Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Pembrolizumab
MK-3475 · 1 trial · 14 indications
An adverse event is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after a participant provides informed consent. A TEAE is any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug. Serious adverse event (SAE) is defined as an event that meets 1 of the following criteria: is fatal or life threatening, results in persistent or significant disability or incapacity, constitutes a congenital anomaly or birth defect, is clinically meaningful (i.e. defined as an event that jeopardizes the participant or requires potential medical or surgical intervention to prevent 1 of the outcomes listed above) or requires inpatient hospitalization or prolongation of existing hospitalization.
ORR was percentage of participants with best overall response \[complete response (CR) or partial response (PR)\], per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
| Arm | Type | Description |
|---|---|---|
| Phase 1: MK-3475 + INCB024360 | EXPERIMENTAL | Phase 1: MK-3475 + INCB024360 25 mg twice a day (BID) as starting dose, followed by dose escalations (Phase 1) until recommended phase 2 dose of INCB024360 is determined |
| Phase 2: MK-3475 + INCB024360 | EXPERIMENTAL | (recommended phase 2 dose) |
| Name | Type | Description |
|---|---|---|
| MK-3475 | DRUG | IV infusion |
| INCB024360 | DRUG | Oral daily dosing |
Inclusion Criteria: * Subjects with histologically or cytologically non-small cell lung cancer (NSCLC), melanoma, transitional cell carcinoma of the genitourinary (GU) tract, renal cell cancer, triple negative breast cancer, adenocarcinoma of the endometrium or squamous cell carcinoma of the head a...
MK-3475, also known as pembrolizumab, is an investigational antibody being studied in oncology. It is being evaluated in clinical trials for head and neck cancer, melanoma, colorectal cancer, lung cancer, urothelial cancer, and triple-negative breast cancer. It is currently in Phase 1 development.
MK-3475 is a monoclonal antibody, a type of -mab antibody. It is being studied in combination with other agents in clinical trials for various cancers, including melanoma and renal cell carcinoma. Its specific molecular target is not disclosed in the available information.
MK-3475 is being developed by Incyte Corporation, which is listed on the stock exchange under the ticker INCY. The drug is currently in Phase 1 clinical development for multiple oncology indications.
MK-3475 is in Phase 1 of clinical development. It is an investigational drug and has not been approved by regulatory authorities. It is being studied in clinical trials for several cancer types, including melanoma and triple-negative breast cancer.
MK-3475 is being studied in several clinical trials. These include a Phase 3 trial in melanoma (NCT02752074), a Phase 3 trial in renal cell carcinoma (NCT03260894), and Phase 2 trials in triple-negative breast cancer (NCT05491226 and NCT07015853). The trials are conducted in multiple countries.
Yes, MK-3475 is also known as pembrolizumab. The drug is being studied under both names in clinical trials. It is an investigational antibody being developed by Incyte Corporation for various cancer indications.