Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pembrolizumab Dose C · 1 trial · 1 indication
AUC was defined as a measure of pembrolizumab exposure that was calculated as the product of plasma drug concentration and time. Blood samples were collected at designated time points and a pharmacokinetic (PK) model based on historical intravenous pembrolizumab PK data were used for the determination of the AUC of pembrolizumab. Geometric least-square mean (GM) and 95% confidence intervals were derived from mixed-effects model performed on natural log-transformed values. Data were reported by treatment received.
Cmax was defined as the maximum concentration of pembrolizumab observed in plasma following a single dose. Blood samples were collected at designated time points and a PK model based on historical intravenous pembrolizumab PK data were used for the determination of the AUC of pembrolizumab. GM and 95% confidence intervals were derived from mixed-effects model performed on natural log-transformed values. Data were reported by treatment received.
Blood samples were collected at designated time points and a population PK model based on historical intravenous pembrolizumab PK data was used for the determination of the F of pembrolizumab. Per protocol, an integrated population PK analysis was performed and combined data for Cohort A was reported.
Blood samples were collected at designated time points and a population PK model based on historical intravenous pembrolizumab PK data was used for the determination of the Ka of pembrolizumab. Per protocol, an integrated population PK analysis was performed and combined data for Cohort A was reported. Participants in Cohort B weren't analyzed, per protocol.
Blood samples were collected at designated time points for the determination of the Tmax of pembrolizumab.
Blood samples were collected at designated time points and a population PK model based on historical intravenous pembrolizumab PK data was used for the determination of the CL of pembrolizumab. Per protocol, an integrated population PK analysis was performed and combined data for Cohort A was reported.
Blood samples were collected at designated time points and a population PK model based on historical intravenous pembrolizumab PK data was used for the determination of the Vc of pembrolizumab. Per protocol, an integrated population PK analysis was performed and combined data for Cohort A was reported.
ORR was defined as the percentage of participants in the analysis population who had a 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). Responses were based upon blinded independent central review (BICR) per RECIST 1.1. ORR was reported for participants in Cohort B.
| Arm | Type | Description |
|---|---|---|
| Cohort A Pembrolizumab Treatment Sequence 1 | EXPERIMENTAL | Participants receive a single dose of pembrolizumab in each 21-day cycle in the following sequence: Cycle 1 Day 1: pembrolizumab 165 mg/mL subcutaneously (SC); Cycle 2 Day 1: pembrolizumab 200 mg intravenously (IV); Cycle 3 Day 1: pembrolizumab 130 mg/mL SC; Cycle 4 Day 1 and every cycle thereafter, up to a total of 35 cycles (up to approximately 2 years), Day 1: pembrolizumab 200 mg IV. |
| Cohort A Pembrolizumab Treatment Sequence 2 | EXPERIMENTAL | Participants receive a single dose of pembrolizumab in each 21-day cycle in the following sequence: Cycle 1 Day 1: pembrolizumab 165 mg/mL SC; Cycle 2 Day 1: pembrolizumab 130 mg/mL SC; Cycle 3 Day 1: pembrolizumab 200 mg IV; Cycle 4 Day 1 and every cycle thereafter, up to a total of 35 cycles (up to approximately 2 years), Day 1: pembrolizumab 200 mg IV. |
| Cohort A Pembrolizumab Treatment Sequence 3 | EXPERIMENTAL | Participants receive a single dose of pembrolizumab in each 21-day cycle in the following sequence: Cycle 1 Day 1: pembrolizumab 130 mg/mL SC; Cycle 2 Day 1: pembrolizumab 165 mg/mL SC; Cycle 3 Day 1: pembrolizumab 200 mg IV; Cycle 4 Day 1 and every cycle thereafter, up to a total of 35 cycles (up to approximately 2 years), Day 1: pembrolizumab 200 mg IV. |
