, angolul)
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
- Állapot (regiszter)
- Toborzás még nem indult
- Fázis (regiszter)
- 2/3. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 470 (tervezett)
- Első benyújtás
- 2026. okt. 28.
- Kezdés
- 2026. dec. 13.
- Elsődleges befejezés
- 2037. márc. 13.
- Fő szponzor
- Merck Sharp & Dohme LLC
- Betegségek
- Diffúz nagy B-sejtes limfóma (DLBCL)
- NCT-szám
- NCT07917754
- EU CT-szám
- 2025-524261-24-00
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 2/3. fázis
- Tervezett résztvevők: 470
- 2026. dec. 13. és az elsődleges befejezés (2037. márc. 13.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Has received a solid organ transplant.
- Has ongoing corticosteroid therapy (in dosing exceeding 30 mg daily of prednisone equivalent).
- 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.
Más betegség
- Has a known or suspected history of hemophagocytic lymphohistiocytosis (HLH).
- 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 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 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.
Egyéb
- Has a diagnosis of primary mediastinal B-cell lymphoma.
- Has a rare type of DLBCL.
- Has known active CNS lymphoma or involvement of CNS with DLBCL.
- Has been found to be primary refractory to monomethyl auristatin E (MMAE)-containing agents
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
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