PDL-1 Inhibition and Focal Sensitizing Radiotherapy in Recurrent Ovarian/Primary Peritoneal/Fallopian Tube Cancers.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03283943|
Recruitment Status : Unknown
Verified July 2018 by Anna Tinker, British Columbia Cancer Agency.
Recruitment status was: Recruiting
First Posted : September 15, 2017
Last Update Posted : July 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Primary Peritoneal Carcinoma Fallopian Tube Cancer||Radiation: Focal radiotherapy Drug: Durvalumab||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I (Safety Assessment) of Durvalumab (MEDI4736) With Focal Sensitizing Radiotherapy in Platinum Resistant Ovarian, Primary Peritoneal or Fallopian Tube Epithelial Carcinoma|
|Actual Study Start Date :||April 1, 2018|
|Estimated Primary Completion Date :||December 16, 2020|
|Estimated Study Completion Date :||December 16, 2020|
Experimental: Durvalumab and focal radiotherapy
Durvalumab 1500 mg IV every 28 days, and 2 fractions of focal sensitizing radiation with cycles 1 and 2 of treatment.
Radiation: Focal radiotherapy
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).
Durvalumab 1500 mg IV every 28 days
Other Name: MEDI 4736
- Determine the maximum tolerated dose of durvalumab combined with focal irradiation for use in recurrent ovarian cancer [ Time Frame: First 4 weeks of therapy ]The maximum tolerated dose will be defined by dose-limiting toxicities and serious adverse events.
- Objective response rate [ Time Frame: 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 ]Objective Response rate as evaluated by RECIST (v 1.1) criteria 2) Progression free survival 3) Overall survival
- CA-125 response rate [ Time Frame: From date of study enrollment until confirmed CA-125 progression, through study completion, an average of 1 year ]Using GCIG CA-125 response criteria
- Immune-related response rate [ Time Frame: From date of study enrollment until confirmed immune-related disease progression, through study completion, an average of one1year ]Using Immune-related response criteria
- Survival [ Time Frame: From date of study enrollment until death or study completion (maximum 12 months). ]Progression free survival and overall survival of the study population
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): NCT03283943
|Contact: Anna Tinker, MDfirstname.lastname@example.org|
|Canada, British Columbia|
|BC Cancer Agency||Recruiting|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Contact: Anna Tinker, MD 6048776000 email@example.com|