Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as LM-299
MK-2010 · 2 trials · 3 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
DLT is defined as any drug-related adverse event (AE) observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next dose.
ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) 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.
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 dose.
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 |
|---|---|---|
| MK-2010 + FOLFOX | EXPERIMENTAL | Participants receive MK-2010 intravenously in combination with FOLFOX chemotherapy (comprising Leucovorin or Levoleucovorin, 5-Fluorouracil, and Oxaliplatin). |
| Pembrolizumab + FOLFOX | ACTIVE_COMPARATOR | Participants receive Pembrolizumab intravenously in combination with FOLFOX chemotherapy (comprising Leucovorin or Levoleucovorin, 5-Fluorouracil, and Oxaliplatin). |
| MK-2010 Monotherapy | EXPERIMENTAL | Participants receive MK-2010 intravenously as monotherapy. |
| MK-2010 + Belzutifan | EXPERIMENTAL | Participants receive MK-2010 intravenously in combination with oral Belzutifan. |
| MK-2010 + Gemcitabine/Cisplatin | EXPERIMENTAL | Participants receive MK-2010 intravenously in combination with Gemcitabine and Cisplatin chemotherapy. |
| MK-2010 + Carboplatin and Paclitaxel/Nab-paclitaxel | EXPERIMENTAL | Participants receive MK-2010 intravenously in combination with Carboplatin and either Paclitaxel or Nab-paclitaxel chemotherapy. |
| MK-2010 + Pemetrexed and Cisplatin/Carboplatin | EXPERIMENTAL | Participants receive MK-2010 intravenously in combination with Pemetrexed and either Cisplatin or Carboplatin chemotherapy. |
| Part 1: Safety Lead-In Cohort | EXPERIMENTAL | Participants will receive MK-2010 in combination with sac-TMT. |
| Part 2: Signal-Finding Cohorts | EXPERIMENTAL | Participants will receive MK-2010 in combination with sac-TMT at the dose determined in Part 1. |
| Name | Type | Description |
|---|---|---|
| MK-2010 | BIOLOGICAL | Administered as an intravenous (IV) infusion. |
| Pembrolizumab | BIOLOGICAL | Administered intravenously as 400 mg every 6 weeks. |
| 5-Fluorouracil | DRUG | Administered intravenously per approved product label. |
| Leucovorin or Levoleucovorin | DRUG | Administered intravenously per approved product label. |
| Oxaliplatin | DRUG | Administered intravenously per approved product label. |
| Belzutifan | DRUG | Administered orally as 120 mg daily. |
| Gemcitabine | DRUG | Administered intravenously per approved product label. |
| Cisplatin | DRUG | Administered intravenously per approved product label. |
| Carboplatin | DRUG | Administered intravenously per approved product label. |
| Paclitaxel | DRUG | Administered intravenously per approved product label. |
| Nab-paclitaxel | DRUG | Administered intravenously per approved product label. |
| Pemetrexed | DRUG | Administered intravenously per approved product label. |
| Epinephrine | DRUG | Administered per approved product label as rescue medication. |
| Sacituzumab tirumotecan | BIOLOGICAL | Administered as an IV infusion |
| Histamine H1 Receptor Antagonist | DRUG | Administered as a premedication per the approved product label |
| Histamine H2 Receptor Antagonist | DRUG | Administered as a premedication per the approved product label |
| Acetaminophen (or equivalent) | DRUG | Administered as a premedication per the approved product label |
| Dexamethasone (or equivalent) | DRUG | Administered as a premedication per the approved product label |
| Steroid mouthwash (dexamethasone or equivalent) | DRUG | Administered orally per the approved product label as a rescue medication |
Inclusion Criteria: * Has radiographically measurable disease per protocol * If to receive oral study treatment, has the ability to swallow and retain oral medication and does not have gastrointestinal abnormalities that may alter absorption * Has well-controlled human immunodeficiency virus (HIV) ...
| 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-2010 is an investigational monoclonal antibody being studied for the treatment of advanced solid tumors and malignant neoplasms. It is in Phase 2 clinical development in oncology. It is not approved for any indication and remains an experimental therapy being evaluated in clinical trials.
MK-2010 is being developed by Merck & Company, Inc., which trades under the ticker MRK. Merck is the sponsor of the clinical program evaluating MK-2010 in advanced solid tumors and malignant neoplasms.
MK-2010 is in Phase 2 clinical development. It is an investigational monoclonal antibody and has not been approved by the FDA for any indication. The Phase 2 program is evaluating MK-2010 in advanced solid tumors and malignant neoplasms.
MK-2010 is being studied in two Phase 2 trials. NCT07793942 is a not-yet-recruiting trial of MK-2010 alone and with other treatments in advanced solid tumors, enrolling 480 participants in the United States and Switzerland. NCT07785609 is a recruiting trial of MK-2010 with sacituzumab tirumotecan in solid tumors, enrolling 200 participants in the United States, Hong Kong, and Switzerland.
No. MK-2010 is an investigational monoclonal antibody in Phase 2 clinical development and has not been approved by the FDA. It is being evaluated in clinical trials for advanced solid tumors and malignant neoplasms.