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Also known as Pembrolizumab, MK-3475, pembrolizumab, KEYTRUDA®, KEYTRUDA, Pembrolizumab Injection [Keytruda], Pembrolizumab (Keytruda), Pembrolizumab (MK-3475)
Pembrolizumab/Vibostolimab coformulation · 2 trials · 2 indications
A DLT is defined as an event with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment that are not due to pre-existing conditions as defined by the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE 5.0). Percentage of participants who experience a DLT per CTCAE 5.0 are reported.
An AE is any unfavorable 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 of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. The number of participants who experience an AE are reported.
An AE is any unfavorable 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 of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. The number of participants discontinued from the study treatment due to an AE are reported.
PFS is defined as the time from randomization to the first documented disease progression (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR is presented.
| Arm | Type | Description |
|---|---|---|
| Pembrolizumab/vibostolimab coformulation | EXPERIMENTAL | Participants will receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years. |
| Arm 1: Pembrolizumab/Vibostolimab coformulation + Docetaxel | EXPERIMENTAL | Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous (IV) infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years plus docetaxel 75 mg/m\^2 via IV infusion Q3W. Each cycle will be 21 days. |
| Arm 2: Pembrolizumab/Vibostolimab coformulation | EXPERIMENTAL | Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W for up to 35 cycles up to approximately 2 years. Each cycle will be 21 days. |
| Arm 3: Placebo + Docetaxel | ACTIVE_COMPARATOR | Participants receive normal saline placebo via IV infusion Q3W for up to 35 cycles up to approximately 2 years plus docetaxel 75 mg/m\^2 IV infusion Q3W. Each cycle will be 21 days. |
| Name | Type | Description |
|---|---|---|
| Pembrolizumab/vibostolimab coformulation | BIOLOGICAL | Pembrolizumab 200 mg + vibostolimab 200 mg/20 mL vial IV infusion Q3W up to approximately 2 years. |
| Docetaxel | DRUG | Docetaxel 75 mg\^m2 IV infusion Q3W until discontinuation due to progressive disease or unacceptable toxicity. Docetaxel will serve as part of an experimental treatment in Arm 1, and as an active comparator in Arm 3. |
| Placebo | DRUG | Normal saline IV infusion Q3W up to approximately 2 years |
Inclusion Criteria \- Have confirmed relapsed/refractory classic Hodgkins Lymphoma (cHL), Primary mediastinal B-cell lymphoma (PMBCL), Follicular Lymphoma (FL), Diffuse large B-cell lymphoma (DLBCL) or Non-Hodgkins Lymphoma (NHL), or multiple myeloma (MM). For PMBCL, DLBCL, FL, and MM: \- Must be...
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MK-3475, also known as pembrolizumab and marketed as KEYTRUDA, is an investigational antibody being studied for several oncology indications, including Primary Mediastinal Large B-cell Lymphoma (PMBCL), prostate cancer, anal cancer, squamous cell carcinoma, non-small-cell lung cancer, B-cell lymphoma, and oligometastatic squamous cell carcinoma of the head and neck.
MK-3475 is a monoclonal antibody (target class -mab) that targets the PD-1 receptor. By binding to PD-1, it is designed to block the interaction with its ligands, potentially enhancing the immune system's ability to fight cancer cells.
MK-3475 is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck is conducting clinical trials to evaluate the drug's safety and efficacy across multiple cancer types.
MK-3475 is in Phase 1 clinical development. It has received a Priority Review designation from the FDA. The drug is investigational and not yet approved, with ongoing trials assessing its use in various cancers.
MK-3475 is being studied in 17 clinical trials, with 5 active and 12 completed, enrolling over 8,000 participants. Notable trials include NCT02635360 for cervical cancer, NCT04875195 for Hodgkin's lymphoma and PMBCL, NCT04976634 for solid tumors, and NCT05815927 for head and neck cancer.
Yes, MK-3475 is the same as pembrolizumab, which is also known by the brand name KEYTRUDA. The drug is referred to by multiple names including Pembrolizumab 200 mg, Pembrolizumab Injection, and Pembrolizumab (MK-3475), among others.