Trial Outcomes & Findings for Study of Intralesional Administration of MK-4621 (RGT100) in Adult Participants With Advanced or Recurrent Tumors (MK-4621-001/RGT100-001) (NCT NCT03065023)

Last Updated: 2019-07-30

Results Overview

An AE was defined as any untoward medical occurrence in a study participant administered study treatment which did not necessarily have a causal relationship with this treatment. Treatment-related was defined as having a "Possible" or "Related" relationship to study treatment, as assessed by the Investigator. Severity of AE referred to the extent to which an AE affected the participants daily activities as assessed by the Investigator and was based on NCI CTCAE grades: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe or medically significant but not immediately life-threatening); Grade 4 (Life-threatening consequences); or Grade 5 (Death related to AE). The number of participants who experienced at least one treatment-related AE or laboratory abnormality are presented by severity.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

15 participants

Primary outcome timeframe

Up to 90 days post last injection (Up to approximately 192 days)

Results posted on

2019-07-30

Participant Flow

Participant milestones

Participant milestones
Measure	Group A: MK-4621 0.2 mg Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.2.mg via intratumoral (IT)/intralesional (IL) injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.4 mg Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.4 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.6 mg Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.6 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.8 mg Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.8 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.
Overall Study STARTED	3	3	3	6
Overall Study COMPLETED	1	1	2	3
Overall Study NOT COMPLETED	2	2	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Group A: MK-4621 0.2 mg Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.2.mg via intratumoral (IT)/intralesional (IL) injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.4 mg Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.4 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.6 mg Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.6 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.8 mg Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.8 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.
Overall Study Progressive Disease	0	1	0	0
Overall Study Death	2	0	1	1
Overall Study Lost to Follow-up	0	1	0	0
Overall Study Participant Decision	0	0	0	1
Overall Study Withdrawal by Subject	0	0	0	1

Baseline Characteristics

Study of Intralesional Administration of MK-4621 (RGT100) in Adult Participants With Advanced or Recurrent Tumors (MK-4621-001/RGT100-001)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group A: MK-4621 0.2 mg n=3 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.2.mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.4 mg n=3 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.4 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.6 mg n=3 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.6 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.8 mg n=6 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.8 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Total n=15 Participants Total of all reporting groups
Age, Continuous	51.7 Years STANDARD_DEVIATION 26.8 • n=93 Participants	48.7 Years STANDARD_DEVIATION 18.1 • n=4 Participants	55.3 Years STANDARD_DEVIATION 16.0 • n=27 Participants	64.2 Years STANDARD_DEVIATION 8.3 • n=483 Participants	56.8 Years STANDARD_DEVIATION 15.9 • n=36 Participants
Sex: Female, Male Female	2 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants	2 Participants n=483 Participants	7 Participants n=36 Participants
Sex: Female, Male Male	1 Participants n=93 Participants	2 Participants n=4 Participants	1 Participants n=27 Participants	4 Participants n=483 Participants	8 Participants n=36 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	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
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=93 Participants	3 Participants n=4 Participants	3 Participants n=27 Participants	6 Participants n=483 Participants	15 Participants n=36 Participants
Ethnicity (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
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	3 Participants n=27 Participants	6 Participants n=483 Participants	15 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
Plasma Cytokine Release by Cytokine Type IL-6	9.3 ng/L n=93 Participants	9.3 ng/L n=4 Participants	10 ng/L n=27 Participants	7.5 ng/L n=483 Participants	9.3 ng/L n=36 Participants
Plasma Cytokine Release by Cytokine Type TNF-a	8.3 ng/L n=93 Participants	8.3 ng/L n=4 Participants	24.2 ng/L n=27 Participants	9.7 ng/L n=483 Participants	9.7 ng/L n=36 Participants

PRIMARY outcome

Timeframe: Up to 90 days post last injection (Up to approximately 192 days)

Population: The safety population consisted of all participants who received ≥1 injection of MK-4621.