| Cohort A Pembrolizumab Treatment Sequence 4 | EXPERIMENTAL | Participants receive a single dose of pembrolizumab in each 21-day cycle in the following sequence: Cycle 1 Day 1: pembrolizumab 200 mg SC; Cycle 2 Day 1: pembrolizumab 200 mg IV; Cycle 3 Day 1: pembrolizumab 130 mg/mL SC; Cycle 4 Day 1 and every cycle thereafter, up to a total of 35 cycles (up to approximately 2 years), Day 1: pembrolizumab Dose 200 mg IV. |
| Cohort A Pembrolizumab Treatment Sequence 5 | EXPERIMENTAL | Participants receive a single dose of pembrolizumab in each 21-day cycle in the following sequence: Cycle 1 Day 1: pembrolizumab 200 mg IV; Cycle 2 Day 1: pembrolizumab 130 mg/mL SC; Cycle 3 Day 1: pembrolizumab 165 mg/mL SC: Cycle 4 Day 1 and every cycle thereafter, up to a total of 35 cycles (up to approximately 2 years), Day 1: pembrolizumab 200 mg IV. |
| Cohort A Pembrolizumab Treatment Sequence 6 | EXPERIMENTAL | Participants receive a single dose of pembrolizumab in each 21-day cycle in the following sequence: Cycle 1 Day 1: pembrolizumab 200 mg IV; Cycle 2 Day 1: pembrolizumab 165 mg/mL SC; Cycle 3 Day 1: pembrolizumab 130 mg/mL SC; Cycle 4 Day 1 and every cycle thereafter, up to a total of 35 cycles (up to approximately 2 years), Day 1: pembrolizumab 200 mg IV. |
| Cohort B Pembrolizumab 400 mg IV | EXPERIMENTAL | Participants receive a single dose of pembrolizumab 400 mg IV on Day 1 of each 42-day cycle (every 6 weeks; Q6W) for up to 18 cycles (up to approximately 2 years). |
| Name | Type | Description |
|---|---|---|
| Pembrolizumab Dose C | BIOLOGICAL | 165 mg/mL administered to a final dose of 285 mg via subcutaneous injection |
| Pembrolizumab Dose A | BIOLOGICAL | 130 mg/mL administered to a final dose of 285 mg via subcutaneous injection |
| Pembrolizumab Dose B | BIOLOGICAL | 200 mg administered via intravenous infusion |
| Pembrolizumab Dose D | BIOLOGICAL | 400 mg administered via intravenous infusion |
Inclusion Criteria: * Has histologically or cytologically confirmed diagnosis of advanced melanoma. * Has unresectable Stage III or Stage IV melanoma, as per American Joint Committee on Cancer (AJCC) staging system not amenable to local therapy. * Has been untreated for advanced or metastatic disea...
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Pembrolizumab Dose C is an investigational monoclonal antibody being studied for the treatment of advanced melanoma. It is a specific dose formulation of pembrolizumab, a PD-1 inhibitor, evaluated in a clinical trial for participants with this condition. The drug is still in clinical development and has not been approved for this use.
Pembrolizumab Dose C is developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker MRK. The company is conducting clinical research on this drug for the treatment of melanoma.
Pembrolizumab Dose C is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied for safety, tolerability, and pharmacokinetics in patients with advanced melanoma.
Pembrolizumab Dose C is being studied in one completed Phase 1 clinical trial, NCT03665597, titled "Relative Bioavailability Study of Subcutaneous Injection Versus Intravenous Infusion of Pembrolizumab (MK-3475) in Participants With Advanced Melanoma (MK-3475-555/KEYNOTE-555)." The trial enrolled 138 participants and was conducted in Australia, South Africa, Spain, and Sweden.
Pembrolizumab Dose C is a monoclonal antibody that targets the PD-1 receptor, a protein on immune cells that can suppress the immune response against tumors. By blocking PD-1, the drug aims to enhance the body's immune system to fight cancer cells. This mechanism is being evaluated in the treatment of melanoma.
Pembrolizumab Dose C is a specific dose formulation of pembrolizumab, which is also known as MK-3475. It is being studied to compare the bioavailability of subcutaneous injection versus intravenous infusion of the drug. The trial is part of the KEYNOTE-555 study program.