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

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: NCT02340975
Recruitment Status : Active, not recruiting
First Posted : January 19, 2015
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

Tracking Information
First Submitted Date  ICMJE January 14, 2015
First Posted Date  ICMJE January 19, 2015
Last Update Posted Date February 11, 2019
Actual Study Start Date  ICMJE March 31, 2015
Estimated Primary Completion Date April 18, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2017)
  • Number (percentage) of subjects reporting adverse events and number (percentage) of subjects reporting serious adverse events. [ Time Frame: Follow-up 90 days after the last dose of study medication ]
  • Number of subjects experiencing dose-limiting toxicities [ Time Frame: First dose of study medications through 4 weeks after the first dose of study medication ]
  • Phase 2: Objective Response Rate [ Time Frame: Followed through 5 years after the last subject receives the first dose of study medication ]
  • Phase 2: Progression Free Survival at 6 months [ Time Frame: Followed through 5 years after the last subject receives the first dose of study medication ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 14, 2015)
  • Number (percentage) of subjects reporting adverse events and number (percentage) of subjects reporting serious adverse events. [ Time Frame: Screening through 3 months after the last dose of study medication ]
  • Number of subjects experiencing dose-limiting toxicities [ Time Frame: First dose of study medications through 4 weeks after the first dose of study medication ]
  • Phase 2: Objective Response Rate [ Time Frame: Screening trhough 5 years after the last subject receives the first dose of study medication ]
  • Phase 2: Progression Free Survival at 6 months [ Time Frame: Screening through 5 years after the last subject receives the first dose of study medication ]
Change History Complete list of historical versions of study NCT02340975 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2017)
  • Phase 1: Objective Response Rate [ Time Frame: Follow up through 5 years after the last subject receives the first dose of study medication ]
  • Phase 1: Progression Free Survival at 6 months [ Time Frame: Follow up through 5 years after the last subject receives the first dose of study medication ]
  • Disease Control Rate [ Time Frame: Follow up through 5 years after the last subject receives the first dose of study medication ]
  • PD-L1 expression [ Time Frame: Follow up through 3 months after last dose of study medication ]
  • Overall Survival [ Time Frame: Follow up through 5 years after the last subjects receives the first dose of study medication ]
  • Duration of Response [ Time Frame: Follow up through 5 years after the last subject receives the first dose of study medication ]
  • Phase 2: Number (percentage) of subjects reporting adverse events and number (percentage) of subjects reporting serious adverse events. [ Time Frame: Follow-up 90 days after the last dose of study medication ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2015)
  • Phase 1: Objective Response Rate [ Time Frame: Screening through 5 years after the last subject receives the first dose of study medication ]
  • Phase 1: Progression Free Survival at 6 months [ Time Frame: Screening through 5 years after the last subject receives the first dose of study medication ]
  • Disease Control Rate [ Time Frame: Screening through 5 years after the last subject receives the first dose of study medication ]
  • PD-L1 expression [ Time Frame: Screening through 3 months after last dose of study medication ]
  • Overall Survival [ Time Frame: Screening through 5 years after the last subjects receives the first dose of study medication ]
  • Duration of Response [ Time Frame: Screening through 5 years after the last subject receives the first dose of study medication ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 1b/2 Study of MEDI4736 With Tremelimumab, MEDI4736 or Tremelimumab Monotherapy in Gastric or GEJ Adenocarcinoma
Official Title  ICMJE A Phase 1b/2 Study of MEDI4736 in Combination With Tremelimumab, MEDI4736 Monotherapy, and Tremelimumab Monotherapy in Subjects With Metastatic or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma
Brief 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 subjects with metastatic or recurrent gastric or gastroesophageal junction adenocarcinoma
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastric or Gastroesophageal Junction Adenocarcinoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: MEDI4736 + tremelimumab (Arm A)
    Second line subjects with metastatic or recurrent gastric or GEJ adenocarcinoma
    Intervention: Biological: MEDI4736 + tremelimumab
  • Experimental: MEDI4736 (Arm B)
    Second line subjects with metastatic or recurrent Gastric or GEJ adenocarcinoma
    Intervention: Biological: MEDI4736
  • Experimental: Tremelimumab (Arm C)
    Second line subjects with metastatic or recurrent Gastric or GEJ adenocarcinoma
    Intervention: Biological: Tremelimumab
  • Experimental: MEDI4736 + tremelimumab (Arm D)
    Third line subjects with metastatic or recurrent Gastric or GEJ adenocarcinoma
    Intervention: Biological: MEDI4736 + tremelimumab
  • Experimental: MEDI4736 + tremelimumab (Arm E)
    Second or third line biomarker-selected subjects with metastatic or recurrent Gastric or GEJ adenocarcinoma
    Intervention: Biological: MEDI4736+tremelimumab
Publications * Not Provided

*   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 16, 2018)
114
Original Estimated Enrollment  ICMJE
 (submitted: January 14, 2015)
174
Estimated Study Completion Date  ICMJE April 18, 2019
Estimated Primary Completion Date April 18, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male and female subjects
  2. 18 years and older
  3. Histological or cytological confirmation of metastatic or recurrent gastric or gastroesophageal junction adenocarcinoma
  4. Subjects must have received and have progressed, or are refractory to standard regimens
  5. Subjects must have at least one lesion amenable to biospy

Exclusion Criteria:

  1. Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment
  2. Previous immunotherapy
  3. Concurrent or prior use of immunosuppressive medication with 14 days
  4. Active or prior documented autoimmune or inflammatory disease within 3 years with some exceptions
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (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 Canada,   Japan,   Korea, Republic of,   Singapore,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02340975
Other Study ID Numbers  ICMJE D4190C00021
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party MedImmune LLC
Study Sponsor  ICMJE MedImmune LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MedImmune, LLC MedImmune, LLC MedImmune LLC
PRS Account MedImmune LLC
Verification Date February 2019

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