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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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This is a single arm, Phase II study using the combination of atezolizumab and bevicacizumab in women with advanced, recurrent or persistent endometrial cancer. Safety and futility of this drug combination will be assessed to see what effect this treatment has on this patient population.
This phase 2 study using atezolizumab and bevacizumab aims to study the objective tumor response in women with recurrent endometrial cancer. Drugs will be administered via IV every 21 days until disease progression, unacceptable toxicity, or loss of clinical benefit as determined by investigator. Subjects will receive routine cancer care as well as tests and procedures required for the purposes of this study. It is expected this combination will be produce an anti-cancer effect with manageable toxicities in this patient population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab + Atezolizumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab will be administered by IV infusion at 15mg/kg on Day 1 of every 21-days cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who experience complete or partial tumor response | To estimate the objective tumor response in women of this patient population | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | To estimate progression-free survival (PFS) and overall survival (OS) of patients with recurrent or persistent endometrial cancer treated with Atezolizumab and Bevacizumab. | up to 3 years |
| Overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen Moore, MD | Obstetrics and Gynecology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Women and Infants Center | Birmingham | Alabama | 35233 | United States | ||
| Washington University School of Medicine |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| C000594389 | atezolizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Atezolizumab | Drug | Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle until disease progression, unacceptable toxicity, loss of clinical benefit as determined by the investigator. |
|
To estimate overall survival (OS) of patients with recurrent or persistent endometrial cancer treated with Atezolizumab and Bevacizumab.
| up to 3 years |
| Number of patients who experience toxicity | To determine the nature and degree of toxicity in combination of atezolizumab and bevacizumab. | 6 months |
| Number of participants who experience immune related response | To estimate response using immune related response criteria (irRC) in patients receiving Atezolizumab and Bevacizumab. | 6 months |
| St Louis |
| Missouri |
| 63108 |
| United States |
| Stephenson Cancer Center, University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73117 | United States |
| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |