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Nivolumab Plus Chemoradiotherapy in Patients With Muscle-invasive Bladder Cancer (MIBC) Not Undergoing Cystectomy

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ClinicalTrials.gov Identifier: NCT03993249
Recruitment Status : Recruiting
First Posted : June 20, 2019
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
Hellenic GenitoUrinary Cancer Group

Brief Summary:
The purpose of this study is to investigate the effect synchronous use of nivolumab in addition to chemoradiotherapy in patients withnon-metastatic MIBC who are not candidates for radical cystectomy

Condition or disease Intervention/treatment Phase
Bladder Cancer Biological: Nivolumab Other: chemoradiotherapy Phase 2

Detailed Description:

The initial hypothesis is that addition of nivolumab will increase 2-year locoregional control rate from 55% (control arm) to 75% (immunotherapy arm)

There is a 24 month accrual period during which 78 patients will be randomized in a control group (standard chemo-radiotherapy) and the treatment group (chemo-radiotherapy + Nivolumab)

The primary objective would be to compare locoregional control rate at 2-years between patients with MIBC receiving or not receiving nivolumab in addition to chemoradiotherapy.

The secondary objectives are

  1. To study the safety of the addition of nivolumab to chemoradiotherapy in patients with MIBC
  2. To compare 2-year bladder cancer failure-free (BCFF) rates, defined as distant metastasis free survival (MFS) AND/OR locoregional failure (defined as in primary objective)
  3. To compare median overall survival (OS) in patients with MIBC receiving or not receiving nivolumab in addition to chemoradiotherapy
  4. Assess the effect of combined treatment on the quality of life

Correlative studies of outcomes with PD-L1expression and with lymphocytic populations in the environment of the tumor


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized controlled
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nivolumab Plus Chemoradiotherapy in Patients With Muscle-invasive Bladder Cancer (MIBC) Not Undergoing Cystectomy: a Phase II, Randomized Study
Actual Study Start Date : May 28, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer
Drug Information available for: Nivolumab

Arm Intervention/treatment
Chemoradiotherapy
standard of care chemo-radiotherapy
Other: chemoradiotherapy
standard of care chemoradiotherapy

Experimental: Combination
standard of care chemo-radiotherapy + Nivolumab
Biological: Nivolumab
standard of care chemoradiotherapy + Nivolumab

Other: chemoradiotherapy
standard of care chemoradiotherapy




Primary Outcome Measures :
  1. Locoregional control rate [ Time Frame: 2 years ]
    To compare locoregional control rate at 2-years between patients with MIBC receiving or not receiving nivolumab in addition to chemoradiotherapy


Secondary Outcome Measures :
  1. Incidence Rate of treatment-related adverse event (safety and tolerability) [ Time Frame: 2 years ]
    Incidence of adverse events as assessed by CTCAE. After radiotherapy completion, AEs will be assessed according to RTOG/EORTC Late Radiation Morbidity Scoring Schema

  2. Bladder cancer failure-free (BCFF) rates [ Time Frame: 2 years ]
    To compare 2-year bladder cancer failure-free (BCFF) rates, defined as distant metastasis free survival (MFS) AND/OR locoregional failure (defined as in primary objective)

  3. Median overall survival (OS) [ Time Frame: 2 years ]
    To compare median overall survival (OS) in patients with MIBC receiving or not receiving nivolumab in addition to chemoradiotherapy

  4. Quality of life [ Time Frame: 2 years ]
    Quality of life score assessed by Quality of Life of Cancer Patients Questionnaire (EORTC QLQ-C30). Discomfort measured in a scale from 1 (not at all) to 4 (very much) Overall health and quality of life score measured in a scale from 1 (very poor) to 7 (excellent)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically proven, muscle-invasive carcinoma of the bladder, cT2-T4aN0M0
  • Urothelial, squamous or glandular histology according to WHO 2016 classification (Fig 1)
  • Undergone a vigorous TURB
  • Not candidates for radical cystectomy.
  • PS:0-1
  • age >18 years old
  • Adequate bone marrow function
  • Adequate renal function

Exclusion Criteria:

Key Exclusion Criteria

  • Histology other than transitional-cell, squamous or adenocarcinoma
  • Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, prostate cancer cervix or breast.
  • Previous systemic chemotherapy or prior biologic agents within 4 weeks, or intravesical Bacillus Calmette-Guerin (BCG) within 6 weeks of the first dose of study treatment.
  • Prior treatment with any PD-1 or PDL-1 inhibitor or anti CTLA4 agent
  • Previous pelvic radiation therapy.
  • Patients with inherited syndromes associated with hypersensitivity to ionizing radiation
  • Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation
  • Any history of inflammatory bowel disease and or history of abdominal fistula
  • Previous allergy to any of the study drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03993249


Contacts
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Contact: Vasiliki Magoula, MSc +302107777791 res2@eeoogek.gr

Locations
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Greece
Hellenic GenitoUrinary Cancer Group Recruiting
Athens, Attica, Greece, 11527
Contact: Aristotelis Bamias, Professor    00302107777791    abamias@med.uoa.gr   
Sponsors and Collaborators
Hellenic GenitoUrinary Cancer Group

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Responsible Party: Hellenic GenitoUrinary Cancer Group
ClinicalTrials.gov Identifier: NCT03993249     History of Changes
Other Study ID Numbers: REQ-0000020479
First Posted: June 20, 2019    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents