NCT03598608Leállítva1/2. fázis
Study to Evaluate the Safety and Efficacy of a Combination of Favezelimab (MK-4280) and Pembrolizumab (MK-3475) in Participants With Hematologic Malignancies (MK-4280-003)
A Phase 1/Phase 2 Clinical Study to Evaluate the Safety and Efficacy of a Combination of MK-4280 and Pembrolizumab (MK-3475) in Participants With Hematologic Malignancies
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. júl. 28.
Megadott ok: Business Reason
Rövid összefoglaló (regiszter, angolul)
This study will evaluate the safety and efficacy of favezelimab (MK-4280) in combination with pembrolizumab (MK-3475) using a non-randomized study design in participants with the following hematological malignancies: * classical Hodgkin lymphoma (cHL) * diffuse large B-cell lymphoma (DLBCL) * indolent non-Hodgkin lymphoma (iNHL) This study will also evaluate the safety and efficacy of pembrolizumab or favezelimab administered as monotherapy in participants with cHL using a 1:1 randomized study design. The study will have 2 phases: a safety lead-in and an efficacy expansion phase. The recommended Phase 2 dose (RP2D) will be determined in the safety lead-in phase by evaluating dose-limiting toxicities. There is no primary hypothesis for this study.
- Állapot (regiszter)
- Leállítva
- Fázis (regiszter)
- 1/2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 137 (tényleges)
- Első benyújtás
- 2018. júl. 16.
- Kezdés
- 2018. okt. 17.
- Elsődleges befejezés
- 2026. jan. 28.
- Fő szponzor
- Merck Sharp & Dohme LLC
- Betegségek
- Hodgkin-limfóma
- NCT-szám
- NCT03598608
- EU CT-szám
- 2023-503587-17-00
- EudraCT-szám
- 2018-001461-16
Ki nem vehet részt
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Korábbi kezelés
- Has received chimeric antigen receptors (CAR)-T-cell therapy for cHL and DLBCL Cohorts
- Has received prior anticancer therapy or thoracic radiation therapy within 14 days before the first dose of study treatment
- Has ≥Grade 2 non-hematological residual toxicities from prior therapy
- Has had a prior anticancer monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤Grade 1 or at baseline) from AEs due to agents administered ≥4 weeks earlier
- Has received a live vaccine within 30 days prior to first dose of study treatment. Administration of killed vaccines are allowed
- Has received an investigational agent or used an investigational device within 4 weeks prior to intervention administration
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug
- Has a known additional malignancy that is progressing or requires active treatment with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy
- Has had an allogeneic hematopoetic stem cell/solid organ transplantation within the last 5 years
Más betegség
- Has active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs)
- Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
- Has an active infection requiring intravenous systemic therapy
- Has a known history of human immunodeficiency virus (HIV) infection
- Has known, active hepatitis B or hepatitis C infection
Laborértékek
- Has received prior therapy with an anti-lymphocyte activation gene-3 (LAG-3) antibody
Egyéb
- Has known clinically active central nervous system (CNS) involvement
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment
Kiket keres a vizsgálat
- Has measurable disease, defined as ≥1 lesion that can be accurately measured in 2 dimensions with diagnostic quality cross sectional anatomic imaging (computed tomography or magnetic resonance imaging). Minimum measurement must be >15 mm in the longest diameter or >10 mm in the short axis
- Is able to provide a core or excisional tumor biopsy for biomarker analysis from an archival (within 3 months) or newly obtained biopsy at screening
- Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (25)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Monash Health (Site 0201) | Clayton | Ausztrália | Ismeretlen állapot |
| Concord Repatriation & General Hospital (Site 0203) | Concord | Ausztrália | Ismeretlen állapot |
| St Vincent s Hospital (Melbourne) Limited (Site 0202) | Fitzroy | Ausztrália | Ismeretlen állapot |
| Princess Alexandra Hospital (Site 0204) | Woollongabba | Ausztrália | Ismeretlen állapot |
| Jewish General Hospital (Site 0105) | Montreal | Kanada | Ismeretlen állapot |
| Princess Margaret Cancer Centre (Site 0100) | Toronto | Kanada | Ismeretlen állapot |
| BC Cancer (Site 0107) | Vancouver | Kanada | Ismeretlen állapot |
| CancerCare Manitoba (Site 0101) | Winnipeg | Kanada | Ismeretlen állapot |
| U. klinikum Koeln AOER (Site 0326) | Cologne | Németország | Ismeretlen állapot |
| Universitaetsklinikum Leipzig AOeR (Site 0327) | Leipzig | Németország | Ismeretlen állapot |
| Rambam Medical Center (Site 0382) | Haifa | Izrael | Ismeretlen állapot |
| Hadassah Ein Karem Jerusalem (Site 0383) | Jerusalem | Izrael | Ismeretlen állapot |
| Chaim Sheba Medical Center. (Site 0380) | Ramat Gan | Izrael | Ismeretlen állapot |
| Sourasky Medical Center (Site 0381) | Tel Aviv | Izrael | Ismeretlen állapot |
| A.O. Universitaria Policlinico S. Orsola-Malpighi (Site 0351) | Bologna | Olaszország | Ismeretlen állapot |
| Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (Site 0354) | Meldola | Olaszország | Ismeretlen állapot |
| Humanitas-U.O di Oncologia medica ed Ematologia (Site 0352) | Rozzano | Olaszország | Ismeretlen állapot |
| Texas Oncology-Austin Midtown (Site 8002) | Austin | Egyesült Államok | Ismeretlen állapot |
| Dana Farber Cancer Institute (Site 0002) | Boston | Egyesült Államok | Ismeretlen állapot |
| City of Hope (Site 0001) | Duarte | Egyesült Államok | Ismeretlen állapot |
| Banner MD Anderson Cancer Center (Site 0020) | Gilbert | Egyesült Államok | Ismeretlen állapot |
| Ronald Reagan UCLA Medical Center (Radiological Sciences) (Site 0007) | Los Angeles | Egyesült Államok | Ismeretlen állapot |
| Pacific Cancer Care (Site 0006) | Monterey | Egyesült Államok | Ismeretlen állapot |
| Fox Chase Cancer Center (Site 0019) | Philadelphia | Egyesült Államok | Ismeretlen állapot |
| University of California San Francisco (Site 0023) | San Francisco | Egyesült Államok | Ismeretlen állapot |
Kapcsolódó publikációk
- Phase 1/2 study of favezelimab plus pembrolizumab in anti-PD-1-naive relapsed or refractory classical Hodgkin lymphoma.Blood Adv · 2026 · PMID 42826707
- Favezelimab plus pembrolizumab for anti-PD-1-refractory classic Hodgkin lymphoma: an open-label phase 1/2 study.Blood Neoplasia · 2026 · PMID 42699247
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