Trial Outcomes & Findings for Durvalumab With Radiotherapy for Adjuvant Treatment of Intermediate Risk SCCHN (NCT NCT03529422)
NCT ID: NCT03529422
Last Updated: 2025-07-20
Results Overview
Disease-free Survival Rate (DFS) defined as the percentage of participants who were disease-free and alive at 3 years, counting the time from day 1 of treatment to time of disease recurrence or death, was calculated based on the Kaplan-Meier method.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
3 years
Results posted on
2025-07-20
Participant Flow
Participants were enrolled in the study between 10/07/2019 and 05/04/2021 at three cancer centers in the United States.
Participant milestones
| Measure |
Open-label, Single-arm
Durvalumab in combination with intensity modulated radiotherapy (IMRT) treatments
Durvalumab: Durvalumab 1500mg IV every 3 weeks for 6 cycles
Intensity Modulated Radiotherapy Treatments: Total dose will be 60 Gray (Gy) at 2Gy per fractions for 30 fractions delivered Monday through Friday for 6 weeks
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Open-label, Single-arm
Durvalumab in combination with intensity modulated radiotherapy (IMRT) treatments
Durvalumab: Durvalumab 1500mg IV every 3 weeks for 6 cycles
Intensity Modulated Radiotherapy Treatments: Total dose will be 60 Gray (Gy) at 2Gy per fractions for 30 fractions delivered Monday through Friday for 6 weeks
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Disease progression
|
2
|
Baseline Characteristics
Durvalumab With Radiotherapy for Adjuvant Treatment of Intermediate Risk SCCHN
Baseline characteristics by cohort
| Measure |
Open-label, Single-arm
n=18 Participants
Durvalumab in combination with intensity modulated radiotherapy (IMRT) treatments
Durvalumab: Durvalumab 1500mg IV every 3 weeks for 6 cycles
Intensity Modulated Radiotherapy Treatments: Total dose will be 60 Gray (Gy) at 2Gy per fractions for 30 fractions delivered Monday through Friday for 6 weeks
|
|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 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
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: Participants started to study treatment and treatment responses were assessed.
Disease-free Survival Rate (DFS) defined as the percentage of participants who were disease-free and alive at 3 years, counting the time from day 1 of treatment to time of disease recurrence or death, was calculated based on the Kaplan-Meier method.
Outcome measures
| Measure |
Open-label, Single-arm
n=16 Participants
Durvalumab in combination with intensity modulated radiotherapy (IMRT) treatments
Durvalumab: Durvalumab 1500mg IV every 3 weeks for 6 cycles
Intensity Modulated Radiotherapy Treatments: Total dose will be 60 Gray (Gy) at 2Gy per fractions for 30 fractions delivered Monday through Friday for 6 weeks
|
|---|---|
|
Disease-free Survival Rate
|
68.8 percentage of participants
Interval 46.0 to 91.5
|
SECONDARY outcome
Timeframe: Up to 30 daysPopulation: Participants started to study the treatment.
To characterize safety by evaluating Grade 3-4 acute toxicities of adjuvant durvalumab with radiotherapy in intermediate-risk Head and Neck Squamous Cell Carcinoma patients receiving adjuvant durvalumab with radiotherapy. Toxicity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
Outcome measures
| Measure |
Open-label, Single-arm
n=16 Participants
Durvalumab in combination with intensity modulated radiotherapy (IMRT) treatments
Durvalumab: Durvalumab 1500mg IV every 3 weeks for 6 cycles
Intensity Modulated Radiotherapy Treatments: Total dose will be 60 Gray (Gy) at 2Gy per fractions for 30 fractions delivered Monday through Friday for 6 weeks
|
|---|---|
|
Number of Participants With Grade 3-4 Acute Toxicities
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The type of Grade 3 Adverse Events observed in 5 subjects were included.
To characterize the Grade 3-4 chronic toxicities of adjuvant durvalumab with radiotherapy in intermediate-risk Head and Neck Squamous Cell Carcinoma patients. Toxicity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
Outcome measures
| Measure |
Open-label, Single-arm
n=16 Participants
Durvalumab in combination with intensity modulated radiotherapy (IMRT) treatments
Durvalumab: Durvalumab 1500mg IV every 3 weeks for 6 cycles
Intensity Modulated Radiotherapy Treatments: Total dose will be 60 Gray (Gy) at 2Gy per fractions for 30 fractions delivered Monday through Friday for 6 weeks
|
|---|---|
|
Chronic Toxicities of Adjuvant Durvalumab With Radiotherapy
Grade 3- Weight loss
|
1 Participants
|
|
Chronic Toxicities of Adjuvant Durvalumab With Radiotherapy
Grade 3- Mucositis oral
|
1 Participants
|
|
Chronic Toxicities of Adjuvant Durvalumab With Radiotherapy
Grade 3- Hypertension
|
1 Participants
|
|
Chronic Toxicities of Adjuvant Durvalumab With Radiotherapy
Grade 3- wrist pain
|
1 Participants
|
|
Chronic Toxicities of Adjuvant Durvalumab With Radiotherapy
Grade 3-Dysphagia
|
1 Participants
|
|
Chronic Toxicities of Adjuvant Durvalumab With Radiotherapy
Grade 3- Lymphedema
|
1 Participants
|
|
Chronic Toxicities of Adjuvant Durvalumab With Radiotherapy
Grade 3- Odynophagia
|
1 Participants
|
SECONDARY outcome
Timeframe: 5 yearsTo estimate median OS in patients with intermediate-risk HNSCC treated with adjuvant durvalumab with radiotherapy.-To correlate PD-L1 expression with disease free survival
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsTo correlate PD-L1 expression with disease free survival.
