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Trial record 1 of 1 for:    d4190c00010
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A Phase 1 Study of MEDI4736 in Combination With Tremelimumab in Subjects With Advanced Solid Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT02261220
First received: October 2, 2014
Last updated: June 19, 2017
Last verified: June 2017
  Purpose
This is a multicenter, open-label, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, PK and immunogenicity of MEDI4736 in combination with tremelimumab in subjects with select advanced solid tumors.

Condition Intervention Phase
Advanced Solid Tumors Biological: MEDI4736 Biological: tremelimumab Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase I Study of MEDI4736 (Anti-PD-L1 Antibody) in Combination With Tremelimumab (Anti-CTLA-4 Antibody) in Subjects With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Number of subjects reporting adverse events [ Time Frame: Screening through 5 years after the last subject receives the first dose of study medication ]
  • Number of subjects reporting serious adverse events [ Time Frame: Screening through 5 years after the last subject receives the first dose of study medication ]
  • Number of subjects experiencing a dose-limiting toxicity [ Time Frame: First dose of study medication through 4 weeks after the first dose of study medication ]
  • Change from Baseline in laboratory evaluations [ Time Frame: Screening through 3 months after the last dose of study medication ]
  • Change from Baseline in vital signs [ Time Frame: Screening through 3 months after the last dose of study medication ]
  • Change from Baseline in electrocardiogram evaluations [ Time Frame: Screening through 3 months after the last dose of study medication ]
  • Overall Response Rate in Select Tumor Types [ Time Frame: First dose of study medication through 5 years after the last subject receives the first dose of study medication ]

Secondary Outcome Measures:
  • Overall Response Rate [ Time Frame: First dose of study medication through 5 years after the last subject receives the first dose of study medication ]
  • Disease Control Rate [ Time Frame: First dose of study medication through 5 years after the last subject receives the last dose of study medication ]
  • Duration of Response [ Time Frame: First dose of study medication through 5 years after the last subject received the last dose of study medication ]
  • Progression-Free Survival [ Time Frame: First dose of study medication through 5 years after the last subject receives the first dose of study medication ]
  • Overall Survival [ Time Frame: First dose of study medication through 5 years after the last subject receives the first dose of study medication ]
  • Individual MEDI4736 concentrations [ Time Frame: First dose of MEDI4736 through 3 months after the last dose of study medication ]
  • Individual tremelimumab concentrations [ Time Frame: First dose of tremelimumab through 3 months after the last dose of study medication ]
  • MEDI4736 area under the concentration-curve [ Time Frame: First dose of MEDI4736 through 3 months after the last dose of study medication ]
  • Tremelimumab area under the concentration-curve [ Time Frame: First dose of tremelimumab through 3 months after the last dose of study medication ]
  • Number of subjects that develop detectable antidrug antibodies to MEDI4736 [ Time Frame: First dose of MEDI4736 through 6 months after the last dose of study medication ]
  • Number of subjects that develop antidrug antibodies to tremelimumab [ Time Frame: First dose of tremelimumab through 6 months after the last dose of study medication ]

Other Outcome Measures:
  • Change in Biomarkers [ Time Frame: Screening through 3 months following the last dose of study medication ]

Enrollment: 381
Actual Study Start Date: October 13, 2014
Estimated Study Completion Date: January 19, 2018
Estimated Primary Completion Date: January 19, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MEDI4736 + Tremelimumab
Subjects with multiple tumor types.
Biological: MEDI4736
MEDI4736 is administered by IV infusion in combination with tremelimumab
Biological: tremelimumab
Tremelimumab is administered by IV infusion in combination with MEDI4736

  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects
  • 18 years and older
  • Histologic confirmation of advanced solid tumors
  • Subjects must have recurrent/metastatic disease and may have been previously treated in the recurrent/metastatic setting.

Exclusion Criteria:

  • Any concurrent chemotherapy, immune-mediated therapy or biologic or hormonal therapy for cancer treatment
  • Active or prior documented autoimmune disease within the past 2 years
  • Current or prior use of immunosuppressive medication within 14 days with some exceptions.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02261220

  Show 75 Study Locations
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: MedImmune LLC MedImmune LLC
  More Information

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT02261220     History of Changes
Other Study ID Numbers: D4190C00010
Study First Received: October 2, 2014
Last Updated: June 19, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by MedImmune LLC:
advanced solid tumors
durvalumab
tremelimumab

Additional relevant MeSH terms:
Antibodies, Monoclonal
Tremelimumab
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 27, 2017