No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
32 (estimated)
Sponsor
Yale University · Other
Who this trial is looking for
This trial is looking for adults with advanced urothelial cancer who have had disease control from a specific treatment. Participants will receive surgery to remove tumors after being on a specific therapy for a certain time.
Are You a Good Fit for This Trial?
Must be takingEnfortumab vedotin
You may be able to join if
I am at least 18 years old.
I can give my informed consent.
I am a surgical candidate for tumor removal.
I have stable disease or better from my last scan.
I have been diagnosed with urothelial carcinoma with a few metastatic lesions.
I have been receiving specific therapy for at least three months.
You may not be able to join if
I have received any cancer treatment in the last three weeks.
I received radiotherapy in the last two weeks.
I am pregnant or breastfeeding.
I have health issues that may affect my ability to participate.
I have a history of brain metastasis.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This study investigates the therapeutic benefit of consolidative local therapy with extirpative surgery for participants with locally advanced or oligo-metastatic urothelial carcinoma that have disease control with enfortumab vedotin-based systemic therapy and surgically resectable or previously radiated metastatic sites.
Trial Locations
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City
State
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Status
Eligibility Criteria
Inclusion Criteria:
1. Be at least 18 years of age.
2. Have provided informed consent.
3. Have ECOG Performance status of 0 or 1.
4. Be surgical candidate for extirpative surgery of primary site with standard bilateral pelvic lymph node dissection and urinary diversion at the discretion of urologic…
Inclusion Criteria:
1. Be at least 18 years of age.
2. Have provided informed consent.
3. Have ECOG Performance status of 0 or 1.
4. Be surgical candidate for extirpative surgery of primary site with standard bilateral pelvic lymph node dissection and urinary diversion at the discretion of urological oncologist.
5. If applicable, must be a surgical candidate for resection of non-irradiated metastatic lesion(s) at the discretion of the treating surgeon.
6. Have adequate organ function as defined by:
1. Hgb \>9.0 ng/dL.
2. WBC \>3.0 K/mcL.
3. PLT \>100 K /mcL.
4. AST \<3.0 x ULN U/L.
5. ALT \<3.0 x ULN U/L.
6. Total Bilirubin \<2.0 x UNL mg/dL.
Disease characteristics:
7. Have histologically confirmed diagnosis of locally advanced or oligo-metastatic urothelial carcinoma defined by presence of five or few distinct metastatic lesions at the time of diagnosis of metastatic disease.
8. If variant histology present, it must be \<50% and UC must be predominant.
9. Must have begun the first cycle of enfortumab-vedotin-based first-line therapy at least three months prior to the surgery and have continued therapy. Treatment interruption, modification and discontinuation due to adverse events are allowed. Metastasis-directed radiotherapy (MDRT) is allowed.
10. The most recent restaging scan prior to signing ICD must show stable disease, partial response or complete response per treating investigator-assessed RECIST v1.1. In case of stable disease or partial response, MDRT is highly recommended. Enrollment of such participants should be discussed with the PI.
Exclusion Criteria:
Participants who meet any of the following criteria will be excluded from study entry.
1. Received systemic anti-cancer therapy within three weeks prior to the surgery.
2. Received radiotherapy within two weeks prior to the surgery.
3. Have a positive serum pregnancy test or women who are breastfeeding.
4. Have other concurrent medical, surgical or psychiatric conditions that, in the treating investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.
5. Have any medical condition that, in the treating investigator's opinion, poses an undue risk to the participant's participation in the study.
6. Have history of central nervous system (CNS) metastasis and/or leptomeningeal metastasis.
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