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Avelumab Plus Bacille Calmette-Guerin (BCG) in Patients With Non-muscle Invasive Bladder Cancer
Phase 1, PHASE2 trial testing Avelumab in Bladder Cancer in 18 participants. Completed in 13 August 2023.
| Lead sponsor | University of Oklahoma |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 18 |
| Start date | 1 May 2019 |
| Primary completion | 23 March 2021 |
| Estimated completion | 13 August 2023 |
| Sites | 1 location across United States |
University of Oklahoma
18 and older, any sex, with Bladder Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Proportion of patients receiving complete induction course, defined as freedom from DLT preventing completion of at least 5 of 6 treatments of BCG + avelumab
| Group | Value | 95% CI |
|---|---|---|
| BCG + Avelumab | 0.833 | 0.5774 – 0.9559 |
completion of at least 2 of 3 treatments within each 5 week period
| Group | Value | 95% CI |
|---|---|---|
| BCG + Avelumab | 0.9091 | 0.5712 – 0.9952 |
based on negative cystoscopy and urine cytology. A negative biopsy at 6 months will provide evidence of complete response.
| Group | Value | 95% CI |
|---|---|---|
| BCG + Avelumab | 17.6 | 3.8 – 43.4 |
based on negative cystoscopy and urine cytology. A negative biopsy at 6 months will provide evidence of complete response.
| Group | Value | 95% CI |
|---|---|---|
| BCG + Avelumab | 41.2 | 18.4 – 67.1 |
defined as percent of patients who are alive and free of persistent or recurrent NMIBC based on cystoscopy, cytology and/or biopsy.
| Group | Value | 95% CI |
|---|---|---|
| BCG + Avelumab | 88.89 | 43.29 – 98.36 |
defined as proportion of patients who are alive and free of persistent or recurrent NMIBC based on cystoscopy, cytology and/or biopsy
| Group | Value | 95% CI |
|---|---|---|
| BCG + Avelumab | 0.8889 | .4329 – .9836 |
defined by time from day of first treatment to first progression to higher grade or stage, including muscle-invasive disease or death from any cause
| Group | Value | 95% CI |
|---|---|---|
| BCG + Avelumab | 0.8824 | .6059 – .9692 |
defined by time from day of first treatment to first progression to higher grade or stage, including muscle-invasive disease or death from any cause
| Group | Value | 95% CI |
|---|---|---|
| BCG + Avelumab | 0.8145 | .5263 – .9364 |
Time frame: 2 years, 9 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | BCG + Avelumab |
|---|---|---|
| Atrial flutter | Cardiac disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Non-cardiac chest pain | General disorders | — |
| Lung infection | Infections and infestations | — |
| Sepsis | Infections and infestations | — |
| Infusion related reaction | Injury, poisoning and procedural complications | — |
| Cardiac troponin I increased | Investigations | — |
| Depressed level of consciousness | Nervous system disorders | — |
| Myasthenia gravis | Nervous system disorders | — |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | — |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | — |
| Reaction | System | BCG + Avelumab |
|---|---|---|
| Dysuria | Renal and urinary disorders | — |
| Urinary frequency | Renal and urinary disorders | — |
| Urinary tract infection | Infections and infestations | — |
| Fatigue | General disorders | — |
| Infusion related reaction | Injury, poisoning and procedural complications | — |
| Hematuria | Renal and urinary disorders | — |
| Urinary urgency | Renal and urinary disorders | — |
| Flu like symptoms | General disorders | — |
| Creatinine increased | Investigations | — |
| Constipation | Gastrointestinal disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Hypothyroidism | Endocrine disorders | — |
| Chills | General disorders | — |
| Shingles | Infections and infestations | — |
| CPK increased | Investigations | — |
| Bladder spasm | Renal and urinary disorders | — |
| Prostatic pain | Reproductive system and breast disorders | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — |
| Hypertension | Vascular disorders | — |
| Vertigo | Ear and labyrinth disorders | — |
| Hyperthyroidism | Endocrine disorders | — |
| Blurred vision | Eye disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Dental caries | Gastrointestinal disorders | — |
| Dry mouth | Gastrointestinal disorders | — |
| Mucositis oral | Gastrointestinal disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Other SpecifyDiverticulitis | Gastrointestinal disorders | — |
| Rectal hemorrhage | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Infusion site extravasation | General disorders | — |
| Penile infection | Infections and infestations | — |
| Bruising | Injury, poisoning and procedural complications | — |
| Activated partial thromboplastin time prolonged | Investigations | — |
| Cardiac troponin I increased | Investigations | — |
| Thyroid stimulating hormone increased | Investigations | — |
| Hyperglycemia | Metabolism and nutrition disorders | — |
| Hyperkalemia | Metabolism and nutrition disorders | — |
| Flank pain | Musculoskeletal and connective tissue disorders | — |
| Myositis | Musculoskeletal and connective tissue disorders | — |
Most-reported serious reactions: Atrial flutter, Diarrhea, Non-cardiac chest pain, Lung infection, Sepsis, Infusion related reaction, Cardiac troponin I increased, Depressed level of consciousness.
Data from ClinicalTrials.gov NCT03892642 adverse events section.
The purpose of this study is to test the safety of avelumab and Bacille Calmette-Guerin (BCG) and see what effects (good and bad) that this combination treatment has on subjects with recurrent bladder cancer.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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