Anti-PD-L1 and SAbR for Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT03312114|
Recruitment Status : Terminated (low accrual)
First Posted : October 17, 2017
Last Update Posted : April 3, 2020
Programmed death-1 receptor ligand (PD-L1) the ligand for PD-1 is a key therapeutic target in the reactivation of the immune response against multiple cancers. Pharmacologic inhibitors of PD-1 have also demonstrated significant anti-tumor activity and are currently under active clinical exploration. avelumab (MSB0010718C; anti-PD-L1 is a fully human anti-PD-L1 igG1 antibody that has shown promising efficacy and an acceptable safety profile in multiple tumor types.
Radiation therapy (RT) is one of the mainstream treatments of cancer therapy along with surgery and chemotherapy, yet RT is the only treatment that does not leave the patients immunocompromised (unlike chemotherapy) and keeps the dying tumor / antigen depot within the host (unlike surgery), providing an opportunity for antigen presentation. Therefore, RT is a rational choice to combine with immunotherapy for cancer treatment.
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Epithelial Cancer of Ovary Primary Peritoneal Carcinoma Fallopian Tube Cancer||Drug: Avelumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Concurrent Anti-PD-L1 and SAbR for Patients With Persistent or Recurrent Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer (With Safety lead-in)|
|Actual Study Start Date :||November 9, 2017|
|Actual Primary Completion Date :||March 19, 2019|
|Actual Study Completion Date :||March 19, 2019|
Experimental: Single arm
Avelumab and SABR
Avelumab* (MSB0010718C; anti-PD-L1 is a fully human anti-PD- L1 IgG1 antibody)
Other Name: Bavencio
- Overall clinical response rates [ Time Frame: 5 years ]Overall objective clinical response rates per RECIST criteria. Compare the response rates to historical data.
- overall survival [ Time Frame: 5 years ]Overall survival (OS) for cohort
- Evaluate and compare complete response rate [ Time Frame: 5 years ]Complete response rate per RECIST criteria. Compare complete response rate with historical data
- evaluate and compare time to progression [ Time Frame: 5 years ]Time to progression (TTP). It is defined as time between date of first cycle and date of documented progression. Compare TTP with historical data
- Evaluate and compare median response duration [ Time Frame: 5 years ]Median response duration is defined as the time between the date a response (CR or PR) was first seen until date of progression. Compare median response duration with historical data
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): NCT03312114
|United States, Texas|
|University of Texas Southwestern Medical Center|
|Dallas, Texas, United States, 75390|