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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06717347
Registration number
NCT06717347
Ethics application status
Date submitted
2/12/2024
Date registered
5/12/2024
Date last updated
16/07/2025
Titles & IDs
Public title
A Study to Evaluate Zilovertamab Vedotin (MK-2140) Combination With Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Previously Untreated DLBCL (MK-2140-010)
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Scientific title
A Randomized, Open-Label, Multicenter, Phase 3 Study of Zilovertamab Vedotin (MK-2140) in Combination With R-CHP Versus R-CHOP in Participants With Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL) (waveLINE-010)
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Secondary ID [1]
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MK-2140-010
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Secondary ID [2]
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2140-010
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diffuse Large B-Cell Lymphoma
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0
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Condition category
Condition code
Cancer
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0
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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0
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Zilovertamab vedotin
Treatment: Other - Rituximab
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Doxorubicin
Treatment: Other - Rituximab Biosimilar
Treatment: Drugs - Prednisone
Treatment: Drugs - Prednisolone
Treatment: Drugs - Vincristine
Treatment: Drugs - Rescue medication
Experimental: Zilovertamab vedotin + Rituximab + Cyclophosphamide, Doxorubicin, Prednisone (R-CHP) - Participants receive a dose of zilovertamab vedotin (1.75 mg/kg) plus 750 mg/m\^2 cyclophosphamide, 50 mg/m\^2 doxorubicin, and 375 mg/m\^2 rituximab or rituximab biosimilar administered by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 6 cycles (up to approximately 4 months) plus 2 cycles of rituximab or biosimilar for participants with high risk DLBCL. Participants also receive 100 mg prednisone or prednisolone via oral tablet per day during Days 1-5 of each 21-day cycle for up to 6 cycles (up to approximately 4 months).
Active comparator: Rituximab + Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (R-CHOP) - Participants receive 750 mg/m\^2 cyclophosphamide, 50 mg/m\^2 doxorubicin, and 375 mg/m\^2 rituximab or rituximab biosimilar, 1.4 mg/m\^2 vincristine administered by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 6 cycles (up to approximately 4 months) plus 2 cycles of rituximab or biosimilar for participants with high risk DLBCL. Participants also receive 100 mg prednisone or prednisolone via oral tablet per day during Days 1-5 of each 21-day cycle for up to 6 cycles (up to approximately 4 months).
Treatment: Other: Zilovertamab vedotin
IV infusion
Treatment: Other: Rituximab
IV infusion
Treatment: Drugs: Cyclophosphamide
IV infusion
Treatment: Drugs: Doxorubicin
IV infusion
Treatment: Other: Rituximab Biosimilar
IV infusion
Treatment: Drugs: Prednisone
Per Approved Product Label
Treatment: Drugs: Prednisolone
Oral administration
Treatment: Drugs: Vincristine
IV infusion
Treatment: Drugs: Rescue medication
Participants receive rescue medication at the investigator's discretion, per approved product label. The recommended rescue medication is granulocyte colony-stimulating factor (G-CSF).
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free survival (PFS)
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Assessment method [1]
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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.
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Timepoint [1]
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Up to ~ 50 months
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Secondary outcome [1]
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Complete Response at End of Treatment (CR at EOT)
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Assessment method [1]
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CR at EOT is defined as a CR per Lugano response criteria as assessed by BICR at end of treatment. Participants with missing data or who discontinue treatment or study prior to reaching EOT will be considered non-responders and included in the total number of participants.
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Timepoint [1]
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Up to ~ 32 months
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Secondary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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OS is defined as the time from randomization to death due to any cause.
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Timepoint [2]
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Up to ~ 74 months
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Secondary outcome [3]
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Event-free Survival (EFS)
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Assessment method [3]
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EFS is defined as the time from randomization to any of the following events: progressive disease that precludes surgery, local or distant recurrence, second primary malignancy or death due to any cause. The EFS for all participants will be presented.
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Timepoint [3]
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0
Up to ~ 74 months
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Secondary outcome [4]
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Duration of Complete Response (DurCR)
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Assessment method [4]
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For participants who demonstrate CR at EOT per Lugano response criteria by BICR, duration of complete response is defined as the time from the first documented evidence of CR at or before EOT until disease progression or death due to any cause, whichever occurs first.
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Timepoint [4]
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0
Up to ~ 74 months
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Secondary outcome [5]
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Number of Participants Who Experience an Adverse Event (AE)
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Assessment method [5]
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An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience at least one AE will be presented.
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Timepoint [5]
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0
Up to ~ 9 months
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Secondary outcome [6]
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Number of Participants Who Discontinue Study Treatment Due to an AE
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Assessment method [6]
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An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be presented.
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Timepoint [6]
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Up to ~ 6 months
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Secondary outcome [7]
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Change From Baseline in Health-Related Quality Of Life (HRQoL) on Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym) Trial Outcome Index (TOI) Score
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Assessment method [7]
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The FACT-Lym is a 42-item questionnaire designed to measure HRQoL and cancer-specific symptoms in non-Hodgkin lymphoma patients. Subscales include FACT-General (FACT-G), FACT-Trial Outcome Index (FACT-TOI), FACT-Lym total score (FACT-Lym TS), and the Lymphoma subscale (Lym S). The Lym S has a single domain consisting of 15 items specific to lymphoma burden with a score ranging from 0 to 60. FACT-G has 4 well-being domains, physical (7 items), social/family (7), emotional (6), and functional (7), with scores ranging from 0 to 108. FACT-TOI combines FACT-G's physical and functional domains with Lym S, with scores ranging from 0 to 116. FACT-Lym TS combines FACT-G with Lym S, with scores ranging from 0 to 168. The scoring of FACT-Lym is on a 5-point Likert scale from 0 to 4, with 0= not at all, 1= a little bit, 2= somewhat, 3=quite a bit, 4=very much. The higher the score the better the quality of life.
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Timepoint [7]
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Baseline and Week 25
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Secondary outcome [8]
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Change From Baseline in HRQoL on FACT-Lym Total Score
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Assessment method [8]
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The FACT-Lym is a 42-item questionnaire designed to measure HRQoL and cancer-specific symptoms in non-Hodgkin lymphoma patients. Subscales include FACT-General (FACT-G), FACT-Trial Outcome Index (FACT-TOI), FACT-Lym total score (FACT-Lym TS), and the Lymphoma subscale (Lym S). The Lym S has a single domain consisting of 15 items specific to lymphoma burden with a score ranging from 0 to 60. FACT-G has 4 well-being domains, physical (7 items), social/family (7), emotional (6), and functional (7), with scores ranging from 0 to 108. FACT-TOI combines FACT-G's physical and functional domains with Lym S, with scores ranging from 0 to 116. FACT-Lym TS combines FACT-G with Lym S, with scores ranging from 0 to 168. The scoring of FACT-Lym is on a 5-point Likert scale from 0 to 4, with 0= not at all, 1= a little bit, 2= somewhat, 3=quite a bit, 4=very much. The higher the score the better the quality of life.
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Timepoint [8]
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Baseline and Week 25
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Secondary outcome [9]
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Change From Baseline in HRQoL on FACT-Lym Physical Wellbeing (PWB) Score
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Assessment method [9]
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0
The FACT-Lym is a 42-item questionnaire designed to measure HRQoL and cancer-specific symptoms in non-Hodgkin lymphoma patients. Subscales include FACT-General (FACT-G), FACT-Trial Outcome Index (FACT-TOI), FACT-Lym total score (FACT-Lym TS), and the Lymphoma subscale (Lym S). The Lym S has a single domain consisting of 15 items specific to lymphoma burden with a score ranging from 0 to 60. FACT-G has 4 well-being domains, physical (7 items), social/family (7), emotional (6), and functional (7), with scores ranging from 0 to 108. FACT-TOI combines FACT-G's physical and functional domains with Lym S, with scores ranging from 0 to 116. FACT-Lym TS combines FACT-G with Lym S, with scores ranging from 0 to 168. The scoring of FACT-Lym is on a 5-point Likert scale from 0 to 4, with 0= not at all, 1= a little bit, 2= somewhat, 3=quite a bit, 4=very much. The higher the score the better the quality of life.
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Timepoint [9]
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Baseline and Week 25
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Secondary outcome [10]
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Change From Baseline in HRQoL on Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) Neurotoxicity Subscale Score
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Assessment method [10]
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The FACT GOG-NTX provides a targeted assessment of symptoms of peripheral neuropathy, including sensory, motor, and auditory problems and cold sensitivity. It is an 11-item questionnaire designed to measure the neurotoxicity subscale. The scoring of FACT GOG-NTX is on a 5-point Likert scale from 0 to 4, with 0= not at all, 1= a little bit, 2= somewhat, 3=quite a bit, 4=very much. To produce a Neurotoxicity Subscale score (range 0-44), multiply the sum of the item scores by the number of items in the subscale, then divide by the number of items answered.
