An open label, single-arm, phase 2 study od neoadjuvant nivolumab and nab-paclitaxel before cystectomy for patients with muscle-invasive bladder cancer - NURE-Combo

OSPEDALE SAN RAFFAELE0 sites29 target enrollmentAugust 30, 2021

Conditionsmuscle-invasive bladder cancer MedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

DrugsABRAXANE - 5 MG/ML - POLVERE PER SOSPENSIONE PER INFUSIONE - USO ENDOVENOSO- 100 MG - FLACONCINO(VETRO) 1 FLACONCINO OPDIVO - 10 MG/ML- CONCENTRATO PER SOLUZIONE PER INFUSIONE- USO ENDOVENOSO- FLACONCINO (VETRO)- 10 ML- 1 FLACONCINO

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: muscle-invasive bladder cancer
Sponsor: OSPEDALE SAN RAFFAELE
Enrollment: 29
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 30, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

OSPEDALE SAN RAFFAELE

Eligibility Criteria

Inclusion Criteria

•2\.Female or male subjects, \>18 years of age, able to understand and give written informed consent.
•3\.Histopathologically confirmed urothelial carcinoma. Patients with mixed histologies are required to have a dominant (i.e. 50% at least) transitional cell pattern.
•4\.Fit and planned for RC (according to local guidelines).
•5\.ECOG performance status score of 0 or 1\.
•6\.Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation (Hemoglobin \= 9 g/dL, ANC \= 1,500/ mm3, and Platelets \= 100,000/ µL).
•7\.Adequate hepatic function (Bilirubin \= 1\.5 IULN, AST and ALT \= 2\.5 x IULN or \= 5 x IULN if known liver metastases and serum albumin \>3 g/dl).
•8\.Creatinine clearance \=30 mL/min as assessed by the Cockcroft\-Gault equation.
•9\.Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication, and must not be lactating. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
•10\.Female subjects of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of the study through 4 months after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \>2 years.
•11\.Male subjects must agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study therapy.

Exclusion Criteria

•1\.A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
•2\.Prior immunotherapy with an anti\-PD\-1, anti\-PD\-L1, or anti\-PD\-L2 agent or with an agent directed to another stimulatory or co\-inhibitory T\-cell receptor (eg, CTLA\-4, OX\-40, CD137\).
•3\.Has received prior systemic anti\-cancer therapy including investigational agents.
•4\.Has received prior radiotherapy on the bladder tumor.
•5\.Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette–Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
•6\.Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
•7\.Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
•8\. Has severe hypersensitivity (\=Grade 3\) to nivolumab or nab\-paclitaxel and/or any of its excipients.
•9\. Has a history of (non\-infectious) pneumonitis that required steroids or has current pneumonitis.
•10\. Has an active infection requiring systemic therapy.