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| Name | Class |
|---|---|
| Ozmosis Research Inc. | INDUSTRY |
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It is postulated that focal sensitizing radiotherapy may potentiate the effectiveness of durvalumab. The purpose of this study is to test the safety and tolerability of 2 different dose levels of focal sensitizing radiation therapy given with durvalumab.
Durvalumab is a PDL-1 inhibitor, part of class of agents (called checkpoint inhibitors) designed to increase the ability of the immune system to recognize and work to eliminate cancers. Checkpoint inhibitors have been studied in recurrent ovarian, primary peritoneal and Fallopian cancers, and on their own show a low level of activity.
Radiation therapy is usually used in women with recurrent ovarian, primary peritoneal and Fallopian cancers to palliate symptoms related to progressive disease. However, radiation is know to modify the cancer immune environment and to release tumour antigens. These actions may potentiate the function of immune checkpoint inhibitors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Durvalumab and focal radiotherapy | Experimental | Durvalumab 1500 mg IV every 28 days, and 2 fractions of focal sensitizing radiation with cycles 1 and 2 of treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Focal radiotherapy | Radiation | Focal sensitizing radiotherapy will be given at a starting dose level of 24 Gray (6 Gy X 4 fractions), and may be escalated to 32 Gy (8Gy X4 fractions). |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the maximum tolerated dose of durvalumab combined with focal irradiation for use in recurrent ovarian cancer | The maximum tolerated dose will be defined by dose-limiting toxicities and serious adverse events. | First 4 weeks of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | Objective Response rate as evaluated by RECIST (v 1.1) criteria 2) Progression free survival 3) Overall survival | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
| CA-125 response rate |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | Progression free survival and overall survival of the study population | From date of study enrollment until death or study completion (maximum 12 months). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Tinker, MD | Contact | 604-877-6000 | atinker@bccancer.bc.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BC Cancer Agency | Recruiting | Vancouver | British Columbia | V5Z 4E6 | Canada |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 5, 2017 | Sep 8, 2017 |
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| Durvalumab | Drug | Durvalumab 1500 mg IV every 28 days |
|
|
Using GCIG CA-125 response criteria |
| From date of study enrollment until confirmed CA-125 progression, through study completion, an average of 1 year |
| Immune-related response rate | Using Immune-related response criteria | From date of study enrollment until confirmed immune-related disease progression, through study completion, an average of one1year |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
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| ID | Term |
|---|---|
| C000613593 | durvalumab |
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