Trial Outcomes & Findings for Dose Evaluation of MK-1966 in Combination With SD-101 in Participants With Advanced Malignancies (MK-1966-001) (NCT NCT02731742)

Last Updated: 2019-02-04

Results Overview

The occurrence of any of the following toxicities during Cycle 1 (Days 1-21), if assessed by the Investigator to be possibly, probably or definitely related to MK-1966 or SD-101, was considered a DLT: 1. Grade (Gr) 4 non-hematologic toxicity; 2. Gr 4 hematologic toxicity lasting \>7 days, except thrombocytopenia: \*Gr 4 thrombocytopenia of any duration; \*Gr 3 thrombocytopenia if associated with bleeding; 3. Gr 3 non-hematologic toxicity lasting \>3 days despite optimal supportive care; 4. Any Gr 3 or Gr 4 non-hematologic laboratory abnormality, if: medical intervention is required OR abnormality leads to hospitalization OR abnormality persists for \>1 week; 5. Febrile neutropenia Gr 3 or Gr 4; 6. Any drug-related AE which caused participant to discontinue study drug during Cycle 1 7. Gr 5 toxicity; or 8. Delay in initiation of Cycle 2 for \>2 weeks due to study drug-related toxicity. The percentage of participants who experienced a DLT during Cycle 1 is presented.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

14 participants

Primary outcome timeframe

From time of first dose of study drug to the end of Cycle 1. Each cycle was 21 days. (Up to 21 days)

Results posted on

2019-02-04

Participant Flow

The study was terminated prior to completion of Part A enrollment and prior to initiation of Parts B or C enrollment. This results disclosure is for Part A only.

Participant milestones

Participant milestones
Measure	MK-1966 70 mg+SD-101 1 mg Participants received a combination of MK-1966 70 mg intravenously (IV) (on Day 1 of each 3-week cycle for up to 8 cycles) and SD-101 1 mg intratumorally (IT) (on Days 1, 8 and 15 of Cycle 1, and then on Day 1 of up to 7 additional 3-week cycles) in Part A of the study. Participants were then to continue in one of two expansion cohorts (Part B or C) and were to receive up to 8 cycles of treatment on Day 1 of each 3-week cycle (approximately 24 weeks), but the study was terminated by the Sponsor prior to completion of Part A enrollment and prior to initiation of Parts B or C enrollment.	MK-1966 70 mg+SD-101 4 mg Participants received a combination of MK-1966 70 mg IV (on Day 1 of each 3-week cycle for up to 8 cycles) and SD-101 4 mg IT (on Days 1, 8 and 15 of Cycle 1, and then on Day 1 of up to 7 additional 3-week cycles) in Part A of the study. Participants were then to continue in one of two expansion cohorts (Part B or C) and were to receive up to 8 cycles of treatment on Day 1 of each 3-week cycle (approximately 24 weeks), but the study was terminated by the Sponsor prior to completion of Part A enrollment and prior to initiation of Parts B or C enrollment.	MK-1966 210 mg+SD-101 4 mg Participants received a combination of MK-1966 210 mg IV (on Day 1 of each 3-week cycle for up to 8 cycles) and SD-101 4 mg IT (on Days 1, 8 and 15 of Cycle 1, and then on Day 1 of up to 7 additional 3-week cycles) in Part A of the study. Participants were then to continue in one of two expansion cohorts (Part B or C) and were to receive up to 8 cycles of treatment on Day 1 of each 3-week cycle (approximately 24 weeks), but the study was terminated by the Sponsor prior to completion of Part A enrollment and prior to initiation of Parts B or C enrollment.	MK-1966 700 mg+SD-101 4 mg Participants received a combination of MK-1966 700 mg IV (on Day 1 of each 3-week cycle for up to 8 cycles) and SD-101 4 mg IT (on Days 1, 8 and 15 of Cycle 1, and then on Day 1 of up to 7 additional 3-week cycles) in Part A of the study. Participants were to continue in one of two expansion cohorts (Part B or C) and were to receive up to 8 cycles of treatment on Day 1 of each 3-week cycle (approximately 24 weeks), but the study was terminated by the Sponsor prior to completion of Part A enrollment and prior to initiation of Parts B or C enrollment.
Overall Study STARTED	3	3	6	2
Overall Study COMPLETED	0	0	0	0
Overall Study NOT COMPLETED	3	3	6	2

Reasons for withdrawal

Reasons for withdrawal
Measure	MK-1966 70 mg+SD-101 1 mg Participants received a combination of MK-1966 70 mg intravenously (IV) (on Day 1 of each 3-week cycle for up to 8 cycles) and SD-101 1 mg intratumorally (IT) (on Days 1, 8 and 15 of Cycle 1, and then on Day 1 of up to 7 additional 3-week cycles) in Part A of the study. Participants were then to continue in one of two expansion cohorts (Part B or C) and were to receive up to 8 cycles of treatment on Day 1 of each 3-week cycle (approximately 24 weeks), but the study was terminated by the Sponsor prior to completion of Part A enrollment and prior to initiation of Parts B or C enrollment.	MK-1966 70 mg+SD-101 4 mg Participants received a combination of MK-1966 70 mg IV (on Day 1 of each 3-week cycle for up to 8 cycles) and SD-101 4 mg IT (on Days 1, 8 and 15 of Cycle 1, and then on Day 1 of up to 7 additional 3-week cycles) in Part A of the study. Participants were then to continue in one of two expansion cohorts (Part B or C) and were to receive up to 8 cycles of treatment on Day 1 of each 3-week cycle (approximately 24 weeks), but the study was terminated by the Sponsor prior to completion of Part A enrollment and prior to initiation of Parts B or C enrollment.	MK-1966 210 mg+SD-101 4 mg Participants received a combination of MK-1966 210 mg IV (on Day 1 of each 3-week cycle for up to 8 cycles) and SD-101 4 mg IT (on Days 1, 8 and 15 of Cycle 1, and then on Day 1 of up to 7 additional 3-week cycles) in Part A of the study. Participants were then to continue in one of two expansion cohorts (Part B or C) and were to receive up to 8 cycles of treatment on Day 1 of each 3-week cycle (approximately 24 weeks), but the study was terminated by the Sponsor prior to completion of Part A enrollment and prior to initiation of Parts B or C enrollment.	MK-1966 700 mg+SD-101 4 mg Participants received a combination of MK-1966 700 mg IV (on Day 1 of each 3-week cycle for up to 8 cycles) and SD-101 4 mg IT (on Days 1, 8 and 15 of Cycle 1, and then on Day 1 of up to 7 additional 3-week cycles) in Part A of the study. Participants were to continue in one of two expansion cohorts (Part B or C) and were to receive up to 8 cycles of treatment on Day 1 of each 3-week cycle (approximately 24 weeks), but the study was terminated by the Sponsor prior to completion of Part A enrollment and prior to initiation of Parts B or C enrollment.
Overall Study Death	1	2	5	0
Overall Study Physician Decision	0	0	0	1
Overall Study Study Terminated by Sponsor	2	1	1	1

