Clinical Trials /

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

NCT02935634

Description:

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.

Related Conditions:
  • Adenocarcinoma of the Gastroesophageal Junction
  • Esophagogastric Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study to Test Combination Treatments in Patients With Advanced Gastric Cancer
  • Official Title: A Phase 2, Fast Real-time Assessment of Combination Therapies in Immuno-ONcology Study in Participants With Advanced Gastric Cancer (FRACTION-Gastric Cancer)

Clinical Trial IDs

  • ORG STUDY ID: CA018-003
  • SECONDARY ID: 2016-002807-24
  • NCT ID: NCT02935634

Conditions

  • Advanced Gastric Cancer

Interventions

DrugSynonymsArms
NivolumabOpdivo, BMS-936558Nivolumab (nivo) and Ipilimumab (ipi) Combination
IpilimumabYervoy, BMS-734016Nivolumab (nivo) and Ipilimumab (ipi) Combination
RelatlimabBMS-986016nivo and Relatlimab Combination
BMS-986205nivo and BMS-986205 Combination
RucaparibRubracaNivo and rucaparib Combination

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Nivolumab (nivo) and Ipilimumab (ipi) CombinationActive Comparator
  • Nivolumab
  • Ipilimumab
nivo and Relatlimab CombinationExperimental
  • Nivolumab
  • Relatlimab
nivo and BMS-986205 CombinationExperimental
  • Nivolumab
  • BMS-986205
Nivo and rucaparib CombinationExperimental
  • Rucaparib
Ipi with rucaparib CombinationExperimental
  • Rucaparib
nivo with ipi and rucaparibExperimental
  • Rucaparib

Eligibility Criteria

        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
      
Maximum Eligible Age:110 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective Response Rate (ORR)
Time Frame:Up to 24 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Incidence of Adverse Events (AEs)
Time Frame:Approximately 28 months
Safety Issue:
Description:
Measure:Incidence of Serious Adverse Events (SAEs)
Time Frame:Approximately 28 months
Safety Issue:
Description:
Measure:Incidence of AEs leading to discontinuation
Time Frame:Approximately 28 months
Safety Issue:
Description:
Measure:Incidence of AEs leading to death
Time Frame:Approximately 28 months
Safety Issue:
Description:
Measure:Incidence of Clinical laboratory test abnormalities
Time Frame:Approximately 28 Months
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Bristol-Myers Squibb

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