Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06460961 | A Study of MK-6837 as a Monotherapy and Combination Therapy in Participants With Advanced/Metastatic Solid Tumors (MK-6837-001) | PHASE1 | ACTIVE NOT_RECRUITING | 168 | — | — | Jul 14, 2024 | Jul 13, 2027 | Dec 31, 2025 | 7 | United States, Australia +2 |
The following events will be considered a DLT unless clearly due to underlying disease or extraneous causes: Grade 4 neutropenia lasting \>7 days; Grade 3 or higher thrombocytopenia associated with clinically significant bleeding, regardless of duration; All Grade 3 or higher nonhematologic toxicities (with exceptions); Any abnormality that results in a drug induced liver injury; Febrile neutropenia Grade 3 or 4; Prolonged delay (\>2 weeks) in initiating treatment after the first 21 days due to intervention-related toxicity; Any intervention-related toxicity that causes the participant to discontinue intervention during the first 21 days; Grade 5 toxicity. The number of participants who experience a DLT will be presented.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
| Arm | Type | Description |
|---|---|---|
| Arm 1: MK-6837 Monotherapy | EXPERIMENTAL | Participants receive escalating doses of MK-6837 via intravenous (IV) infusion once every 3 weeks (Q3W) (Day 1 of every 21-day cycle) until progressive disease or discontinuation. |
| Arm 2: MK-6837 + Pembrolizumab Combination Therapy | EXPERIMENTAL | Participants receive escalating doses of MK-6837 via IV infusion Q3W (Day 1 of every 21-day cycle) until progressive disease or discontinuation PLUS 200mg of pembrolizumab via IV infusion Q3W (Day 1 of every 21-day cycle) for up to 35 administrations (up to \~2 years). |
| Name | Type | Description |
|---|---|---|
| MK-6837 | BIOLOGICAL | IV Infusion |
| Pembrolizumab | BIOLOGICAL | IV Infusion |
| Rescue Medications | DRUG | Antihistamine, H2 receptor antagonist, acetaminophen (or equivalent), dexamethasone (or equivalent) administered per product label prior to MK-6837. |
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Histologically or cytologically confirmed solid tumor by pathology report that is advanced or metastatic * Human Immunodeficiency Virus (HIV)-infected participants must have well controlled HIV on Antir...