Enfortumab Vedotin Plus Pembrolizumab With Selective Bladder Sparing for Treatment of Muscle-invasive Bladder Cancer

Part of paid clinical trials in Duarte, California.

Sponsor
Matthew Galsky
Study ID
NCT06809140
Phase
PHASE2
Status
Recruiting
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Conditions

  • Muscle Invasive Bladder Urothelial Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Enfortumab vedotin — DRUG
    1.25 mg/kg (maximum dose 125 mg)
  • Pembrolizumab — DRUG
    200 mg

Study Details

Patients with MIBC will receive 3 cycles (C1-C3) of induction enfortumab vedotin plus pembrolizumab followed by restaging including MRI of the bladder, urine cytology, and cystoscopy with TURBT of any visible tumor and/or resection site plus random biopsies using a recommended template. Patients achieving a stringently defined cCR (clinical complete response) will receive 14 cycles of "maintenance" treatment. Enfortumab vedotin will be administered during the first 6 cycles (C4-C9) of "maintenance" treatment and pembrolizumab will be given all 14 cycles (C4-C14). Patients with any residual disease at clinical restaging (i.e., \>cTa disease) will undergo cystectomy.

Key Dates

Start date
Apr 7, 2025
Status verified
Feb 2026
Primary completion
Nov 30, 2027
Completion
Nov 30, 2029

Study Design

Enrollment
47 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Enfortumab vedotin plus pembrolizumab
    Patients with MIBC will receive 3 cycles (C1-C3) of induction enfortumab vedotin (1.25 mg/kg for a maximum dose of 125 mg) plus pembrolizumab (200 mg) followed by restaging including MRI of the bladder, urine cytology, and cystoscopy with TURBT of any visible tumor and/or resection site plus random biopsies using a recommended template. Patients achieving a stringently defined cCR (defined below) will receive 14 cycles of "maintenance" treatment. Enfortumab vedotin (1.25 mg/kg for a maximum dose of 125 mg) will be administered during the first 6 cycles (C4-C9) of "maintenance" treatment and pembrolizumab (200 mg) will be given all 14 cycles (C4-C14). Patients with any residual disease at clinical restaging (i.e., \>cTa disease) will undergo cystectomy.

Primary Outcome Measure

Complete response rate with enfortumab vedotin plus pembrolizumab for MIBC [ Time Frame: 9 weeks ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010
Dorreth King-Rucker, MBA
[email protected]
626-218-9815
Abhishek Tripathi, MD (PRINCIPAL_INVESTIGATOR)
Indiana University Melvin and Bren Simon Comprehensive Cancer CenterIndianapolisIndiana46202
Jessica Corman, CCRP
[email protected]
317-278-5646
Tareq Salous, MD (PRINCIPAL_INVESTIGATOR)
Columbia University Irving Medical CenterNew YorkNew York10032
Denisse Mirauti
[email protected]
212-304-5485
Alexander Wei, MD (PRINCIPAL_INVESTIGATOR)
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Lindsay Diamond
[email protected]
347-514-1561
Matthew Galsky, MD (PRINCIPAL_INVESTIGATOR)
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111
Alexa Gerchman
[email protected]
Elizabeth Plimack, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Duarte, CA

By research site
City of Hope· Duarte, CAIndiana University Melvin and Bren Simon Comprehensive Cancer Center· Indianapolis, INColumbia University Irving Medical Center· New York, NYIcahn School of Medicine at Mount Sinai· New York, NYFox Chase Cancer Center· Philadelphia, PA

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