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Safety and Pharmacology Study of Atezolizumab Alone and in Combination With Bacille Calmette-Guérin (BCG) in High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) Participants
Phase 1, PHASE2 trial testing Atezolizumab in Bladder Cancer in 24 participants. Terminated before completion.
| Lead sponsor | Hoffmann-La Roche |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 13 June 2016 |
| Primary completion | 29 September 2020 |
| Estimated completion | 29 September 2020 |
| Sites | 8 locations across United States |
Hoffmann-La Roche — 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.
Percentage of participants with at least one adverse event during the study.
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1A: Atezolizumab (BCG-unresponsive NMIBC) | 100 | |
| Cohort 1B: Atezolizumab + BCG (BCG-unresponsive NMIBC) | 100 |
Percentage of participants with dose-limiting toxicities (DLT) of BCG in Cohort 1B.
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1B: Atezolizumab + BCG (BCG-unresponsive NMIBC) | 16.7 |
Maximum administered dose (MAD) of BCG.
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1B: Atezolizumab + BCG (BCG-unresponsive NMIBC) | 50 |
CR at 6 months after the start of study treatment as assessed by the investigator on the basis of cystoscopic assessment and urine cytology.
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1A: Atezolizumab (BCG-unresponsive NMIBC) | 33.3 | 9.9 – 65.1 |
| Cohort 1B: Atezolizumab + BCG (BCG-unresponsive NMIBC) | 41.7 | 15.2 – 72.3 |
CR at the 3-month disease assessment, evaluated by both cystoscopy and cytology.
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1A: Atezolizumab (BCG-unresponsive NMIBC) | 16.7 | 2.1 – 48.4 |
| Cohort 1B: Atezolizumab + BCG (BCG-unresponsive NMIBC) | 41.7 | 15.2 – 72.3 |
Duration of CR will be defined for participants with a CR as the time from the first occurrence of a documented complete response to recurrence of high-grade NMIBC or death from any cause.
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1A: Atezolizumab (BCG-unresponsive NMIBC) | 6.80 | 3.06 – NA |
| Cohort 1B: Atezolizumab + BCG (BCG-unresponsive NMIBC) | NA | NA – NA |
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1A: Atezolizumab (BCG-unresponsive NMIBC) | NA | NA – NA |
| Cohort 1B: Atezolizumab + BCG (BCG-unresponsive NMIBC) | NA | 3.71 – NA |
Maximum observed serum concentration of Atezolizumab (Cmax)
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1A: Atezolizumab (BCG-unresponsive NMIBC) | 413 | ± 109 |
| Cohort 1B: Atezolizumab + BCG (BCG-unresponsive NMIBC) | 310 | ± 63.7 |
Minimum observed serum concentration of atezolizumab (Cmin)
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1A: Atezolizumab (BCG-unresponsive NMIBC) | 92.2 | ± 14.9 |
| Cohort 1B: Atezolizumab + BCG (BCG-unresponsive NMIBC) | 90.5 | ± 42.6 |
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1A: Atezolizumab (BCG-unresponsive NMIBC) | 143 | ± 26.1 |
| Cohort 1B: Atezolizumab + BCG (BCG-unresponsive NMIBC) | 133 | ± 74.4 |
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1A: Atezolizumab (BCG-unresponsive NMIBC) | 174 | ± 38.4 |
| Cohort 1B: Atezolizumab + BCG (BCG-unresponsive NMIBC) | 162 | ± 91.1 |
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1A: Atezolizumab (BCG-unresponsive NMIBC) | 211 | ± 59.4 |
| Cohort 1B: Atezolizumab + BCG (BCG-unresponsive NMIBC) | 192 | ± 117 |
Percentage of participants with anti-therapeutic antibody (ADA) response to atezolizumab.
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1A: Atezolizumab (BCG-unresponsive NMIBC) | 9.1 | |
| Cohort 1B: Atezolizumab + BCG (BCG-unresponsive NMIBC) | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1A: Atezolizumab (BCG-unresponsive NMIBC) | 8.3 | |
| Cohort 1B: Atezolizumab + BCG (BCG-unresponsive NMIBC) | 41.7 |
Time frame: From the first study drug to the data cutoff date: 29 September 2020 (up to 4.3 years). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Cohort 1A: Atezolizumab (B… | Cohort 1B: Atezolizumab + … | Cohort 2: Atezolizumab + B… | Cohort 3: Atezolizumab + B… |
|---|---|---|---|---|---|
| Haematuria | Renal and urinary disorders | — | — | — | — |
| Blood loss anaemia | Blood and lymphatic system disorders | — | — | — | — |
| Atrial fibrillation | Cardiac disorders | — | — | — | — |
| Complication associated with device | General disorders | — | — | — | — |
| Pyrexia | General disorders | — | — | — | — |
| Coronavirus infection | Infections and infestations | — | — | — | — |
| Pneumonia | Infections and infestations | — | — | — | — |
| Pyelonephritis | Infections and infestations | — | — | — | — |
| Aspiration | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Urinary retention | Renal and urinary disorders | — | — | — | — |
| Reaction | System | Cohort 1A: Atezolizumab (B… | Cohort 1B: Atezolizumab + … | Cohort 2: Atezolizumab + B… | Cohort 3: Atezolizumab + B… |
|---|---|---|---|---|---|
| Fatigue | General disorders | — | — | — | — |
| Pollakiuria | Renal and urinary disorders | — | — | — | — |
| Bladder spasm | Renal and urinary disorders | — | — | — | — |
| Haematuria | Renal and urinary disorders | — | — | — | — |
| Dysuria | Renal and urinary disorders | — | — | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — | — | — |
| Hypothyroidism | Endocrine disorders | — | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — |
| Influenza like illness | General disorders | — | — | — | — |
| Pyrexia | General disorders | — | — | — | — |
| Urinary tract infection | Infections and infestations | — | — | — | — |
| Aspartate aminotransferase increased | Investigations | — | — | — | — |
| Blood creatinine increased | Investigations | — | — | — | — |
| Lymphocyte count decreased | Investigations | — | — | — | — |
| Hyperglycaemia | Metabolism and nutrition disorders | — | — | — | — |
| Hyponatraemia | Metabolism and nutrition disorders | — | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — |
| Micturition urgency | Renal and urinary disorders | — | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Rash macular | Skin and subcutaneous tissue disorders | — | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — | — |
| Lymphadenopathy | Blood and lymphatic system disorders | — | — | — | — |
| Atrial fibrillation | Cardiac disorders | — | — | — | — |
| Dry eye | Eye disorders | — | — | — | — |
| Eye irritation | Eye disorders | — | — | — | — |
| Abdominal distension | Gastrointestinal disorders | — | — | — | — |
| Dry mouth | Gastrointestinal disorders | — | — | — | — |
| Dysphagia | Gastrointestinal disorders | — | — | — | — |
| Lip oedema | Gastrointestinal disorders | — | — | — | — |
| Stomatitis | Gastrointestinal disorders | — | — | — | — |
| Chills | General disorders | — | — | — | — |
| Injury associated with device | General disorders | — | — | — | — |
| Mucosal inflammation | General disorders | — | — | — | — |
| Oedema | General disorders | — | — | — | — |
| Oedema peripheral | General disorders | — | — | — | — |
Most-reported serious reactions: Haematuria, Blood loss anaemia, Atrial fibrillation, Complication associated with device, Pyrexia, Coronavirus infection, Pneumonia, Pyelonephritis.
Data from ClinicalTrials.gov NCT02792192 adverse events section.
This Phase Ib/II study is designed to assess the safety, tolerability, pharmacokinetics, immunogenicity, patient reported outcomes (PROs), and preliminary anti-tumor activity of atezolizumab administered by intravenous (IV) infusion alone and in combination with intravesical BCG in high-risk NMIBC participants. The study will be conducted in following cohorts: Cohort 1A, Cohort 1B, Cohort 2, and Cohort 3. Atezolizumab will be administered at a fixed dose of 1200 milligrams (mg) every 3 weeks (q3w) for a maximum of 96 weeks. BCG will be administered to evaluate dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), or maximum administered dose (MAD). De-escalation will be allowed for up to three dose levels of BCG (full dose \[50 mg\], 66 percent \[%\] of a full dose, and 33% of a full dose \[Cohort 1B only\]). After the MTD or MAD is determined for Cohort 1B, this dose will be used for all subsequent participants enrolled into Cohorts 1B, 2, and 3, unless the MTD is determined to be 33% of a full BCG dose. If MTD is determined to be 33% of a full BCG dose, then, no participants will be enrolled into Cohorts 2 and 3 until an assessment of the safety and activity of the combination of atezolizumab plus 33% of a full BCG dose is completed.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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