Avelumab in Combination With Fluorouracil and Mitomycin or Cisplatin and Radiation Therapy in Treating Participants With Muscle-Invasive Bladder Cancer
CompletedPhase 2Results postedLast updated 6 January 2023
What this trial tests
Phase 2 trial testing Avelumab in Bladder Carcinoma Infiltrating the Muscle of the Bladder Wall in 2 participants. Completed in 27 July 2020.
18 and older, any sex, with Bladder Carcinoma Infiltrating the Muscle of the Bladder Wall or Stage II Bladder Cancer AJCC v8. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Proportion of Participants With Complete Response (At 6 Months)Primary· At 6 months from registration
Patients enrolled will have non-measurable disease based on imaging at baseline. Patients will be assessed for a response after 6 months of treatment using the results of a biopsy and cytology test. A complete response (CR) is defined as having a negative biopsy and negative urine cytology at 6 months from registration after finishing of concurrent RT and immunotherapy. Imaging of abdomen and pelvis confirming no systemic disease within 4 weeks of cystoscopy will be completed.
The proportion of patients reporting a CR is reported here with confidence intervals for the true success proportion
Group
Value
95% CI
Avelumab and Cisplatin IV
0.5
0.013 – 0.987
Adverse Events Per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v5.0)Secondary· Up to 12 months
The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. The number of patients reporting a grade 3+ adverse event regardless of attribution is reported here.
Group
Value
95% CI
Avelumab and Cisplatin IV
2
Avelumab and Cisplatin IV
0
Progression-free SurvivalSecondary· From registration to time of first documentation of progression or death from any cause, assessed up to 12 months
Progression-free survival is defined as the time from registration to the time of progression or death. This study will not use RECIST criteria to evaluate response or progression. The patients enrolled will have non-measurable disease on imaging and response will be evaluated with biopsy or cytology. Progression is defined as progression in T stage, N stage or M stage both clinically or radiologically. Histological confirmation of metastatic disease is at the discretion of the treating provider. The median time will be estimated using the method of Kaplan-Meier.
Group
Value
95% CI
Avelumab and Cisplatin IV
NA
NA – NA
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events were assessed at the end of every 14 day cycle during treatment, up to 12 cycles..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This phase II trial studies the side effects of avelumab and how well it works in combination with fluorouracil and mitomycin or cisplatin and radiation therapy in treating participants with muscle-invasive bladder cancer. Monoclonal antibodies, such as avelumab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as fluorouracil, mitomycin, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Giving avelumab with chemotherapy and radiotherapy may work better in treating participants with muscle-invasive bladder cancer.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06939036 — Study of 225Ac-SS0110 in Subjects With ES-SCLC or MCC (SANTANA-225 )
· Phase 1, PHASE2
· terminated
NCT05687721 — Copanlisib and Avelumab as a Maintenance Therapy for Advanced Bladder Cancer
· Phase 1, PHASE2
· withdrawn
NCT06518564 — Avelumab and M1774 in ARID1A-mutated Endometrial Cancer
· Phase 2
· recruiting
NCT06424717 — Study of Avelumab and Tuvusertib in Participants With Advanced Urothelial Cancer That Has Progressed on Prior Anti-PD-(L
· Phase 2
· withdrawn
NCT06302426 — Trial of INI-4001 in Patients With Advanced Solid Tumours
· Phase 1
· recruiting
Other Mayo Clinic trials
Trials by the same sponsor.
NCT07126548 — A Point of Prostate Cancer Diagnosis Virtual Reality Assistant Intervention in Supporting Newly Diagnosed Black Men
· NA
· not yet recruiting
NCT07221656 — Evaluation of Prolonged Asparaginase Activity Levels After Calaspargase Pegol Administration
· not yet recruiting
NCT06891001 — The Utilization of a Shoe Insert on Individuals With Unilateral Greater Trochanteric Pain Syndrome on Single Leg Stance,
· NA
· not yet recruiting
NCT07169799 — Impact of Cryotherapy Spray (Tru-Freeze) for the Eradication of Gastric Antral Vascular Ectasia (ICE-GAVE)
· NA
· recruiting
NCT07086183 — Perioperative Risk in Patients on Chronic Aspirin Undergoing Craniotomy
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Mayo Clinic
Last refreshed: 6 January 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03617913.