Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18+
Clinical summary
Summary
The main purpose of the study is to transition participants into an extension study to collect long-term safety and efficacy data.
This study will include participants who are safely tolerating bomedemstat, receiving clinical benefit from its use in estimation of the Investigator, and have shown the following criteria:
- Partcipants from the IMG-7289-202/MK-3543-005 (NCT05223920) study must have received at least 6 months of treatment with bomedemstat;
- Essential thrombocythemia (ET) and polycythemia vera (PV) participants from studies other than IMG-7289-202/MK-3543-005 must have achieved confirmed haematologic remission.
Eligibility
Inclusion
- Is from a bomedemstat study sponsored by Imago BioSciences, Inc. (a subsidiary of Merck & Co., Inc.) or MSD, and established by the Sponsor as MK-3543-017 ready
- Has received at least 6 months of treatment with bomedemstat in the IMG-7289-202/MK-3543-005 study, while safely tolerating bomedemstat, and receiving clinical benefit from its use in the estimation of the investigator
- ET and PV participants from established feeder studies other than IMG-7289- 202/MK-3543-005 must have achieved confirmed hematologic remission, must be safely tolerating bomedemstat, and must be receiving clinical benefit from its use in the estimation of the investigator
- Is not currently on a dose hold
- Participant must be able to swallow oral medication and follow instructions for at-home dosing of bomedemstat
Exclusion
- Has received prohibited concomitant medications
- Ongoing or planned participation in another investigational study
- Has noncompliance in prior bomedemstat study receiving <90% of assigned doses excluding suspensions or holds as assigned by the investigator
Inclusion
- You have previously participated in a certain specific clinical trial.
- You are able to swallow medication by mouth.
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
- NCT06351631 *
- 3543-017; 2023-506996-89-00; U1111-1294-8621; MK-3543-017
Trial sponsor
Merck Sharp & Dohme LLC
Scientific Title
A Multicenter, Open-Label, Extension Study Evaluating the Safety and Efficacy of Bomedemstat for the Treatment of Participants Enrolled in a Prior Bomedemstat Clinical Study
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