Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-1084 · 2 trials · 2 indications
A DLT is defined as the occurrence of protocol-specified toxicities if assessed by the investigator to be possibly, probably, or definitely related to study intervention administration, excluding toxicities clearly not related to the drug.
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.
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 RECIST 1.1. The percentage of participants who experience CR or PR as assessed by BICR will be presented.
DLT will be defined as any drug-related AE observed during the DLT evaluation period (up to 42 days) that results in a change to a given dose or a delay in initiating the next treatment.
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.
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 Blinded Independent Central Review (BICR) will be presented.
| Arm | Type | Description |
|---|---|---|
| Arm A- Pembrolizumab + MK-1084 | EXPERIMENTAL | Participants receive 400 mg of Pembrolizumab every 6 weeks and MK-1084 dose regimen. |
| Arm B- Pembrolizumab + MK-1084 + Cetuximab | EXPERIMENTAL | Participants receive 400 mg of Pembrolizumab every 6 weeks, MK-1084 dose regimen, and Cetuximab 500 mg/m\^2 every 2 weeks. |
| Arm C- Pembrolizumab + MK-1084 + sacituzumab tirumotecan (sac-TMT) | EXPERIMENTAL | Participants receive 400 mg of Pembrolizumab every 6 weeks, MK-1084 dose regimen, and 4 mg/kg sacituzumab tirumotecan (sac-TMT) every 2 weeks. |
| MK-1084 + Patritumab deruxtecan (HER3-DXd) | EXPERIMENTAL | Participants will receive MK-1084 and HER3-DXd until discontinuation due to toxicity, adverse event (AE) or at the discretion of an investigator. |
| MK-1084 + Sacituzumab tirumotecan (Sac-TMT) | EXPERIMENTAL | Participants will receive MK-1084 and sac-TMT until discontinuation due to toxicity, AE or at the discretion of an investigator. |
| MK-1084 + Cetuximab | EXPERIMENTAL | Participants will receive MK-1084 and cetuximab until discontinuation due to toxicity, AE or at the discretion of an investigator. Per amendment 3, the MK-1084 + Cetuximab arm was discontinued. |
| Name | Type | Description |
|---|---|---|
| MK-1084 | DRUG | Oral Administration |
| Pembrolizumab | BIOLOGICAL | Intravenous administration |
| Cetuximab | BIOLOGICAL | Intravenous administration |
| Sacituzumab tirumotecan (sac-TMT) | BIOLOGICAL | Injection powder for intravenous infusion |
| Rescue medication | DRUG | Participants receive the following rescue medications, per approved product label, as premedication to study treatment to prevent hypersensitivity and/or infusion reactions: diphenhydramine (or equivalent histamine-1 \[Hl\] receptor antagonist), H2 receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion, and granulocyte colony-stimulating factor (G-CSF). A steroid mouthwash (dexamethasone or equivalent) will be given as prophylaxis for stomatitis/oral mucositis. |
| Patritumab deruxtecan | BIOLOGICAL | IV infusion |
| Sacituzumab tirumotecan | BIOLOGICAL | IV Infusion |
| Rescue Medications | DRUG | Participants receive rescue medication at the investigator's discretion for prevention of nausea and vomiting, per approved product label. Recommended rescue medications are histamine-1 (H1) receptor antagonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion, or steroid mouthwash (dexamethasone or equivalent), 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist, neurokinin 1 (NK-1) receptor antagonist and corticosteroid. |
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has histologically or cytologically confirmed diagnosis of advanced or metastatic nonsquamous Non-Small Cell Lung Cancer (NSCLC) * Has tumor tissue or circulating tumor deoxyribonucleic acid (ctDNA) tha...
MK-1084 is an investigational small molecule being studied for the treatment of malignant neoplasms, including non-small cell lung cancer (NSCLC) with KRAS G12C mutations. It is currently in Phase 1 and Phase 2 clinical trials as part of combination therapy regimens for these cancers.
MK-1084 targets KRAS G12C, a specific mutation in the KRAS gene associated with certain cancers, including non-small cell lung cancer. By targeting this mutation, MK-1084 is designed to interfere with cancer cell growth and survival in tumors harboring the KRAS G12C alteration.
MK-1084 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. Merck is conducting clinical trials to evaluate MK-1084 in combination with other treatments for KRAS G12C-mutated cancers.
MK-1084 is in Phase 1 and Phase 2 clinical development. It is an investigational drug, not yet approved by regulatory authorities, and is being studied in combination with other therapies for non-small cell lung cancer and other malignant neoplasms.
MK-1084 is being studied in two recruiting trials. NCT07252739 is a Phase 2 study of pembrolizumab plus MK-1084 in NSCLC with KRAS G12C mutations. NCT07286149 is a Phase 1 study of MK-1084 with other treatments for NSCLC. Both trials enroll adults aged 18 and older.
No, MK-1084 is not the same as pembrolizumab. MK-1084 is a small molecule targeting KRAS G12C, while pembrolizumab is an immunotherapy that targets PD-1. In clinical trials, MK-1084 is being studied in combination with pembrolizumab for the treatment of KRAS G12C-mutated non-small cell lung cancer.