Baseline Characteristics

Dose Evaluation of MK-1966 in Combination With SD-101 in Participants With Advanced Malignancies (MK-1966-001)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MK-1966 70 mg+SD-101 1 mg n=3 Participants Participants received a combination of MK-1966 70 mg intravenously (IV) (on Day 1 of each 3-week cycle for up to 8 cycles) and SD-101 1 mg intratumorally (IT) (on Days 1, 8 and 15 of Cycle 1, and then on Day 1 of up to 7 additional 3-week cycles) in Part A of the study. Participants were then to continue in one of two expansion cohorts (Part B or C) and were to receive up to 8 cycles of treatment on Day 1 of each 3-week cycle (approximately 24 weeks), but the study was terminated by the Sponsor prior to completion of Part A enrollment and prior to initiation of Parts B or C enrollment.	MK-1966 70 mg+SD-101 4 mg n=3 Participants Participants received a combination of MK-1966 70 mg IV (on Day 1 of each 3-week cycle for up to 8 cycles) and SD-101 4 mg IT (on Days 1, 8 and 15 of Cycle 1, and then on Day 1 of up to 7 additional 3-week cycles) in Part A of the study. Participants were then to continue in one of two expansion cohorts (Part B or C) and were to receive up to 8 cycles of treatment on Day 1 of each 3-week cycle (approximately 24 weeks), but the study was terminated by the Sponsor prior to completion of Part A enrollment and prior to initiation of Parts B or C enrollment.	MK-1966 210 mg+SD-101 4 mg n=6 Participants Participants received a combination of MK-1966 210 mg IV (on Day 1 of each 3-week cycle for up to 8 cycles) and SD-101 4 mg IT (on Days 1, 8 and 15 of Cycle 1, and then on Day 1 of up to 7 additional 3-week cycles) in Part A of the study. Participants were then to continue in one of two expansion cohorts (Part B or C) and were to receive up to 8 cycles of treatment on Day 1 of each 3-week cycle (approximately 24 weeks), but the study was terminated by the Sponsor prior to completion of Part A enrollment and prior to initiation of Parts B or C enrollment.	MK-1966 700 mg+SD-101 4 mg n=2 Participants Participants received a combination of MK-1966 700 mg IV (on Day 1 of each 3-week cycle for up to 8 cycles) and SD-101 4 mg IT (on Days 1, 8 and 15 of Cycle 1, and then on Day 1 of up to 7 additional 3-week cycles) in Part A of the study. Participants were to continue in one of two expansion cohorts (Part B or C) and were to receive up to 8 cycles of treatment on Day 1 of each 3-week cycle (approximately 24 weeks), but the study was terminated by the Sponsor prior to completion of Part A enrollment and prior to initiation of Parts B or C enrollment.	Total n=14 Participants Total of all reporting groups
Age, Continuous	64.7 Years STANDARD_DEVIATION 1.5 • n=93 Participants	63.0 Years STANDARD_DEVIATION 6.9 • n=4 Participants	63.7 Years STANDARD_DEVIATION 6.8 • n=27 Participants	50.5 Years STANDARD_DEVIATION 2.1 • n=483 Participants	61.9 Years STANDARD_DEVIATION 7.0 • n=36 Participants
Sex: Female, Male Female	3 Participants n=93 Participants	0 Participants n=4 Participants	3 Participants n=27 Participants	1 Participants n=483 Participants	7 Participants n=36 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	3 Participants n=4 Participants	3 Participants n=27 Participants	1 Participants n=483 Participants	7 Participants n=36 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) White	3 Participants n=93 Participants	3 Participants n=4 Participants	6 Participants n=27 Participants	2 Participants n=483 Participants	14 Participants n=36 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants

PRIMARY outcome

Timeframe: From time of first dose of study drug to the end of Cycle 1. Each cycle was 21 days. (Up to 21 days)

Population: The DLT evaluable population consisted of all participants who completed study drug in Cycle 1 or discontinued study drug during Cycle 1 due to a DLT.

