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JOURNAL ONKOLOGIE – STUDIE

Pan Tumor Rollover Study

Rekrutierend

NCT-Nummer:
NCT03899155

Studienbeginn:
August 2019

Letztes Update:
07.08.2024

Wirkstoff:
Nivolumab, Ipilimumab, Cabozantinib, Trametinib, Relatlimab, Nivolumab + Relatlimab, Capecitabin, Bevacizumab, Temozolomide, Rucaparib, Daratumumab, Regorafinib, Leucovorin, Fluorouracil, Oxaliplatin, Enzalutamide, Sunitinib, Pemetrexed, Pembrolizumab

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Bristol-Myers Squibb

Collaborator:
Exelixis, Novartis, Clovis Oncology, Inc., Janssen Pharmaceuticals,

Studienleiter

Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb

Kontakt

BMS Study Connect Contact http://www.bmsstudyconnect.com/
Kontakt:
Phone: 855-907-3286
E-Mail: Clinical.Trials@bms.com» Kontaktdaten anzeigen
First line of the email MUST contain NCT# and Site#

Studienlocations
(3 von 355)

Local Institution - 0332
90419 Nuremberg
(Bayern)
GermanyZurückgezogen» Google-Maps
Local Institution - 0296
50937 Cologne
(Nordrhein-Westfalen)
GermanyZurückgezogen» Google-Maps
Local Institution
07548 Gera
(Thüringen)
GermanyZurückgezogen» Google-Maps
Local Institution
37075 Goettingen
(Niedersachsen)
GermanyZurückgezogen» Google-Maps
Local Institution
69120 Heidelberg
(Baden-Württemberg)
GermanyZurückgezogen» Google-Maps
Lungenkrebszentrum des NCT Heidelberg; Thoraxklinik Heidelberg
Im Neuenheimer Feld 672
69126 Heidelberg
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Helge Bischoff, Site 0148
Phone: 4962213961304» Ansprechpartner anzeigen
Oberaeztin Neurologische Klinik und Nationales Tumorzentrum Universitaetsklinik Heidelberg Im Neuenheimer
D-69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Antje Wick, Site 0342
Phone: +496221567075» Ansprechpartner anzeigen
Universitaetsklinikum Jena - Klinik und Poliklinik fuer Urologie
07747 Jena
(Thüringen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Marc-Oliver Grimm, Site 0216
Phone: +49(0)36419329901» Ansprechpartner anzeigen
Local Institution
24105 Kiel
(Schleswig-Holstein)
GermanyZurückgezogen» Google-Maps
Local Institution
50937 Koeln
(Nordrhein-Westfalen)
GermanyZurückgezogen» Google-Maps
Local Institution - 0298
74245 Loewenstein
(Baden-Württemberg)
GermanyZurückgezogen» Google-Maps
Local Institution - 0098
23538 Luebeck
(Schleswig-Holstein)
GermanyZurückgezogen» Google-Maps
Local Institution
55131 Mainz
(Rheinland-Pfalz)
GermanyZurückgezogen» Google-Maps
Local Institution - 0277
72076 Tuebingen
(Baden-Württemberg)
GermanyZurückgezogen» Google-Maps
University of Arizona College of Medicine
85724 Tucson
United StatesZurückgezogen» Google-Maps
Innovative Clinical Research Institute
90262 Lynwood
United StatesZurückgezogen» Google-Maps
Local Institution
94115 San Francisco
United StatesZurückgezogen» Google-Maps
UCSF Medical Center - Helen Diller Family Comprehensive Cancer Center - Melanoma Center
94143 San Francisco
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Adil Daud, Site 0099
Phone: 415-353-7392» Ansprechpartner anzeigen
Local Institution - 0095
06520 New Haven
United StatesZurückgezogen» Google-Maps
Florida Cancer Affiliates
34474 Ocala
United StatesZurückgezogen» Google-Maps
Local Institution - 0105
60637 Chicago
United StatesAbgeschlossen» Google-Maps
Local Institution - 0081
02215 Boston
United StatesZurückgezogen» Google-Maps
Local Institution
63110 Saint Louis
United StatesZurückgezogen» Google-Maps
Local Institution - 0205
68130 Omaha
United StatesAbgeschlossen» Google-Maps
Local Institution
87131 Albuquerque
United StatesZurückgezogen» Google-Maps
Local Institution - 0246
74146 Tulsa
United StatesZurückgezogen» Google-Maps
Allegheny Valley Hospital
15065 Natrona Heights
United StatesZurückgezogen» Google-Maps
Local Institution
19104 Philadelphia
United StatesZurückgezogen» Google-Maps
Local Institution - 0162
19111 Philadelphia
United StatesZurückgezogen» Google-Maps
Local Institution - 0110
15213 Pittsburgh
United StatesAbgeschlossen» Google-Maps
Local Institution
29615 Greenville
United StatesZurückgezogen» Google-Maps
Local Institution
37404 Chattanooga
United StatesZurückgezogen» Google-Maps
Vanderbilt University Medical Center
37232 Nashville
United StatesZurückgezogen» Google-Maps
Local Institution
22908 Charlottesville
United StatesZurückgezogen» Google-Maps
Public Hospital of King County District 1 Valley Medical Center
98055 Renton
United StatesZurückgezogen» Google-Maps
Local Institution - 0191
4000 San Miguel De Tucumán
ArgentinaAbgeschlossen» Google-Maps
Local Institution - 0201
C1199 ABH Buenos Aires
ArgentinaZurückgezogen» Google-Maps
Local Institution - 0170
X5004FHP Cordoba
ArgentinaZurückgezogen» Google-Maps
North Coast Area Health Service NCAHS - The North Coast Cancer Institute NCCI - Coffs Harbour Health Campus
2450 Coffs Harbour
AustraliaRekrutierend» Google-Maps
Ansprechpartner:
Karen Briscoe, Site 0045
Phone: 61266565737» Ansprechpartner anzeigen
Local Institution - 0293
9100 Sint-Niklaas
BelgiumZurückgezogen» Google-Maps
Local Institution - 0263
01308-050 São Paulo
BrazilZurückgezogen» Google-Maps
Local Institution - 0040
H4A 3J1 Montreal
CanadaZurückgezogen» Google-Maps
Local Institution - 0079
2540364 Vina Del Mar
ChileZurückgezogen» Google-Maps
Local Institution - 0244
710 03 Heraklion
GreeceZurückgezogen» Google-Maps
Local Institution - 0227
Dublin 7 Dublin
IrelandZurückgezogen» Google-Maps
Local Institution - 0219
920-8641 Kanazawa-shi
JapanZurückgezogen» Google-Maps
Local Institution - 0230
961-8566 Chuo-ku Niigata-shi
JapanAbgeschlossen» Google-Maps
Local Institution - 0212
5698686 Takatsuki shi
JapanAbgeschlossen» Google-Maps
Local Institution - 0207
16499 Suwon Si
Korea, Republic ofAbgeschlossen» Google-Maps
Local Institution - 0335
1066 CX Amsterdam
NetherlandsZurückgezogen» Google-Maps
Local Institution - 0271
8011 Christchurch
New ZealandZurückgezogen» Google-Maps
Local Institution - 0179
L33 Santiago de Surco
PeruAbgeschlossen» Google-Maps
Local Institution - 0189
400015 Cluj-Napoca
RomaniaAbgeschlossen» Google-Maps
Local Institution - 0257
350040 Krasnodar
Russian FederationZurückgezogen» Google-Maps
Local Institution - 0256
660133 Krasnoyarsk
Russian FederationZurückgezogen» Google-Maps
N.N. Blokhin National Medical Research Center of Oncology
115478 Moscow
Russian FederationAbgebrochen» Google-Maps
Local Institution
38230 Santa Cruz de Tenerife
SpainZurückgezogen» Google-Maps
Local Institution - 0299
EH4 2XU Edinburgh
United KingdomZurückgezogen» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

Main Objective of this study is to examine long-term safety of nivolumab monotherapy

including combinations and other cancer therapies in various tumor types.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Signed Written Informed Consent.

- Eligible to receive continued study treatment per the Parent Study, including

treatment beyond progression per investigator assessment in the Parent Study.

- On treatment hold in the Parent Study following long-lasting response or are

eligible for treatment rechallenge as defined in the Parent Study.

- WOCBP and male participants who are sexually active must agree to follow

instructions for method(s) of contraception as described below and included in the

ICF.

Exclusion Criteria:

- Participant is not eligible for study treatment per the Parent Study eligibility

criteria.

- Participants not receiving clinical benefit as assessed by the Investigator.

- Any clinical adverse event (AE), laboratory abnormality, or intercurrent illness

which, in the opinion of the Investigator, indicates that participation in the study

is not in the best interest of the participant.

