KEYMAKER-U04 Substudy 04D: A Clinical Study of New Treatments Given With Enfortumab Vedotin and Pembrolizumab in People With Urothelial Cancer (MK-3475-04D/KEYMAKER-U04)
Phase 1/2
18+
3 sites in CA, OH, UT
What this study is about
This Phase 1/Phase 2 study is testing Pembrolizumab in people with bladder cancer. The primary outcome being measured is Number of Participants Who Discontinue Study Treatment Due to an AE.
Simplified from trial records by PatientMatch.
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Assignment is predetermined by the study protocol.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
pembrolizumab (Immune checkpoint inhibitor; blocks PD-1 to boost T-cell attack on cancer)
infusion
Primary: Number of Participants Who Discontinue Study Treatment Due to an AE, Number of Participants Who Experience a Dose Limiting Toxicity (DLT), Number of Participants Who Experience an Adverse Event (AE), Objective Response Rate (ORR) as Assessed by Investigator
Secondary: Duration of Response (DOR) as Assessed by Investigator, Plasma Cmax of EV Free Payload, Plasma Cmax of MK-3120 Free Payload, Serum Cmax of EV ADC, Serum Cmax of EV TAb, Serum Cmax of MK-3120 Total Antibodies (TAb), Serum Maximum Concentration (Cmax) of MK-3120 Antibody-Drug Conjugate (ADC)
Oncology