Trial Outcomes & Findings for A Study of Bomedemstat (IMG-7289/MK-3543) in Participants With Polycythemia Vera (IMG-7289-CTP-203/MK-3543-004) (NCT NCT05558696)

Last Updated: 2026-05-07

Results Overview

An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with one or more AEs are reported.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

Up to approximately 52 weeks

Results posted on

2026-05-07

Participant Flow

This study recruited participants with Polycythemia Vera (PV) requiring cytoreduction that have failed at least one standard cytoreductive therapy (failure is the equivalent of resistance or intolerance).

Participant milestones

Participant milestones
Measure	Bomedemstat Participants received 40 mg bomedemstat orally once daily for 52 weeks.
Overall Study STARTED	20
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Bomedemstat Participants received 40 mg bomedemstat orally once daily for 52 weeks.
Overall Study Withdrawal by Subject	4
Overall Study Progressive Disease	1
Overall Study Physician Decision	2
Overall Study Death	1
Overall Study Transition Into Extension Study	7

Baseline Characteristics

A Study of Bomedemstat (IMG-7289/MK-3543) in Participants With Polycythemia Vera (IMG-7289-CTP-203/MK-3543-004)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bomedemstat n=20 Participants Participants received 40 mg bomedemstat orally once daily for 52 weeks.
Age, Continuous	65.0 Years STANDARD_DEVIATION 12.5 • n=54 Participants
Sex: Female, Male Female	5 Participants n=54 Participants
Sex: Female, Male Male	15 Participants n=54 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=54 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=54 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=54 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=54 Participants
Race (NIH/OMB) Asian	0 Participants n=54 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=54 Participants
Race (NIH/OMB) Black or African American	0 Participants n=54 Participants
Race (NIH/OMB) White	20 Participants n=54 Participants
Race (NIH/OMB) More than one race	0 Participants n=54 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=54 Participants
Mean Hematocrit Counts at Baseline	43.99 Percentage STANDARD_DEVIATION 4.27 • n=54 Participants

PRIMARY outcome

Timeframe: Up to approximately 52 weeks

Population: All participants who received at least one dose of study intervention

Outcome measures

Outcome measures
Measure	Bomedemstat n=20 Participants Participants received 40 mg bomedemstat orally once daily for 52 weeks.
Number of Participants With Adverse Events (AEs)	20 Participants

PRIMARY outcome

Timeframe: Up to approximately 52 weeks

Population: All participants who received at least one dose of study intervention

Outcome measures

Outcome measures
Measure	Bomedemstat n=20 Participants Participants received 40 mg bomedemstat orally once daily for 52 weeks.
Number of Participants Who Discontinued Study Intervention Due to AEs	0 Participants

PRIMARY outcome

Timeframe: Up to approximately 36 weeks

Population: All participants who received at least one dose of study intervention and had a valid baseline and one valid post-baseline hematology measure

Hematocrit (Hct) was analyzed by taking blood samples from participants at designated time points during the study. Participants were considered responders if they achieved a sustained reduction of Hct to \<45% for 12 weeks (84 calendar days) by Week 36 AND there was no concomitant phlebotomy performed during the sustained reduction. Baseline data was defined as the data most recently collected prior to the first dose. A Clopper-Pearson (exact binomial) two-sided 95% confidence interval for the percentage of responders was presented. The percentage of participants who achieved a sustained 12-week reduction of Hct to \<45% without concomitant phlebotomy at Week 36 are reported.

Outcome measures

Outcome measures
Measure	Bomedemstat n=20 Participants Participants received 40 mg bomedemstat orally once daily for 52 weeks.
Percentage of Participants With Sustained 12-week Reduction of Hematocrit (Hct) to <45% Without Concomitant Phlebotomy by Week 36	45.0 Percentage of Participants Interval 23.1 to 68.5

SECONDARY outcome

Timeframe: Up to approximately 22 months

Population: All participants who received at least one dose of study intervention and had a sustained reduction of Hct to \<45% at any timepoint

Total response duration was defined as the summation of all Hct \<45% response durations, where an individual response duration starts at the timepoint where the Hct \<45% and ends at the first subsequent occurrence of phlebotomy or Hct \>=45%. Hct was analyzed by taking blood samples from participants at designated time points during the study. Duration of reduction of Hct to \<45% without phlebotomy was presented.

