NCT05406401Active, not recruitingPhase 2
A Study of Zilovertamab Vedotin (MK-2140) in Combination With Cyclophosphamide, Doxorubicin, and Prednisone Plus Rituximab or Rituximab Biosimilar (Truxima) (R-CHP) in Participants With Diffuse Large B-Cell Lymphoma (DLBCL) (MK-2140-007)
A Multicenter, Open-label, Phase 2 Dose Escalation and Confirmation, and Efficacy Expansion Study of Zilovertamab Vedotin (MK-2140) in Combination With R-CHP in Participants With DLBCL (waveLINE)
Source: ClinicalTrials.gov · Last updated 15 Oct 2024
Brief summary (registry, in English)
This study consists of a dose escalation/confirmation phase and an efficacy expansion phase. The dose escalation/confirmation phase is to determine the safety and tolerability and establish a preliminary recommended Phase 2 dose (RP2D) of zilovertamab vedotin when administered in combination with R-CHP in participants with DLBCL who have received no prior treatment for their disease. The efficacy expansion phase is to determine the efficacy of the RP2D of zilovertamab vedotin when administered in combination with R-CHP in participants with DLBCL who have received no prior treatment for their disease.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 1 Jun 2022
- Start date
- 14 Jul 2022
- Primary completion date
- 26 Apr 2029
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- Diffuse large B-cell lymphoma
- NCT number
- NCT05406401
- EU CT number
- 2022-501380-40-00
- EudraCT number
- 2021-005861-41
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From 14 Jul 2022 to the primary completion date, 26 Apr 2029
- 22 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- The main inclusion and exclusion criteria include but are not limited to the following:
- Inclusion:
- Has histologically confirmed diagnosis of DLBCL by prior biopsy
- Has PET-positive disease verified by blinded independent central review (BICR) at screening, defined as 4-5 on the Lugano response criteria 5-point scale
- Has received no prior treatment for DLBCL
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days prior to the start of study intervention
- Exclusion:
- Has a history of transformation of indolent disease to DLBCL
- Has received solid organ transplant at any time
- Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL)
- Has clinically significant (ie, active) cardiovascular disease: cerebral vascular accident/stroke (\<6 months prior to enrollment), myocardial infarction (\<6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), or serious cardiac arrhythmia requiring medication
- Has pericardial effusion or clinically significant pleural effusion
- Has ongoing Grade \>1 peripheral neuropathy
- Has a demyelinating form of Charcot-Marie-Tooth disease
- History of a second malignancy unless potentially curative treatment has been completed with no evidence of malignancy for 2 years with the exception of participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous-cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder
- Has received prior radiotherapy within 28 days of start of study intervention
- Has ongoing corticosteroid therapy (exceeding 30 mg daily of prednisone equivalent)
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
- Has received a strong inhibitor or inducer of CYP3A4 (including itraconazole, ketoconazole, posaconazole, or voriconazole) within 7 days prior to the start of study intervention or expected requirement for chronic use of a strong CYP3A4 inhibitor until \<30 days after the last dose
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 28 days before the first dose of study intervention
- Has known active central nervous system (CNS) lymphoma
- Has an active infection requiring systemic therapy
- Has a known history of human immunodeficiency virus (HIV) infection
- Has a known active hepatitis C virus infection
- Has a known active hepatitis B virus infection
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (22)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopital du Sacre-Coeur de Montreal ( Site 0108) Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| William Osler Health System ( Site 0106) Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| BC Cancer Victoria-Clinical Trials Unit ( Site 0105) Coordinator of this site? Confirm its status | Victoria | Canada | Unknown status |
| Catalan Institute of Oncology Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Active, not recruiting |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Hadassah Medical Center ( Site 0401) Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Sheba Medical Center-Hemato Oncology ( Site 0400) Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Azienda Ospedaliera Nazionale Ss Antonio E Biagio E C Arrigo Alessandria Coordinator of this site? Confirm its status | Alexandria | Italy | Active, not recruiting |
| Careggi University Hospital Coordinator of this site? Confirm its status | Florence | Italy | Active, not recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello Coordinator of this site? Confirm its status | Palermo | Italy | Active, not recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Seoul National University Hospital ( Site 0201) Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center ( Site 0200) Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Active, not recruiting |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Gliwice | Poland | Active, not recruiting |
| Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi Coordinator of this site? Confirm its status | Lodz | Poland | Active, not recruiting |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 0801) Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Trakya University ( Site 0805) Coordinator of this site? Confirm its status | Edirne | Turkey (Türkiye) | Unknown status |
| Mega Medipol-Hematology ( Site 0808) Coordinator of this site? Confirm its status | Stanbul | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.