| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02132754 | Study of MK-4166 and MK-4166 in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-4166-001) | PHASE1 | COMPLETED | 116 | — | — | Jun 27, 2014 | Jul 31, 2019 | Jan 28, 2021 | - | — |
DLT's were assessed during the first cycle (21 days) for each dose level and included the following if assessed by the Investigator to be possibly, probably or definitely related to MK-4166 or MK-4166 plus pembrolizumab combination: Grade 4 non-hematologic toxicity; Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia (Grade 4 thrombocytopenia of any duration or Grade 3 thrombocytopenia if associated with bleeding); Grade 3 non-hematologic toxicity lasting \>3 days despite optimal supportive care; Grade 3 nausea, vomiting or diarrhea if \>3 days despite optimal supportive care; any Grade 3 or Grade 4 non-hematologic laboratory abnormality if medical intervention is required or if leading to hospitalization or if persisting for \>1 week; febrile neutropenia Grade 3 or Grade 4; any drug-related AE which caused participant to discontinue treatment during Cycle 1; Grade 5 toxicity; any treatment-related toxicity which caused a \>2 week delay in initiation of Cycle 2.
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. Per protocol, the number of participants experiencing an AE was assessed and reported by arm (MK-4166 monotherapy and MK-4166 plus pembrolizumab combination therapy) as well as by dose cohort.
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. Per protocol, the number of participants discontinuing study treatment due to AEs was assessed and reported by arm (MK-4166 monotherapy and MK-4166 plus pembrolizumab combination therapy) as well as by dose cohort.
| Arm | Type | Description |
|---|---|---|
| MK-4166 0.0015 mg | EXPERIMENTAL | Participant received 0.0015 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles. |
| MK-4166 0.0045 mg | EXPERIMENTAL | Participant received 0.0045 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles. |
| MK-4166 0.014 mg | EXPERIMENTAL | Participant received 0.014 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles. |
| MK-4166 0.04 mg | EXPERIMENTAL | Participant received 0.04 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles. |
| MK-4166 0.12 mg | EXPERIMENTAL | Participant received 0.12 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles. |
| MK-4166 0.37 mg | EXPERIMENTAL | Participant received 0.37 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles. |
| MK-4166 1.1 mg | EXPERIMENTAL | Participant received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles. |
| MK-4166 3.3 mg | EXPERIMENTAL | Participant received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles. |
| MK-4166 10 mg | EXPERIMENTAL | Participant received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles. |
| MK-4166 30 mg | EXPERIMENTAL | Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles. |
| MK-4166 42 mg | EXPERIMENTAL | Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles. |
| MK-4166 59 mg | EXPERIMENTAL | Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles. |
| MK-4166 82 mg | EXPERIMENTAL | Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles. |
| MK-4166 120 mg | EXPERIMENTAL | Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles. |
| MK-4166 170 mg | EXPERIMENTAL | Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles. |
| MK-4166 240 mg | EXPERIMENTAL | Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles. |
| MK-4166 340 mg | EXPERIMENTAL | Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles. |
| MK-4166 480 mg | EXPERIMENTAL | Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles. |
| MK-4166 670 mg | EXPERIMENTAL | Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles. |
| MK-4166 900 mg | EXPERIMENTAL | Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles. |
| MK-4166 1.1 mg + Pembro | EXPERIMENTAL | Participants received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles. |
| MK-4166 3.3 mg + Pembro | EXPERIMENTAL | Participants received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles. |
| MK-4166 10 mg + Pembro | EXPERIMENTAL | Participants received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles. |
| MK-4166 30 mg + Pembro | EXPERIMENTAL | Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles. |
| MK-4166 42 mg + Pembro | EXPERIMENTAL | Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles. |
| MK-4166 59 mg + Pembro | EXPERIMENTAL | Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles. |
| MK-4166 82 mg + Pembro | EXPERIMENTAL | Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles. |
| MK-4166 120 mg + Pembro | EXPERIMENTAL | Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles. |
| MK-4166 170 mg + Pembro | EXPERIMENTAL | Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles. |
| MK-4166 240 mg + Pembro | EXPERIMENTAL | Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles. |
| MK-4166 340 mg + Pembro | EXPERIMENTAL | Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles. |
| MK-4166 480 mg + Pembro | EXPERIMENTAL | Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles. |
| MK-4166 670 mg + Pembro | EXPERIMENTAL | Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles. |
| MK-4166 900 mg + Pembro | EXPERIMENTAL | Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles. |
| Name | Type | Description |
|---|---|---|
| MK-4166 | BIOLOGICAL | - |
| Pembrolizumab | BIOLOGICAL | - |
Inclusion criteria: * Has a histologically- or cytologically-confirmed metastatic solid tumor for which there is no available therapy which may convey clinical benefit. Part E: Has advanced malignant melanoma. * Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab, V503, GARDASIL |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| AstraZeneca PLC | AZN | 1 | — | Trastuzumab deruxtecan |