Outcome measures
Outcome data not reported
Adverse Events
Open-label, Single-arm
Serious events: 1 serious events
Other events: 17 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Open-label, Single-arm
n=18 participants at risk
Durvalumab in combination with intensity-modulated radiotherapy (IMRT) treatments
|
|---|---|
|
Vascular disorders
Vascular Disorders - Other, Specify
|
5.6%
1/18 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
Other adverse events
| Measure |
Open-label, Single-arm
n=18 participants at risk
Durvalumab in combination with intensity-modulated radiotherapy (IMRT) treatments
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
5.6%
1/18 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Ear and labyrinth disorders
Ear And Labyrinth Disorders - Other, Specify
|
5.6%
1/18 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Ear and labyrinth disorders
Hearing Impaired
|
5.6%
1/18 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Ear and labyrinth disorders
Tinnitus
|
5.6%
1/18 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Endocrine disorders
Hyperthyroidism
|
11.1%
2/18 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Endocrine disorders
Hypothyroidism
|
5.6%
1/18 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Gastrointestinal disorders
Dry Mouth
|
22.2%
4/18 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Gastrointestinal disorders
Dysphagia
|
5.6%
1/18 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Gastrointestinal disorders
Esophageal Stenosis
|
5.6%
1/18 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
5.6%
1/18 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Gastrointestinal disorders
Gastrointestinal Disorders - Other, Specify
|
5.6%
1/18 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Gastrointestinal disorders
Mucositis Oral
|
5.6%
1/18 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Gastrointestinal disorders
Oral Pain
|
5.6%
1/18 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
General disorders
Fatigue
|
16.7%
3/18 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
General disorders
Pain
|
5.6%
1/18 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Infections and infestations
Infections And Infestations - Other, Specify
|
5.6%
1/18 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Investigations
Alanine Aminotransferase Increased
|
5.6%
1/18 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Investigations
Aspartate Aminotransferase Increased
|
5.6%
1/18 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Investigations
Blood Bilirubin Increased
|
5.6%
1/18 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Investigations
Lipase Increased
|
5.6%
1/18 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Investigations
Lymphocyte Count Decreased
|
38.9%
7/18 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Investigations
Serum Amylase Increased
|
11.1%
2/18 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Investigations
Weight Loss
|
16.7%
3/18 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Investigations
White Blood Cell Decreased
|
11.1%
2/18 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.6%
1/18 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
5.6%
1/18 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Musculoskeletal and connective tissue disorders
Fibrosis Deep Connective Tissue
|
5.6%
1/18 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
5.6%
1/18 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Nervous system disorders
Dizziness
|
5.6%
1/18 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Nervous system disorders
Dysgeusia
|
22.2%
4/18 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Nervous system disorders
Nervous System Disorders - Other, Specify
|
5.6%
1/18 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.6%
1/18 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.6%
1/18 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Edema
|
5.6%
1/18 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Skin and subcutaneous tissue disorders
Nail Loss
|
5.6%
1/18 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
5.6%
1/18 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Skin and subcutaneous tissue disorders
Skin And Subcutaneous Tissue Disorders - Other, Specify
|
5.6%
1/18 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Vascular disorders
Hypertension
|
11.1%
2/18 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Vascular disorders
Lymphedema
|
16.7%
3/18 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Vascular disorders
Vascular Disorders - Other, Specify
|
5.6%
1/18 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
Additional Information
Melahat Canter
UNC Lineberger Comprehensive Cancer Center
Phone: 919-962-0000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Subcontractor agrees that the first publication of the Study results will be made by Institution as a multi-site publication. Subcontractor can publish its site-specific results after Institution's publication, 12 months post-study completion, or upon Institution's notice of completion. Subcontractor must provide Institution 30 days for manuscript review and may delay publication for 45 days for institution's patent filing. Institution will register the Study and post results as required by law.
- Publication restrictions are in place
Restriction type: OTHER