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An Investigational Immuno-therapy Study of Relatlimab Plus Nivolumab Compared to Various Standard-of-Care Therapies in Previously Treated Participants With Recurrent, Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma

NCT03704077 — Phase 2, Withdrawn, Bristol-Myers Squibb
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A Randomized, Active-Controlled, Open-Label, Phase 2 Clinical Trial of BMS-986213, in Combination With Various Standard-of-Care Therapeutic Regimens, in Participants With Recurrent, Locally Advanced, or Metastatic Gastric Cancer (GC) or Gastroesophageal Junction (GEJ) Adenocarcinoma

RegistryNCT03704077
StatusWithdrawn - Replaced it with another clinical trial
PhasePhase 2
Study typeInterventional; randomized, parallel, masking: none, treatment
SponsorBristol-Myers Squibb (Industry)
ConditionsGastric Cancer, Cancer of the Stomach, Stomach Cancer, Gastroesophageal Junction
InterventionsRelatlimab + Nivolumab, Nivolumab, Paclitaxel, Ramucirumab (Biological, drug)
Datesstart 2019-10-31 (estimated), primary completion 2022-02-27 (estimated), completion 2024-09-30 (estimated), first posted 2018-10-12, last updated 2020-05-19
Locations84 sites in United States, Argentina, Australia, Brazil, Canada, Chile, Colombia, Germany and 6 more countries

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-Summary

The purpose of this study is to determine the effectiveness of relatlimab plus nivolumab, alone or in combination with various standard-of-care treatments in participants with gastric cancer (GC) or gastroesophageal junction (GEJ) adenocarcinoma that has come back or spread to other places in the body after prior therapy.

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+Arms and interventions

ArmTypeInterventionsDescription
Cohort A: relatlimab + nivolumab + paclitaxelExperimentalBiological: Relatlimab + Nivolumab; Biological: Nivolumab; Drug: Paclitaxel
Cohort A: nivolumab + paclitaxelExperimentalBiological: Nivolumab; Drug: Paclitaxel
Cohort A: ramucirumab + paclitaxelActive comparatorDrug: Paclitaxel; Drug: RamucirumabStandard-of-care
Cohort B: relatlimab + nivolumabExperimentalBiological: Relatlimab + Nivolumab; Biological: Nivolumab
Cohort B: nivolumabActive comparatorBiological: NivolumabStandard-of-care
Cohort C: relatlimab + nivolumabExperimentalBiological: Relatlimab + Nivolumab; Biological: Nivolumab
  • Relatlimab + Nivolumab (Biological), also known as BMS-986213: Specified dose on specified days
  • Nivolumab (Biological), also known as Opdivo: Specified dose on specified days
  • Paclitaxel (Drug), also known as Taxol, Onxal: Specified dose on specified days
  • Ramucirumab (Drug), also known as Cyramza: Specified dose on specified days

+Outcome measures

Primary outcomes

  • Overall response rate (ORR) [Approximately 31 months]

Secondary outcomes

  • Incidence of adverse events (AEs) [Approximately 5 years]
  • Incidence of serious adverse events (SAEs) [Approximately 5 years]
  • Incidence of AEs leading to discontinuation [Approximately 5 years]
  • Incidence of deaths [Approximately 5 years]
  • Incidence of laboratory abnormalities [Approximately 5 years]
  • ORR [Approximately 5 years]: Cohort A1
  • Duration of response (DOR) [Approximately 5 years]
  • Progression free survival (PFS) [Approximately 5 years]
  • Overall survival (OS) [Approximately 5 years]

+Eligibility

Sex: All, ages: 18 Years to any

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

Inclusion Criteria:

* Histologically or cytologically confirmed locally advanced or recurrent or metastatic GC or GEJ adenocarcinoma that is considered incurable by local therapies such as radiation or surgery
* Evidence of progressive disease (PD) on at least one prior platinum- and fluoropyrimidine-containing chemotherapy regimen
* Available tumor tissue for biomarker analysis

Exclusion Criteria:

* Must not have squamous cell or undifferentiated GC or GEJ
* Untreated known central nervous system (CNS) metastases
* Uncontrolled or significant cardiovascular disease

Other protocol defined inclusion/exclusion criteria could apply

+Locations (84)

FacilityCityCountryStatus
Local InstitutionDaphne, AlabamaUnited States
Local InstitutionBakersfield, CaliforniaUnited States
Local InstitutionFullerton, CaliforniaUnited States
Local InstitutionLos Angeles, CaliforniaUnited States
Local InstitutionRedondo Beach, CaliforniaUnited States
Local InstitutionSanta Barbara, CaliforniaUnited States
Local InstitutionAurora, ColoradoUnited States
Local InstitutionLakewood, ColoradoUnited States
Local InstitutionMiami, FloridaUnited States
Local InstitutionTampa, FloridaUnited States
Local InstitutionMarietta, GeorgiaUnited States
Local InstitutionBoston, MassachusettsUnited States
Local InstitutionSt Louis, MissouriUnited States
Local InstitutionNew Brunswick, New JerseyUnited States
Local InstitutionChapel Hill, North CarolinaUnited States
Local InstitutionCharlotte, North CarolinaUnited States
Local InstitutionFargo, North DakotaUnited States
Local InstitutionAllentown, PennsylvaniaUnited States
Local InstitutionSioux Falls, South DakotaUnited States
Local InstitutionVancouver, WashingtonUnited States
Local InstitutionViedma, Río Negro ProvinceArgentina
Local InstitutionBuenos AiresArgentina
Local InstitutionBuenos AiresArgentina
Local InstitutionCABAArgentina
Local InstitutionCórdobaArgentina
Local InstitutionWestmead, New South WalesAustralia
Local InstitutionHeidelberg, VictoriaAustralia
Local InstitutionMalvern, VictoriaAustralia
Local InstitutionMelbourne, VictoriaAustralia
Local InstitutionBedford ParkAustralia
Local InstitutionMurdochAustralia
Local InstitutionFortaleza, CearáBrazil
Local InstitutionBelo Horizonte, Minas GeraisBrazil
Local InstitutionPorto Alegre, Rio Grande do SulBrazil
Local InstitutionBarretos, São PauloBrazil
Local InstitutionJaú, São PauloBrazil
Local InstitutionRio de JaneiroBrazil
Local InstitutionSão PauloBrazil
Local InstitutionHalifax, Nova ScotiaCanada
Local InstitutionHamilton, OntarioCanada
Local InstitutionOttawa, OntarioCanada
Local InstitutionToronto, OntarioCanada
Local InstitutionToronto, OntarioCanada
Local InstitutionMontreal, QuebecCanada
Local InstitutionSherbrooke, QuebecCanada
Local InstitutionSantiago, Santiago MetropolitanChile
Local InstitutionSantiago, Santiago MetropolitanChile
Local InstitutionMedellínColombia
Local InstitutionBerlinGermany
Local InstitutionCologneGermany
Local InstitutionErlangenGermany
Local InstitutionEssenGermany
Local InstitutionFrankfurt am MainGermany
Local InstitutionFreiburg im BreisgauGermany
Local InstitutionHamburgGermany
Local InstitutionHanoverGermany
Local InstitutionJenaGermany
Local InstitutionMainzGermany
Local InstitutionMannheimGermany
Local InstitutionMarburgGermany
Local InstitutionPaderbornGermany
Local InstitutionReutlingenGermany
Local InstitutionWiesbadenGermany
Local InstitutionBergamoItaly
Local InstitutionMilanItaly
Local InstitutionNaplesItaly
Local InstitutionReggio EmiliaItaly
Local InstitutionTuxtla Gutiérrez, ChiapasMexico
Local InstitutionZONA Centro. LEON, GuanajuatoMexico
Local InstitutionMexico City, Mexico CityMexico
Local InstitutionMérida, YucatánMexico
Local InstitutionAguascalientesMexico
Local InstitutionLisbonPortugal
Local InstitutionPortoPortugal
Local InstitutionRio PiedrasPuerto Rico
Local InstitutionBucharestRomania
Local InstitutionCluj-NapocaRomania
Local InstitutionCraiovaRomania
Local InstitutionFloreştiRomania
Local InstitutionBadajozSpain
Local InstitutionMadridSpain
Local InstitutionMadridSpain
Local InstitutionMadridSpain
Local InstitutionValenciaSpain

+Investigators

  • Bristol-Myers Squibb, Study director, Bristol-Myers Squibb

+Funding

NIH grants: 2018

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