Advanced Solid Tumors Clinical Trial
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
| Verified date | March 2020 |
| Source | MedImmune LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 380 |
| Est. completion date | January 27, 2020 |
| Est. primary completion date | January 27, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 99 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Research Site | London | Ontario |
| Canada | Research Site | Montreal | Quebec |
| Canada | Research Site | Quebec | |
| Canada | Research Site | Toronto | Ontario |
| Canada | Research Site | Toronto | Ontario |
| France | Research Site | Angers Cedex 02 | |
| France | Research Site | BESANCON Cedex | |
| France | Research Site | Bordeaux Cedex | |
| France | Research Site | Lyon | |
| France | Research Site | Marseille | |
| France | Research Site | Montpellier | |
| France | Research Site | Pierre Benite | |
| France | Research Site | Vandoeuvre les Nancy | |
| France | Research Site | Villejuif | |
| Germany | Research Site | Jena | |
| Germany | Research Site | Münster | |
| Germany | Research Site | Tübingen | |
| Israel | Research Site | Haifa | |
| Israel | Research Site | Jerusalem | |
| Israel | Research Site | Kfar Saba | |
| Israel | Research Site | Tel-Aviv | |
| Korea, Republic of | Research Site | Busan | |
| Korea, Republic of | Research Site | Daegu | |
| Korea, Republic of | Research Site | Daegu | |
| Korea, Republic of | Research Site | Gwangju | |
| Korea, Republic of | Research Site | Seongnam-si | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Netherlands | Research Site | Amsterdam | |
| Netherlands | Research Site | Amsterdam | |
| Netherlands | Research Site | Tilburg | |
| Spain | Research Site | Barcelona | |
| Spain | Research Site | Barcelona | |
| Spain | Research Site | Barcelona | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Pamplona | |
| Spain | Research Site | Valencia | |
| United Kingdom | Research Site | Glasgow | |
| United Kingdom | Research Site | London | |
| United Kingdom | Research Site | London | |
| United Kingdom | Research Site | Middlesborough | |
| United Kingdom | Research Site | Oxford | |
| United Kingdom | Research Site | Wirral | |
| United States | Research Site | Ann Arbor | Michigan |
| United States | Research Site | Aurora | Colorado |
| United States | Research Site | Bronx | New York |
| United States | Research Site | Chicago | Illinois |
| United States | Research Site | Chicago | Illinois |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Cleveland | Ohio |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | Duarte | California |
| United States | Research Site | Fairfax | Virginia |
| United States | Research Site | Greenville | South Carolina |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Iowa City | Iowa |
| United States | Research Site | La Jolla | California |
| United States | Research Site | Los Angeles | California |
| United States | Research Site | Los Angeles | California |
| United States | Research Site | Louisville | Kentucky |
| United States | Research Site | Miami Beach | Florida |
| United States | Research Site | New Haven | Connecticut |
| United States | Research Site | New York | New York |
| United States | Research Site | New York | New York |
| United States | Research Site | Philadelphia | Pennsylvania |
| United States | Research Site | Pittsburgh | Pennsylvania |
| United States | Research Site | Portland | Oregon |
| United States | Research Site | Portland | Oregon |
| United States | Research Site | San Antonio | Texas |
| United States | Research Site | Scottsdale | Arizona |
| United States | Research Site | Seattle | Washington |
| United States | Research Site | Tampa | Florida |
| United States | Research Site | Whittier | California |
| Lead Sponsor | Collaborator |
|---|---|
| MedImmune LLC |
United States, Canada, France, Germany, Israel, Korea, Republic of, Netherlands, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Change in Biomarkers | Screening through 3 months following the last dose of study medication | ||
| Primary | Number of subjects reporting adverse events | Screening through 15 months after the last subject enters re-treatment | ||
| Primary | Number of subjects reporting serious adverse events | Screening through 15 months after the last subject enters re-treatment | ||
| Primary | Number of subjects experiencing a dose-limiting toxicity | First dose of study medication through 4 weeks after the first dose of study medication | ||
| Primary | Change from Baseline in laboratory evaluations | Screening through 3 months after the last dose of study medication | ||
| Primary | Change from Baseline in vital signs | Screening through 3 months after the last dose of study medication | ||
| Primary | Change from Baseline in electrocardiogram evaluations | Screening through 3 months after the last dose of study medication | ||
| Primary | Overall Response Rate in Select Tumor Types | First dose of study medication through 15 months after the last subject enters re-treatment | ||
| Secondary | Overall Response Rate | First dose of study medication through 15 months after the last subject enters re-treatment | ||
| Secondary | Disease Control Rate | First dose of study medication through 15 months after the last subject enters re-treatment | ||
| Secondary | Duration of Response | First dose of study medication through 15 months after the last subject enters re-treatment | ||
| Secondary | Progression-Free Survival | First dose of study medication through 15 months after the last subject enters re-treatment | ||
| Secondary | Overall Survival | First dose of study medication through 15 months after the last subject enters re-treatment | ||
| Secondary | Individual MEDI4736 concentrations | First dose of MEDI4736 through 3 months after the last dose of study medication | ||
| Secondary | Individual tremelimumab concentrations | First dose of tremelimumab through 3 months after the last dose of study medication | ||
| Secondary | MEDI4736 area under the concentration-curve | First dose of MEDI4736 through 3 months after the last dose of study medication | ||
| Secondary | Tremelimumab area under the concentration-curve | First dose of tremelimumab through 3 months after the last dose of study medication | ||
| Secondary | Number of subjects that develop detectable antidrug antibodies to MEDI4736 | First dose of MEDI4736 through 3 months after the last dose of study medication | ||
| Secondary | Number of subjects that develop antidrug antibodies to tremelimumab | First dose of tremelimumab through 3 months after the last dose of study medication |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
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