A Phase 1b/2 Study of MEDI4736 With Tremelimumab, MEDI4736 or Tremelimumab Monotherapy in Gastric or GEJ Adenocarcinoma

Part of paid clinical trials in Los Angeles, California.

Sponsor
MedImmune LLC
Study ID
NCT02340975
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Gastric or Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • MEDI4736 + tremelimumab — BIOLOGICAL
    MEDI4736 will be administered by IV infusion in combination with tremelimumab.
  • MEDI4736 + tremelimumab — BIOLOGICAL
    MEDI4736 will be administered by IV infusion in combination with tremelimumab.
  • MEDI4736 — BIOLOGICAL
    MEDI4736 will be administered by IV infusion.
  • Tremelimumab — BIOLOGICAL
    Tremelimumab will be administered by IV infusion.
  • MEDI4736+tremelimumab — BIOLOGICAL
    MEDI4736 will be administered by IV infusion in combination with tremelimumab.
  • MEDI4736 + tremelimumab — BIOLOGICAL
    MEDI4736 will be administered by IV infusion in combination with tremelimumab.

Study Details

This is a randomized, multicenter, open-label, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, PK, pharmacodynamics, and immunogenicity of MEDI4736 in combination with tremelimumab, MEDI4736 monotherapy or tremelimumab monotherapy in participants with metastatic or recurrent gastric or gastroesophageal junction adenocarcinoma.

Key Dates

Start date
Mar 31, 2015
Status verified
May 2020
Primary completion
Apr 29, 2019
Completion
Apr 29, 2019

Study Design

Enrollment
114 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1b-M20 mg/kg (Q4W) + T 1 mg/kg (Q4W) Fw M10 mg/kg (Q2W)
    Participants in second-line therapy with gastric or gastroesophageal junction (GEJ) adenocarcinoma will receive intravenous (IV) infusion of 20 mg/kg MEDI4736 every 4 weeks (Q4W) for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, participants will receive MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
  • Experimental: Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)
    Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma will receive IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, participants will receive MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
  • Experimental: Phase 2 Arm B-M10 mg/kg (Q2W)
    Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma will receive IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).
  • Experimental: Phase 2 Arm C-T10 mg/kg (Q4W)
    Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma will receive IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).
  • Experimental: Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)
    Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma will receive IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, participants will receive MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
  • Experimental: Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W)
    Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature will receive IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, participants will receive MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).

Primary Outcome Measure

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) in Phase 1b [ Time Frame: Day 1 up to 90 days after the last dose (approximately 4 years and one month) ]

Locations (15)

FacilityCityStateZIPSite coordinators
Research SiteLos AngelesCalifornia90033-
Research SiteSanta MonicaCalifornia90404-
Research SiteNew HavenConnecticut06520-
Research SiteTampaFlorida33612-
Research SiteChicagoIllinois60637-
Research SiteBaltimoreMaryland21231-
Research SiteNew YorkNew York10032-
Research SiteNew YorkNew York10065-
Research SiteNew YorkNew York10116-
Research SiteClevelandOhio44106-
Research SitePortlandOregon97213-
Research SitePhiladelphiaPennsylvania19111-
Research SiteGreenvilleSouth Carolina29605-
Research SiteNashvilleTennessee37203-
Research SiteHoustonTexas77030-

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