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A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Study of Investigational Agents in Combination With Enfortumab Vedotin Plus Pembrolizumab as First-Line Treatment in Participants With Locally Advanced or Metastatic Urothelial Carcinoma: KEYMAKER-U04–Substudy 04D

Status
Not yet recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-522253-19-00
Enrollment
6
Registered
2026-02-03
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urothelial carcinoma

Brief summary

Number of Participants Who Experienced At Least One Adverse Event (AE), Number of Participants with Dose-limiting Toxicities, Number of Participants Who Discontinued Study Treatment Due to an AE, Objective Response Rate (ORR) as Assessed by Investigator

Detailed description

Duration of Response (DOR) as Assessed by Investigator, Serum Maximum Concentration (Cmax) of MK-3120 Antibody-Drug Conjugate (ADC), Serum Trough Concentration (Ctrough) of MK-3120 ADC, Serum Cmax of MK-3120 Total Antibodies (TAb), Serum Ctrough of MK-3120 TAb, Plasma Cmax of MK-3120 Free Payload, Plasma Ctrough of MK-3120 Free Payload, Serum Cmax of Enfortumab Vedotin (EV) ADC, Serum Ctrough of EV ADC, Serum Cmax of EV TAb, Serum Ctrough of EV TAb, Plasma Cmax of EV Free Payload, Plasma Ctrough of EV Free Payload

Interventions

DRUGMK-3120
DRUGENFORTUMAB VEDOTIN
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion.

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Number of Participants Who Experienced At Least One Adverse Event (AE), Number of Participants with Dose-limiting Toxicities, Number of Participants Who Discontinued Study Treatment Due to an AE, Objective Response Rate (ORR) as Assessed by Investigator—

Secondary

MeasureTime frame
Duration of Response (DOR) as Assessed by Investigator, Serum Maximum Concentration (Cmax) of MK-3120 Antibody-Drug Conjugate (ADC), Serum Trough Concentration (Ctrough) of MK-3120 ADC, Serum Cmax of MK-3120 Total Antibodies (TAb), Serum Ctrough of MK-3120 TAb, Plasma Cmax of MK-3120 Free Payload, Plasma Ctrough of MK-3120 Free Payload, Serum Cmax of Enfortumab Vedotin (EV) ADC, Serum Ctrough of EV ADC, Serum Cmax of EV TAb, Serum Ctrough of EV TAb, Plasma Cmax of EV Free Payload, Plasma Ctrough of EV Free Payload—

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026