Outcome measures

Outcome measures
Measure	Bomedemstat n=18 Participants Participants received 40 mg bomedemstat orally once daily for 52 weeks.
Duration of Reduction of Hematocrit (Hct) to <45% Without Phlebotomy	6.4 Months Interval 0.3 to 21.2

SECONDARY outcome

Timeframe: Up to approximately 36 weeks

Population: All participants who received at least one dose of study intervention and had a valid baseline and one valid post-baseline hematology measure

Platelet count was analyzed by taking blood samples from participants at designated time points during the study. Participants who enter the study with platelet counts ≤450 X 10\^9/L must achieve an additional on-study platelet count ≤450 X 10\^9/L to be considered responders. A Clopper-Pearson (exact binomial) two-sided 95% confidence interval for the percentage of responders is presented. Baseline data was defined as the data most recently collected prior to the first dose. The percentage of participants who have a platelet count ≤450 X 10\^9/L by week 36 are reported.

Outcome measures

Outcome measures
Measure	Bomedemstat n=20 Participants Participants received 40 mg bomedemstat orally once daily for 52 weeks.
Percentage of Participants With Platelet Count ≤ 450 x 10^9/L by Week 36	90.0 Percentage of Participants Interval 68.3 to 98.8

SECONDARY outcome

Timeframe: Up to approximately 22 months

Population: All participants who received at least one dose of study intervention and had platelet count ≤ 450 x 10\^9/L at any timepoint

Total response duration was defined as the summation of all platelet ≤450 x 10\^9/L response durations, where an individual response duration starts at the timepoint where platelet count ≤450 x 10\^9/L and ends at the first subsequent occurrence of platelet \>450 x 10\^9/L. Platelet counts were analyzed by taking blood samples from participants at designated time points during the study. The duration of platelet count ≤450 X 10\^9/L in participants are reported.

Outcome measures

Outcome measures
Measure	Bomedemstat n=18 Participants Participants received 40 mg bomedemstat orally once daily for 52 weeks.
Duration of Platelet Count ≤ 450 x 10^9/L	11.3 Months Interval 0.0 to 18.1

SECONDARY outcome

Timeframe: Up to approximately 36 weeks

Population: All participants who received at least one dose of study intervention and a valid baseline and one valid post-baseline hematology measure

WBC count was analyzed by taking blood samples from participants at designated time points during the study. Participants who enter the study with WBC counts \<10 X 10\^9/L must achieve an additional on-study WBC count \<10 X 10\^9/L to be considered responders. A Clopper-Pearson (exact binomial) two-sided 95% confidence interval for the percentage of responders is presented. Baseline data was defined as the data most recently collected prior to the first dose. The percentage of participants who have a WBC count \<10 X 10\^9/L week 36 are reported.

Outcome measures

Outcome measures
Measure	Bomedemstat n=20 Participants Participants received 40 mg bomedemstat orally once daily for 52 weeks.
Percentage of Participants With White Blood Cell (WBC) Count <10 x 10^9/L by Week 36	75.0 Percentage of Participants Interval 50.9 to 91.3

SECONDARY outcome

Timeframe: Up to approximately 22 months

Population: All participants who received at least one dose of study intervention and had WBC count \<10 x 10\^9/L at any timepoint

Total response duration was defined as the summation of all WBC \<10 x 10\^9/L response durations, where an individual response duration starts at the timepoint when WBC \<10 x 10\^9/L and ends at the first subsequent occurrence of WBC ≥ 10 x 10\^9/L. WBC count was analyzed by taking blood samples from participants at designated time points during the study. The duration of WBC count \<10 X 10\^9/L in participants are reported.

Outcome measures

Outcome measures
Measure	Bomedemstat n=19 Participants Participants received 40 mg bomedemstat orally once daily for 52 weeks.
Duration of White Blood Cell (WBC) Count <10 x 10^9/L	6.5 Months Interval 0.0 to 18.2

SECONDARY outcome

Timeframe: Up to approximately 22 months

Population: All participants who received at least one dose of study intervention and a valid baseline and one valid post-baseline hematology measure

Thrombotic events are defined as: new or recurrent acute myocardial infarction; unstable angina; stroke; transient ischemic attack (TIA); deep venous thrombosis (DVT); pulmonary embolism (PE); thrombotic digital ischemia; other thrombotic events such as peripheral limb ischemia or Budd-Chiari syndrome that are assessed to be due to underlying polycythemia vera (PV); other vascular occlusive events such as symptoms of cardiac, abdominal or peripheral limb ischemia supported by objective evidence of vessel disease and/or ischemia. Baseline data was defined as the data most recently collected prior to the first dose. The number of participants with thrombotic events are reported.