Outcome measures

Outcome measures
Measure	Group A: MK-4621 0.2 mg n=3 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.2.mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.4 mg n=3 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.4 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.6 mg n=3 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.6 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.8 mg n=6 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.8 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.
Number of Participants Who Experienced a Treatment-related Adverse Event (AE) or Laboratory Abnormality by Severity Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Criteria Grade 1	1 Participants	2 Participants	2 Participants	3 Participants
Number of Participants Who Experienced a Treatment-related Adverse Event (AE) or Laboratory Abnormality by Severity Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Criteria Grade 2	0 Participants	1 Participants	1 Participants	2 Participants
Number of Participants Who Experienced a Treatment-related Adverse Event (AE) or Laboratory Abnormality by Severity Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Criteria Grade 3	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants Who Experienced a Treatment-related Adverse Event (AE) or Laboratory Abnormality by Severity Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Criteria Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Who Experienced a Treatment-related Adverse Event (AE) or Laboratory Abnormality by Severity Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Criteria Grade 5	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 90 days post last injection (Up to approximately 192 days)

Population: The safety population consisted of all participants who received ≥1 injection of MK-4621.

A SAE was defined as any AE, regardless of dose, causality or expectedness, that: * Resulted in death; * Was life-threatening; * Required inpatient hospitalization or prolonged existing inpatient hospitalization; * Resulted in persistent or significant incapacity or disability; * Was a congenital anomaly or birth defect; or * Was any other medically important event.

Outcome measures

Outcome measures
Measure	Group A: MK-4621 0.2 mg n=3 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.2.mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.4 mg n=3 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.4 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.6 mg n=3 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.6 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.8 mg n=6 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.8 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.
Number of Participants Who Experienced a Serious Adverse Event (SAE)	2 Participants	2 Participants	1 Participants	3 Participants

PRIMARY outcome

Timeframe: Up to last injection (Up to approximately 102 days)

Population: The safety population consisted of all participants who received ≥1 injection of MK-4621.

An AE was defined as any untoward medical occurrence in a study participant administered a study treatment which did not necessarily have a causal relationship with this treatment. Treatment-related was defined as having a "Possible" or "Related" relationship to study treatment, as assessed by the Investigator. The number of participants who discontinued study treatment due to a treatment-related AE is presented.

Outcome measures

Outcome measures
Measure	Group A: MK-4621 0.2 mg n=3 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.2.mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.4 mg n=3 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.4 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.6 mg n=3 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.6 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.8 mg n=6 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.8 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.
Number of Participants Who Discontinued Study Treatment Due to a Treatment-related Adverse Event (AE)	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Cycle 1 (Up to approximately 28 days); Each cycle was 28 days.

Population: The DLT evaluable population consisted of participants who completed Cycle 1 (Day 28) or withdrew early for experiencing a DLT.

DLTs were assessed during the first treatment cycle (28 days) \& were defined as any drug-related toxicity that occurred during the 28-day DLT period and included: * Non-hematologic toxicity grade ≥3 (except diarrhea, nausea, and vomiting unless lasting \>3 days despite optimal supportive care); * Confirmed (with a second measurement after 24 hours) non-hematologic appropriately graded laboratory findings of Grade ≥3 that were ≤ Grade 1 at baseline; * Hematologic toxicity: * Grade 4 neutropenia ≥5 days, or Grade 3 neutropenia with fever (fever is \>38.4ºC) * Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia lasting \>7 days or with bleeding; and * Any other toxicity assessed as related to MK-4621, and which, in the opinion of the Investigator and the Sponsor physician constituted a DLT. The number of participants who experienced a DLT is presented by NCI CTCAE version 4.03 severity grade.

Outcome measures

Outcome measures
Measure	Group A: MK-4621 0.2 mg n=3 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.2.mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.4 mg n=3 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.4 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.6 mg n=3 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.6 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.8 mg n=6 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.8 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.
Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) by Severity Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Criteria Grade 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) by Severity Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Criteria Grade 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) by Severity Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Criteria Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) by Severity Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Criteria Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) by Severity Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Criteria Grade 5	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 60 days post last injection (Up to approximately 162 days)

Population: The efficacy population consisted of all allocated participants.

