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A Phase 1 Study of MEDI4736 in Combination With Tremelimumab in Subjects With Advanced Solid Tumors

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: NCT02261220
Recruitment Status : Completed
First Posted : October 10, 2014
Last Update Posted : March 6, 2020
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Advanced Solid Tumors Biological: MEDI4736 Biological: tremelimumab Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 380 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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
Actual Study Start Date : October 13, 2014
Actual Primary Completion Date : January 27, 2020
Actual Study Completion Date : January 27, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Durvalumab

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Number of subjects reporting adverse events [ Time Frame: Screening through 15 months after the last subject enters re-treatment ]
  2. Number of subjects reporting serious adverse events [ Time Frame: Screening through 15 months after the last subject enters re-treatment ]
  3. 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 ]
  4. Change from Baseline in laboratory evaluations [ Time Frame: Screening through 3 months after the last dose of study medication ]
  5. Change from Baseline in vital signs [ Time Frame: Screening through 3 months after the last dose of study medication ]
  6. Change from Baseline in electrocardiogram evaluations [ Time Frame: Screening through 3 months after the last dose of study medication ]
  7. Overall Response Rate in Select Tumor Types [ Time Frame: First dose of study medication through 15 months after the last subject enters re-treatment ]

Secondary Outcome Measures :
  1. Overall Response Rate [ Time Frame: First dose of study medication through 15 months after the last subject enters re-treatment ]
  2. Disease Control Rate [ Time Frame: First dose of study medication through 15 months after the last subject enters re-treatment ]
  3. Duration of Response [ Time Frame: First dose of study medication through 15 months after the last subject enters re-treatment ]
  4. Progression-Free Survival [ Time Frame: First dose of study medication through 15 months after the last subject enters re-treatment ]
  5. Overall Survival [ Time Frame: First dose of study medication through 15 months after the last subject enters re-treatment ]
  6. Individual MEDI4736 concentrations [ Time Frame: First dose of MEDI4736 through 3 months after the last dose of study medication ]
  7. Individual tremelimumab concentrations [ Time Frame: First dose of tremelimumab through 3 months after the last dose of study medication ]
  8. MEDI4736 area under the concentration-curve [ Time Frame: First dose of MEDI4736 through 3 months after the last dose of study medication ]
  9. Tremelimumab area under the concentration-curve [ Time Frame: First dose of tremelimumab through 3 months after the last dose of study medication ]
  10. Number of subjects that develop detectable antidrug antibodies to MEDI4736 [ Time Frame: First dose of MEDI4736 through 3 months after the last dose of study medication ]
  11. Number of subjects that develop antidrug antibodies to tremelimumab [ Time Frame: First dose of tremelimumab through 3 months after the last dose of study medication ]

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

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02261220


Locations
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Sponsors and Collaborators
MedImmune LLC
Investigators
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Study Director: MedImmune LLC MedImmune LLC
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT02261220    
Other Study ID Numbers: D4190C00010
First Posted: October 10, 2014    Key Record Dates
Last Update Posted: March 6, 2020
Last Verified: March 2020

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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:
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Neoplasms
Durvalumab
Tremelimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents