A Phase 1 Study of MEDI4736 in Combination With Tremelimumab in Subjects With Advanced Solid Tumors
Sponsor
MedImmune LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT02261220
Collaborator
(none)
380
75
1
63.5
5.1
0.1
Study Details
Study Description
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 |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
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
:
Oct 13, 2014
Actual Primary Completion Date
:
Jan 27, 2020
Actual Study Completion Date
:
Jan 27, 2020
Arms and Interventions
| 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
Primary Outcome Measures
- Number of subjects reporting adverse events [Screening through 15 months after the last subject enters re-treatment]
- Number of subjects reporting serious adverse events [Screening through 15 months after the last subject enters re-treatment]
- Number of subjects experiencing a dose-limiting toxicity [First dose of study medication through 4 weeks after the first dose of study medication]
- Change from Baseline in laboratory evaluations [Screening through 3 months after the last dose of study medication]
- Change from Baseline in vital signs [Screening through 3 months after the last dose of study medication]
- Change from Baseline in electrocardiogram evaluations [Screening through 3 months after the last dose of study medication]
- Overall Response Rate in Select Tumor Types [First dose of study medication through 15 months after the last subject enters re-treatment]
Secondary Outcome Measures
- Overall Response Rate [First dose of study medication through 15 months after the last subject enters re-treatment]
- Disease Control Rate [First dose of study medication through 15 months after the last subject enters re-treatment]
- Duration of Response [First dose of study medication through 15 months after the last subject enters re-treatment]
- Progression-Free Survival [First dose of study medication through 15 months after the last subject enters re-treatment]
- Overall Survival [First dose of study medication through 15 months after the last subject enters re-treatment]
- Individual MEDI4736 concentrations [First dose of MEDI4736 through 3 months after the last dose of study medication]
- Individual tremelimumab concentrations [First dose of tremelimumab through 3 months after the last dose of study medication]
- MEDI4736 area under the concentration-curve [First dose of MEDI4736 through 3 months after the last dose of study medication]
- Tremelimumab area under the concentration-curve [First dose of tremelimumab through 3 months after the last dose of study medication]
- Number of subjects that develop detectable antidrug antibodies to MEDI4736 [First dose of MEDI4736 through 3 months after the last dose of study medication]
- Number of subjects that develop antidrug antibodies to tremelimumab [First dose of tremelimumab through 3 months after the last dose of study medication]
Other Outcome Measures
- Change in Biomarkers [Screening through 3 months following the last dose of study medication]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 99 Years
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Scottsdale | Arizona | United States | 85258 |
| 2 | Research Site | Duarte | California | United States | 91010 |
| 3 | Research Site | La Jolla | California | United States | 92093 |
| 4 | Research Site | Los Angeles | California | United States | 90025 |
| 5 | Research Site | Los Angeles | California | United States | 90095 |
| 6 | Research Site | Whittier | California | United States | 90603 |
| 7 | Research Site | Aurora | Colorado | United States | 80045 |
| 8 | Research Site | New Haven | Connecticut | United States | 06510 |
| 9 | Research Site | Miami Beach | Florida | United States | 33140 |
| 10 | Research Site | Tampa | Florida | United States | 33612 |
| 11 | Research Site | Chicago | Illinois | United States | 60611 |
| 12 | Research Site | Chicago | Illinois | United States | 60637 |
| 13 | Research Site | Iowa City | Iowa | United States | 52242-1008 |
| 14 | Research Site | Louisville | Kentucky | United States | 40202 |
