Trial Outcomes & Findings for A Study of Zilovertamab Vedotin (MK-2140/VLS-101) in Participants With Solid Tumors (MK-2140-002) (NCT NCT04504916)

NCT ID: NCT04504916

Last Updated: 2025-11-10

Results Overview

The percentage of participants who achieved a Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: a ≥30% decrease in the sum of diameters \[SOD\] of target lesions) using per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 by BICR was reported.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 102 participants
• Primary outcome timeframe: Up to ~18 months
• Results posted on: 2025-11-10

Participant Flow

Participants enrolled prior to Amendment 3 received intravenous (IV) zilovertamab vedotin 2.5 mg/kg on Day 1 of each repeated 21-day cycle (Q1/3W). Participants enrolled after Amendment 3 received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 (Q2/3W) of each repeated 21-day cycle.

Participant milestones

Measure	Zilovertamab Vedotin Q1/3W Participants received IV zilovertamab vedotin 2.5 mg/kg on Day 1 of each repeated 21-day cycle (Q1/3W). Treatment continued until progressive disease or discontinuation.	Zilovertamab Vedotin Q2/3W Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.
Overall Study STARTED	70	32
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	70	32

Reasons for withdrawal

Measure	Zilovertamab Vedotin Q1/3W Participants received IV zilovertamab vedotin 2.5 mg/kg on Day 1 of each repeated 21-day cycle (Q1/3W). Treatment continued until progressive disease or discontinuation.	Zilovertamab Vedotin Q2/3W Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.
Overall Study Study terminated	7	8
Overall Study Death	54	18
Overall Study Lost to Follow-up	1	1
Overall Study Withdrawal by Subject	8	4
Overall Study Did not agree to follow-up	0	1

Baseline Characteristics

A Study of Zilovertamab Vedotin (MK-2140/VLS-101) in Participants With Solid Tumors (MK-2140-002)

Baseline characteristics by cohort

Measure	Zilovertamab Vedotin Q1/3W n=70 Participants Participants received IV zilovertamab vedotin 2.5 mg/kg on Day 1 of each repeated 21-day cycle (Q1/3W). Treatment continued until progressive disease or discontinuation.	Zilovertamab Vedotin Q2/3W n=32 Participants Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.	Total n=102 Participants Total of all reporting groups
Age, Continuous	58.7 Years STANDARD_DEVIATION 11.79 • n=5 Participants	62.7 Years STANDARD_DEVIATION 11.62 • n=20 Participants	60.0 Years STANDARD_DEVIATION 11.82 • n=40 Participants
Sex: Female, Male Female	64 Participants n=5 Participants	24 Participants n=20 Participants	88 Participants n=40 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	8 Participants n=20 Participants	14 Participants n=40 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	1 Participants n=20 Participants	7 Participants n=40 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	63 Participants n=5 Participants	29 Participants n=20 Participants	92 Participants n=40 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=20 Participants	3 Participants n=40 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=20 Participants	1 Participants n=40 Participants
Race (NIH/OMB) Asian	11 Participants n=5 Participants	1 Participants n=20 Participants	12 Participants n=40 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	1 Participants n=20 Participants	8 Participants n=40 Participants
Race (NIH/OMB) White	46 Participants n=5 Participants	29 Participants n=20 Participants	75 Participants n=40 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	1 Participants n=20 Participants	6 Participants n=40 Participants

PRIMARY outcome

Timeframe: Up to ~18 months

Population: Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug

The percentage of participants who achieved a Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: a ≥30% decrease in the sum of diameters [SOD] of target lesions) using per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 by BICR was reported.

Outcome measures

Measure	Zilovertamab Vedotin Q2/3W n=70 Participants Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.	Zilovertamab Vedotin Q2/3W n=32 Participants Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.
Objective Response Rate (ORR)- Blinded Independent Central Review (BICR)	1.4 Percentage of Participants Interval 0.0 to 7.7	0.0 Percentage of Participants None of the participants met criteria

SECONDARY outcome

Timeframe: Up to ~18 months

Population: FAS which included all participants who received ≥1 dose of study drug

The percentage of participants who achieved a CR (disappearance of all target lesions) or PR (≥30% decrease in the sum of diameters [SOD] of target lesions) per RECIST, Version 1.1 by investigator was reported.

Outcome measures

Measure	Zilovertamab Vedotin Q2/3W n=70 Participants Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.	Zilovertamab Vedotin Q2/3W n=32 Participants Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.
ORR- Investigator Assessed	1.4 Percentage of Participants Interval 0.0 to 7.7	0.0 Percentage of Participants None of the participants met criteria

SECONDARY outcome

Timeframe: Up to ~30 months

Population: Responding Analysis Set which included data from participants in the FAS who had measurable disease, who could be evaluated for tumor response with both baseline and on-study tumor evaluations, and who achieved an objective response.

TTR, defined as the time from the start of study treatment to the first documentation of objective tumor response per RECIST, Version 1.1 by BICR was reported.

Outcome measures

Measure	Zilovertamab Vedotin Q2/3W n=1 Participants Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.	Zilovertamab Vedotin Q2/3W Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.
Time to Response (TTR)- BICR	1.9 Months Standard Deviation NA Could not be calculated due to N=1	—

SECONDARY outcome

Timeframe: Up to ~30 months

Population: Responding Analysis Set which included data from participants in the FAS who had measurable disease, who could be evaluated for tumor response with both baseline and on-study tumor evaluations, and who achieved an objective response.

DOR, defined as the interval from the first documentation of objective tumor response to the earlier of the first documentation of disease progression or death from any cause per RECIST, Version 1.1 by BICR was reported.

Outcome measures

Measure	Zilovertamab Vedotin Q2/3W n=1 Participants Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.	Zilovertamab Vedotin Q2/3W Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.
Duration of Response (DOR)- BICR	1 Months Not reached due to censoring	—

SECONDARY outcome

Timeframe: Up to ~30 months

Population: FAS which included all participants who received ≥1 dose of study drug

PFS, defined as the interval from the start of study treatment to the earlier of the first documentation of disease progression or death from any cause per RECIST, Version 1.1 by BICR was reported.

Outcome measures

Measure	Zilovertamab Vedotin Q2/3W n=70 Participants Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.	Zilovertamab Vedotin Q2/3W n=32 Participants Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.
Progression-free Survival (PFS)- BICR	2.3 Months Interval 2.0 to 4.1	1.9 Months Interval 1.7 to 2.1

SECONDARY outcome

Timeframe: Up to ~30 months

Population: FAS which included all participants who received ≥1 dose of study drug

TTF, defined as the time from the start of study treatment to the earliest of the first documentation of disease progression, the permanent cessation of study drug due to an AE, or death from any cause per RECIST, Version 1.1 by BICR was reported.

Outcome measures

Measure	Zilovertamab Vedotin Q2/3W n=70 Participants Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.	Zilovertamab Vedotin Q2/3W n=32 Participants Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.
Time to Treatment Failure (TTF)- BICR	2.2 Months Interval 1.9 to 4.1	1.9 Months Interval 1.7 to 2.1

SECONDARY outcome

Timeframe: Up to ~30 months

Population: FAS which included all participants who received ≥1 dose of study drug

OS, defined as the interval from the start of study treatment to death from any cause will be reported.

Outcome measures

Measure	Zilovertamab Vedotin Q2/3W n=70 Participants Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.	Zilovertamab Vedotin Q2/3W n=32 Participants Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.
Overall Survival (OS)	8.3 Months Interval 5.2 to 10.3	5.5 Months Interval 4.4 to 11.0

SECONDARY outcome

Timeframe: Up to ~30 months

Population: FAS which included all participants who received ≥1 dose of study drug

An AE was any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also an AE. The number of participants who experienced an AE was reported.

Outcome measures

Measure	Zilovertamab Vedotin Q2/3W n=70 Participants Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.	Zilovertamab Vedotin Q2/3W n=32 Participants Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.
Number of Participants Who Experienced an Adverse Event (AE)	70 Participants	32 Participants

SECONDARY outcome

Timeframe: Up to ~11 months

Population: FAS which included all participants who received ≥1 dose of study drug

An AE was any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also an AE. The number of participants who discontinued study treatment due to an AE was reported.

Outcome measures

Measure	Zilovertamab Vedotin Q2/3W n=70 Participants Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.	Zilovertamab Vedotin Q2/3W n=32 Participants Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.
Number of Participants Who Discontinued Study Treatment Due to an AE	7 Participants	6 Participants

SECONDARY outcome

Timeframe: Day 1 [(predose; end of infusion (EOI); and 2 and 4 hours after EOI)], Day 8 (168 hr), Day 15 (336 hr), and Cycle 2 Day 1 (predose); each cycle=21 days

Population: Evaluable Analysis Set which included participants in the FAS who had the necessary baseline and on-study measurements to provide interpretable results for specific parameters of interest.

Cmax of zilovertamab vedotin determined by blood samples collected pre-dose and at designated timepoints post-dose were reported. Per protocol the Zilovertamab vedotin Q2/3W Dosing Group was not included in this analysis.

Outcome measures

Measure	Zilovertamab Vedotin Q2/3W n=70 Participants Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.	Zilovertamab Vedotin Q2/3W Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.
Maximum Plasma Concentration (Cmax) of Zilovertamab Vedotin-Q1/3W Dosing Schedule	53.4 μg/mL Geometric Coefficient of Variation 20.5	—

SECONDARY outcome

Timeframe: Day 1 [(predose; end of infusion (EOI); and 2 and 4 hours after EOI)], Day 8 (168 hr), Day 15 (336 hr), and Cycle 2 Day 1 (predose); each cycle=21 days

Population: Evaluable Analysis Set which included participants in the FAS who had the necessary baseline and on-study measurements to provide interpretable results for specific parameters of interest.