Outcome measures

Outcome measures
Measure	Bomedemstat n=20 Participants Participants received 40 mg bomedemstat orally once daily for 52 weeks.
Number of Participants With Thrombotic Events	0 Participants

SECONDARY outcome

Timeframe: Up to approximately 22 months

Population: All participants who received at least one dose of study intervention and a valid baseline and one valid post-baseline hematology measure

Hemorrhagic events were defined as: Major Bleeding (MB) Events such as fatal bleeding, and/or symptomatic bleeding in a critical area or organ such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or bleeding causing a fall in hemoglobin level of 2 g/dL or more, or leading to transfusion of 2 or more units of whole blood or red cells; Clinically Relevant Non-Major Bleeding (CRNMB) Events Leading to hospitalization or increased level of care or clinically important, prompting a face-to-face medical evaluation. Baseline data was defined as the data most recently collected prior to the first dose. The number of participants with major hemorrhagic events are reported.

Outcome measures

Outcome measures
Measure	Bomedemstat n=20 Participants Participants received 40 mg bomedemstat orally once daily for 52 weeks.
Number of Participants With Major Hemorrhagic Events	1 Participants

SECONDARY outcome

Timeframe: Up to approximately 36 weeks

Population: All participants who received at least one dose of study intervention and had an enlarged spleen of \>450 cm\^3 at baseline and had a valid baseline and post-baseline measurement

Spleen volume was measured by magnetic resonance imaging (MRI) (or computerized tomography \[CT\] if participant is not a candidate for MRI) of the abdomen according to standard procedures. Baseline data was defined as the data most recently collected prior to the first dose. The number of participants with an enlarged spleen at baseline (volume \>450 cm\^3) who achieved any reduction in spleen volume by Week 36 are reported.

Outcome measures

Outcome measures
Measure	Bomedemstat n=15 Participants Participants received 40 mg bomedemstat orally once daily for 52 weeks.
Number of Participants With an Enlarged Spleen at Baseline Who Had a Reduction in Splenic Volume by 36 Weeks	6 Participants

SECONDARY outcome

Timeframe: Up to approximately 52 weeks

Population: All participants who received at least one dose of study intervention and a valid baseline and one valid post-baseline hematology measure

PD was defined as the worsening of Polycythemia Vera (PV) to post-PV myelofibrosis, myelodysplastic syndrome or transformation to acute myeloid leukemia. Baseline data was defined as the data most recently collected prior to the first dose. The number of participants with PD are reported.

Outcome measures

Outcome measures
Measure	Bomedemstat n=20 Participants Participants received 40 mg bomedemstat orally once daily for 52 weeks.
Number of Participants With Progressive Disease (PD)	1 Participants

Adverse Events

Bomedemstat

Serious events: 8 serious events

Other events: 20 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Bomedemstat n=20 participants at risk Participants received 40 mg bomedemstat orally once daily for 52 weeks.
Blood and lymphatic system disorders Anaemia	5.0% 1/20 • Number of events 1 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
Cardiac disorders Cardiac failure	5.0% 1/20 • Number of events 1 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
Ear and labyrinth disorders Vertigo	5.0% 1/20 • Number of events 1 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
Infections and infestations Diverticulitis	5.0% 1/20 • Number of events 1 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
Infections and infestations Osteomyelitis acute	5.0% 1/20 • Number of events 1 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
Infections and infestations Wound infection	5.0% 1/20 • Number of events 1 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
Metabolism and nutrition disorders Hyperkalaemia	5.0% 1/20 • Number of events 2 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
Nervous system disorders Encephalopathy	5.0% 1/20 • Number of events 1 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
Nervous system disorders Haemorrhagic stroke	5.0% 1/20 • Number of events 1 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
Nervous system disorders Headache	5.0% 1/20 • Number of events 1 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
Nervous system disorders Syncope	5.0% 1/20 • Number of events 1 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
Renal and urinary disorders Urinary retention	5.0% 1/20 • Number of events 1 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
Vascular disorders Haemorrhage	5.0% 1/20 • Number of events 1 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.

Other adverse events

Other adverse events
Measure	Bomedemstat n=20 participants at risk Participants received 40 mg bomedemstat orally once daily for 52 weeks.
Blood and lymphatic system disorders Thrombocytopenia	10.0% 2/20 • Number of events 4 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
Blood and lymphatic system disorders Thrombocytosis	10.0% 2/20 • Number of events 3 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
Gastrointestinal disorders Abdominal distension	10.0% 2/20 • Number of events 2 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
Gastrointestinal disorders Abdominal pain	25.0% 5/20 • Number of events 6 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
Gastrointestinal disorders Abdominal pain lower	10.0% 2/20 • Number of events 2 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
Gastrointestinal disorders Constipation	45.0% 9/20 • Number of events 11 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
Gastrointestinal disorders Diarrhoea	40.0% 8/20 • Number of events 18 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
Gastrointestinal disorders Nausea	35.0% 7/20 • Number of events 9 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
Gastrointestinal disorders Vomiting	15.0% 3/20 • Number of events 4 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
General disorders Fatigue	40.0% 8/20 • Number of events 17 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
General disorders Oedema peripheral	10.0% 2/20 • Number of events 5 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
Infections and infestations COVID-19	20.0% 4/20 • Number of events 4 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
Infections and infestations Postoperative wound infection	10.0% 2/20 • Number of events 3 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
Infections and infestations Sinusitis	10.0% 2/20 • Number of events 2 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
Infections and infestations Tooth infection	10.0% 2/20 • Number of events 2 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
Infections and infestations Upper respiratory tract infection	10.0% 2/20 • Number of events 2 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
Infections and infestations Urinary tract infection	20.0% 4/20 • Number of events 4 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
Infections and infestations Wound infection	15.0% 3/20 • Number of events 3 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
Injury, poisoning and procedural complications Contusion	30.0% 6/20 • Number of events 7 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
Investigations Neutrophil count decreased	10.0% 2/20 • Number of events 2 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
Investigations Platelet count decreased	20.0% 4/20 • Number of events 10 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
Investigations Weight decreased	20.0% 4/20 • Number of events 7 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
Metabolism and nutrition disorders Decreased appetite	15.0% 3/20 • Number of events 3 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
Musculoskeletal and connective tissue disorders Arthralgia	35.0% 7/20 • Number of events 8 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
Musculoskeletal and connective tissue disorders Joint swelling	10.0% 2/20 • Number of events 2 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
Musculoskeletal and connective tissue disorders Muscle spasms	10.0% 2/20 • Number of events 3 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
Musculoskeletal and connective tissue disorders Pain in extremity	15.0% 3/20 • Number of events 4 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	10.0% 2/20 • Number of events 2 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	10.0% 2/20 • Number of events 2 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
Nervous system disorders Dizziness	10.0% 2/20 • Number of events 3 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
Nervous system disorders Dysgeusia	40.0% 8/20 • Number of events 10 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
Nervous system disorders Headache	25.0% 5/20 • Number of events 10 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
Nervous system disorders Paraesthesia	10.0% 2/20 • Number of events 2 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
Psychiatric disorders Insomnia	10.0% 2/20 • Number of events 2 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
Renal and urinary disorders Pollakiuria	10.0% 2/20 • Number of events 2 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
Respiratory, thoracic and mediastinal disorders Cough	10.0% 2/20 • Number of events 2 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
Respiratory, thoracic and mediastinal disorders Dyspnoea	10.0% 2/20 • Number of events 2 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
Skin and subcutaneous tissue disorders Hyperhidrosis	15.0% 3/20 • Number of events 4 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
Skin and subcutaneous tissue disorders Pruritus	30.0% 6/20 • Number of events 8 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
Skin and subcutaneous tissue disorders Rash	15.0% 3/20 • Number of events 4 • Up to approximately 22 months All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor will actively pursue publication of the results of the study in cooperation with the Lead Investigators subject to the terms and conditions of the clinical trial agreement between Sponsor and Investigators. The Lead/Coordinating Investigator, with the agreement of Sponsor, will coordinate the principal publication of the data arising from the study. Participant names and other personal data may not be disclosed in any publication without prior written authorization.
Publication restrictions are in place

Restriction type: OTHER