Outcome measures

Outcome measures
Measure	MK-1966 70 mg+SD-101 1 mg n=3 Participants Participants received a combination of MK-1966 70 mg intravenously (IV) (on Day 1 of each 3-week cycle for up to 8 cycles) and SD-101 1 mg intratumorally (IT) (on Days 1, 8 and 15 of Cycle 1, and then on Day 1 of up to 7 additional 3-week cycles) in Part A of the study. Participants were then to continue in one of two expansion cohorts (Part B or C) and were to receive up to 8 cycles of treatment on Day 1 of each 3-week cycle (approximately 24 weeks), but the study was terminated by the Sponsor prior to completion of Part A enrollment and prior to initiation of Parts B or C enrollment.	MK-1966 70 mg+SD-101 4 mg n=3 Participants Participants received a combination of MK-1966 70 mg IV (on Day 1 of each 3-week cycle for up to 8 cycles) and SD-101 4 mg IT (on Days 1, 8 and 15 of Cycle 1, and then on Day 1 of up to 7 additional 3-week cycles) in Part A of the study. Participants were then to continue in one of two expansion cohorts (Part B or C) and were to receive up to 8 cycles of treatment on Day 1 of each 3-week cycle (approximately 24 weeks), but the study was terminated by the Sponsor prior to completion of Part A enrollment and prior to initiation of Parts B or C enrollment.	MK-1966 210 mg+SD-101 4 mg n=5 Participants Participants received a combination of MK-1966 210 mg IV (on Day 1 of each 3-week cycle for up to 8 cycles) and SD-101 4 mg IT (on Days 1, 8 and 15 of Cycle 1, and then on Day 1 of up to 7 additional 3-week cycles) in Part A of the study. Participants were then to continue in one of two expansion cohorts (Part B or C) and were to receive up to 8 cycles of treatment on Day 1 of each 3-week cycle (approximately 24 weeks), but the study was terminated by the Sponsor prior to completion of Part A enrollment and prior to initiation of Parts B or C enrollment.	MK-1966 700 mg+SD-101 4 mg n=2 Participants Participants received a combination of MK-1966 700 mg IV (on Day 1 of each 3-week cycle for up to 8 cycles) and SD-101 4 mg IT (on Days 1, 8 and 15 of Cycle 1, and then on Day 1 of up to 7 additional 3-week cycles) in Part A of the study. Participants were to continue in one of two expansion cohorts (Part B or C) and were to receive up to 8 cycles of treatment on Day 1 of each 3-week cycle (approximately 24 weeks), but the study was terminated by the Sponsor prior to completion of Part A enrollment and prior to initiation of Parts B or C enrollment.
Percentage of Participants With a Dose Limiting Toxicity (DLT)	0.0 Percentage of Participants Interval 0.0 to 33.1	0.0 Percentage of Participants Interval 0.0 to 33.1	20.0 Percentage of Participants Interval 5.1 to 44.8	0.0 Percentage of Participants Interval 0.0 to 41.5

PRIMARY outcome

Timeframe: From first dose of study drug through 90 days after last dose of study drug (Up to approximately 22 weeks)

Population: The safety analysis population consisted of all participants who received ≥1 dose of study drug.

An AE was defined as any untoward medical occurrence in a participant administered study drug and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study drug, was also an AE. The number of participants who experienced as AE is presented.

Outcome measures

Outcome measures
Measure	MK-1966 70 mg+SD-101 1 mg n=3 Participants Participants received a combination of MK-1966 70 mg intravenously (IV) (on Day 1 of each 3-week cycle for up to 8 cycles) and SD-101 1 mg intratumorally (IT) (on Days 1, 8 and 15 of Cycle 1, and then on Day 1 of up to 7 additional 3-week cycles) in Part A of the study. Participants were then to continue in one of two expansion cohorts (Part B or C) and were to receive up to 8 cycles of treatment on Day 1 of each 3-week cycle (approximately 24 weeks), but the study was terminated by the Sponsor prior to completion of Part A enrollment and prior to initiation of Parts B or C enrollment.	MK-1966 70 mg+SD-101 4 mg n=3 Participants Participants received a combination of MK-1966 70 mg IV (on Day 1 of each 3-week cycle for up to 8 cycles) and SD-101 4 mg IT (on Days 1, 8 and 15 of Cycle 1, and then on Day 1 of up to 7 additional 3-week cycles) in Part A of the study. Participants were then to continue in one of two expansion cohorts (Part B or C) and were to receive up to 8 cycles of treatment on Day 1 of each 3-week cycle (approximately 24 weeks), but the study was terminated by the Sponsor prior to completion of Part A enrollment and prior to initiation of Parts B or C enrollment.	MK-1966 210 mg+SD-101 4 mg n=6 Participants Participants received a combination of MK-1966 210 mg IV (on Day 1 of each 3-week cycle for up to 8 cycles) and SD-101 4 mg IT (on Days 1, 8 and 15 of Cycle 1, and then on Day 1 of up to 7 additional 3-week cycles) in Part A of the study. Participants were then to continue in one of two expansion cohorts (Part B or C) and were to receive up to 8 cycles of treatment on Day 1 of each 3-week cycle (approximately 24 weeks), but the study was terminated by the Sponsor prior to completion of Part A enrollment and prior to initiation of Parts B or C enrollment.	MK-1966 700 mg+SD-101 4 mg n=2 Participants Participants received a combination of MK-1966 700 mg IV (on Day 1 of each 3-week cycle for up to 8 cycles) and SD-101 4 mg IT (on Days 1, 8 and 15 of Cycle 1, and then on Day 1 of up to 7 additional 3-week cycles) in Part A of the study. Participants were to continue in one of two expansion cohorts (Part B or C) and were to receive up to 8 cycles of treatment on Day 1 of each 3-week cycle (approximately 24 weeks), but the study was terminated by the Sponsor prior to completion of Part A enrollment and prior to initiation of Parts B or C enrollment.
Number of Participants With Adverse Events (AEs)	3 Participants	3 Participants	6 Participants	2 Participants

