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Durvalumab And Radiation Therapy Followed by Adjuvant Durvalumab in Patients With Urothelial Cancer (T2-4 N0-2 M0) of the Bladder
Phase 1, PHASE2 trial testing durvalumab in Urothelial Cancer in 26 participants. Terminated before completion.
| Lead sponsor | Monika Joshi, MD |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 26 |
| Start date | 16 November 2016 |
| Primary completion | 6 August 2019 |
| Estimated completion | 27 April 2022 |
| Sites | 7 locations across United States |
Monika Joshi, MD
18 and older, any sex, with Urothelial Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
To assess the safety of combining durvalumab with RT in that DLT rate is lower than than 33% based on CTCAEv4.0
| Group | Value | 95% CI |
|---|---|---|
| Arm Ib: Safety Run In Phase Ib | 0 |
Progression free survival rate at one year is defined as the probability that a patient remains free of progression of disease (SD+CR+PR) by modified RECIST 1.1 and cystoscopy at 1 year from the start of durvalumab treatment, D1 of durvaRT. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
| Group | Value | 95% CI |
|---|---|---|
| Phase Ib and II | 71.5 | 55.6 – 91.9 |
The number of all subjects is reported with stable disease (SD) for 8 weeks, or partial response (PR), or complete response (CR) according to modified RECIST 1.1 and cystoscopy, from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the start of treatment). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diamete
| Group | Value | 95% CI |
|---|---|---|
| Arm II: Investigational Treatment Phase II | 13 |
We will be determining the disease control rate, defined as percentage of patients achieving CR, PR, SD post completion of concurrent durvaRT. This will give us some preliminary evidence for efficacy of durvaRT combination. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease(SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD,
| Group | Value | 95% CI |
|---|---|---|
| Phase Ib and Phase II | 72.7 | 51.8 – 86.8 |
Median progression free survival will be determined for all subjects.
| Group | Value | 95% CI |
|---|---|---|
| All Phases | 21.8 | 14.8 – NA |
Estimate the rate of CR is one of the secondary objectives for phase II part of this study. This will help us determine the actual effectiveness of durvaRT approach. CR will be determined with the help of imaging and cystoscopy post completion of durvaRT per modified RECIST 1.1. Number of subjects reporting CR will be reported here. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions.
| Group | Value | 95% CI |
|---|---|---|
| Arm II: Investigational Treatment Phase II | 17 |
Estimate the overall survival (OS), defined as time from start of treatment, D1, to the date of death due to any cause. OS is defined, as time from start of treatment to the date of death due to any cause, or to the date of censoring at the last time the subject was known to be alive in intention-to-treat population. OS is one of the secondary objectives of this study. This is an immunotherapy based clinical trial and it is prudent to determine the OS to reflect the long-term benefit from this therapeutic approach.
| Group | Value | 95% CI |
|---|---|---|
| All Phases | 30.8 | 21.8 – NA |
Time frame: Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Arm Ib: Safety Run In Phas… | Arm II: Investigational Tr… |
|---|---|---|---|
| URINARY TRACT INFECTION | Infections and infestations | — | — |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | — | — |
| LUNG INFECTION | Infections and infestations | — | — |
| ABDOMINAL PAIN | Gastrointestinal disorders | — | — |
| DEHYDRATION | Metabolism and nutrition disorders | — | — |
| ESOPHAGITIS | Gastrointestinal disorders | — | — |
| GASTRITIS | Gastrointestinal disorders | — | — |
| HIP FRACTURE | Injury, poisoning and procedural complications | — | — |
| MYOCARDIAL INFARCTION | Cardiac disorders | — | — |
| OBSTRUCTION GASTRIC | Gastrointestinal disorders | — | — |
| RENAL AND URINARY DISORDERS | Renal and urinary disorders | — | — |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | — | — |
| SEPSIS | Infections and infestations | — | — |
| SKIN AND SUBCUTANEOUS TISSUE DISORDERS | Skin and subcutaneous tissue disorders | — | — |
| STROKE | Nervous system disorders | — | — |
| THROMBOEMBOLIC EVENT | Vascular disorders | — | — |
| ANEMIA | Blood and lymphatic system disorders | — | — |
| ATRIOVENTRICULAR BLOCK COMPLETE | Cardiac disorders | — | — |
| CARDIAC DISORDERS | Cardiac disorders | — | — |
| DELIRIUM | Psychiatric disorders | — | — |
| DIARRHEA | Gastrointestinal disorders | — | — |
| DYSPNEA | Respiratory, thoracic and mediastinal disorders | — | — |
| INFECTIONS AND INFESTATIONS | Infections and infestations | — | — |
| SINUS BRADYCARDIA | Cardiac disorders | — | — |
| SYNCOPE | Nervous system disorders | — | — |
| Reaction | System | Arm Ib: Safety Run In Phas… | Arm II: Investigational Tr… |
|---|---|---|---|
| HYPERTENSION | Vascular disorders | — | — |
| FATIGUE | General disorders | — | — |
| CREATININE INCREASED | Investigations | — | — |
| CONSTIPATION | Gastrointestinal disorders | — | — |
| DIARRHEA | Gastrointestinal disorders | — | — |
| EDEMA LIMBS | General disorders | — | — |
| GASTROESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | — | — |
| RENAL AND URINARY DISORDERS | Renal and urinary disorders | — | — |
| URINARY TRACT INFECTION | Infections and infestations | — | — |
| ANEMIA | Blood and lymphatic system disorders | — | — |
| HEMATURIA | Renal and urinary disorders | — | — |
| HYPERURICEMIA | Metabolism and nutrition disorders | — | — |
| LYMPHOCYTE COUNT DECREASED | Investigations | — | — |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | — | — |
| CHRONIC KIDNEY DISEASE | Renal and urinary disorders | — | — |
| ARTHRITIS | Musculoskeletal and connective tissue disorders | — | — |
| CHOLESTEROL HIGH | Investigations | — | — |
| HYPERKALEMIA | Metabolism and nutrition disorders | — | — |
| RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS | Respiratory, thoracic and mediastinal disorders | — | — |
| URINARY TRACT PAIN | Renal and urinary disorders | — | — |
| CARDIAC DISORDERS | Cardiac disorders | — | — |
| CYSTITIS NONINFECTIVE | Renal and urinary disorders | — | — |
| DIZZINESS | Nervous system disorders | — | — |
| GASTROINTESTINAL DISORDERS | Gastrointestinal disorders | — | — |
| SKIN AND SUBCUTANEOUS TISSUE DISORDERS | Skin and subcutaneous tissue disorders | — | — |
| URINARY INCONTINENCE | Renal and urinary disorders | — | — |
| EYE DISORDERS | Eye disorders | — | — |
| ALLERGIC RHINITIS | Respiratory, thoracic and mediastinal disorders | — | — |
| ANOREXIA | Metabolism and nutrition disorders | — | — |
| ATRIAL FIBRILLATION | Cardiac disorders | — | — |
| BACK PAIN | Musculoskeletal and connective tissue disorders | — | — |
| DYSPNEA | Respiratory, thoracic and mediastinal disorders | — | — |
| INSOMNIA | Psychiatric disorders | — | — |
| INVESTIGATIONS | Investigations | — | — |
| NAUSEA | Gastrointestinal disorders | — | — |
| SERUM AMYLASE INCREASED | Investigations | — | — |
| SLEEP APNEA | Respiratory, thoracic and mediastinal disorders | — | — |
| URINARY FREQUENCY | Renal and urinary disorders | — | — |
| FALL | Injury, poisoning and procedural complications | — | — |
| HYPOTENSION | Vascular disorders | — | — |
Most-reported serious reactions: URINARY TRACT INFECTION, ACUTE KIDNEY INJURY, LUNG INFECTION, ABDOMINAL PAIN, DEHYDRATION, ESOPHAGITIS, GASTRITIS, HIP FRACTURE.
Data from ClinicalTrials.gov NCT02891161 adverse events section.
This is an open label, multi-institutional, single arm study of a phase Ib study, followed by a phase II study of durvalumab with radiation therapy (RT) in patients with urothelial cancer (UC). No randomization or blinding is involved.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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