Trial Outcomes & Findings for Avelumab for Recurrent/Metastatic Nasopharyngeal Cancer (NCT NCT02875613)
NCT ID: NCT02875613
Last Updated: 2024-08-28
Results Overview
Based on Response Evaluation Criteria in Solid Tumors (RECIST)
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
6 months
Results posted on
2024-08-28
Participant Flow
Description of discrepancy between the enrollment number in the Protocol Section (6) and number of participants Started in the Participant Flow module (5): there were a total of six participants who signed consent for the study. One of the participants was a screen fail. Another participant withdrew consent prior to completing screening procedures. When determining the number of participants enrolled, these two participants were still considered. The correct enrollment number should be four.
Participant milestones
| Measure |
Avelumab
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 Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Avelumab
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 Study
Withdrawal by Subject
|
1
|
|
Overall Study
Screen Failure
|
1
|
Baseline Characteristics
Avelumab for Recurrent/Metastatic Nasopharyngeal Cancer
Baseline characteristics by cohort
| Measure |
Avelumab
n=4 Participants
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.
|
|---|---|
|
Age, Continuous
|
49.25 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsBased on Response Evaluation Criteria in Solid Tumors (RECIST)
Outcome measures
| Measure |
Avelumab
n=4 Participants
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 Response Rate
Progressive Disease at 6 months
|
2 Participants
|
|
Overall Response Rate
Stable Disease at 6 months
|
2 Participants
|
Adverse Events
Avelumab
Serious events: 3 serious events
Other events: 4 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Avelumab
n=4 participants at risk
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.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
25.0%
1/4 • 2 years
|
|
General disorders
Non-cardiac chest pain
|
25.0%
1/4 • 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • 2 years
|
|
Investigations
Blood bilirubin increased
|
25.0%
1/4 • 2 years
|
|
Hepatobiliary disorders
Hepatic hemorrhage
|
25.0%
1/4 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
1/4 • 2 years
|
|
Infections and infestations
Sepsis
|
25.0%
1/4 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
25.0%
1/4 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
25.0%
1/4 • 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
1/4 • 2 years
|
Other adverse events
| Measure |
Avelumab
n=4 participants at risk
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.
|
|---|---|
|
Metabolism and nutrition disorders
Hyponatremia
|
50.0%
2/4 • 2 years
|
|
General disorders
Fever
|
25.0%
1/4 • 2 years
|
|
General disorders
Chills
|
25.0%
1/4 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
1/4 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • 2 years
|
|
Infections and infestations
Peritoneal infection
|
25.0%
1/4 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
25.0%
1/4 • 2 years
|
|
General disorders
Non-cardiac chest pain
|
25.0%
1/4 • 2 years
|
|
Hepatobiliary disorders
Hepatic hemorrhage
|
25.0%
1/4 • 2 years
|
|
General disorders
Pain
|
25.0%
1/4 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
1/4 • 2 years
|
|
Infections and infestations
Skin infection
|
25.0%
1/4 • 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
2/4 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • 2 years
|
|
General disorders
Edema limbs
|
25.0%
1/4 • 2 years
|
|
Gastrointestinal disorders
Dysphagia
|
25.0%
1/4 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
75.0%
3/4 • 2 years
|
|
Investigations
Weight loss
|
50.0%
2/4 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
25.0%
1/4 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
25.0%
1/4 • 2 years
|
|
Skin and subcutaneous tissue disorders
Body odor
|
25.0%
1/4 • 2 years
|
|
Infections and infestations
Papulopustular rash
|
25.0%
1/4 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
25.0%
1/4 • 2 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
25.0%
1/4 • 2 years
|
|
Infections and infestations
Tooth infection
|
25.0%
1/4 • 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
25.0%
1/4 • 2 years
|
Additional Information
Dr. Assuntina Sacco
UC San Diego - Moores Cancer Center
Phone: 858-822-5210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place