PRIMARY outcome

Timeframe: From first dose of study drug up to last dose of study drug (Up to approximately 9 weeks)

Population: The safety analysis population consisted of all participants who received ≥1 dose of study drug.

The number of participants who discontinued study drug due to an AE is presented.

Outcome measures

Outcome measures
Measure	MK-1966 70 mg+SD-101 1 mg n=3 Participants Participants received a combination of MK-1966 70 mg intravenously (IV) (on Day 1 of each 3-week cycle for up to 8 cycles) and SD-101 1 mg intratumorally (IT) (on Days 1, 8 and 15 of Cycle 1, and then on Day 1 of up to 7 additional 3-week cycles) in Part A of the study. Participants were then to continue in one of two expansion cohorts (Part B or C) and were to receive up to 8 cycles of treatment on Day 1 of each 3-week cycle (approximately 24 weeks), but the study was terminated by the Sponsor prior to completion of Part A enrollment and prior to initiation of Parts B or C enrollment.	MK-1966 70 mg+SD-101 4 mg n=3 Participants Participants received a combination of MK-1966 70 mg IV (on Day 1 of each 3-week cycle for up to 8 cycles) and SD-101 4 mg IT (on Days 1, 8 and 15 of Cycle 1, and then on Day 1 of up to 7 additional 3-week cycles) in Part A of the study. Participants were then to continue in one of two expansion cohorts (Part B or C) and were to receive up to 8 cycles of treatment on Day 1 of each 3-week cycle (approximately 24 weeks), but the study was terminated by the Sponsor prior to completion of Part A enrollment and prior to initiation of Parts B or C enrollment.	MK-1966 210 mg+SD-101 4 mg n=6 Participants Participants received a combination of MK-1966 210 mg IV (on Day 1 of each 3-week cycle for up to 8 cycles) and SD-101 4 mg IT (on Days 1, 8 and 15 of Cycle 1, and then on Day 1 of up to 7 additional 3-week cycles) in Part A of the study. Participants were then to continue in one of two expansion cohorts (Part B or C) and were to receive up to 8 cycles of treatment on Day 1 of each 3-week cycle (approximately 24 weeks), but the study was terminated by the Sponsor prior to completion of Part A enrollment and prior to initiation of Parts B or C enrollment.	MK-1966 700 mg+SD-101 4 mg n=2 Participants Participants received a combination of MK-1966 700 mg IV (on Day 1 of each 3-week cycle for up to 8 cycles) and SD-101 4 mg IT (on Days 1, 8 and 15 of Cycle 1, and then on Day 1 of up to 7 additional 3-week cycles) in Part A of the study. Participants were to continue in one of two expansion cohorts (Part B or C) and were to receive up to 8 cycles of treatment on Day 1 of each 3-week cycle (approximately 24 weeks), but the study was terminated by the Sponsor prior to completion of Part A enrollment and prior to initiation of Parts B or C enrollment.
Number of Participants Discontinuing Study Drug Due to AEs	0 Participants	0 Participants	1 Participants	0 Participants

