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JOURNAL ONKOLOGIE – STUDIE

FRACTION-GC A Study to Test Combination Treatments in Patients With Advanced Gastric Cancer

Rekrutierend

NCT-Nummer:
NCT02935634

Studienbeginn:
November 2016

Letztes Update:
26.08.2020

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

Indikation (Clinical Trials):
Stomach Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Bristol-Myers Squibb

Collaborator:
Clovis Oncology, Inc.

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 45)

Local Institution
V5Z 4E6 Vancouver
CanadaAktiv, nicht rekrutierend» Google-Maps
Sunnybrook Research Institution
M4N 3M5 Toronto,
CanadaAktiv, nicht rekrutierend» Google-Maps
Local Institution
13273 Marseille Cedex 9
FranceZurückgezogen» Google-Maps
Local Institution
34298 Montpellier Cedex 5
FranceZurückgezogen» Google-Maps
Local Institution
08916 Badalona-barcelona
SpainZurückgezogen» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

The purpose of this study is to determine whether Nivolumab in combination with other therapies is more effective than Nivolumab in combination with Ipilimumab in treating patients/subjects with advanced gastric cancer.

Ein-/Ausschlusskriterien

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

Inclusion Criteria:

- Advanced Gastric Cancer

- Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work

- Must have at least 1 lesion with measurable disease

- All participants must have inoperable, advanced, or metastatic EC, GC or GEJ carcinoma and have histologically confirmed predominant adenocarcinoma or squamous cell carcinoma. (sub protocol C)

Exclusion Criteria:

- Patients/subjects with HER2 positive tumor that have not been treated with trastuzumab prior to enrollment

- Must not have suspected or known central nervous system metastases unless adequately treated

- Patients/subjects with autoimmune disease

- Patients/subjects who need daily oxygen therapy

- Participants who are considered to be refractory or resistant to platinum agents (sub protocol c)

- Participants who have inability to swallow capsules or pills (sub protocol c)

- Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could interfere with absorption of orally administered systemic treatments (sub protocol c)

- Participants with diagnosis or history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). (sub protocol C)

- Prior treatment with a PARP inhibitor (such as rucaparib, olaparib, niraparib, talozaparib, etc.) or a targeted DNA damage response inhibitor (such as ATM or ataxia telangiectasia and Rad3-related protein [ATR] inhibitor). (sub protocol C)

Other protocol defined inclusion/exclusion criteria could apply

Studien-Rationale

Primary outcome:

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

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

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

4. Incidence of Adverse Events (AEs) in Part 1 (Time Frame - Approximately 28 Months)

5. Incidence of Serious Adverse Events in Part 1 (Time Frame - Approximately 28 Months)

6. Incidence of AEs leading to Discontinuation in Part 1 (Time Frame - Approximately 28 Months)

7. Incidence of Deaths in Part 1 (Time Frame - Approximately 28 Months)

8. Incidence of Clinical Laboratory Abnormalities in Part 1 (Time Frame - Approximately 28 Months)

Secondary outcome:

1. Incidence of Adverse Events (AEs) (Time Frame - Approximately 28 months)

2. Incidence of Serious Adverse Events (SAEs) (Time Frame - Approximately 28 months)

3. Incidence of AEs leading to discontinuation (Time Frame - Approximately 28 months)

4. Incidence of AEs leading to death (Time Frame - Approximately 28 months)

5. Incidence of Clinical laboratory test abnormalities (Time Frame - Approximately 28 Months)

Studien-Arme

  • Active Comparator: Nivolumab (nivo) and Ipilimumab (ipi) Combination
  • Experimental: nivo and Relatlimab Combination
  • Experimental: nivo and BMS-986205 Combination
  • Experimental: Nivo and rucaparib Combination
  • Experimental: Ipi with rucaparib Combination
  • Experimental: nivo with ipi and rucaparib

Geprüfte Regime

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

Quelle: ClinicalTrials.gov


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