ORR was defined as the percentage of participants who had a Complete Response (CR) or a Partial Response. Per irRECIST, CR (irCR) was defined as the complete disappearance of all measurable and non-measurable lesions. Lymph nodes must also have decreased to \<0 mm in short axis. And, per irRECIST, Partial Response (irPR) was defined as a decrease of ≥30% in total measured tumor burden (TMTB) relative to baseline. For this study, irRECIST was modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The percentage of participants who experienced an irCR or irPR based on irRECIST is presented.

Outcome measures

Outcome measures
Measure	Group A: MK-4621 0.2 mg n=3 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.2.mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.4 mg n=3 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.4 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.6 mg n=3 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.6 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.8 mg n=6 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.8 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.
Objective Response Rate as Evaluated Radiologically Using Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)	0 Percentage of Participants Interval 0.0 to 70.8	0 Percentage of Participants Interval 0.0 to 70.8	0 Percentage of Participants Interval 0.0 to 70.8	0 Percentage of Participants Interval 0.0 to 45.9

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Cycle 1 Day 1 (6 hours post injection) (Up to 1 day); Each cycle was 28 days.

Population: The cytokine evaluable population consisted of all participants who received ≥1 dose of MK-4621 and had baseline and post treatment cytokine data.

Blood samples were collected at various time points for the analysis of mean fold change from baseline in cytokine release for selected cytokines (Interleukin-6 \[IL-6\] and tumor necrosis factor-alpha \[TNF-a\]) in plasma.

Outcome measures

Outcome measures
Measure	Group A: MK-4621 0.2 mg n=3 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.2.mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.4 mg n=3 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.4 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.6 mg n=3 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.6 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.8 mg n=6 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.8 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.
Mean Fold Change From Baseline in Plasma Cytokine Release by Cytokine Type: Day 1 (6 Hours Post Injection) IL-6	1 Fold change Standard Deviation 0	1.95 Fold change Standard Deviation 1.64	2.71 Fold change Standard Deviation 2.34	2.52 Fold change Standard Deviation 3.14
Mean Fold Change From Baseline in Plasma Cytokine Release by Cytokine Type: Day 1 (6 Hours Post Injection) TNF-a	1 Fold change Standard Deviation 0	1 Fold change Standard Deviation 0	1 Fold change Standard Deviation 0.6	0.89 Fold change Standard Deviation 0.28

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Cycle 1 Day 1 (24 hours post injection) (Up to 2 days); Each cycle was 28 days.

Population: The cytokine evaluable population consisted of all participants who received ≥1 dose of MK-4621 and had baseline and post treatment cytokine data.

Outcome measures

Outcome measures
Measure	Group A: MK-4621 0.2 mg n=2 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.2.mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.4 mg n=3 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.4 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.6 mg n=3 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.6 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.8 mg n=6 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.8 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.
Mean Fold Change From Baseline in Plasma Cytokine Release by Cytokine Type: Day 1 (24 Hours Post Injection) IL-6	1 Fold change Standard Deviation 0	1.27 Fold change Standard Deviation 0.46	1.14 Fold change Standard Deviation 0.3	1.68 Fold change Standard Deviation 0.97
Mean Fold Change From Baseline in Plasma Cytokine Release by Cytokine Type: Day 1 (24 Hours Post Injection) TNF-a	1 Fold change Standard Deviation 0	1 Fold change Standard Deviation 0	1.48 Fold change Standard Deviation 1.44	0.89 Fold change Standard Deviation 0.28

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Cycle 1 Day 25 (6 hours post injection) (Up to 25 days); Each cycle was 28 days.

Population: The cytokine evaluable population consisted of all participants who received ≥1 dose of MK-4621 and had baseline and post treatment cytokine data.

