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

  • STATUS
    Recruiting
  • End date
    Dec 13, 2023
  • participants needed
    78
  • sponsor
    Hellenic GenitoUrinary Cancer Group
Updated on 13 April 2022
radical cystectomy
cancer
carcinoma
nivolumab
bladder cancer
invasive bladder cancer
TURB
bladder tumor
bladder carcinoma

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

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

Details
Condition Bladder Cancer
Treatment Nivolumab, Chemoradiotherapy
Clinical Study IdentifierNCT03993249
SponsorHellenic GenitoUrinary Cancer Group
Last Modified on13 April 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note