- Other protocol-defined Inclusion/Exclusion Criteria apply

Studien-Rationale

Primary outcome:

1. Incidence of Adverse Events (AEs) (Time Frame - From Day 1 up to 135 Days after discontinuation of treatment)

2. Incidence of drug related AEs (Time Frame - From Day 1 up to 135 Days after discontinuation of treatment)

3. Incidence of AEs leading to Discontinuation (Time Frame - From Day 1 up to 135 Days after discontinuation of treatment)

4. Incidence of Serious Adverse Events (SAEs) (Time Frame - From signature of Informed Consent up to 135 Days after discontinuation of treatment)

5. Incidence of Select AEs (Time Frame - From Day 1 up to 135 Days after discontinuation of treatment)

6. Incidence of Immune-Mediated AEs (Time Frame - From Day 1 up to 135 Days after discontinuation of treatment)

7. Incidence of Death (Time Frame - From signature of Informed Consent up to 135 Days after discontinuation of treatment)

Studien-Arme

  • Experimental: A1: Nivolumab Monotherapy Dose 1
  • Experimental: A2: Nivolumab Monotherapy Dose 2
  • Experimental: B1: Nivolumab + Ipilimumab
  • Experimental: B2: Nivolumab + Ipilimumab + Cabozantinib
  • Experimental: B3: Nivolumab + Ipilimumab + Trametinib
  • Experimental: C1: Relatlimab + Nivolumab Fixed Dose Combination Dose 1
  • Experimental: C3: Relatlimab + Nivolumab Fixed Dose Combination Dose 2
  • Experimental: C2: Relatlimab + Nivolumab Single Agent Vial (SAV) Dose 1
  • Experimental: C4: Relatlimab + Nivolumab SAV Dose 2
  • Experimental: C5: Relatlimab + Nivolumab + Ipilimumab
  • Experimental: C6: Relatlimab + Nivolumab + Capecitabine
  • Experimental: C7: Relatlimab + Nivolumab SAV Dose 3
  • Experimental: C10: Relatlimab + Nivolumab SAV Dose 4
  • Experimental: C12: Relatlimab + Nivolumab SAV Dose 5
  • Experimental: C8: Relatlimab + Nivolumab SAV + PDCT Dose 1
  • Experimental: C9: Relatlimab + Nivolumab SAV + Bevacizumab
  • Experimental: C11: Relatlimab + Nivolumab SAV + PDCT Dose 2
  • Experimental: D1: Nivolumab + Temozolomide
  • Experimental: D2: Nivolumab + Rucaparib
  • Experimental: D3: Nivolumab + Daratumumab
  • Experimental: D4: Nivolumab + Bevacizumab
  • Experimental: E1: Bevacizumab Monotherapy
  • Experimental: E2: Regorafinib Monotherapy
  • Experimental: E4: Leucovorin + Oxaliplatin + Fluorouracil
  • Experimental: E5: Enzalutamide Monotherapy
  • Experimental: E6: Sunitinib Monotherapy
  • Experimental: E7: Rucaparib Monotherapy
  • Experimental: E8: Capecitabine Monotherapy
  • Experimental: E9: Cabozantinib Monotherapy
  • Experimental: E10: Pemetrexed Monotherapy
  • Experimental: E11: Pembrolizumab Monotherapy
  • Experimental: E3: Leucovorin + Fluorouracil

Geprüfte Regime

  • Nivolumab (BMS-936558-01):
    Specified dose on specified days
  • Ipilimumab:
    Specified dose on specified days
  • Cabozantinib:
    Specified dose on specified days
  • Trametinib:
    Specified dose on specified days
  • Relatlimab (BMS-986016-01):
    Specified dose on specified days
  • Nivolumab + Relatlimab (BMS-986213):
    Specified dose on specified days
  • Capecitabine:
    Specified dose on specified days
  • Bevacizumab:
    Specified dose on specified days
  • Temozolomide:
    Specified dose on specified days
  • Rucaparib:
    Specified dose on specified days
  • Daratumumab:
    Specified dose on specified days
  • Regorafinib:
    Specified dose on specified days
  • Leucovorin:
    Specified dose on specified days
  • Fluorouracil:
    Specified dose on specified days
  • Oxaliplatin:
    Specified dose on specified days
  • Enzalutamide:
    Specified dose on specified days
  • Sunitinib:
    Specified dose on specified days
  • Pemetrexed:
    Specified dose on specified days
  • Pembrolizumab:
    Specified dose on specified days

Quelle: ClinicalTrials.gov


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