Outcome measures

Outcome measures
Measure	Group A: MK-4621 0.2 mg n=3 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.2.mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.4 mg n=3 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.4 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.6 mg n=3 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.6 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.8 mg n=5 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.8 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.
Mean Fold Change From Baseline in Plasma Cytokine Release by Cytokine Type: Day 25 (6 Hours Post Injection) IL-6	0.95 Fold change Standard Deviation 0.08	2 Fold change Standard Deviation 1.11	1.02 Fold change Standard Deviation 0.31	1.5 Fold change Standard Deviation 0.61
Mean Fold Change From Baseline in Plasma Cytokine Release by Cytokine Type: Day 25 (6 Hours Post Injection) TNF-a	1 Fold change Standard Deviation 0	1 Fold change Standard Deviation 0	0.77 Fold change Standard Deviation 0.21	0.77 Fold change Standard Deviation 0.29

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Cycle 1 Day 25 (24 hours post injection) (Up to 26 days); Each cycle was 28 days.

Population: The cytokine evaluable population consisted of all participants who received ≥1 dose of MK-4621 and had baseline and post treatment cytokine data.

Outcome measures

Outcome measures
Measure	Group A: MK-4621 0.2 mg n=3 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.2.mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.4 mg n=3 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.4 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.6 mg n=3 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.6 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.8 mg n=5 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.8 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.
Mean Fold Change From Baseline in Plasma Cytokine Release by Cytokine Type: Day 25 (24 Hours Post Injection) IL-6	1.52 Fold change Standard Deviation 0.9	1 Fold change Standard Deviation 0	0.99 Fold change Standard Deviation 0.1	0.89 Fold change Standard Deviation 0.19
Mean Fold Change From Baseline in Plasma Cytokine Release by Cytokine Type: Day 25 (24 Hours Post Injection) TNF-a	1 Fold change Standard Deviation 0	1 Fold change Standard Deviation 0	1.02 Fold change Standard Deviation 0.63	0.88 Fold change Standard Deviation 0.32

OTHER_PRE_SPECIFIED outcome

Timeframe: Cycle 1 Day 1: Predose, 5 and 30 minutes, 2, 4, 6 and 24 hours post dose (Up to 2 days); Each cycle was 28 days.

Population: The pharmacokinetic evaluable population consisted of all participants who received ≥1 injection of MK-4621 and had pre- and post-treatment pharmacokinetic data for AUC0-t on Cycle 1 Day 1.

Blood samples were collected at various time points during Cycle 1 for the determination of MK-4621 AUC0-t on Day 1, which was defined as the AUC from the start time of dosing to the time of the last observed concentration above the limit of quantitation (LOQ).

Outcome measures

Outcome measures
Measure	Group A: MK-4621 0.2 mg n=3 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.2.mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.4 mg n=3 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.4 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.6 mg n=3 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.6 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.8 mg n=6 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.8 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.
Area Under the Concentration-Time Curve From Start of Dosing to Last Observed Concentration Above Limit of Quantitation (AUC0-t) of MK-4621: Day 1	0.00 h*ng/mL Standard Deviation 0.00	0.174 h*ng/mL Standard Deviation 0.157	0.0360 h*ng/mL Standard Deviation 0.0623	1.87 h*ng/mL Standard Deviation 4.55

OTHER_PRE_SPECIFIED outcome

Timeframe: Cycle 1 Day 25: Predose, 5 and 30 minutes, 2, 4, 6 and 24 hours post dose (Up to 26 days); Each cycle was 28 days.

Blood samples were collected at various time points during Cycle 1 for the determination of MK-4621 AUC0-t on Day 25, which was defined as the AUC from the start time of dosing to the time of the last observed concentration above the limit of quantitation (LOQ).

Outcome measures

Outcome measures
Measure	Group A: MK-4621 0.2 mg n=3 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.2.mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.4 mg n=3 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.4 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.6 mg n=3 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.6 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.8 mg n=5 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.8 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.
Area Under the Concentration-Time Curve From Start of Dosing to Last Observed Concentration Above Limit of Quantitation (AUC0-t) of MK-4621: Day 25	0.00 h*ng/mL Standard Deviation 0.00	1.07 h*ng/mL Standard Deviation 0.767	0.099 h*ng/mL Standard Deviation 0.172	0.156 h*ng/mL Standard Deviation 0.350

OTHER_PRE_SPECIFIED outcome

Timeframe: Cycle 1 Day 1: Predose, 5 and 30 minutes, 2, 4, 6 and 24 hours post dose (Up to 2 days); Each cycle was 28 days.

Blood samples were collected at various time points during Cycle 1 for the determination of MK-4621 Cmax on Day 1.

Outcome measures

Outcome measures
Measure	Group A: MK-4621 0.2 mg n=3 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.2.mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.4 mg n=3 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.4 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.6 mg n=3 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.6 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.8 mg n=6 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.8 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.
Maximum Plasma Concentration (Cmax) of MK-4621: Day 1	0.00 ng/mL Standard Deviation 0.00	4.18 ng/mL Standard Deviation 3.76	0.863 ng/mL Standard Deviation 1.50	9.24 ng/mL Standard Deviation 21.9

OTHER_PRE_SPECIFIED outcome

Timeframe: Cycle 1 Day 25: Predose, 5 and 30 minutes, 2, 4, 6 and 24 hours post dose (Up to 26 days); Each cycle was 28 days.

Blood samples were collected at various time points during Cycle 1 for the determination of MK-4621 Cmax on Day 25.

Outcome measures

Outcome measures
Measure	Group A: MK-4621 0.2 mg n=3 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.2.mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.4 mg n=3 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.4 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.6 mg n=3 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.6 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.8 mg n=5 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.8 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.
Maximum Plasma Concentration (Cmax) of MK-4621: Day 25	0.00 ng/mL Standard Deviation 0.00	7.43 ng/mL Standard Deviation 2.44	1.703 ng/mL Standard Deviation 2.95	3.75 ng/mL Standard Deviation 8.39

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 prior to injection (Up to 1 day)

Population: The immune infiltration evaluable population consisted of all participants who received ≥1 dose of MK-4621 and had pre- and post-treatment immune infiltration data.

Sequential participant tumor biopsies were assessed via immunohistochemistry for the presence of tumor infiltrating CD3 T cell co-receptor-marked cells and Ki-67 nuclear protein-marked cells in tumor biopsies. CD3 is a marker of T cells and KI-67 is a cell marker of proliferation and activation. The percentage of positive CD3-marked cells and double-positive CD3 and Ki-67 nuclear protein-marked cells in tumor biopsies predose on Day 1 are presented.

Outcome measures

Outcome measures
Measure	Group A: MK-4621 0.2 mg n=1 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.2.mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.4 mg n=3 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.4 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.6 mg n=1 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.6 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.8 mg n=1 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.8 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.
Immune Infiltration of Injected Tumors by CD3 T Cell Receptor and Ki-67 Nuclear Protein: Day 1 CD3 Cells	8.81 Percentage Positive Cells Interval 8.81 to 8.81	17.58 Percentage Positive Cells Interval 7.03 to 20.81	34.64 Percentage Positive Cells Interval 34.64 to 34.64	17.34 Percentage Positive Cells Interval 17.34 to 17.34
Immune Infiltration of Injected Tumors by CD3 T Cell Receptor and Ki-67 Nuclear Protein: Day 1 Ki-67 Positive CD3 Cells	25.44 Percentage Positive Cells Interval 25.44 to 25.44	25.19 Percentage Positive Cells Interval 18.46 to 48.86	39.23 Percentage Positive Cells Interval 39.23 to 39.23	32.19 Percentage Positive Cells Interval 32.19 to 32.19

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 25 post injection (Up to 25 days)

Population: The immune infiltration evaluable population consisted of all participants who received ≥1 dose of MK-4621 and had pre- and post-treatment immune infiltration data.

