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Gemcitabine, Cisplatin, Plus Nivolumab in Patients With Muscle-invasive Bladder Cancer With Selective Bladder Sparing
Phase 2 trial testing Nivolumab in Bladder Cancer in 76 participants. Completed in 7 March 2024.
| Lead sponsor | Matthew Galsky |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 76 |
| Start date | 13 July 2018 |
| Primary completion | 16 February 2024 |
| Estimated completion | 7 March 2024 |
| Sites | 7 locations across United States |
Matthew Galsky — full company profile →
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.
Clinical complete response rate will be defined as the percentage of patients who achieved cT0 or cTa disease after gemcitabine, cisplatin, plus nivolumab.
| Group | Value | 95% CI |
|---|---|---|
| Gemcitabine, Cisplatin and Nivolumab | 43 | 32 – 55 |
Determine the ability of clinical complete response (cT0 or cTa) to predict benefit from treatment.Benefit will be defined as a pathologic complete response (\<pT1) in patients undergoing cystectomy and 2 year metastasis-free in patients pursuing surveillance. The positive predictive value of CCR with 95% confidence interval are presented in Outcome Measure Data Table. Positive predictive value is the ratio of patients truly diagnosed as positive to all those who had positive test results.
| Group | Value | 95% CI |
|---|---|---|
| Gemcitabine, Cisplatin and Nivolumab | 0.97 | 0.91 – 1 |
The frequency and severity of all grade 3+ treatment-emergent adverse events occurring in at least 10% of patients are reported by CTCAEv4 term and grade.
| Group | Value | 95% CI |
|---|---|---|
| Gemcitabine, Cisplatin and Nivolumab | 12 |
| Group | Value | 95% CI |
|---|---|---|
| Gemcitabine, Cisplatin and Nivolumab | 26 |
| Group | Value | 95% CI |
|---|---|---|
| Gemcitabine, Cisplatin and Nivolumab | 13 |
| Group | Value | 95% CI |
|---|---|---|
| Gemcitabine, Cisplatin and Nivolumab | 5 |
| Group | Value | 95% CI |
|---|---|---|
| Gemcitabine, Cisplatin and Nivolumab | 4 |
| Group | Value | 95% CI |
|---|---|---|
| Gemcitabine, Cisplatin and Nivolumab | 3 |
| Group | Value | 95% CI |
|---|---|---|
| Gemcitabine, Cisplatin and Nivolumab | 4 |
| Group | Value | 95% CI |
|---|---|---|
| Gemcitabine, Cisplatin and Nivolumab | 3 |
Bladder-intact overall survival is defined as the time from initiation of treatment until death or cystectomy.
| Group | Value | 95% CI |
|---|---|---|
| Gemcitabine, Cisplatin and Nivolumab | NA | 47.34 – NA |
| Group | Value | 95% CI |
|---|---|---|
| Gemcitabine, Cisplatin and Nivolumab | 4.53 | 4.24 – 4.93 |
Recurrence-free survival is defined as the time from initiation of treatment to death or recurrence, depending on which occurs first
| Group | Value | 95% CI |
|---|---|---|
| Gemcitabine, Cisplatin and Nivolumab | 51.52 | 39.92 – NA |
| Group | Value | 95% CI |
|---|---|---|
| Gemcitabine, Cisplatin and Nivolumab | NA | 24.21 – NA |
Pathologic complete response rate in patients undergoing radical cystectomy is defined as the proportion of patients with \<pT1
| Group | Value | 95% CI |
|---|---|---|
| Gemcitabine, Cisplatin and Nivolumab | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Gemcitabine, Cisplatin and Nivolumab | 3 |
Benefit will be defined as a pathologic complete response (p\<T1) in patients undergoing cystectomy and 2 years metastasis-free in patients pursuing surveillance. The positive predictive value of CCR with or without genomic alterations in baseline TURBT tissue for a composite outcome measure of 2-year bladder-intact survival in patients forgoing immediate cystectomy or \<ypT1N0 in patients undergoing immediate cystectomy are presented with 95% confidence interval in Outcome Measure Data Table. Positive predictive value is the ratio of patients truly diagnosed as positive to all those who had
| Group | Value | 95% CI |
|---|---|---|
| Gemcitabine, Cisplatin and Nivolumab | 0.72 | 0.56 – 0.87 |
Overall survival is defined as the time from initiation of treatment to death.
| Group | Value | 95% CI |
|---|---|---|
| Gemcitabine, Cisplatin and Nivolumab | NA | NA – NA |
| Group | Value | 95% CI |
|---|---|---|
| Gemcitabine, Cisplatin and Nivolumab | NA | 41.49 – NA |
Time frame: All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Gemcitabine, Cisplatin and… |
|---|---|---|
| URINARY TRACT INFECTION | Infections and infestations | — |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | — |
| HYPONATREMIA | Metabolism and nutrition disorders | — |
| SEPSIS | Infections and infestations | — |
| INFECTIONS AND INFESTATIONS - OTHER, SPECIFY | Infections and infestations | — |
| THROMBOEMBOLIC EVENT | Vascular disorders | — |
| ABDOMINAL PAIN | Gastrointestinal disorders | — |
| ATRIAL FIBRILLATION | Cardiac disorders | — |
| RENAL AND URINARY DISORDERS - OTHER, SPECIFY | Renal and urinary disorders | — |
| ADRENAL INSUFFICIENCY | Endocrine disorders | — |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | — |
| ANEMIA | Blood and lymphatic system disorders | — |
| BACK PAIN | Musculoskeletal and connective tissue disorders | — |
| BLOOD AND LYMPHATIC SYSTEM DISORDERS - OTHER, SPECIFY | Blood and lymphatic system disorders | — |
| BLOOD BILIRUBIN INCREASED | Investigations | — |
| DEPRESSION | Psychiatric disorders | — |
| DYSPNEA | Respiratory, thoracic and mediastinal disorders | — |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | — |
| FEVER | General disorders | — |
| HEMATURIA | Renal and urinary disorders | — |
| HYPERTHYROIDISM | Endocrine disorders | — |
| HYPOTENSION | Vascular disorders | — |
| KIDNEY INFECTION | Infections and infestations | — |
| LUNG INFECTION | Infections and infestations | — |
| PLATELET COUNT DECREASED | Investigations | — |
| Reaction | System | Gemcitabine, Cisplatin and… |
|---|---|---|
| FATIGUE | General disorders | — |
| ANEMIA | Blood and lymphatic system disorders | — |
| NEUTROPHIL COUNT DECREASED | Investigations | — |
| NAUSEA | Gastrointestinal disorders | — |
| CREATININE INCREASED | Investigations | — |
| CONSTIPATION | Gastrointestinal disorders | — |
| HYPERGLYCEMIA | Metabolism and nutrition disorders | — |
| WHITE BLOOD CELL DECREASED | Investigations | — |
| PLATELET COUNT DECREASED | Investigations | — |
| ANOREXIA | Metabolism and nutrition disorders | — |
| TINNITUS | Ear and labyrinth disorders | — |
| ALOPECIA | Skin and subcutaneous tissue disorders | — |
| HYPONATREMIA | Metabolism and nutrition disorders | — |
| DYSPNEA | Respiratory, thoracic and mediastinal disorders | — |
| HEMATURIA | Renal and urinary disorders | — |
| RENAL AND URINARY DISORDERS - OTHER, SPECIFY | Renal and urinary disorders | — |
| BLOOD AND LYMPHATIC SYSTEM DISORDERS - OTHER, SPECIFY | Blood and lymphatic system disorders | — |
| HYPERTENSION | Vascular disorders | — |
| URINARY TRACT INFECTION | Infections and infestations | — |
| HYPOMAGNESEMIA | Metabolism and nutrition disorders | — |
| VOMITING | Gastrointestinal disorders | — |
| BACK PAIN | Musculoskeletal and connective tissue disorders | — |
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | — |
| HYPOALBUMINEMIA | Metabolism and nutrition disorders | — |
| HYPOKALEMIA | Metabolism and nutrition disorders | — |
| DIARRHEA | Gastrointestinal disorders | — |
| HYPOCALCEMIA | Metabolism and nutrition disorders | — |
| PRURITUS | Skin and subcutaneous tissue disorders | — |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | — |
| HEADACHE | Nervous system disorders | — |
| SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY | Skin and subcutaneous tissue disorders | — |
| WEIGHT LOSS | Investigations | — |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | — |
| DYSGEUSIA | Nervous system disorders | — |
| INSOMNIA | Psychiatric disorders | — |
| PROTEINURIA | Renal and urinary disorders | — |
| ABDOMINAL PAIN | Gastrointestinal disorders | — |
| EDEMA LIMBS | General disorders | — |
| HYPERKALEMIA | Metabolism and nutrition disorders | — |
| PAIN | General disorders | — |
Most-reported serious reactions: URINARY TRACT INFECTION, ACUTE KIDNEY INJURY, HYPONATREMIA, SEPSIS, INFECTIONS AND INFESTATIONS - OTHER, SPECIFY, THROMBOEMBOLIC EVENT, ABDOMINAL PAIN, ATRIAL FIBRILLATION.
Data from ClinicalTrials.gov NCT03558087 adverse events section.
This is a phase 2 trial seeking to define the safety and activity of gemcitabine, cisplatin, plus nivolumab as neoadjuvant therapy in patients with muscle-invasive bladder cancer and to define the role of clinical complete response in predicting benefit in patients opting to avoid cystectomy.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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