Phase 2
N=2
Avelumab in Combination With Fluorouracil and Mitomycin or Cisplatin and Radiation Therapy in Treating Participants With Muscle-Invasive Bladder Cancer
Bladder Carcinoma Infiltrating the Muscle of the Bladder Wall · Stage II Bladder Cancer AJCC v8 · Stage II Renal Pelvis Cancer AJCC v8 · Stage II Ureter Cancer AJCC v8 · Stage II Urethral Cancer AJCC v8
Bottom Line
View on ClinicalTrials.gov: NCT03617913 ↗Enrolled (actual)
2
Serious AEs
50.0%
Results posted
Feb 2021
Primary outcome: Primary: Proportion of Participants With Complete Response (At 6 Months) — 0.5 proportion of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Avelumab (Drug); Cisplatin (Drug); Fluorouracil (Drug); Mitomycin (Drug); Quality-of-Life Assessment (Other); Radiation Therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants With Complete Response (At 6 Months) |
0.5 | — |
| SECONDARY Adverse Events Per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v5.0) |
2; 0 | — |
| SECONDARY Patient-reported Outcomes (European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire [QLQ]-30 |
— | — |
| SECONDARY Patient-reported Outcomes (European Organization for Research and Treatment of Cancer [EORTC] EORTCQOL-Muscle-Invasive Bladder Cancer Module [BLM]30 |
— | — |
| SECONDARY Progression-free Survival |
NA | — |
| SECONDARY Recurrence-free Survival |
— | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Histologic proof of T2-T4a N0M0 (American Joint Committee on Cancer [AJCC] 8th edition) with predominant urothelial carcinoma. Mixed histologies are acceptable provided urothelial carcinoma is the predominant histology. Small cell urothelial carcinoma is excluded.
- Cystoscopy with maximal TURBT performed = = 1500/mm^3 = = 9 gm/dl = = 30 ml/min using the Cockcroft-Gault formula = = 6 months.
- Negative serum pregnancy test done = 2 years prior to registration except for:
- Non-melanoma skin cancer and/or localized prostate cancer (T2 a or b , Gleason = 160 mm Hg and/or diastolic blood pressure (DBP) >= 100 mm Hg, with or without anti-hypertensive medication(s).
- History of untreated human immunodeficiency virus (HIV)
- NOTE: There is no requirement to screen patients for HIV. Patients with history of HIV infection are allowed if on effective highly active antiretroviral therapy (HAART) therapy and CD4 count more than 250.
- History of active hepatitis B infection
- NOTE: There is no requirement to screen patients for hepatitis B.
- Known diagnosis of any condition (i.e. post-hematopoietic or organ transplant, rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, etc.) that requires chronic immunosuppressive therapy.
- NOTE: Usage of non-steroidal anti-inflammatory medications (NSAIDS) for the treatment of osteoarthritis and uric acid synthesis inhibitors for the treatment of gout are permitted. For questions, please consult the study chair.
- Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocol.
- Pregnant or breast-feeding women.
- Women of child-bearing potential, who are biologically able to conceive, and not employing two forms of highly effective contraception. Highly effective contraception must be used throughout the trial and up to 8 weeks after the last dose of study drug (e.g. male condom with spermicidal; diaphragm with spermicide; intra-uterine device). Women of child-bearing potential, defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses any time in the preceding 12 consecutive months), must have a negative serum pregnancy test = = 3).
Data sourced from ClinicalTrials.gov (NCT03617913). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.