Outcome measures

Outcome measures
Measure	Group A: MK-4621 0.2 mg n=1 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.2.mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.4 mg n=3 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.4 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.6 mg n=1 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.6 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.8 mg n=1 Participants Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.8 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.
Immune Infiltration of Injected Tumors by CD3 T Cell Receptor and Ki-67 Nuclear Protein: Day 25 CD3 Cells	12.72 Percentage Positive Cells Interval 12.72 to 12.72	8.43 Percentage Positive Cells Interval 8.09 to 12.0	11.77 Percentage Positive Cells Interval 11.77 to 11.77	32.19 Percentage Positive Cells Interval 32.19 to 32.19
Immune Infiltration of Injected Tumors by CD3 T Cell Receptor and Ki-67 Nuclear Protein: Day 25 Ki-67 Positive CD3 Cells	16.96 Percentage Positive Cells Interval 16.96 to 16.96	36.39 Percentage Positive Cells Interval 35.81 to 48.32	17.93 Percentage Positive Cells Interval 17.93 to 17.93	12.16 Percentage Positive Cells Interval 12.16 to 12.16

Adverse Events

Group A: MK-4621 0.2 mg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 2 deaths

Group A: MK-4621 0.4 mg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Group A: MK-4621 0.6 mg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

Group A: MK-4621 0.8 mg

Serious events: 3 serious events

Other events: 6 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Group A: MK-4621 0.2 mg n=3 participants at risk Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.2.mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.4 mg n=3 participants at risk Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.4 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.6 mg n=3 participants at risk Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.6 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.	Group A: MK-4621 0.8 mg n=6 participants at risk Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received MK-4621 0.8 mg via IT/IL injection twice each week over a period of 4 weeks during Cycle 1. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (could have been up to approximately 2 years). Each cycle was 28 days.
General disorders Disease progression	0.00% 0/3 • From first dose through up to 90 days after last dose (Up to approximately 192 days) Safety Population: All participants who received ≥1 injection of MK-4621. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/3 • From first dose through up to 90 days after last dose (Up to approximately 192 days) Safety Population: All participants who received ≥1 injection of MK-4621. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/3 • From first dose through up to 90 days after last dose (Up to approximately 192 days) Safety Population: All participants who received ≥1 injection of MK-4621. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	16.7% 1/6 • Number of events 1 • From first dose through up to 90 days after last dose (Up to approximately 192 days) Safety Population: All participants who received ≥1 injection of MK-4621. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
General disorders Pyrexia	0.00% 0/3 • From first dose through up to 90 days after last dose (Up to approximately 192 days) Safety Population: All participants who received ≥1 injection of MK-4621. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	33.3% 1/3 • Number of events 1 • From first dose through up to 90 days after last dose (Up to approximately 192 days) Safety Population: All participants who received ≥1 injection of MK-4621. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/3 • From first dose through up to 90 days after last dose (Up to approximately 192 days) Safety Population: All participants who received ≥1 injection of MK-4621. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • From first dose through up to 90 days after last dose (Up to approximately 192 days) Safety Population: All participants who received ≥1 injection of MK-4621. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Device related infection	0.00% 0/3 • From first dose through up to 90 days after last dose (Up to approximately 192 days) Safety Population: All participants who received ≥1 injection of MK-4621. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/3 • From first dose through up to 90 days after last dose (Up to approximately 192 days) Safety Population: All participants who received ≥1 injection of MK-4621. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/3 • From first dose through up to 90 days after last dose (Up to approximately 192 days) Safety Population: All participants who received ≥1 injection of MK-4621. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	16.7% 1/6 • Number of events 1 • From first dose through up to 90 days after last dose (Up to approximately 192 days) Safety Population: All participants who received ≥1 injection of MK-4621. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Pneumonia	0.00% 0/3 • From first dose through up to 90 days after last dose (Up to approximately 192 days) Safety Population: All participants who received ≥1 injection of MK-4621. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/3 • From first dose through up to 90 days after last dose (Up to approximately 192 days) Safety Population: All participants who received ≥1 injection of MK-4621. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/3 • From first dose through up to 90 days after last dose (Up to approximately 192 days) Safety Population: All participants who received ≥1 injection of MK-4621. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	16.7% 1/6 • Number of events 1 • From first dose through up to 90 days after last dose (Up to approximately 192 days) Safety Population: All participants who received ≥1 injection of MK-4621. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Soft tissue infection	33.3% 1/3 • Number of events 1 • From first dose through up to 90 days after last dose (Up to approximately 192 days) Safety Population: All participants who received ≥1 injection of MK-4621. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/3 • From first dose through up to 90 days after last dose (Up to approximately 192 days) Safety Population: All participants who received ≥1 injection of MK-4621. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/3 • From first dose through up to 90 days after last dose (Up to approximately 192 days) Safety Population: All participants who received ≥1 injection of MK-4621. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • From first dose through up to 90 days after last dose (Up to approximately 192 days) Safety Population: All participants who received ≥1 injection of MK-4621. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm progression	0.00% 0/3 • From first dose through up to 90 days after last dose (Up to approximately 192 days) Safety Population: All participants who received ≥1 injection of MK-4621. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/3 • From first dose through up to 90 days after last dose (Up to approximately 192 days) Safety Population: All participants who received ≥1 injection of MK-4621. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	33.3% 1/3 • Number of events 1 • From first dose through up to 90 days after last dose (Up to approximately 192 days) Safety Population: All participants who received ≥1 injection of MK-4621. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • From first dose through up to 90 days after last dose (Up to approximately 192 days) Safety Population: All participants who received ≥1 injection of MK-4621. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Reproductive system and breast disorders Breast swelling	0.00% 0/3 • From first dose through up to 90 days after last dose (Up to approximately 192 days) Safety Population: All participants who received ≥1 injection of MK-4621. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	33.3% 1/3 • Number of events 1 • From first dose through up to 90 days after last dose (Up to approximately 192 days) Safety Population: All participants who received ≥1 injection of MK-4621. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/3 • From first dose through up to 90 days after last dose (Up to approximately 192 days) Safety Population: All participants who received ≥1 injection of MK-4621. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • From first dose through up to 90 days after last dose (Up to approximately 192 days) Safety Population: All participants who received ≥1 injection of MK-4621. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • From first dose through up to 90 days after last dose (Up to approximately 192 days) Safety Population: All participants who received ≥1 injection of MK-4621. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/3 • From first dose through up to 90 days after last dose (Up to approximately 192 days) Safety Population: All participants who received ≥1 injection of MK-4621. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	33.3% 1/3 • Number of events 1 • From first dose through up to 90 days after last dose (Up to approximately 192 days) Safety Population: All participants who received ≥1 injection of MK-4621. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • From first dose through up to 90 days after last dose (Up to approximately 192 days) Safety Population: All participants who received ≥1 injection of MK-4621. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Respiratory failure	33.3% 1/3 • Number of events 1 • From first dose through up to 90 days after last dose (Up to approximately 192 days) Safety Population: All participants who received ≥1 injection of MK-4621. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/3 • From first dose through up to 90 days after last dose (Up to approximately 192 days) Safety Population: All participants who received ≥1 injection of MK-4621. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/3 • From first dose through up to 90 days after last dose (Up to approximately 192 days) Safety Population: All participants who received ≥1 injection of MK-4621. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • From first dose through up to 90 days after last dose (Up to approximately 192 days) Safety Population: All participants who received ≥1 injection of MK-4621. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Vascular disorders Haemorrhage	0.00% 0/3 • From first dose through up to 90 days after last dose (Up to approximately 192 days) Safety Population: All participants who received ≥1 injection of MK-4621. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/3 • From first dose through up to 90 days after last dose (Up to approximately 192 days) Safety Population: All participants who received ≥1 injection of MK-4621. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/3 • From first dose through up to 90 days after last dose (Up to approximately 192 days) Safety Population: All participants who received ≥1 injection of MK-4621. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	16.7% 1/6 • Number of events 1 • From first dose through up to 90 days after last dose (Up to approximately 192 days) Safety Population: All participants who received ≥1 injection of MK-4621. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment 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 review and approve any results of the study or abstracts for professional meetings prepared by the Investigator(s). Published data must not compromise the objectives of the study. Data from individual study sites in multicenter studies must not be published separately.
Publication restrictions are in place

Restriction type: OTHER