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Timepoint [10]
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Baseline and Week 25
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Eligibility
Key inclusion criteria
* Has histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL), by prior biopsy, based on local testing according to the WHO classification of neoplasms of the hematopoietic and lymphoid tissues
* Has positron emission tomography (PET) positive disease at screening, defined as 4 to 5 on the Lugano 5-point scale
* Has received no prior treatment for their DLBCL
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before randomization
* Has an ejection fraction =45% as determined by either echocardiogram (ECHO) or multigated acquisition (MUGA)
* Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART)
* Who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load prior to randomization
* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Has a history of transformation of indolent disease to DLBCL
* Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL) or Grey zone lymphoma
* Has Ann Arbor Stage I DLBCL
* Has clinically significant (i.e., 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 clinically significant pericardial or pleural effusion
* Has ongoing Grade >1 peripheral neuropathy
* Has a demyelinating form of Charcot-Marie-Tooth disease
* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
* Has ongoing corticosteroid therapy
* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
* Known additional malignancy that is progressing or has required active treatment within the past 2 years
* Known active central nervous system (CNS) lymphoma
* Has active autoimmune disease that has required systemic treatment in the past 2 years
* Has active infection requiring systemic therapy
* Has concurrent active HBV (defined as HBsAg positive and detectable HBV DNA) and HCV (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid (RNA)) infection
* Has history of allogeneic tissue/solid organ transplant
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/01/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
29/03/2032
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Actual
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Sample size
Target
1046
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Townsville University Hospital ( Site 3006) - Douglas
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Recruitment postcode(s) [1]
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4814 - Douglas
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Recruitment outside Australia
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Arizona
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California
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Illinois
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Indiana
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Kansas
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New York
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Tennessee
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Argentina
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Buenos Aires
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Caba
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Santa Fe
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Hainaut
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Parana
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Rio Grande Do Norte
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Ontario
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Biobio
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Coquimbo
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Los Rios
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Valparaiso
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Anhui
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Zhejiang
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Colombia
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Tel Aviv
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Israel
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Tiberias
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Torino
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Ancona
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Novara
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Japan
Query!
State/province [83]
0
0
Ehime
Query!
Country [84]
0
0
Japan
Query!
State/province [84]
0
0
Hyogo
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Country [85]
0
0
Japan
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State/province [85]
0
0
Ishikawa
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Country [86]
0
0
Japan
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State/province [86]
0
0
Kanagawa
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Country [87]
0
0
Japan
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State/province [87]
0
0
Miyagi
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Country [88]
0
0
Japan
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State/province [88]
0
0
Osaka
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Country [89]
0
0
Japan
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State/province [89]
0
0
Saitama
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Country [90]
0
0
Japan
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State/province [90]
0
0
Tokyo
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Country [91]
0
0
Japan
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State/province [91]
0
0
Yamanashi
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Country [92]
0
0
Japan
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State/province [92]
0
0
Chiba
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Country [93]
0
0
Japan
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State/province [93]
0
0
Fukuoka
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Country [94]
0
0
Japan
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State/province [94]
0
0
Hiroshima
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Country [95]
0
0
Japan
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State/province [95]
0
0
Kyoto
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Country [96]
0
0
Japan
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State/province [96]
0
0
Miyazaki
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Country [97]
0
0
Japan
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State/province [97]
0
0
Okayama
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Country [98]
0
0
Japan
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State/province [98]
0
0
Yamagata
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Country [99]
0
0
Korea, Republic of
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State/province [99]
0
0
Kyonggi-do
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Country [100]
0
0
Korea, Republic of
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State/province [100]
0
0
Pusan-Kwangyokshi
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Country [101]
0
0
Korea, Republic of
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State/province [101]
0
0
Taejon-Kwangyokshi
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Country [102]
0
0
Korea, Republic of
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State/province [102]
0
0
Seoul
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Country [103]
0
0
Malaysia
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State/province [103]
0
0
Sabah
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Country [104]
0
0
Malaysia
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State/province [104]