Cmax of total antibody determined by blood samples collected pre-dose and at designated timepoints post-dose was reported. Total Antibody was defined as total zilovertamab vedotin plus any antibody that was not conjugated to monomethyl auristatin E (MMAE). Per protocol the Zilovertamab vedotin Q2/3W Dosing Group was not included in this analysis.

Outcome measures

Measure	Zilovertamab Vedotin Q2/3W n=70 Participants Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.	Zilovertamab Vedotin Q2/3W Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.
Cmax of Total Antibody-Q1/3W Dosing Schedule	51.2 μg/mL Geometric Coefficient of Variation 23.3	—

SECONDARY outcome

Timeframe: Day 1 [(predose; end of infusion (EOI); and 2 and 4 hours after EOI)], Day 8 (168 hr), Day 15 (336 hr), and Cycle 2 Day 1 (predose); each cycle=21 days

Population: Evaluable Analysis Set which included participants in the FAS who had the necessary baseline and on-study measurements to provide interpretable results for specific parameters of interest

Cmax of MMAE determined by blood samples collected pre-dose and at designated timepoints post-dose was reported. Per protocol the Zilovertamab vedotin Q2/3W Dosing Group was not included in this analysis.

Outcome measures

Measure	Zilovertamab Vedotin Q2/3W n=70 Participants Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.	Zilovertamab Vedotin Q2/3W Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.
Cmax of MMAE-Q1/3W Dosing Schedule	0.00393 μg/mL Geometric Coefficient of Variation 65.7	—

SECONDARY outcome

Timeframe: Day 1 [(predose; end of infusion (EOI); and 2 and 4 hours after EOI)], Day 8 (168 hr), Day 15 (336 hr), and Cycle 2 Day 1 (predose); each cycle=21 days

Population: Evaluable Analysis Set which included participants in the FAS who had the necessary baseline and on-study measurements to provide interpretable results for specific parameters of interest

AUC0-504hrs of Zilovertamab Vedotin determined by blood samples collected pre-dose and at designated timepoints post-dose was reported. Per protocol the Zilovertamab vedotin Q2/3W Dosing Group was not included in this analysis.

Outcome measures

Measure	Zilovertamab Vedotin Q2/3W n=62 Participants Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.	Zilovertamab Vedotin Q2/3W Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.
Area Under the Plasma Concentration-time Curve (AUC) 0-504hrs of Zilovertamab Vedotin- Q1/3W Dosing Schedule	4030 hr*μg/mL Geometric Coefficient of Variation 27.3	—

SECONDARY outcome

Timeframe: Day 1 [(predose; end of infusion (EOI); and 2 and 4 hours after EOI)], Day 8 (168 hr), Day 15 (336 hr), and Cycle 2 Day 1 (predose); each cycle=21 days

Population: Evaluable Analysis Set which included participants in the FAS who had the necessary baseline and on-study measurements to provide interpretable results for specific parameters of interest

AUC0-504hrs of total antibody determined by blood samples collected pre-dose and at designated timepoints post-dose was reported. Total Antibody was defined as total zilovertamab vedotin plus any antibody that was not conjugated to monomethyl auristatin E (MMAE). Per protocol the Zilovertamab vedotin Q2/3W Dosing Group was not included in this analysis.

Outcome measures

Measure	Zilovertamab Vedotin Q2/3W n=62 Participants Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.	Zilovertamab Vedotin Q2/3W Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.
AUC0-504hrs of Total Antibodies-Q1/3W Dosing Schedule	6720 hr*μg/mL Geometric Coefficient of Variation 28.6	—

SECONDARY outcome

Timeframe: Day 1 [(predose; end of infusion (EOI); and 2 and 4 hours after EOI)], Day 8 (168 hr), Day 15 (336 hr), and Cycle 2 Day 1 (predose); each cycle=21 days

Population: Evaluable Analysis Set which included participants in the FAS who had the necessary baseline and on-study measurements to provide interpretable results for specific parameters of interest

AUC0-504hrs of MMAE by blood collected pre-dose and at designated timepoints post-dose was reported. Per protocol the Zilovertamab vedotin Q2/3W Dosing Group was not included in this analysis.

Outcome measures

Measure	Zilovertamab Vedotin Q2/3W n=28 Participants Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.	Zilovertamab Vedotin Q2/3W Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.
AUC0-504hrs of MMAE-Q1/3W Dosing Schedule	0.828 hr*μg/mL Geometric Coefficient of Variation 58.1	—

SECONDARY outcome

Timeframe: Day 1 [(predose; end of infusion (EOI)], Day 8 (predose); each cycle=21 days

Population: Evaluable Analysis Set which included participants in the FAS who had the necessary baseline and on-study measurements to provide interpretable results for specific parameters of interest

Cmax of zilovertamab vedotin determined by blood samples collected pre-dose and at designated timepoints post-dose were reported. Per protocol the Zilovertamab vedotin Q1/3W Dosing Group was not included in this analysis.

Outcome measures

Measure	Zilovertamab Vedotin Q2/3W n=23 Participants Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.	Zilovertamab Vedotin Q2/3W Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.
Cmax of Zilovertamab Vedotin-Q2/3W Dosing Schedule: Day 1	28.6 μg/mL Geometric Coefficient of Variation 40.8	—

SECONDARY outcome

Timeframe: Day 1 [(predose; end of infusion (EOI)], Day 8 (predose); each cycle=21 days

Population: Evaluable Analysis Set which included participants in the FAS who had the necessary baseline and on-study measurements to provide interpretable results for specific parameters of interest

Cmax of total antibody determined by blood samples collected pre-dose and at designated timepoints post-dose was reported. Total Antibody was defined as total zilovertamab vedotin plus any antibody that was not conjugated to monomethyl auristatin E (MMAE). Per protocol the Zilovertamab vedotin Q1/3W Dosing Group was not included in this analysis.

Outcome measures

Measure	Zilovertamab Vedotin Q2/3W n=23 Participants Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.	Zilovertamab Vedotin Q2/3W Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.
Cmax of Total Antibody-Q2/3W Dosing Schedule: Day 1	26.2 μg/mL Geometric Coefficient of Variation 39.8	—

SECONDARY outcome

Timeframe: Day 1 [(predose; end of infusion (EOI)], Day 8 (predose); each cycle=21 days

Population: Evaluable Analysis Set which included participants in the FAS who had the necessary baseline and on-study measurements to provide interpretable results for specific parameters of interest

Cmax of MMAE determined by blood samples collected pre-dose and at designated timepoints post-dose were reported. Per protocol the Zilovertamab vedotin Q1/3W Dosing Group was not included in this analysis.

Outcome measures

Measure	Zilovertamab Vedotin Q2/3W n=23 Participants Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.	Zilovertamab Vedotin Q2/3W Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.
Cmax of MMAE-Q2/3W Dosing Schedule: Day 1	.00121 μg/mL Geometric Coefficient of Variation 332.3	—

SECONDARY outcome

Timeframe: Day 8 [(predose; end of infusion (EOI)], Day 15 (168 hr), Cycle 2 Day 1 Predose; each cycle=21 days

Population: Evaluable Analysis Set which included participants in the FAS who had the necessary baseline and on-study measurements to provide interpretable results for specific parameters of interest

Cmax of zilovertamab vedotin determined by blood samples collected pre-dose and at designated timepoints post-dose were reported. Per protocol the Zilovertamab vedotin Q1/3W Dosing Group was not included in this analysis.

Outcome measures

Measure	Zilovertamab Vedotin Q2/3W n=27 Participants Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.	Zilovertamab Vedotin Q2/3W Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.
Cmax of Zilovertamab Vedotin-Q2/3W Dosing Schedule: Day 8	35.0 μg/mL Geometric Coefficient of Variation 90.3	—

SECONDARY outcome

Timeframe: Day 8 [(predose; end of infusion (EOI)], Day 15 (168 hr), Cycle 2 Day 1 Predose; each cycle=21 days

Population: Evaluable Analysis Set which included participants in the FAS who had the necessary baseline and on-study measurements to provide interpretable results for specific parameters of interest

Cmax of total antibody determined by blood samples collected pre-dose and at designated timepoints post-dose was reported. Total Antibody was defined as total zilovertamab vedotin plus any antibody that was not conjugated to monomethyl auristatin E (MMAE). Per protocol the Zilovertamab vedotin Q1/3W Dosing Group was not included in this analysis.

Outcome measures

Measure	Zilovertamab Vedotin Q2/3W n=27 Participants Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.	Zilovertamab Vedotin Q2/3W Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.
Cmax of Total Antibody-Q2/3W Dosing Schedule: Day 8	39.1 μg/mL Geometric Coefficient of Variation 73.7	—

SECONDARY outcome

Timeframe: Day 8 [(predose; end of infusion (EOI)], Day 15 (168 hr), Cycle 2 Day 1 Predose; each cycle=21 days

Population: Evaluable Analysis Set which included participants in the FAS who had the necessary baseline and on-study measurements to provide interpretable results for specific parameters of interest

Cmax of MMAE determined by blood samples collected pre-dose and at designated timepoints post-dose were reported. Per protocol the Zilovertamab vedotin Q1/3W Dosing Group was not included in this analysis.

Outcome measures

Measure	Zilovertamab Vedotin Q2/3W n=27 Participants Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.	Zilovertamab Vedotin Q2/3W Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.
Cmax of MMAE-Q2/3W Dosing Schedule: Day 8	0.00289 μg/mL Geometric Coefficient of Variation 90.9	—

SECONDARY outcome

Timeframe: Day 1 [(predose; end of infusion (EOI)], Day 8 (predose); each cycle=21 days

Population: Evaluable Analysis Set which included participants in the FAS who had the necessary baseline and on-study measurements to provide interpretable results for specific parameters of interest.

AUC0-168hrs of zilovertamab vedotin determined by blood samples collected pre-dose and at designated timepoints post-dose was reported. Per protocol the Zilovertamab vedotin Q1/3W Dosing Group was not included in this analysis.

Outcome measures

Measure	Zilovertamab Vedotin Q2/3W n=10 Participants Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.	Zilovertamab Vedotin Q2/3W Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.
AUC0-168hrs of Zilovertamab Vedotin -Q2/3W Dosing Schedule: Day 1	2070 hr*μg/mL Geometric Coefficient of Variation 26.1	—

SECONDARY outcome

Timeframe: Day 1 [(predose; end of infusion (EOI)], Day 8 (predose); each cycle=21 days

Population: Evaluable Analysis Set which included participants in the FAS who had the necessary baseline and on-study measurements to provide interpretable results for specific parameters of interest.

AUC0-168hrs of total antibody determined by blood samples collected pre-dose and at designated timepoints post-dose was reported. Total Antibody was defined as total zilovertamab vedotin plus any antibody that is not conjugated to monomethyl auristatin E (MMAE). Per protocol the Zilovertamab vedotin Q1/3W Dosing Group was not included in this analysis.

Outcome measures

Measure	Zilovertamab Vedotin Q2/3W n=10 Participants Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.	Zilovertamab Vedotin Q2/3W Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.
AUC0-168hrs of Total Antibody-Q2/3W Dosing Schedule: Day 1	2730 hr*μg/mL Geometric Coefficient of Variation 25.0	—

SECONDARY outcome

Timeframe: Day 1 [(predose; end of infusion (EOI)], Day 8 (predose); each cycle=21 days

Population: Evaluable Analysis Set which included participants in the FAS who had the necessary baseline and on-study measurements to provide interpretable results for specific parameters of interest.

AUC0-168hrs of MMAE determined by blood samples collected pre-dose and at designated timepoints post-dose were reported. Per protocol the Zilovertamab vedotin Q1/3W Dosing Group was not included in this analysis.

Outcome measures

Measure	Zilovertamab Vedotin Q2/3W n=10 Participants Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.	Zilovertamab Vedotin Q2/3W Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.
AUC0-168 hr of MMAE-Q2/3W Dosing Schedule: Day 1	0.202 hr*μg/mL Geometric Coefficient of Variation 101.2	—

SECONDARY outcome

Timeframe: Day 8 [(predose; end of infusion (EOI)], Day 15 (168hr), Cycle 2 Day 1 Predose; each cycle=21 days

Population: Evaluable Analysis Set which included participants in the FAS who had the necessary baseline and on-study measurements to provide interpretable results for specific parameters of interest.

AUC168-336 hrs of zilovertamab vedotin determined by blood samples collected pre-dose and at designated timepoints post-dose was reported. Per protocol the Zilovertamab vedotin Q1/3W Dosing Group was not included in this analysis.

Outcome measures

Measure	Zilovertamab Vedotin Q2/3W n=11 Participants Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.	Zilovertamab Vedotin Q2/3W Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.
AUC168-336hrs of Zilovertamab Vedotin-Q2/3W Dosing Schedule: Day 8	2900 hr*μg/mL Geometric Coefficient of Variation 66.0	—

SECONDARY outcome

Timeframe: Day 8 [(predose; end of infusion (EOI)], Day 15 (168hr), Cycle 2 Day 1 Predose; each cycle=21 days

Population: Evaluable Analysis Set which included participants in the FAS who had the necessary baseline and on-study measurements to provide interpretable results for specific parameters of interest.

AUC168-336hrs of total antibody determined by blood samples collected pre-dose and at designated timepoints post-dose was reported. Total Antibody was defined as total zilovertamab vedotin plus any antibody that was not conjugated to MMAE. Per protocol the Zilovertamab vedotin Q1/3W Dosing Group was not included in this analysis.

Outcome measures

Measure	Zilovertamab Vedotin Q2/3W n=11 Participants Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.	Zilovertamab Vedotin Q2/3W Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.
AUC168-336 Hrs of Total Antibody-Q2/3W Dosing Schedule: Day 8	5890 hr*μg/mL Geometric Coefficient of Variation 48.1	—

SECONDARY outcome

Timeframe: Day 8 [(predose; end of infusion (EOI)], Day 15 (168hr), Cycle 2 Day 1 Predose; each cycle=21 days

Population: Evaluable Analysis Set which included participants in the FAS who had the necessary baseline and on-study measurements to provide interpretable results for specific parameters of interest.

AUC168-336 of MMAE determined by blood samples collected pre-dose and at designated timepoints post-dose will be reported.

