Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Avelumab for Recurrent/Metastatic Nasopharyngeal Cancer

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: NCT02875613
Recruitment Status : Terminated (Slow patient accrual)
First Posted : August 23, 2016
Results First Posted : September 5, 2019
Last Update Posted : September 5, 2019
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Assuntina Sacco, M.D., University of California, San Diego

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Nasopharyngeal Cancer
Intervention Drug: Avelumab
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Avelumab
Hide Arm/Group Description

Avelumab 10mg/kg IV infusion on days 1 and 15 of 28-day cycle

Avelumab: Avelumab 10mg/kg IV on days 1 and 15 of each 28-day cycle. Treatment will be given until disease progression, unacceptable toxicity, investigator decision or patient withdrawal.

Period Title: Overall Study
Started 5
Completed 4
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Avelumab
Hide Arm/Group Description

Avelumab 10mg/kg IV infusion on days 1 and 15 of 28-day cycle

Avelumab: Avelumab 10mg/kg IV on days 1 and 15 of each 28-day cycle. Treatment will be given until disease progression, unacceptable toxicity, investigator decision or patient withdrawal.

Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants
49.25  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
1
  25.0%
Male
3
  75.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
  50.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
  25.0%
White
1
  25.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Overall Response Rate
Hide Description Based on Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Avelumab
Hide Arm/Group Description:

Avelumab 10mg/kg IV infusion on days 1 and 15 of 28-day cycle

Avelumab: Avelumab 10mg/kg IV on days 1 and 15 of each 28-day cycle. Treatment will be given until disease progression, unacceptable toxicity, investigator decision or patient withdrawal.

Overall Number of Participants Analyzed 2
Measure Type: Count of Participants
Unit of Measure: Participants
Progressive Disease at 6 months
1
  50.0%
Stable Disease at 6 months
1
  50.0%
Time Frame 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Avelumab
Hide Arm/Group Description

Avelumab 10mg/kg IV infusion on days 1 and 15 of 28-day cycle

Avelumab: Avelumab 10mg/kg IV on days 1 and 15 of each 28-day cycle. Treatment will be given until disease progression, unacceptable toxicity, investigator decision or patient withdrawal.

All-Cause Mortality
Avelumab
Affected / at Risk (%)
Total   2/4 (50.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Avelumab
Affected / at Risk (%)
Total   3/4 (75.00%) 
Blood and lymphatic system disorders   
Anemia   1/4 (25.00%) 
Gastrointestinal disorders   
Abdominal pain   1/4 (25.00%) 
General disorders   
Non-cardiac chest pain   1/4 (25.00%) 
Hepatobiliary disorders   
Hepatic hemorrhage   1/4 (25.00%) 
Infections and infestations   
Sepsis   1/4 (25.00%) 
Investigations   
Blood bilirubin increased   1/4 (25.00%) 
Respiratory, thoracic and mediastinal disorders   
Pleural effusion   1/4 (25.00%) 
Dyspnea   1/4 (25.00%) 
Aspiration   1/4 (25.00%) 
Epistaxis   1/4 (25.00%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Avelumab
Affected / at Risk (%)
Total   4/4 (100.00%) 
Blood and lymphatic system disorders   
Anemia   2/4 (50.00%) 
Gastrointestinal disorders   
Abdominal pain   1/4 (25.00%) 
Nausea   1/4 (25.00%) 
Dysphagia   1/4 (25.00%) 
Vomiting   3/4 (75.00%) 
Gastroesophageal reflux disease   1/4 (25.00%) 
General disorders   
Fever   1/4 (25.00%) 
Chills   1/4 (25.00%) 
Non-cardiac chest pain   1/4 (25.00%) 
Pain   1/4 (25.00%) 
Edema limbs   1/4 (25.00%) 
Hepatobiliary disorders   
Hepatic hemorrhage   1/4 (25.00%) 
Infections and infestations   
Peritoneal infection   1/4 (25.00%) 
Skin infection   1/4 (25.00%) 
Papulopustular rash   1/4 (25.00%) 
Tooth infection   1/4 (25.00%) 
Investigations   
Weight loss   2/4 (50.00%) 
Metabolism and nutrition disorders   
Hyponatremia   2/4 (50.00%) 
Anorexia   1/4 (25.00%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea   1/4 (25.00%) 
Cough   1/4 (25.00%) 
Pleural effusion   1/4 (25.00%) 
Epistaxis   1/4 (25.00%) 
Postnasal drip   1/4 (25.00%) 
Pneumonitis   1/4 (25.00%) 
Skin and subcutaneous tissue disorders   
Body odor   1/4 (25.00%) 
Pruritis   1/4 (25.00%) 
Indicates events were collected by 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: Dr. Assuntina Sacco
Organization: UC San Diego - Moores Cancer Center
Phone: 858-822-5210
EMail: agsacco@ucsd.edu
Layout table for additonal information
Responsible Party: Assuntina Sacco, M.D., University of California, San Diego
ClinicalTrials.gov Identifier: NCT02875613     History of Changes
Other Study ID Numbers: 160114
First Submitted: August 18, 2016
First Posted: August 23, 2016
Results First Submitted: August 15, 2019
Results First Posted: September 5, 2019
Last Update Posted: September 5, 2019