| 15 | Research Site | Ann Arbor | Michigan | United States | 48109 |
| 16 | Research Site | Bronx | New York | United States | 10461 |
| 17 | Research Site | New York | New York | United States | 10065 |
| 18 | Research Site | New York | New York | United States | 10116 |
| 19 | Research Site | Cincinnati | Ohio | United States | 45219 |
| 20 | Research Site | Cleveland | Ohio | United States | 44106 |
| 21 | Research Site | Portland | Oregon | United States | 97213 |
| 22 | Research Site | Portland | Oregon | United States | 97239 |
| 23 | Research Site | Philadelphia | Pennsylvania | United States | 19111 |
| 24 | Research Site | Pittsburgh | Pennsylvania | United States | 15212 |
| 25 | Research Site | Greenville | South Carolina | United States | 29605 |
| 26 | Research Site | Dallas | Texas | United States | 75230 |
| 27 | Research Site | Houston | Texas | United States | 77521 |
| 28 | Research Site | San Antonio | Texas | United States | 78229 |
| 29 | Research Site | Fairfax | Virginia | United States | 22031 |
| 30 | Research Site | Seattle | Washington | United States | 98104 |
| 31 | Research Site | London | Ontario | Canada | N6A 4L6 |
| 32 | Research Site | Toronto | Ontario | Canada | M4N 3M5 |
| 33 | Research Site | Toronto | Ontario | Canada | M5G 1X5 |
| 34 | Research Site | Montreal | Quebec | Canada | H3T 1E2 |
| 35 | Research Site | Quebec | Canada | G1R 2J6 | |
| 36 | Research Site | Angers Cedex 02 | France | 49055 | |
| 37 | Research Site | BESANCON Cedex | France | 25030 | |
| 38 | Research Site | Bordeaux Cedex | France | 33075 | |
| 39 | Research Site | Lyon | France | 69008 | |
| 40 | Research Site | Marseille | France | 13005 | |
| 41 | Research Site | Montpellier | France | 34298 | |
| 42 | Research Site | Pierre Benite | France | 69495 | |
| 43 | Research Site | Vandoeuvre les Nancy | France | 54519 | |
| 44 | Research Site | Villejuif | France | 94805 | |
| 45 | Research Site | Jena | Germany | 07747 | |
| 46 | Research Site | Münster | Germany | 48149 | |
| 47 | Research Site | Tübingen | Germany | 72076 | |
| 48 | Research Site | Haifa | Israel | 31096 | |
| 49 | Research Site | Jerusalem | Israel | 91031 | |
| 50 | Research Site | Kfar Saba | Israel | 44410 | |
| 51 | Research Site | Tel-Aviv | Israel | 64239 | |
| 52 | Research Site | Busan | Korea, Republic of | 49241 | |
| 53 | Research Site | Daegu | Korea, Republic of | 41404 | |
| 54 | Research Site | Daegu | Korea, Republic of | 42601 | |
| 55 | Research Site | Gwangju | Korea, Republic of | 61469 | |
| 56 | Research Site | Seongnam-si | Korea, Republic of | 13620 | |
| 57 | Research Site | Seoul | Korea, Republic of | 03722 | |
| 58 | Research Site | Seoul | Korea, Republic of | 06591 | |
| 59 | Research Site | Seoul | Korea, Republic of | 135-710 | |
| 60 | Research Site | Amsterdam | Netherlands | 1066 CX | |
| 61 | Research Site | Amsterdam | Netherlands | 1081 HV | |
| 62 | Research Site | Tilburg | Netherlands | 5042AD | |
| 63 | Research Site | Barcelona | Spain | 08026 | |
| 64 | Research Site | Barcelona | Spain | 08035 | |
| 65 | Research Site | Barcelona | Spain | 08036 | |
| 66 | Research Site | Madrid | Spain | 28034 | |
| 67 | Research Site | Madrid | Spain | 28041 | |
| 68 | Research Site | Pamplona | Spain | 31008 | |
| 69 | Research Site | Valencia | Spain | 46010 | |
| 70 | Research Site | Glasgow | United Kingdom | G12 0YN | |
| 71 | Research Site | London | United Kingdom | EC1M 6BQ | |
| 72 | Research Site | London | United Kingdom | NW1 2BU | |
| 73 | Research Site | Middlesborough | United Kingdom | TS4 3BW | |
| 74 | Research Site | Oxford | United Kingdom | OX3 7LE | |
| 75 | Research Site | Wirral | United Kingdom | CH63 4JY |
Sponsors and Collaborators
- MedImmune LLC
Investigators
- Study Director: MedImmune LLC, MedImmune LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT02261220
Other Study ID Numbers:
- D4190C00010
First Posted:
Oct 10, 2014
Last Update Posted:
Mar 6, 2020
Last Verified:
Mar 1, 2020
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by MedImmune LLC
Additional relevant MeSH terms: