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An Investigational Study of Immunotherapy Combinations With Chemotherapy in Patients With Gastric or Gastroesophageal Junction (GEJ) Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03662659
Recruitment Status : Active, not recruiting
First Posted : September 7, 2018
Results First Posted : May 9, 2022
Last Update Posted : November 7, 2022
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE September 6, 2018
First Posted Date  ICMJE September 7, 2018
Results First Submitted Date  ICMJE April 13, 2022
Results First Posted Date  ICMJE May 9, 2022
Last Update Posted Date November 7, 2022
Actual Study Start Date  ICMJE October 16, 2018
Actual Primary Completion Date August 27, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2022)
BICR-Assessed Objective Response Rate (ORR) in Randomized LAG-3 Positive (>=1 %) Participants [ Time Frame: Up to 25 months ]
The number of LAG-3 Positive (>=1%) participants with a Best Overall Response (BOR) of confirmed Complete Response (CR) or Partial Response (PR) divided by the number of randomized LAG-3 positive (>=1%) participants in each arm; recorded between randomization date and the date of objectively documented progression [per RECISIT 1.1], death due to any cause, or date of subsequent anticancer therapy, whichever occurs first. CR= Disappearance of all target lesions PR= At least a 30% decrease in the sum of diameters of target lesions
Original Primary Outcome Measures  ICMJE
 (submitted: September 6, 2018)
Objective Response Rate (ORR) [ Time Frame: Up to 22 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2022)
  • Objective Response Rate (ORR) [ Time Frame: Up to 25 months ]
    Objective response rate (ORR) based on Blinded Independent Central Review (BICR) and Investigator assessments is defined as the number of participants with a Best Overall Response (BOR) of confirmed Complete Response (CR) or Partial Response (PR) divided by the number of randomized participants in each arm; recorded between randomization date and the date of objectively documented progression [per RECISIT 1.1], death due to any cause, or date of subsequent anticancer therapy, whichever occurs first.
  • Duration of Response (DOR) [ Time Frame: Up to 25 months ]
    Duration of Response (DOR) based on Blinded Independent Central Review (BICR) and investigator is defined as the time between the date of first documented response (complete response or partial response) and the date of the first disease progression, per RECIST 1.1, or death due to any cause, or date of subsequent anticancer therapy, whichever occurs first.
  • Overall Survival (OS) [ Time Frame: Up to 25 months ]
    Overall Survival (OS) is defined as the time between the date of randomization and the date of death due to any cause. For those without documentation of death, OS will be censored on the last date the participant was known to be alive.
  • Progression-Free Survival (PFS) [ Time Frame: Up to 25 months ]
    Progression-Free Survival (PFS) per Blinded Independent Central Review (BICR) and Investigator is defined as the time between the date of randomization and the first date of documented progression, or death due to any cause, or date of subsequent anticancer therapy, whichever occurs first. Participants who die without a reported prior progression (and die without start of subsequent therapy) will be considered to have progressed on the date of death.
  • Number of Participants With Adverse Events (AEs) [ Time Frame: From first dose to 30 days post last dose (Up to 23 months) ]
    Number of participants with any grade adverse events (AEs), serious adverse events (SAE), and adverse events leading to discontinuation using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v 5.0) to assess the overall safety and tolerability of BMS-986213 in combination with chemotherapy vs. Nivolumab in combination with chemotherapy.
  • Number of Deaths [ Time Frame: Up to 25 months ]
    Number of deaths in each arm to assess the overall safety and tolerability of BMS-986213 in combination with chemotherapy vs. Nivolumab in combination with chemotherapy.
  • Number of Participants With Laboratory Abnormalities in Specific Liver Tests [ Time Frame: From first dose to up to 30 days post last dose (Up to 23 months) ]
    Number of participants with laboratory abnormalities in specific liver tests based on US conventional units to assess the overall safety and tolerability of BMS-986213 in combination with chemotherapy vs. Nivolumab in combination with chemotherapy. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized:
    • ALT or AST > 3 x ULN, > 5 x ULN, > 10 x ULN and > 20 x ULN
    • Total bilirubin > 2 x ULN
    • ALP > 1.5 x ULN
    • Concurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 1.5 x ULN
    • Concurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 1.5 x ULN
    • Concurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN
    • Concurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN
  • Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests [ Time Frame: From first dose to up to 30 days post last dose (Up to 23 months) ]
    Number of participants with laboratory abnormalities in specific thyroid tests based on US conventional units. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized:
    • TSH value > ULN and
    • with baseline TSH value <= ULN
    • with at least one FT3/FT4 test value < LLN within 2-week window after the abnormal TSH test
    • with all FT3/FT4 test values >= LLN within 2-week window after the abnormal TSH test
    • with FT3/FT4 missing within 2-week window after the abnormal TSH test.
    • TSH < LLN and
    • with baseline TSH value >= LLN
    • with at least one FT3/FT4 test value > ULN within 2-week window after the abnormal TSH test
    • with all FT3/FT4 test values <= ULN within 2-week window after the abnormal TSH test
    • with FT3/FT4 missing within 2-week window after the abnormal TSH test
Original Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2018)
  • Incidence of Adverse Events (AEs) [ Time Frame: Up to 5 years ]
  • Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 5 years ]
  • Incidence of AEs leading to discontinuation [ Time Frame: Up to 5 years ]
  • Incidence of death [ Time Frame: Up to 5 years ]
  • Incidence of laboratory abnormalities [ Time Frame: Up to 5 years ]
  • Duration of Response (DOR) [ Time Frame: Up to 5 years ]
  • Overall survival (OS) [ Time Frame: Up to 5 years ]
  • Progression Free Survival (PFS) [ Time Frame: Up to 5 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Investigational Study of Immunotherapy Combinations With Chemotherapy in Patients With Gastric or Gastroesophageal Junction (GEJ) Cancers
Official Title  ICMJE A Randomized, Open-label, Phase II Clinical Trial of Relatlimab (Anti-LAG-3) and Nivolumab in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy as First-Line Treatment in Patients With Gastric or Gastroesophageal Junction Adenocarcinoma
Brief Summary The purpose of this study is to determine the efficacy and safety of investigational drug relatlimab plus nivolumab in combination with chemotherapy in participants with unresectable, untreated, locally advanced or metastatic gastric or GEJ cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Gastric Cancer
  • Cancer of the Stomach
  • Esophagogastric Junction
Intervention  ICMJE
  • Biological: BMS-986213
    Relatlimab + Nivolumab specified dose on specified days
  • Biological: Nivolumab
    Specified dose on specified days
    Other Names:
    • Opdivo
    • BMS-936558
  • Drug: XELOX
    Oxaliplatin + capecitabine
  • Drug: FOLFOX
    Oxaliplatin + leucovorin + fluorouracil
  • Drug: SOX
    Oxaliplatin + tegafur/gimeracil/oteracil potassium
Study Arms  ICMJE
  • Experimental: BMS-986213 + investigator's choice chemotherapy
    BMS-986213 + XELOX or BMS-986213 + FOLFOX or BMS-986213 + SOX
    Interventions:
    • Biological: BMS-986213
    • Biological: Nivolumab
    • Drug: XELOX
    • Drug: FOLFOX
    • Drug: SOX
  • Experimental: Nivolumab + investigator's choice chemotherapy
    Nivolumab + XELOX or Nivolumab + FOLFOX or Nivolumab + SOX
    Interventions:
    • Biological: Nivolumab
    • Drug: XELOX
    • Drug: FOLFOX
    • Drug: SOX
Publications * Chang X, Ge X, Zhang Y, Xue X. The current management and biomarkers of immunotherapy in advanced gastric cancer. Medicine (Baltimore). 2022 May 27;101(21):e29304. doi: 10.1097/MD.0000000000029304. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 12, 2021)
274
Original Estimated Enrollment  ICMJE
 (submitted: September 6, 2018)
250
Estimated Study Completion Date  ICMJE December 1, 2024
Actual Primary Completion Date August 27, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Histologically- or cytologically-confirmed diagnosis of unresectable and either locally advanced, or metastatic gastric cancer or GEJ adenocarcinoma
  • No prior treatment with systemic treatment (including HER 2 inhibitors) given as primary therapy for unresectable and either locally advanced, or metastatic GC or GEJ adenocarcinoma
  • Tumor tissue must be provided for biomarker analyses

Exclusion Criteria:

  • Participants with HER2 positive status
  • Participants with known untreated central nervous system (CNS) metastases
  • Uncontrolled or significant cardiovascular disease

Other protocol defined inclusion/exclusion criteria could apply

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Canada,   Chile,   Czechia,   France,   Germany,   Italy,   Norway,   Poland,   Puerto Rico,   Singapore,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03662659
Other Study ID Numbers  ICMJE CA224-060
2018-001069-18 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Bristol-Myers Squibb
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Bristol-Myers Squibb
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date November 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP