A Phase 1 Study of MEDI4736 in Combination With Tremelimumab in Subjects With Advanced Solid Tumors
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ClinicalTrials.gov Identifier: NCT02261220 |
Recruitment Status :
Completed
First Posted : October 10, 2014
Last Update Posted : March 6, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced Solid Tumors | Biological: MEDI4736 Biological: tremelimumab | Phase 1 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: MEDI4736 + Tremelimumab
Subjects with multiple tumor types.
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Biological: MEDI4736
MEDI4736 is administered by IV infusion in combination with tremelimumab Biological: tremelimumab Tremelimumab is administered by IV infusion in combination with MEDI4736 |
- Number of subjects reporting adverse events [ Time Frame: Screening through 15 months after the last subject enters re-treatment ]
- Number of subjects reporting serious adverse events [ Time Frame: Screening through 15 months after the last subject enters re-treatment ]
- 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 15 months after the last subject enters re-treatment ]
- Overall Response Rate [ Time Frame: First dose of study medication through 15 months after the last subject enters re-treatment ]
- Disease Control Rate [ Time Frame: First dose of study medication through 15 months after the last subject enters re-treatment ]
- Duration of Response [ Time Frame: First dose of study medication through 15 months after the last subject enters re-treatment ]
- Progression-Free Survival [ Time Frame: First dose of study medication through 15 months after the last subject enters re-treatment ]
- Overall Survival [ Time Frame: First dose of study medication through 15 months after the last subject enters re-treatment ]
- 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 3 months after the last dose of study medication ]
- 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 ]
- Change in Biomarkers [ Time Frame: Screening through 3 months following the last dose of study medication ]

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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 |
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.

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

Study Director: | MedImmune LLC | MedImmune LLC |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
advanced solid tumors durvalumab tremelimumab |
Neoplasms Durvalumab Tremelimumab Antineoplastic Agents, Immunological Antineoplastic Agents |