Outcome measures

Measure	Zilovertamab Vedotin Q2/3W n=14 Participants Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.	Zilovertamab Vedotin Q2/3W Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.
AUC168-336 hr of MMAE-Q2/3W Dosing Schedule: Day 8	0.596 hr*μg/mL Geometric Coefficient of Variation 103.3	—

Adverse Events

Zilovertamab Vedotin Q1/3W

Serious events: 29 serious events

Other events: 66 other events

Deaths: 54 deaths

Zilovertamab Vedotin Q2/3W

Serious events: 16 serious events

Other events: 30 other events

Deaths: 18 deaths

Serious adverse events

Measure	Zilovertamab Vedotin Q1/3W n=70 participants at risk Participants received IV zilovertamab vedotin 2.5 mg/kg on Day 1 of each repeated 21-day cycle (Q1/3W). Treatment continued until progressive disease or discontinuation.	Zilovertamab Vedotin Q2/3W n=32 participants at risk Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.
Blood and lymphatic system disorders Febrile neutropenia	1.4% 1/70 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	0.00% 0/32 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Cardiac disorders Atrial fibrillation	1.4% 1/70 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	0.00% 0/32 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Cardiac disorders Cardiac arrest	1.4% 1/70 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	0.00% 0/32 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Cardiac disorders Sinus tachycardia	1.4% 1/70 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	0.00% 0/32 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Gastrointestinal disorders Abdominal distension	0.00% 0/70 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	3.1% 1/32 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Gastrointestinal disorders Abdominal pain	1.4% 1/70 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	0.00% 0/32 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Gastrointestinal disorders Obstruction gastric	1.4% 1/70 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	0.00% 0/32 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Gastrointestinal disorders Pancreatitis	1.4% 1/70 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	0.00% 0/32 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/70 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	3.1% 1/32 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Gastrointestinal disorders Vomiting	1.4% 1/70 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	3.1% 1/32 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
General disorders Fatigue	0.00% 0/70 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	6.2% 2/32 • Number of events 2 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
General disorders General physical health deterioration	1.4% 1/70 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	0.00% 0/32 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
General disorders Pain	0.00% 0/70 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	3.1% 1/32 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
General disorders Pyrexia	5.7% 4/70 • Number of events 4 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	3.1% 1/32 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
General disorders Sudden death	0.00% 0/70 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	3.1% 1/32 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Hepatobiliary disorders Bile duct stenosis	0.00% 0/70 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	3.1% 1/32 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Hepatobiliary disorders Malignant biliary obstruction	1.4% 1/70 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	0.00% 0/32 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Infections and infestations Cellulitis	1.4% 1/70 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	0.00% 0/32 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Infections and infestations Clostridium difficile infection	1.4% 1/70 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	0.00% 0/32 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Infections and infestations Device related infection	2.9% 2/70 • Number of events 2 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	0.00% 0/32 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Infections and infestations Pneumonia	4.3% 3/70 • Number of events 3 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	0.00% 0/32 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Infections and infestations Respiratory syncytial virus infection	0.00% 0/70 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	3.1% 1/32 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Infections and infestations Urinary tract infection	1.4% 1/70 • Number of events 2 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	0.00% 0/32 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Injury, poisoning and procedural complications Compression fracture	1.4% 1/70 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	0.00% 0/32 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Injury, poisoning and procedural complications Wound complication	1.4% 1/70 • Number of events 2 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	0.00% 0/32 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Investigations Aspartate aminotransferase increased	1.4% 1/70 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	0.00% 0/32 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Investigations Blood bilirubin increased	1.4% 1/70 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	3.1% 1/32 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Investigations Blood glucose decreased	0.00% 0/70 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	3.1% 1/32 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Investigations Blood glucose increased	0.00% 0/70 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	3.1% 1/32 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Investigations Blood phosphorus decreased	0.00% 0/70 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	3.1% 1/32 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Investigations Blood potassium decreased	0.00% 0/70 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	3.1% 1/32 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Investigations Blood sodium decreased	0.00% 0/70 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	3.1% 1/32 • Number of events 2 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Investigations Neutrophil count decreased	2.9% 2/70 • Number of events 2 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	6.2% 2/32 • Number of events 2 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Investigations Oxygen saturation decreased	0.00% 0/70 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	3.1% 1/32 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Musculoskeletal and connective tissue disorders Back pain	2.9% 2/70 • Number of events 2 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	0.00% 0/32 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Musculoskeletal and connective tissue disorders Muscular weakness	1.4% 1/70 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	0.00% 0/32 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Musculoskeletal and connective tissue disorders Pain in extremity	1.4% 1/70 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	3.1% 1/32 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.9% 2/70 • Number of events 2 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	0.00% 0/32 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.9% 2/70 • Number of events 2 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	0.00% 0/32 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Vascular disorders Embolism	0.00% 0/70 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	3.1% 1/32 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Vascular disorders Embolism arterial	0.00% 0/70 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	3.1% 1/32 • Number of events 2 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Vascular disorders Hypotension	1.4% 1/70 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	0.00% 0/32 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	2.9% 2/70 • Number of events 2 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	0.00% 0/32 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.00% 0/70 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	3.1% 1/32 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Nervous system disorders Cerebrovascular accident	1.4% 1/70 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	0.00% 0/32 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Nervous system disorders Dysarthria	1.4% 1/70 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	0.00% 0/32 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Product Issues Device occlusion	1.4% 1/70 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	0.00% 0/32 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Psychiatric disorders Mental status changes	1.4% 1/70 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	0.00% 0/32 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Renal and urinary disorders Acute kidney injury	1.4% 1/70 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	0.00% 0/32 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Reproductive system and breast disorders Breast pain	0.00% 0/70 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	3.1% 1/32 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/70 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	3.1% 1/32 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Respiratory, thoracic and mediastinal disorders Dyspnoea	7.1% 5/70 • Number of events 5 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	3.1% 1/32 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Respiratory, thoracic and mediastinal disorders Haemoptysis	1.4% 1/70 • Number of events 2 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	0.00% 0/32 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Respiratory, thoracic and mediastinal disorders Hypoxia	2.9% 2/70 • Number of events 2 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	3.1% 1/32 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.4% 1/70 • Number of events 3 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	0.00% 0/32 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug

