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

NCT02340975 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2020-06-09

Study results available
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Summary

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.

Conditions

  • Gastric or Gastroesophageal Junction Adenocarcinoma

Interventions

BIOLOGICAL

MEDI4736 + tremelimumab

MEDI4736 will be administered by IV infusion in combination with tremelimumab.

BIOLOGICAL

MEDI4736 + tremelimumab

MEDI4736 will be administered by IV infusion in combination with tremelimumab.

BIOLOGICAL

MEDI4736

MEDI4736 will be administered by IV infusion.

BIOLOGICAL

Tremelimumab

Tremelimumab will be administered by IV infusion.

BIOLOGICAL

MEDI4736+tremelimumab

MEDI4736 will be administered by IV infusion in combination with tremelimumab.

BIOLOGICAL

MEDI4736 + tremelimumab

MEDI4736 will be administered by IV infusion in combination with tremelimumab.

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • MedImmune, LLC MedImmune, LLC · MedImmune LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2019-04-29
Completion
2019-04-29

Countries

  • United States
  • Canada
  • Japan
  • Singapore
  • South Korea
  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02340975 on ClinicalTrials.gov