A Phase 3 interventional study of Rapamycin and Placebo Oral Tablet in Bladder Cancer, sponsored by The University of Texas Health Science Center at San Antonio. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-12.
Sponsored by The University of Texas Health Science Center at San Antonio · Phase 3, Interventional, and Treatment
Among 881 studies in Urinary Bladder Neoplasms with a site in United States — 164 open to participants now, 269 under way, 31 of them phase 3. Urinary Bladder Neoplasms · United States.
Among the 881 studies in Urinary Bladder Neoplasms with a site in United States, this one is the 692nd largest by enrollment of the 714 interventional ones, is one of 48 that started in 2018, is one of 79 in phase 3, and was the 463rd registered.
1,798 studies on the registry are indexed under Urinary Bladder Neoplasms; 445 are open to participants now.
Browse Urinary Bladder Neoplasms studies →164 of the 881 studies in Urinary Bladder Neoplasms with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 336 Urinary Bladder Neoplasms studies recruiting now, 256 (76%) set no upper age limit and 22 (7%) stop at 75 or younger; 22 take children under 18; 21 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →881 studies; the count open now beside each. This study's row is marked.
First in 1988; this study’s year is marked. 48 started in 2018.
Median enrollment 46 across the 714 interventional studies, 180 across the 144 observational. Of the 562 that completed or were terminated, 253 (45%) have results posted.
313 of 881 have an industry lead sponsor. The 10 most frequent:
The University of Texas Health Science Center at San Antonio is the lead sponsor of 445 studies on the registry; 89 are open to participants now.
Of its 65 completed or terminated interventional studies of FDA-regulated products, 35 (54%) have results posted.
The University of Texas Health Science Center at San Antonio has 8 studies filed under Urinary Bladder Neoplasms — fewer than ten, so there is no comparison to draw.
97 of the studies in Urinary Bladder Neoplasms with a site in United States that are under way reach primary completion within a year, 6 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06111235Phase 3CG Oncology, Inc.A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT | 2026-11 |
| NCT04658862Phase 3Janssen Research & Development, LLCA Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder | 2026-12-30 |
| NCT06525571Phase 3Johns Hopkins UniversityOutcomes of High-risk Non-muscle Invasive Bladder Cancer Treated With Blue Light Resection | 2027-01-04 |
| NCT05911295Phase 3Seagen, a wholly owned subsidiary of PfizerDisitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2 | 2027-01-29 |
| NCT04241185Phase 3Merck Sharp & Dohme LLCEfficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Muscle-invasive Bladder Cancer (MIBC) (MK-3475-992/KEYNOTE-992) | 2027-01-31 |
Among the 881 studies in Urinary Bladder Neoplasms with a site in United States, from their registry updates:
The study is a multi-site Phase 3 double-blinded randomized placebo-controlled trial. Subjects are randomly assigned to receive either a placebo or oral Sirolimus: 0.5 mg daily. All subjects will be treated for 2 years or until disease recurrence. Patients will undergo endoscopic evaluation of the bladder every 3 months for the first 2 years following enrollment and then every 6 months for an additional 2 years on study. Selection of BCG immune therapy is at the discretion of the treating urologist but in general is reserved for high-risk patients. Patients concurrently receiving BCG immune therapy will receive standard BCG therapy including induction (weekly for 6 weeks) and maintenance (weekly for 3 weeks at 3 months, 6 months, and then every 6 months following tumor resection).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subject will be randomized to take the Placebo once daily for 2 years or until disease recurrence
Drug: Placebo Oral Tablet
Subject will be randomized to take Sirolimus (Rapamycin) 0.5mg once daily for 2 years or until disease recurrence
Drug: Rapamycin
Subject will be randomized to one of the 2 arms
Also known as: Sirolimus
Subject will be randomized to one of the 2 arms
Test the hypothesis that rapamycin 0.5 mg daily increases recurrence-free survival for patients with non-muscle invasive bladder cancer
Recurrence is defined as histologically-proven bladder cancer (stage CIS, Ta, T1 or ≥T2)
Time frame: Patients are treated for 2 years or until disease relapse
To determine effects of rapamycin on recurrence-free survival (RFS) for subgroup of patients with non-muscle invasive bladder cancer concurrently receiving BCG immune therapy.
Recurrence is defined as histologically-proven bladder cancer (stage CIS, Ta, T1 or ≥T2)
Time frame: Patients are treated for 2 years or until disease relapse
To compare the effects of rapamycin on BCG-specific immunity during treatment of non-muscle invasive bladder cancer with maintenance BCG.
BCG antigen-specific IFN-gamma ELISPOT responses will be measured
Time frame: baseline and 6 months after registration
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2018 (actual). Primary completion is estimated for Feb 2022, 39 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sirolimus
The University of Texas Health Science Center at San Antonio →