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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03816254
Registration number
NCT03816254
Ethics application status
Date submitted
19/12/2018
Date registered
21/12/2018
Date last updated
9/08/2024
Titles & IDs
Public title
A Study of CC-95251, a Monoclonal Antibody Directed Against SIRPa, in Participants With Advanced Solid and Hematologic Cancers
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Scientific title
A Phase 1, Open-label, Dose Finding Study of CC-95251, a Monoclonal Antibody Directed Against SIRPa, Alone and in Combination With Cetuximab or Rituximab in Subjects With Advanced Solid and Hematologic Cancers
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Secondary ID [1]
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U1111-1224-8251
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Secondary ID [2]
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CC-95251-ST-001
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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:
Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Placebo comparator: Placebo - Participants received atogepant-matching placebo tablets, orally, twice daily (BID) for 12 weeks in a double-blind (DB) treatment period.
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Comparator / control treatment
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Control group
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Outcomes
Eligibility
Key inclusion criteria
* Progressed on standard anticancer therapy or for whom no other approved conventional therapy exists and have histological or cytological confirmation of advanced unresectable solid tumors, advanced unresectable colorectal cancer, or squamous cell carcinoma of the head and neck, or CD20-positive non-Hodgkin's lymphoma, or diffuse large B cell lymphoma, or follicular lymphoma
* Solid tumors must have at least one site of measurable disease as determined by RECIST v1.1
* Eastern cooperative oncology group performance status of 0 or 1
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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
* High-grade lymphomas (Burkitt's or lymphoblastic)
* Has cancer with symptomatic central nervous system (CNS) involvement
* History of class III or IV congestive heart failure (CHF) or severe non-ischemic cardiomyopathy, unstable angina, myocardial infarction, or ventricular arrhythmia within the previous 6 months
Other protocol-defined inclusion/exclusion criteria apply
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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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
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not 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
1/02/2019
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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
23/08/2024
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Actual
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Sample size
Target
230
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Celgene
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the safety, tolerability, and preliminary clinical activity of CC-95251 as a single agent and in combination with cetuximab and rituximab in participants with advanced solid and hematologic cancers.
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Trial website
https://clinicaltrials.gov/study/NCT03816254
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
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/NCT03816254
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