0
0
Sarawak
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Country [105]
0
0
Malaysia
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State/province [105]
0
0
Selangor
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Country [106]
0
0
Mexico
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State/province [106]
0
0
Distrito Federal
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Country [107]
0
0
Mexico
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State/province [107]
0
0
Hidalgo
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Country [108]
0
0
Mexico
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State/province [108]
0
0
Michoacan
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Country [109]
0
0
Mexico
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State/province [109]
0
0
Nuevo Leon
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Country [110]
0
0
Mexico
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State/province [110]
0
0
Oaxaca
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Country [111]
0
0
Netherlands
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State/province [111]
0
0
Utrecht
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Country [112]
0
0
Netherlands
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State/province [112]
0
0
Zuid-Holland
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Country [113]
0
0
Peru
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State/province [113]
0
0
Lambayeque
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Country [114]
0
0
Peru
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State/province [114]
0
0
Lima
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Country [115]
0
0
Poland
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State/province [115]
0
0
Mazowieckie
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Country [116]
0
0
Poland
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State/province [116]
0
0
Pomorskie
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Country [117]
0
0
Poland
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State/province [117]
0
0
Slaskie
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Country [118]
0
0
Poland
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State/province [118]
0
0
Warminsko-mazurskie
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Country [119]
0
0
Portugal
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State/province [119]
0
0
Braga
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Country [120]
0
0
Portugal
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State/province [120]
0
0
Porto
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Country [121]
0
0
Puerto Rico
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State/province [121]
0
0
Mayaguez
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Country [122]
0
0
Puerto Rico
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State/province [122]
0
0
San Juan
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Country [123]
0
0
Romania
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State/province [123]
0
0
Cluj
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Country [124]
0
0
Romania
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State/province [124]
0
0
Sibiu
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Country [125]
0
0
Singapore
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State/province [125]
0
0
Central Singapore
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Country [126]
0
0
South Africa
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State/province [126]
0
0
Western Cape
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Country [127]
0
0
Spain
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State/province [127]
0
0
Andalucia
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Country [128]
0
0
Spain
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State/province [128]
0
0
Barcelona
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Country [129]
0
0
Spain
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State/province [129]
0
0
Las Palmas
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Country [130]
0
0
Spain
Query!
State/province [130]
0
0
Valenciana, Comunitat
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Country [131]
0
0
Spain
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State/province [131]
0
0
Madrid
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Country [132]
0
0
Spain
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State/province [132]
0
0
Malaga
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Country [133]
0
0
Spain
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State/province [133]
0
0
Zaragoza
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Country [134]
0
0
Switzerland
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State/province [134]
0
0
Sankt Gallen
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Country [135]
0
0
Switzerland
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State/province [135]
0
0
Ticino
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Country [136]
0
0
Taiwan
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State/province [136]
0
0
Taoyuan
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Country [137]
0
0
Taiwan
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State/province [137]
0
0
Kaohsiung
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Country [138]
0
0
Taiwan
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State/province [138]
0
0
Tainan
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Country [139]
0
0
Taiwan
Query!
State/province [139]
0
0
Taipei
Query!
Country [140]
0
0
Thailand
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State/province [140]
0
0
Chiang Mai
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Country [141]
0
0
Thailand
Query!
State/province [141]
0
0
Krung Thep Maha Nakhon
Query!
Country [142]
0
0
Turkey
Query!
State/province [142]
0
0
Ankara
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Country [143]
0
0
Ukraine
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State/province [143]
0
0
Cherkaska Oblast
Query!
Country [144]
0
0
Ukraine
Query!
State/province [144]
0
0
Ivano-Frankivska Oblast
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Country [145]
0
0
Ukraine
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State/province [145]
0
0
Khmelnytska Oblast
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Country [146]
0
0
Ukraine
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State/province [146]
0
0
Lvivska Oblast
Query!
Country [147]
0
0
Ukraine
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State/province [147]
0
0
Kyiv
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Merck Sharp & Dohme LLC
Query!
Address
Query!
Country
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Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this study is to evaluate if zilovertamab vedotin with standard treatment can help people live longer without the cancer growing or spreading than people who receive standard treatment alone.
Query!
Trial website
https://clinicaltrials.gov/study/NCT06717347
Query!
Trial related presentations / publications
Query!
Public notes
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Contacts
Principal investigator
Name
0
0
Medical Director
Query!
Address
0
0
Merck Sharp & Dohme LLC
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Toll Free Number
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
1-888-577-8839
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Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06717347
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