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JOURNAL ONKOLOGIE – STUDIE
CheckMate 7G8

A Study Comparing the Efficacy and Safety of Nivolumab in Combination With Bacillus Calmette-Guerin (BCG) Versus BCG Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC)

Rekrutierend

NCT-Nummer:
NCT04149574

Studienbeginn:
Dezember 2019

Letztes Update:
23.11.2020

Wirkstoff:
Nivolumab, Bacillus Calmette-Guérin (BCG)

Indikation (Clinical Trials):
Urinary Bladder Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Bristol-Myers Squibb

Collaborator:
-

Studienleiter

Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb

Kontakt

Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
Kontakt:
Phone: please email:
E-Mail: Clinical.Trials@bms.com
» Kontaktdaten anzeigen
First line of the email MUST contain NCT # and Site #

Studienlocations
(3 von 95)

Local Institution
M20 4BX Manchester
United KingdomZurückgezogen» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

A study comparing nivolumab and bacterial drugs given to help the body's immune system in the

bladder versus bacterial drugs alone in high risk bladder cancer participants.

Ein-/Ausschlusskriterien

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please

visit www.BMSStudyConnect.com.

Inclusion:

- Predominant histologic component (> 50%) must be urothelial (transitional cell)

carcinoma

- Persistent or recurrent disease ≤ 24 months of last BCG dose, but not classified as

BCG unresponsive

- Histologically confirmed persistent or recurrent high-risk non-muscle-invasive

urothelial carcinoma (UC)

- Treated with at least 1 adequate course of induction BCG therapy (at least 5 out of 6

doses)

- Sufficient tissue for both biomarker analysis and central pathology review committee

(PRC) confirmation of diagnosis

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2

- Women of child bearing potential (WOCBP) and men with WOCBP partners must agree to

follow contraceptive requirements

Exclusion Criteria

- Previous or concurrent muscle invasive, locally advanced, or disseminated/metastatic

UC

- UC in the upper genitourinary tract (kidneys, renal collecting systems, ureters)

within 24 months of enrollment

- UC and/or CIS in the prostatic urethra within 12 months of enrollment

- Prior surgery (other than transurethral resection of the bladder tumor

(TURBT)/biopsies) for bladder cancer; prior radiation therapy, or systemic

chemotherapy or immunotherapy for bladder cancer or UC

Other inclusion/exclusion criteria apply.

Studien-Rationale

Primary outcome:

1. Event Free Survival (EFS) (Time Frame - approximately 3 years)



Secondary outcome:

1. Worsening- Free Survival (WFS) (Time Frame - approximately 7 years)

2. Overall Survival (OS) (Time Frame - approximately 10 years)

3. Complete Response Rate (CRR) (Time Frame - approximately 3 years)

4. Duration of Response (DOR) (Time Frame - approximately 3 years)

5. Number of laboratory abnormalities (Time Frame - approximately 3 years)

6. Number of Laboratory changes from baseline (Time Frame - approximately 3 years)

7. Incidence of Adverse Events (AEs) (Time Frame - approximately 3 years)

8. Incidence of serious adverse Events (SAEs) (Time Frame - approximately 3 years)

9. Incidence of adverse events leading to discontinuation (Time Frame - approximately 3 years)

10. Incidence of immune-medicated adverse events (IMAEs) (Time Frame - approximately 3 years)

11. Incidence of Deaths (Time Frame - approximately 3 years)

Studien-Arme

  • Experimental: Arm A: nivolumab
  • Placebo Comparator: Arm B: placebo +BCG

Geprüfte Regime

  • nivolumab:
    Specified Dose on Specific Days
  • Placebo:
    Specified Dose on Specific Days
  • Bacillus Calmette-Guérin (BCG):
    Intravesicular

Quelle: ClinicalTrials.gov


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