Bladder CancerPhase 2NCT03993249
Nivolumab Plus Chemoradiotherapy in Patients With Muscle-invasive Bladder Cancer (MIBC) Not Undergoing Cystectomy
A Phase 2 study testing Nivolumab and chemoradiotherapy in people with Bladder Cancer, run by Hellenic GenitoUrinary Cancer Group at 1 site in Greece.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Nivolumab and chemoradiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteGreece
- Study dates
- 28 May 2019to Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Hellenic GenitoUrinary Cancer Group
Athens, Attica, 11527
Aristotelis Bamias, Professor, 00302107777791, abamias@med.uoa.gr
About this study
Official title: Nivolumab Plus Chemoradiotherapy in Patients With Muscle-invasive Bladder Cancer (MIBC) Not Undergoing Cystectomy: a Phase II, Randomized Study
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
Read the 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
- To study the safety of the addition of nivolumab to chemoradiotherapy in patients with MIBC
- 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)
- To compare median overall survival (OS) in patients with MIBC receiving or not receiving nivolumab in addition to chemoradiotherapy
- 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
- Conditions
- Bladder Cancer
- Being tested
- Nivolumab, chemoradiotherapy
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabBiological
standard of care chemoradiotherapy + Nivolumab
chemoradiotherapyOther
standard of care chemoradiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Chemoradiotherapy | Other | standard of care chemo-radiotherapy Receives: Other: chemoradiotherapy |
| Combination | Experimental | standard of care chemo-radiotherapy + Nivolumab Receives: Biological: Nivolumab; Other: chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Locoregional control rate
To compare locoregional control rate at 2-years between patients with MIBC receiving or not receiving nivolumab in addition to chemoradiotherapy
Measured: 2 years
Secondary outcomes (4)
Incidence Rate of treatment-related adverse event (safety and tolerability)
Incidence of adverse events as assessed by CTCAE. After radiotherapy completion, AEs will be assessed according to RTOG/EORTC Late Radiation Morbidity Scoring Schema
Measured: 2 years
Bladder cancer failure-free (BCFF) rates
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)
Measured: 2 years
Median overall survival (OS)
To compare median overall survival (OS) in patients with MIBC receiving or not receiving nivolumab in addition to chemoradiotherapy
Measured: 2 years
Assessment of the effect of the combined treatment on the quality of life
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)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start28 May 2019
- Primary completionAug 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hellenic GenitoUrinary Cancer Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03993249
- Sponsor's protocol ID
- REQ-0000020479
- Status last verified
- Mar 2022
- First submitted
- 4 Jun 2019
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nivolumab Plus Chemoradiotherapy in Patients With Muscle-invasive Bladder Cancer (MIBC) Not Undergoing Cystectomy: a Phase II, Randomized Study
- ClinicalTrials.gov ID
- NCT03993249
- Acronym / sponsor ID
- REQ-0000020479
- Conditions
- Bladder Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Hellenic GenitoUrinary Cancer GroupUniversity, hospital or other
- Study start
- 28 May 2019 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 20 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- To study the safety of the addition of nivolumab to chemoradiotherapy in patients with MIBC
- 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)
- To compare median overall survival (OS) in patients with MIBC receiving or not receiving nivolumab in addition to chemoradiotherapy
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled
| Arm | Type | Receives |
|---|---|---|
| Chemoradiotherapy | Other | Other: chemoradiotherapystandard of care chemo-radiotherapy |
| Combination | Experimental | Biological: Nivolumab, Other: chemoradiotherapystandard of care chemo-radiotherapy + Nivolumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nivolumabstandard of care chemoradiotherapy + Nivolumab | Biological | Combination |
| chemoradiotherapystandard of care chemoradiotherapy | Other | Chemoradiotherapy, Combination |
Primary outcome
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
4 secondary outcomes
Incidence Rate of treatment-related adverse event (safety and tolerability)
Time frame: 2 years
Bladder cancer failure-free (BCFF) rates
Time frame: 2 years
Median overall survival (OS)
Time frame: 2 years
Assessment of the effect of the combined treatment on the quality of life
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab and chemoradiotherapy in people with Bladder Cancer, run by Hellenic GenitoUrinary Cancer Group at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vasiliki Magoula, MSc (+302107777791, res2@eeoogek.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Locoregional control rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2022.