Montag, 19. April 2021
Navigation öffnen
Anzeige:
Vectibix
JOURNAL ONKOLOGIE – STUDIE
FRACTION-RCC

A Study to Test Combination Treatments in People With Advanced Renal Cell Carcinoma

Rekrutierend

NCT-Nummer:
NCT02996110

Studienbeginn:
Januar 2017

Letztes Update:
17.06.2020

Wirkstoff:
BMS-986205, Nivolumab, Ipilimumab, Relatlimab, BMS-813160

Indikation (Clinical Trials):
Carcinoma, Renal Cell

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

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, please email:
Kontakt:
E-Mail: Clinical.Trials@bms.com
» Kontaktdaten anzeigen
First line of the email MUST contain NCT# and Site #.

Studienlocations
(3 von 35)

Local Institution
94115 San Francisco
United StatesZurückgezogen» Google-Maps
Columbia University Medical Center (Cumc)
10032 New York
United StatesZurückgezogen» Google-Maps
Hollings Cancer Center
29425 Charleston
United StatesAbgeschlossen» Google-Maps
Ordensklinikum Linz GmbH
4020 Linz
AustriaAktiv, nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

The purpose of this study is to test the effectiveness and safety of various nivolumab combinations compared to nivolumab and ipilimumab in participants with advanced kidney cancer

Ein-/Ausschlusskriterien

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

- Advanced Renal Cell Carcinoma

- Must have at least 1 lesion with measurable disease

- Life expectancy of at least 3 months

- Karnofsky Performance Status (KPS) must be =>70%

Exclusion Criteria:

- Patients/subjects with suspected or known central nervous system metastases unless adequately treated

- Patients/subjects with autoimmune disease

- Patients/subjects who need daily oxygen therapy

Other protocol defined inclusion/exclusion criteria could apply

Studien-Rationale

Primary outcome:

1. Objective Response Rate (ORR) (Time Frame - Up to 24 weeks)

2. Duration of Response (DOR) (Time Frame - Up to 24 weeks)

3. Progression-free Survival Rate (PFSR) (Time Frame - Up to 24 weeks)

Secondary outcome:

1. Safety as measured by incidence of AEs (Adverse Events) (Time Frame - Up to 2 years)

2. Safety as measured by incidence of SAEs (Serious Adverse Events) (Time Frame - Up to 2 years)

3. Tolerability as measured by incidence of AEs (Time Frame - Up to 2 years)

4. Tolerability as measured by SAEs (Time Frame - Up to 2 years)

Studien-Arme

  • Active Comparator: Nivolumab + Ipilimumab
    Nivolumab + Ipilimumab
  • Experimental: Nivolumab + Relatlimab
    Nivolumab + Relatlimab
  • Experimental: Nivolumab + BMS-986205
    Nivolumab + BMS-986205
  • Experimental: Nivolumab + BMS-813160
    Nivolumab + BMS-813160 (CCR2/5 dual antagonist)

Geprüfte Regime

  • Nivolumab (Opdivo / BMS-936558 / )
  • Ipilimumab (BMS-734016 / Yervoy / )
  • Relatlimab (BMS-986016)
  • BMS-986205
  • BMS-813160

Quelle: ClinicalTrials.gov


Das könnte Sie auch interessieren
Frauenärzte der GenoGyn fordern Maßnahmen gegen riskanten Alkoholkonsum
Frauen%C3%A4rzte+der+GenoGyn+fordern+Ma%C3%9Fnahmen+gegen+riskanten+Alkoholkonsum
© karepa / Fotolia.com

Beim Alkoholkonsum belegt Deutschland im weltweiten Vergleich stets Spitzenplätze: Rund zehn Liter reinen Alkohols werden hierzulande nach aktuellen Informationen des Bundesgesundheitsministeriums jedes Jahr pro Kopf getrunken und verursachen alljährlich volkswirtschaftliche Schäden in Höhe von 26,7 Milliarden Euro. „Obwohl Erkenntnisse über das Suchtpotenzial von Alkohol in der Gesellschaft inzwischen...