Adverse Events

MK-1966 70 mg+SD-101 1 mg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

MK-1966 70 mg+SD-101 4 mg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 2 deaths

MK-1966 210 mg+SD-101 4 mg

Serious events: 3 serious events

Other events: 6 other events

Deaths: 5 deaths

MK-1966 700 mg+SD-101 4 mg

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MK-1966 70 mg+SD-101 1 mg n=3 participants at risk Participants received a combination of MK-1966 70 mg intravenously (IV) (on Day 1 of each 3-week cycle for up to 8 cycles) and SD-101 1 mg intratumorally (IT) (on Days 1, 8 and 15 of Cycle 1, and then on Day 1 of up to 7 additional 3-week cycles) in Part A of the study. Participants were then to continue in one of two expansion cohorts (Part B or C) and were to receive up to 8 cycles of treatment on Day 1 of each 3-week cycle (approximately 24 weeks), but the study was terminated by the Sponsor prior to completion of Part A enrollment and prior to initiation of Parts B or C enrollment.	MK-1966 70 mg+SD-101 4 mg n=3 participants at risk Participants received a combination of MK-1966 70 mg IV (on Day 1 of each 3-week cycle for up to 8 cycles) and SD-101 4 mg IT (on Days 1, 8 and 15 of Cycle 1, and then on Day 1 of up to 7 additional 3-week cycles) in Part A of the study. Participants were then to continue in one of two expansion cohorts (Part B or C) and were to receive up to 8 cycles of treatment on Day 1 of each 3-week cycle (approximately 24 weeks), but the study was terminated by the Sponsor prior to completion of Part A enrollment and prior to initiation of Parts B or C enrollment.	MK-1966 210 mg+SD-101 4 mg n=6 participants at risk Participants received a combination of MK-1966 210 mg IV (on Day 1 of each 3-week cycle for up to 8 cycles) and SD-101 4 mg IT (on Days 1, 8 and 15 of Cycle 1, and then on Day 1 of up to 7 additional 3-week cycles) in Part A of the study. Participants were then to continue in one of two expansion cohorts (Part B or C) and were to receive up to 8 cycles of treatment on Day 1 of each 3-week cycle (approximately 24 weeks), but the study was terminated by the Sponsor prior to completion of Part A enrollment and prior to initiation of Parts B or C enrollment.	MK-1966 700 mg+SD-101 4 mg n=2 participants at risk Participants received a combination of MK-1966 700 mg IV (on Day 1 of each 3-week cycle for up to 8 cycles) and SD-101 4 mg IT (on Days 1, 8 and 15 of Cycle 1, and then on Day 1 of up to 7 additional 3-week cycles) in Part A of the study. Participants were to continue in one of two expansion cohorts (Part B or C) and were to receive up to 8 cycles of treatment on Day 1 of each 3-week cycle (approximately 24 weeks), but the study was terminated by the Sponsor prior to completion of Part A enrollment and prior to initiation of Parts B or C enrollment.
General disorders Pyrexia	33.3% 1/3 • Number of events 1 • From first dose of study drug through 90 days after last dose of study drug (Up to approximately 22 weeks) The safety analysis population consisted of all participants who received ≥1 dose of study drug. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/3 • From first dose of study drug through 90 days after last dose of study drug (Up to approximately 22 weeks) The safety analysis population consisted of all participants who received ≥1 dose of study drug. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/6 • From first dose of study drug through 90 days after last dose of study drug (Up to approximately 22 weeks) The safety analysis population consisted of all participants who received ≥1 dose of study drug. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • From first dose of study drug through 90 days after last dose of study drug (Up to approximately 22 weeks) The safety analysis population consisted of all participants who received ≥1 dose of study drug. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Skin infection	0.00% 0/3 • From first dose of study drug through 90 days after last dose of study drug (Up to approximately 22 weeks) The safety analysis population consisted of all participants who received ≥1 dose of study drug. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/3 • From first dose of study drug through 90 days after last dose of study drug (Up to approximately 22 weeks) The safety analysis population consisted of all participants who received ≥1 dose of study drug. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/6 • From first dose of study drug through 90 days after last dose of study drug (Up to approximately 22 weeks) The safety analysis population consisted of all participants who received ≥1 dose of study drug. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	50.0% 1/2 • Number of events 1 • From first dose of study drug through 90 days after last dose of study drug (Up to approximately 22 weeks) The safety analysis population consisted of all participants who received ≥1 dose of study drug. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Urinary tract infection	0.00% 0/3 • From first dose of study drug through 90 days after last dose of study drug (Up to approximately 22 weeks) The safety analysis population consisted of all participants who received ≥1 dose of study drug. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/3 • From first dose of study drug through 90 days after last dose of study drug (Up to approximately 22 weeks) The safety analysis population consisted of all participants who received ≥1 dose of study drug. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	16.7% 1/6 • Number of events 1 • From first dose of study drug through 90 days after last dose of study drug (Up to approximately 22 weeks) The safety analysis population consisted of all participants who received ≥1 dose of study drug. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • From first dose of study drug through 90 days after last dose of study drug (Up to approximately 22 weeks) The safety analysis population consisted of all participants who received ≥1 dose of study drug. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • From first dose of study drug through 90 days after last dose of study drug (Up to approximately 22 weeks) The safety analysis population consisted of all participants who received ≥1 dose of study drug. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/3 • From first dose of study drug through 90 days after last dose of study drug (Up to approximately 22 weeks) The safety analysis population consisted of all participants who received ≥1 dose of study drug. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	16.7% 1/6 • Number of events 1 • From first dose of study drug through 90 days after last dose of study drug (Up to approximately 22 weeks) The safety analysis population consisted of all participants who received ≥1 dose of study drug. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • From first dose of study drug through 90 days after last dose of study drug (Up to approximately 22 weeks) The safety analysis population consisted of all participants who received ≥1 dose of study drug. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • From first dose of study drug through 90 days after last dose of study drug (Up to approximately 22 weeks) The safety analysis population consisted of all participants who received ≥1 dose of study drug. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	33.3% 1/3 • Number of events 1 • From first dose of study drug through 90 days after last dose of study drug (Up to approximately 22 weeks) The safety analysis population consisted of all participants who received ≥1 dose of study drug. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/6 • From first dose of study drug through 90 days after last dose of study drug (Up to approximately 22 weeks) The safety analysis population consisted of all participants who received ≥1 dose of study drug. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • From first dose of study drug through 90 days after last dose of study drug (Up to approximately 22 weeks) The safety analysis population consisted of all participants who received ≥1 dose of study drug. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Vascular disorders Hypotension	0.00% 0/3 • From first dose of study drug through 90 days after last dose of study drug (Up to approximately 22 weeks) The safety analysis population consisted of all participants who received ≥1 dose of study drug. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/3 • From first dose of study drug through 90 days after last dose of study drug (Up to approximately 22 weeks) The safety analysis population consisted of all participants who received ≥1 dose of study drug. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	16.7% 1/6 • Number of events 1 • From first dose of study drug through 90 days after last dose of study drug (Up to approximately 22 weeks) The safety analysis population consisted of all participants who received ≥1 dose of study drug. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • From first dose of study drug through 90 days after last dose of study drug (Up to approximately 22 weeks) The safety analysis population consisted of all participants who received ≥1 dose of study drug. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.

Other adverse events

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this study 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
Publication restrictions are in place

Restriction type: OTHER