Other adverse events

Measure	Zilovertamab Vedotin Q1/3W n=70 participants at risk Participants received IV zilovertamab vedotin 2.5 mg/kg on Day 1 of each repeated 21-day cycle (Q1/3W). Treatment continued until progressive disease or discontinuation.	Zilovertamab Vedotin Q2/3W n=32 participants at risk Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation.
Respiratory, thoracic and mediastinal disorders Cough	11.4% 8/70 • Number of events 8 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	9.4% 3/32 • Number of events 3 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Respiratory, thoracic and mediastinal disorders Dyspnoea	14.3% 10/70 • Number of events 12 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	21.9% 7/32 • Number of events 8 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Gastrointestinal disorders Nausea	32.9% 23/70 • Number of events 31 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	50.0% 16/32 • Number of events 18 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Gastrointestinal disorders Stomatitis	7.1% 5/70 • Number of events 6 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	0.00% 0/32 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Gastrointestinal disorders Vomiting	20.0% 14/70 • Number of events 21 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	28.1% 9/32 • Number of events 11 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
General disorders Fatigue	35.7% 25/70 • Number of events 30 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	43.8% 14/32 • Number of events 23 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
General disorders Gait disturbance	1.4% 1/70 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	9.4% 3/32 • Number of events 3 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
General disorders Localised oedema	0.00% 0/70 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	6.2% 2/32 • Number of events 2 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
General disorders Oedema peripheral	11.4% 8/70 • Number of events 8 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	12.5% 4/32 • Number of events 4 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
General disorders Pain	5.7% 4/70 • Number of events 4 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	0.00% 0/32 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
General disorders Pyrexia	18.6% 13/70 • Number of events 18 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	15.6% 5/32 • Number of events 5 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Infections and infestations Pneumonia	5.7% 4/70 • Number of events 5 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	6.2% 2/32 • Number of events 2 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Infections and infestations Urinary tract infection	7.1% 5/70 • Number of events 5 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	9.4% 3/32 • Number of events 4 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Injury, poisoning and procedural complications Fall	5.7% 4/70 • Number of events 4 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	6.2% 2/32 • Number of events 3 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Investigations Alanine aminotransferase increased	21.4% 15/70 • Number of events 21 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	6.2% 2/32 • Number of events 2 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Investigations Aspartate aminotransferase increased	32.9% 23/70 • Number of events 41 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	9.4% 3/32 • Number of events 4 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Investigations Blood alkaline phosphatase increased	5.7% 4/70 • Number of events 12 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	9.4% 3/32 • Number of events 4 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Investigations Blood creatinine increased	4.3% 3/70 • Number of events 7 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	9.4% 3/32 • Number of events 11 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Investigations Blood glucose increased	1.4% 1/70 • Number of events 2 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	9.4% 3/32 • Number of events 4 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Investigations Blood magnesium decreased	12.9% 9/70 • Number of events 10 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	18.8% 6/32 • Number of events 7 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Investigations Blood phosphorus decreased	5.7% 4/70 • Number of events 5 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	0.00% 0/32 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Investigations Blood phosphorus increased	0.00% 0/70 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	6.2% 2/32 • Number of events 4 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Investigations Blood potassium decreased	21.4% 15/70 • Number of events 24 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	25.0% 8/32 • Number of events 11 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Investigations Blood sodium decreased	12.9% 9/70 • Number of events 14 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	6.2% 2/32 • Number of events 5 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Investigations Blood uric acid increased	8.6% 6/70 • Number of events 9 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	0.00% 0/32 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Investigations Haemoglobin decreased	21.4% 15/70 • Number of events 39 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	25.0% 8/32 • Number of events 21 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Investigations Lymphocyte count decreased	0.00% 0/70 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	12.5% 4/32 • Number of events 10 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Investigations Neutrophil count decreased	17.1% 12/70 • Number of events 23 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	15.6% 5/32 • Number of events 6 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Investigations Weight decreased	12.9% 9/70 • Number of events 12 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	18.8% 6/32 • Number of events 7 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Investigations White blood cell count decreased	10.0% 7/70 • Number of events 11 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	6.2% 2/32 • Number of events 3 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Metabolism and nutrition disorders Decreased appetite	25.7% 18/70 • Number of events 18 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	12.5% 4/32 • Number of events 5 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Metabolism and nutrition disorders Dehydration	5.7% 4/70 • Number of events 5 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	0.00% 0/32 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Metabolism