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OncoMatch/Clinical Trials/NCT03216525

Alvimopan Versus Placebo in Patients Undergoing Radical Cystectomy on an Enhanced Recovery Protocol

Is NCT03216525 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies Alvimopan for bladder cancer.

Phase 3RecruitingBrigham and Women's HospitalNCT03216525Data as of Jun 2026

Treatment: AlvimopanTo determine if Alvimopan during open or robotic radical cystectomy with urinary diversion results in quicker return of bowel function (GI-2 recovery = time to upper \[first toleration of solid food\] and lower \[first bowel movement\] gastrointestinal recovery) compared to placebo.

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Extracted eligibility criteria

Treatments studied

Other

Alvimopan

Cancer type

Urothelial Carcinoma

Performance status

ASA 1–4

Demographics

Ages ≤ 85

Prior therapy

Cannot have received: chemotherapy

Exception: prior neoadjuvant chemotherapy allowed if >1 month before surgery

Chemotherapy for bladder cancer within 1 month of scheduled surgery; prior neoadjuvant chemotherapy allowed

Lab requirements

Kidney function

no end-stage renal disease

Liver function

no severe hepatic impairment

Cardiac function

no heart failure

Patients with severe hepatic impairment [excluded]. Patients with end-stage renal disease [excluded]. Patients with heart failure [excluded].

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Brigham and Women's Hospital · Boston, Massachusetts

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT03216525 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior chemotherapy disqualifies patients from enrollment.

Is there an age limit?

Yes. Patients must be 85 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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