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JOURNAL ONKOLOGIE – STUDIE
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A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC)

Rekrutierend

NCT-Nummer:
NCT04008030

Studienbeginn:
August 2019

Letztes Update:
01.04.2024

Wirkstoff:
Ipilimumab, Oxaliplatin, Leucovorin, Fluorouracil, Irinotecan, Bevacizumab, Cetuximab, Nivolumab

Indikation (Clinical Trials):
Colorectal Neoplasms, Microsatellite Instability

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Bristol-Myers Squibb

Collaborator:
Ono Pharmaceutical Co. Ltd

Studienleiter

Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb

Kontakt

BMS Study Connect Contact Center 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 172)

Local Institution - 0042
01307 Dresden
(Sachsen)
GermanyAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0007
45122 Essen
(Nordrhein-Westfalen)
GermanyAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0043
20249 Hamburg
(Hamburg)
GermanyAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0117
22763 Hamburg
(Hamburg)
GermanyAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0008
30625 Hannover
(Niedersachsen)
GermanyAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0009
69120 Heidelberg
(Baden-Württemberg)
GermanyAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0044
35043 Marburg
(Hessen)
GermanyAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0010
81377 Munich
(Bayern)
GermanyAktiv, nicht rekrutierend» Google-Maps
Banner MD Anderson Cancer Center
85234 Gilbert
United StatesZurückgezogen» Google-Maps
Local Institution - 0059
90033 Los Angeles
United StatesAbgeschlossen» Google-Maps
Local Institution - 0130
95817 Sacramento
United StatesAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0103
80218 Denver
United StatesAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0119
60005 Arlington Heights
United StatesAbgeschlossen» Google-Maps
Local Institution - 0060
10065 New York
United StatesAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0105
97227 Portland
United StatesAbgeschlossen» Google-Maps
Local Institution
19104 Philadelphia
United StatesZurückgezogen» Google-Maps
Local Institution - 0121
15232 Pittsburgh
United StatesAbgeschlossen» Google-Maps
Local Institution - 0106
75246 Dallas
United StatesAbgeschlossen» Google-Maps
Local Institution
76104 Fort Worth
United StatesZurückgezogen» Google-Maps
Local Institution - 0104
24014 Roanoke
United StatesAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0073
1431 Ciudad Autonoma Beunos Aires
ArgentinaAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0084
1093 Buenos Aires
ArgentinaAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0100
1199 Caba
ArgentinaAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0072
1426 Caba
ArgentinaAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0064
8036 Graz
AustriaAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0068
4010 Linz
AustriaAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0120
5020 Salzburg
AustriaAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0067
2700 Wiener Neustadt
AustriaAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0065
1090 Wien
AustriaAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0045
2820 Bonheiden
BelgiumAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0025
1000 Bruxelles
BelgiumAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0024
3000 Leuven
BelgiumAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0096
35160-158 Ipatinga
BrazilAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0200
59075-740 Natal
BrazilAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0097
90610-000 Porto Alegre
BrazilZurückgezogen» Google-Maps
Local Institution - 0192
91350-200 Porto Alegre
BrazilAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0102
14780-070 Barretos
BrazilAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0095
01509-010 Sao Paulo
BrazilAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0094
15090000 São José do Rio Preto
BrazilAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0199
20231-050 Rio de Janeiro
BrazilAbgeschlossen» Google-Maps
Local Institution - 0193
01246-000 São Paulo
BrazilAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0039
V5Z 4E6 Vancouver
CanadaAbgeschlossen» Google-Maps
Local Institution - 0016
H2X 3E4 Montreal
CanadaAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0015
J1H 5N4 Sherbrooke
CanadaAbgeschlossen» Google-Maps
Local Institution - 0071
7500921 Santiago
ChileAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0069
8320000 Santiago
ChileAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0087
656 53 Brno
CzechiaAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0085
500 05 Hradec Kralove
CzechiaAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0088
741 01 Novy Jicin
CzechiaAbgeschlossen» Google-Maps
Local Institution - 0086
779 00 Olomouc
CzechiaAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0038
2730 Herlev
DenmarkAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0036
7100 Vejle
DenmarkAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0138
59000 Lille
FranceAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0028
25030 Besancon Cedex
FranceAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0029
69373 Lyon Cedex 08
FranceAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0066
13005 Marseille
FranceAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0030
34298 Montpellier
FranceAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0032
44093 Nantes
FranceAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0027
75012 Paris
FranceAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0061
33604 Pessac Cedex
FranceAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0031
86000 Poitiers
FranceAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0040
31059 Toulouse
FranceAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0123
11528 Athens
GreeceAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0124
15562 Holargos
GreeceAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0026
V94 F858 Limerick
IrelandAbgeschlossen» Google-Maps
Local Institution - 0055
95122 Catania
ItalyAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0001
20162 Milan
ItalyAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0002
35128 Padova
ItalyAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0054
00168 Roma
ItalyAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0052
1066 CX Amsterdam
NetherlandsAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0051
1105 AZ Amsterdam
NetherlandsAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0050
3584 CX Utrecht
NetherlandsAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0033
5021 Bergen
NorwayAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0035
0450 Oslo
NorwayAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0058
00935 Rio Piedras
Puerto RicoAbgeschlossen» Google-Maps
Local Institution - 0076
400015 Cluj-Napoca
RomaniaAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0081
200542 Craiova
RomaniaAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0080
022328 Bucharest
RomaniaAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0089
720237 Suceava
RomaniaAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0056
08916 Badalona
SpainAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0173
15006 A Coruna
SpainAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0006
08035 Barcelona
SpainAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0005
28041 Madrid
SpainAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0172
29010 Malaga
SpainAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0063
41013 Sevilla
SpainAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0171
46014 Valencia
SpainAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0092
01060 Adana
TurkeyAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0101
34300 Istanbul
TurkeyAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0127
EC1A 7BE London
United KingdomAktiv, nicht rekrutierend» Google-Maps
Local Institution - 0049
OX3 7LE Oxford
United KingdomAktiv, nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

The main purpose of this study is to compare the clinical benefit, as measured by

Progression-Free Survival (PFS), Objective Response Rate (ORR), and Overall Survival (OS),

achieved by nivolumab in combination with ipilimumab or by nivolumab monotherapy in

participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR)

metastatic colorectal cancer (mCRC). This study will also compare nivolumab plus ipilimumab

combination vs chemotherapy for treatment of MSI-H/dMMR mCRC participants.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Histologically confirmed recurrent or metastatic colorectal cancer (CRC) irrespective

of prior treatment history with chemotherapy and/or targeted agents not amenable to

surgery (Applicable only during Part 1 enrollment of the study)

- Histologically confirmed recurrent or metastatic CRC with no prior treatment history

with chemotherapy and/or targeted agents for metastatic disease and not amenable to

surgery (Applicable during Part 2 enrollment of the study)

- Known tumor microsatellite instability-high (MSI-H) or mismatch repair deficient

(dMMR) status per local standard of practice

- Eastern cooperative oncology group (ECOG) performance status lower than or equal to 1

Exclusion Criteria:

- An active, known or suspected autoimmune disease

- History of interstitial lung disease or pneumonitis

- Known history of positive test for human immunodeficiency virus (HIV) or known

acquired immunodeficiency syndrome (AIDS)

Other protocol-defined inclusion/exclusion criteria apply

Studien-Rationale

Primary outcome:

1. Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) (arm B vs A, all lines, centrally confirmed) (Time Frame - Up to 5 years)

2. PFS by BICR (arm B vs C, 1L, centrally confirmed) (Time Frame - Up to 5 years)

Secondary outcome:

1. Overall Response Rate (ORR) by BICR (arm B vs A, all lines, centrally confirmed) (Time Frame - Up to 5 years)

2. Overall Survival (OS) (arm B vs A, all lines, centrally confirmed) (Time Frame - Up to 5 years)

3. PFS by Investigator Assessment (arm B vs A, all lines, centrally confirmed) (Time Frame - Up to 5 years)

4. PFS by BICR among all randomized participants (arm B vs A, all lines, per local testing) (Time Frame - Up to 5 years)

5. PFS by BICR (arm B vs A, 1L, centrally confirmed) (Time Frame - Up to 5 years)

6. ORR by BICR (arm B vs C, 1L, centrally confirmed) (Time Frame - Up to 5 years)

7. ORR by BICR (arm B vs A, 1L, centrally confirmed) (Time Frame - Up to 5 years)

8. OS (arm B vs A, 1L, centrally confirmed) (Time Frame - Up to 5 years)

9. PFS by BICR (arm A vs C, 1L, centrally confirmed) (Time Frame - Up to 5 years)

10. OS (arm B vs C, 1L, centrally confirmed) (Time Frame - Up to 5 years)

11. ORR by BICR (arm A vs C, 1L, centrally confirmed) (Time Frame - Up to 5 years)

12. OS (arm A vs C, 1L, centrally confirmed) (Time Frame - Up to 5 years)

13. PFS by Investigator (arm A, B and C, 1L, centrally confirmed) (Time Frame - Up to 5 years)

14. PFS by BICR among all randomized participants who have not received prior treatment (arm B vs C, 1L, per local testing) (Time Frame - Up to 5 years)

15. PFS by BICR among all randomized participants who have not received prior treatment (arm B vs A, 1L, per local testing) (Time Frame - Up to 5 years)

16. PFS by BICR (arm B vs C, 1L, by each central test) (Time Frame - Up to 5 years)

17. PFS by BICR (arm B vs A, all lines, by each central test) (Time Frame - Up to 5 years)

18. PFS by BICR (crossover cohort, centrally confirmed) (Time Frame - Up to 5 years)

19. ORR by BICR (crossover cohort, centrally confirmed) (Time Frame - Up to 5 years)

Studien-Arme

  • Experimental: Arm A: Nivolumab Monotherapy
  • Experimental: Arm B: Nivolumab + Ipilimumab Combination
  • Active Comparator: Arm C: Investigator's Choice Chemotherapy
    Participants in Arm C would be allowed to receive Nivolumab + Ipilimumab if they progress

Geprüfte Regime

  • Ipilimumab:
    Specified dose on specified days
  • Oxaliplatin:
    Specified dose on specified days
  • Leucovorin:
    Specified dose on specified days
  • Fluorouracil:
    Specified dose on specified days
  • Irinotecan:
    Specified dose on specified days
  • Bevacizumab:
    Specified dose on specified days
  • Cetuximab:
    Specified dose on specified days
  • Nivolumab:
    Specified dose on specified days

Quelle: ClinicalTrials.gov


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"A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC)"

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