and nutrition disorders Hypochloraemia	1.4% 1/70 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	6.2% 2/32 • Number of events 2 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Musculoskeletal and connective tissue disorders Arthralgia	8.6% 6/70 • Number of events 7 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	6.2% 2/32 • Number of events 2 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Musculoskeletal and connective tissue disorders Back pain	11.4% 8/70 • Number of events 8 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	9.4% 3/32 • Number of events 3 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Musculoskeletal and connective tissue disorders Flank pain	1.4% 1/70 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	6.2% 2/32 • Number of events 4 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Musculoskeletal and connective tissue disorders Muscle spasms	1.4% 1/70 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	9.4% 3/32 • Number of events 3 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Musculoskeletal and connective tissue disorders Myalgia	7.1% 5/70 • Number of events 5 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	6.2% 2/32 • Number of events 2 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Musculoskeletal and connective tissue disorders Pain in extremity	5.7% 4/70 • Number of events 4 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	6.2% 2/32 • Number of events 2 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Nervous system disorders Dizziness	15.7% 11/70 • Number of events 13 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	6.2% 2/32 • Number of events 2 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Nervous system disorders Headache	14.3% 10/70 • Number of events 12 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	15.6% 5/32 • Number of events 6 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Nervous system disorders Hypoaesthesia	0.00% 0/70 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	6.2% 2/32 • Number of events 2 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Nervous system disorders Neuropathy peripheral	5.7% 4/70 • Number of events 4 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	12.5% 4/32 • Number of events 6 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Nervous system disorders Peripheral sensory neuropathy	11.4% 8/70 • Number of events 9 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	6.2% 2/32 • Number of events 3 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Psychiatric disorders Anxiety	0.00% 0/70 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	12.5% 4/32 • Number of events 4 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Psychiatric disorders Insomnia	8.6% 6/70 • Number of events 6 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	15.6% 5/32 • Number of events 5 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Renal and urinary disorders Dysuria	5.7% 4/70 • Number of events 4 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	0.00% 0/32 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Respiratory, thoracic and mediastinal disorders Nasal congestion	1.4% 1/70 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	6.2% 2/32 • Number of events 2 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Respiratory, thoracic and mediastinal disorders Pleural effusion	7.1% 5/70 • Number of events 5 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	0.00% 0/32 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Skin and subcutaneous tissue disorders Alopecia	21.4% 15/70 • Number of events 15 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	25.0% 8/32 • Number of events 8 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Skin and subcutaneous tissue disorders Pruritus	5.7% 4/70 • Number of events 4 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	6.2% 2/32 • Number of events 2 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Skin and subcutaneous tissue disorders Rash maculo-papular	8.6% 6/70 • Number of events 7 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	3.1% 1/32 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Vascular disorders Embolism	2.9% 2/70 • Number of events 2 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	6.2% 2/32 • Number of events 2 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Gastrointestinal disorders Gastrooesophageal reflux disease	8.6% 6/70 • Number of events 6 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	3.1% 1/32 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Gastrointestinal disorders Dyspepsia	4.3% 3/70 • Number of events 3 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	9.4% 3/32 • Number of events 3 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Gastrointestinal disorders Dysphagia	1.4% 1/70 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	6.2% 2/32 • Number of events 2 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Gastrointestinal disorders Flatulence	5.7% 4/70 • Number of events 5 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	0.00% 0/32 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Blood and lymphatic system disorders Eosinophilia	0.00% 0/70 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	6.2% 2/32 • Number of events 4 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Cardiac disorders Sinus tachycardia	1.4% 1/70 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	6.2% 2/32 • Number of events 3 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Gastrointestinal disorders Abdominal distension	4.3% 3/70 • Number of events 4 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	12.5% 4/32 • Number of events 4 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Gastrointestinal disorders Abdominal pain	18.6% 13/70 • Number of events 22 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	12.5% 4/32 • Number of events 5 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Gastrointestinal disorders Constipation	21.4% 15/70 • Number of events 16 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	18.8% 6/32 • Number of events 7 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Gastrointestinal disorders Diarrhoea	30.0% 21/70 • Number of events 29 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	18.8% 6/32 • Number of events 9 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug
Gastrointestinal disorders Dry mouth	7.1% 5/70 • Number of events 5 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug	3.1% 1/32 • Number of events 1 • Up to 30 months Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The results of this study may be published or presented at scientific meetings. The Sponsor will comply with the requirements for publication of study results. If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission.
• Publication restrictions are in place

Restriction type: OTHER