| Titre |
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 |
| Protocole ID |
MK-2140-007 (waveLINE) |
| ClinicalTrials.gov ID |
NCT05406401 |
| Type(s) de cancer |
Lymphome non-hodgkinien (LNH) |
| Phase |
Phase II |
| Stade |
Lymphome diffus à grandes cellules B |
| Type étude |
Clinique |
| Médicament |
Zilovertamab védotine en association avec R-CHP |
| Institution |
CIUSSS DU NORD-DE-L'ILE-DE-MONTREAL
 HOPITAL DU SACRE-COEUR-DE-MONTREAL
5400 boul. Gouin Ouest, Montréal, QC, H4J1C5
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dr Jean-Samuel Boudreault-Pedneault
|
| Coordonnateur(trice) |
Caroline Chagnon
514-338-2222 poste 2818
|
| Statut |
 Actif en recrutement |
| Date d'activation |
06-06-2023 |
| Critètes d'éligibilité |
- Has histologically confirmed diagnosis of DLBCL by prior biopsy
- Has positron emission tomography (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
|
| Critètes d'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
|
Groupe d'étude en oncologie du Québec