Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as SKB410
MK-3120 · 3 trials · 4 indications
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. The number of participants that experience AEs will be reported.
DLT will be defined as any drug-related AE observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next treatment. The number of participants who experience a DLT as Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 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. The number of participants that discontinue study intervention due to an AE will be reported.
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Investigator will be presented.
Any of the following toxicities will be considered a DLT: Hematuria leading to clot or obstruction; Grade (Gr) 4 thrombocytopenia; Gr 3 thrombocytopenia associated with clinically significant bleeding; Febrile neutropenia for more than 1 hour; Other Gr ≥3 hematologic toxicity lasting \>7 days; Nonhematologic AE ≥Gr 3 (with exceptions); ≥Gr 2 pneumonitis/ interstitial lung disease; Any ≥Gr 3 nonhematologic laboratory value if clinically significant medical intervention is required, leads to hospitalization, persists for \>7 days, results in a drug induced liver injury, or elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) lab value \>8 ×upper limit of normal (ULN) regardless of duration and AST or ALT elevation 5 × to 8 × ULN that persists for greater than 2 weeks; Recurrent Gr 2 AE resulting in \>2 weeks delay in receiving the next treatment dose; Any intervention-related toxicity that results in study intervention discontinuation; Gr 5 toxicity or AE.
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
| Arm | Type | Description |
|---|---|---|
| Arm A: MK-3120 + Enfortumab Vedotin (EV) + Pembrolizumab | EXPERIMENTAL | Participants will receive MK-3120 administered intravenously on Day 1 and Day 8 of each 3-week cycle and EV administered intravenously on Day 1 and Day 8 of each 3-week cycle until documented disease progression or any other discontinuation criterion is met and Pembrolizumab 200 mg administered intravenously on Day 1 of each 3-week cycle for up to 35 cycles (\~2 years). |
| MK-3120 | EXPERIMENTAL | Participants will be administered MK-3120 once weekly for the first 6 weeks, followed by once monthly for 9 months. |
| Arm 1 Dose level 1 | EXPERIMENTAL | Participants receive MK-3120 at dose level 1 as per the schedule specified in the arm. |
| Arm 2 Dose level 2 | EXPERIMENTAL | Participants receive MK-3120 at dose level 2 as per the schedule specified in the arm. |
| Name | Type | Description |
|---|---|---|
| MK-3120 | DRUG | Administered via intravenous (IV) infusion on day 1 and day 8 of each 3-week cycle |
| EV | DRUG | Administered via IV infusion on day 1 and day 8 of each 3-week cycle |
| Pembrolizumab | BIOLOGICAL | Administered via IV infusion on day 1 of each 3-week cycle |
| Rescue Medication | DRUG | Participants receive rescue medication at the investigator's discretion, per approved product label. Recommended rescue medication is Granulocyte Colony-Stimulating Factor (G-CSF). |
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has histologically documented urothelial carcinoma (UC) that is locally advanced and unresectable or metastatic * Must provide a newly obtained or archival tumor tissue sample (core or excisional biopsy...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
MK-3120 is an investigational monoclonal antibody being developed by Merck & Company, Inc. (MRK) for the treatment of advanced solid tumors and bladder cancer. It is currently in Phase 1 clinical development, with studies evaluating its safety and efficacy in these patient populations.
The specific molecular target of MK-3120 has not been disclosed in available information. As a monoclonal antibody, it is designed to bind to a specific antigen, but the exact target is not publicly detailed at this time.
MK-3120 is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with advanced solid tumors and bladder cancer.
MK-3120 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials are currently recruiting participants to assess its safety, tolerability, and preliminary efficacy.
MK-3120 is being studied in two Phase 1 trials: NCT06818643, which enrolls 270 participants with advanced solid tumors across multiple countries, and NCT07222488, which enrolls 45 participants with bladder cancer. Both trials are actively recruiting and are controlled, non-randomized studies.
No, MK-3120 is a distinct investigational monoclonal antibody from pembrolizumab. However, a separate trial, NCT07232602 (KEYMAKER-U04), is evaluating new treatments given with enfortumab vedotin and pembrolizumab in urothelial cancer, but MK-3120 is not part of that combination study.