A Study of Enfortumab Vedotin in People With Urothelial Carcinoma of the Upper Urinary Tract

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT05868265
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Enfortumab Vedotin — DRUG
    All patients will receive enfortumab vedotin at 1.25 mg/kg on days 1 and 8 of 21 days cycle, for a total of three cycles.
  • Radical surgery — PROCEDURE
    Radical surgery, such as radical nephroureterectomy, nephrectomy or ureterectomy is to take place within 60 days from the last dose of treatment end of cycle 3 (i.e., cycle 3 day 22).

Study Details

The purpose of this study is to find out whether the study drug, enfortumab vedotin, is an effective and safe treatment for people who have urothelial carcinoma of the upper urinary tract. Study participants will be people who are not eligible to receive or have chosen not to receive the chemotherapy drug cisplatin for treatment of their cancer. In addition, all participants will be planning on having standard surgery to remove their tumor.

Key Dates

Start date
Jun 2, 2023
Status verified
May 2026
Primary completion
Jun 2, 2027
Completion
Jun 2, 2027

Study Design

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

Arms

  • Experimental: Enfortumab Vedotin
    All patients will receive enfortumab vedotin at 1.25 mg/kg on days 1 and 8 of 21 days cycle, for a total of three cycles, followed by radical nephroureterectomy, ureterectomy, or nephrectomy, depending on the site of the tumor and per the clinical decision of the treating urologist.

Primary Outcome Measure

Proportion of patients who achieve pathologic complete response [ Time Frame: up to 2 years ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920
Scot Niglio, MD, MS
646-888-4717
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748
Scot Niglio, MD, MS
646-888-4867
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Scot Niglio, MD, MS
646-888-4867
Memorial Sloan Kettering Suffolk - Commack (Limited protocol activities)CommackNew York11725
Scot Niglio, MD, MS
646-888-4867
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604
Scot Niglio, MD, MS
646-888-4867
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Scot Niglio, MD, MS
646-888-4867
Jonathan Rosenberg, MD
646-888-4741
University of Rochester Medical Center (Data Collection Only)RochesterNew York14642
Brendan Guercio, MD
585-275-5823
Memorial Sloan Kettering Nassau (Limited protocol activities)UniondaleNew York11553
Scot Niglio, MD, MS
646-888-4867

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