Radical Cystectomy for Bladder Cancer

(CONSOLIdATE-1 Trial)

Overseen By Laura Kane

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Yale University

Must be taking: Enfortumab vedotin

Disqualifiers: Pregnancy, Breastfeeding, CNS metastasis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 32

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Fed Ghali, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for adults with advanced or oligo-metastatic urothelial carcinoma who've had some control over their disease using enfortumab vedotin therapy and can undergo surgery. They should have good organ function, an ECOG status of 0 or 1, and no more than five metastatic lesions at diagnosis. Pregnant women, those breastfeeding, or individuals with conditions that could interfere with the study are excluded.

Inclusion Criteria

My surgeon agrees I can have surgery to remove cancer that hasn't been treated with radiation.

I am 18 years old or older.

My cancer is mostly urothelial and less than half is a different type.

Exclusion Criteria

Have a positive serum pregnancy test or women who are breastfeeding

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

I have had cancer treatment within the last 3 weeks before surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Systemic Therapy

Participants receive enfortumab vedotin-based systemic therapy to achieve disease control

Varies based on individual response

Consolidative Local Therapy

Participants undergo radical cystectomy with bilateral pelvic lymph node dissection and metastasectomy

Surgical intervention

1 visit (in-person)

Follow-up

Participants are monitored for safety, effectiveness, and progression-free survival post-surgery

12 months

Visits at 30, 90, 180, 270, and 365 days post-surgery

What Are the Treatments Tested in This Trial?

Interventions

• Radical Cystectomy

Trial Overview The trial tests if removing all visible cancer through surgery (radical cystectomy) after initial success with drug therapy helps patients live longer without their cancer spreading. It's for those whose scans show stable disease or better after first-line treatment and includes metastasis-directed radiotherapy as recommended.

How Is the Trial Designed?

Group I: Radical cystectomy Experimental Treatment 1 Intervention

The intervention in this clinical trial consists of definitive surgical management through radical cystectomy with bilateral pelvic lymph node dissection (PLND), urinary diversion, and metastasectomy of surgically resectable or previously radiated metastatic disease. Surgical approach may be either open or robotic, based on surgeon discretion and patient-specific factors. The PLND will be performed in a standard oncologic fashion, including dissection of the common iliac, external iliac, internal iliac, and obturator nodal basins bilaterally. In cases where metastatic lymph nodes are identified beyond these regions, the lymph node dissection may be extended to achieve gross resection of involved nodal disease within the abdomen or retroperitoneum.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Medical College of Virginia Foundation

Collaborator