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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05169684
Registration number
NCT05169684
Ethics application status
Date submitted
10/12/2021
Date registered
27/12/2021
Date last updated
10/06/2025
Titles & IDs
Public title
A Study of BMS-986218 or BMS-986218 Plus Nivolumab in Combination With Docetaxel in Participants With Metastatic Castration-resistant Prostate Cancer
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Scientific title
A Phase 2, Open-label, Randomized Controlled Trial of BMS-986218 or BMS-986218 Plus Nivolumab in Combination With Docetaxel in Participants With Metastatic Castration-resistant Prostate Cancer
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Secondary ID [1]
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2021-003990-74
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Secondary ID [2]
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CA022-009
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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:
Prostatic Neoplasms, Castration-Resistant
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Condition category
Condition code
Cancer
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Prostate
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - BMS-986218
Treatment: Drugs - Docetaxel
Treatment: Other - Nivolumab
Experimental: Arm 1A: Docetaxel + BMS-986218 -
Experimental: Arm 1B: Docetaxel + BMS-986218 + Nivolumab -
Experimental: Arm 2A: Docetaxel -
Experimental: Arm 2B: Docetaxel + BMS-986218 -
Experimental: Arm 2C: Docetaxel + BMS-986218 + Nivolumab -
Experimental: Arm 2D (Optional Crossover): BMS-986218 + Nivolumab -
Treatment: Other: BMS-986218
Specified dose on specified days
Treatment: Drugs: Docetaxel
Specified dose on specified days
Treatment: Other: Nivolumab
Specified dose on specified days
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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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Number of Participants With Treatment Related Adverse Events
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Assessment method [1]
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Adverse events will presented using National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI CTCAE v5).
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Timepoint [1]
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From first dose to 100 days follow up to last dose (Approximately 22 months)
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Primary outcome [2]
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Number of Participants With Treatment Related Serious Adverse Events
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Assessment method [2]
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Adverse events will presented using National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI CTCAE v5).
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Timepoint [2]
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From first dose to 100 days follow up to last dose (Approximately 22 months)
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Primary outcome [3]
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Number of Participants With Dose Limiting Toxicities
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Assessment method [3]
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DLTs will be defined as: Any treatment-related AEs for which a participant permanently discontinues a study treatment (other than daily prednisone) and that occurs during the first 2 cycles of treatment. Any death not clearly due to the underlying disease or extraneous causes and that occurs during the first 2 cycles of treatment Greater than or equal to Grade 2 pneumonitis lasting greater than 5 days despite appropriate medical therapy and that occurs during the first 2 cycles of treatment Any neutropenic fever as well as Grade 4 neutropenia or thrombocytopenia for \> 7 days that occurs during the first 2 cycles of treatment Any treatment-related AE that delays initiation of Cycle 2 or Cycle 3 of treatment by greater than 2 consecutive weeks.
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Timepoint [3]
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From first dose to 100 days follow up to last dose (Approximately 22 months)
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Primary outcome [4]
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Number of Participants With AEs Leading to Discontinuation
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Assessment method [4]
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Adverse events will presented using National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI CTCAE v5).
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Timepoint [4]
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From first dose to 100 days follow up to last dose (Approximately 22 months)
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Primary outcome [5]
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Number of Participants Who Died
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Assessment method [5]
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Number of participant deaths
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Timepoint [5]
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From first dose to 100 days follow up to last dose (Approximately 22 months)
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Secondary outcome [1]
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Prostate Specific Antigen Response Rate (PSA-RR)
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Assessment method [1]
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PSA-RR is the proportion of randomized participants with a 50% or greater decrease in PSA from baseline to any post-baseline PSA result. A second consecutive value obtained 3 or more weeks later is required to confirm the PSA response.
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Timepoint [1]
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From first dose to 100 days follow up to last dose (Approximately 22 months)
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Secondary outcome [2]
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Objective Response Rate
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Assessment method [2]
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Objective response rate per PCWG3 (ORR-PCWG3) is the proportion of participants who have a confirmed complete or partial best overall response (BOR) per PCWG3 among randomized participants who have measurable disease at baseline. The BOR is defined as the best response designation, as determined by the BICR, recorded between the date of randomization and the date of objectively documented radiographic progression, or last tumor measurement, whichever occurs first.
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Timepoint [2]
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From first dose to 100 days follow up to last dose (Approximately 22 months)
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Secondary outcome [3]
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Time to Response
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Assessment method [3]
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Time to response per PCWG3 (TTR-PCWG3) is the time from randomization date to the date of the first documented CR or PR per PCWG3, as determined by BICR.
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Timepoint [3]
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From first dose to 100 days follow up to last dose (Approximately 22 months)
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Secondary outcome [4]
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Duration of Response
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Assessment method [4]
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Duration of response per PCWG3 (DOR-PCWG3) is the time between the date of first response (CR/PR per PCWG3) to the date of first documented radiographic progression per PCWG3 (as determined by BICR), or death due to any cause.
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Timepoint [4]
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From first dose to 100 days follow up to last dose (Approximately 22 months)
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Secondary outcome [5]
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Overall Survival
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Assessment method [5]
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OS for all randomized participants is the time between randomization date and the date of death from any cause.
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Timepoint [5]
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From first dose to 100 days follow up to last dose (Approximately 22 months)
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Eligibility
Key inclusion criteria
* Histologic confirmation of carcinoma of the prostate without small cell features
* Documented prostate cancer progression by Prostate Cancer Working Group 3 (PCWG3) criteria while castrate
* Evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computed tomography (CT)/magnetic resonance imaging (MRI)
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
* Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) agonist/antagonist or bilateral orchiectomy (i.e., surgical or medical castration) confirmed by testosterone level = 1.73 nmol/L (50 ng/dL) at the screening visit
* Chemotherapy-naive for metastatic castration-resistant prostate cancer (mCRPC) and have received at least one novel antiandrogen therapy (NAT)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment assignment in Part 1 or randomization in Part 2
* Untreated central nervous system (CNS) metastases
* Leptomeningeal metastases
* Active, known or suspected autoimmune disease
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
Randomised controlled 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
Other
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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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
14/02/2022
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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
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Actual
6/12/2023
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Sample size
Target
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Accrual to date
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Final
10
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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United States of America
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Arizona
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California
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Colorado
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Connecticut
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Delaware
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Georgia
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Illinois
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Iowa
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Wisconsin
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France
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Toulouse
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Italy
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MI
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Italy
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Meldola
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Italy
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Modena
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Italy
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State/province [22]
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Pozzuoli
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bristol-Myers Squibb
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to assess the safety, efficacy, tolerability, and toxicity of docetaxel alone, in combination with BMS-986218, or in combination with nivolumab plus BMS-986218 in men who have metastatic castration-resistant prostate cancer (mCRPC) that progressed after novel antiandrogen therapy and have not received chemotherapy for mCRPC.
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Trial website
https://clinicaltrials.gov/study/NCT05169684
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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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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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BMS Study Connect Contact Center www.BMSStudyConnect.com
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Address
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Country
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Phone
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855-907-3286
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Fax
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Email
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[email protected]
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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
Type
Other Details
Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/84/NCT05169684/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/84/NCT05169684/Prot_SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT05169684
Download to PDF