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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
Results First Posted : November 12, 2020
Last Update Posted : November 12, 2020
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Recurrent Epithelial Cancer of Ovary
Primary Peritoneal Carcinoma
Fallopian Tube Cancer
Intervention Drug: Avelumab
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Single Arm
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Avelumab and SABR

Trial of combined Avelumab with SAbR for Recurrent Ovarian and peritoneal, fallopian tube cancer (ROPT) is to assess overall clinical response rates per RECIST criteria.

Period Title: Overall Study
Started 5
Completed 0
Not Completed 5
Reason Not Completed
All the five enrolled dropped out of the             5
Arm/Group Title Single Arm
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Avelumab and SABR

Avelumab: Avelumab* (MSB0010718C; anti-PD-L1 is a fully human anti-PD- L1 IgG1 antibody)

Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 5 participants
63
(60 to 70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
5
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
Hispanic or Latino
Not Hispanic or Latino
Unknown or Not Reported
[1]
Measure Analysis Population Description: data was not analyzed
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants
5
1.Primary Outcome
Title To Assess Overall Clinical Response Rates Per RECIST Criteria.
Hide Description Analysis of (with safety lead-in) trial of combined Avelumab (MSB0010718C) anti-PD-L1checkpoint blockade with SAbR for Recurrent Ovarian and peritoneal ,fallopian tube cancer (ROPT) is to assess overall clinical response rates per RECIST criteria .
Time Frame 1 year,4 months
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Hide Analysis Population Description
All patients progressed- without any response.
Arm/Group Title Recurrent Ovarian and Peritoneal ,Fallopian Tube Cancer (ROP
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The primary objective of this phase II(with safety lead-in) trial of combined Avelumab (MSB0010718C) anti-PD-L1checkpoint blockade with SAbR for Recurrent Ovarian and peritoneal ,fallopian tube cancer (ROPT) is to assess overall clinical response rates per RECIST criteria . This will be after the safety lead-in is completed without DLT at 8 weeks from start of Avelumab, to evaluate the safety of Avelumab and SABR to an acceptable dose of the site radiated.
Overall Number of Participants Analyzed 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2.Secondary Outcome
Title Overall Survival
Hide Description

Patients were started on alternative therapy and were not followed after starting alternative therapy.

Study was stopped because drug was found to be ineffective by the pharmaceutical company

Time Frame 1 year, 4 months
Hide Outcome Measure Data
Hide Analysis Population Description

All the five enrolled dropped out of the study early due to disease progression.

Study was stopped because drug was found to be ineffective by the pharmaceutical company.

Arm/Group Title Single Arm
Hide Arm/Group Description:

Avelumab and SABR

Trial of combined Avelumab with SAbR for Recurrent Ovarian and peritoneal, fallopian tube cancer (ROPT) is to assess overall clinical response rates per RECIST criteria.

Overall Number of Participants Analyzed 5
Measure Type: Count of Participants
Unit of Measure: Participants
NA [1] 
[1]

All the five enrolled dropped out of the study early due to disease progression.

Study was stopped because drug was found to be ineffective by the pharmaceutical company

Time Frame The adverse event were 6 months from enrollment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Concurrent Anti-PD-L1 + SAbR to Metastasis
Hide Arm/Group Description There were no serious adverse events on the trial.
All-Cause Mortality
Concurrent Anti-PD-L1 + SAbR to Metastasis
Affected / at Risk (%)
Total   3/5 (60.00%)    
Hide Serious Adverse Events
Concurrent Anti-PD-L1 + SAbR to Metastasis
Affected / at Risk (%) # Events
Total   0/5 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Concurrent Anti-PD-L1 + SAbR to Metastasis
Affected / at Risk (%) # Events
Total   5/5 (100.00%)    
Blood and lymphatic system disorders   
LYMPHOCYTE COUNT DECREASED *  5/5 (100.00%)  7
Gastrointestinal disorders   
CONSTIPATION *  5/5 (100.00%)  6
General disorders   
FATIGUE *  5/5 (100.00%)  6
ANOERXIA *  5/5 (100.00%)  5
VOMITING *  5/5 (100.00%)  5
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Phase II trial of Concurrent Anti-PD-L1 and SAbR for Patients with Persistent or Recurrent Epithelia
Organization: University of Texas Southwestern Medical Center
Phone: (214) 645-7296
EMail: kevin.albuquerque@utsouthwestern.edu
Layout table for additonal information
Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03312114    
Other Study ID Numbers: STU 032017-078
First Submitted: September 14, 2017
First Posted: October 17, 2017
Results First Submitted: July 19, 2020
Results First Posted: November 12, 2020
Last Update Posted: November 12, 2020