Trial Outcomes & Findings for Screening Trial of Nivolumab With Image Guided, Stereotactic Body Radiotherapy (SBRT) Versus Nivolumab Alone in Patients With Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) (NCT NCT02684253)
NCT ID: NCT02684253
Last Updated: 2022-03-10
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
65 participants
Primary outcome timeframe
96 weeks
Results posted on
2022-03-10
Participant Flow
Participant milestones
| Measure |
Nivolumab 3mg/kg IV Every 2 Weeks
Nivolumab 3mg/kg IV every 2 weeks
Nivolumab
|
Stereotactic Body Radiotherapy & Nivolumab
Image Guided, Stereotactic Body Radiotherapy (27 Gy over 3 fractions given every other day) to a single lesion to start by study day 14 (study day 1 is day of first dose of Nivolumab).
Nivolumab 3mg/kg IV starting day 1 and then every 2 weeks thereafter. Treatment with Nivolumab will continue until progression or unacceptable toxicity.
Nivolumab
Stereotactic Body Radiation Therapy (SBRT)
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
33
|
|
Overall Study
COMPLETED
|
32
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Screening Trial of Nivolumab With Image Guided, Stereotactic Body Radiotherapy (SBRT) Versus Nivolumab Alone in Patients With Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
Baseline characteristics by cohort
| Measure |
Nivolumab 3mg/kg IV Every 2 Weeks
n=32 Participants
Nivolumab 3mg/kg IV every 2 weeks
Nivolumab
|
Stereotactic Body Radiotherapy & Nivolumab
n=33 Participants
Image Guided, Stereotactic Body Radiotherapy (27 Gy over 3 fractions given every other day) to a single lesion to start by study day 14 (study day 1 is day of first dose of Nivolumab).
Nivolumab 3mg/kg IV starting day 1 and then every 2 weeks thereafter. Treatment with Nivolumab will continue until progression or unacceptable toxicity.
Nivolumab
Stereotactic Body Radiation Therapy (SBRT)
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
n=93 Participants
|
65 years
n=4 Participants
|
62.9 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
58 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
61 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
42 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
32 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
65 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 96 weeksPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Nivolumab 3mg/kg IV Every 2 Weeks
n=29 Participants
Nivolumab 3mg/kg IV every 2 weeks
|
Stereotactic Body Radiotherapy & Nivolumab
n=31 Participants
Image Guided, Stereotactic Body Radiotherapy (27 Gy over 3 fractions given every other day) to a single lesion to start by study day 14 (study day 1 is day of first dose of Nivolumab).
Nivolumab 3mg/kg IV starting day 1 and then every 2 weeks thereafter. Treatment with Nivolumab will continue until progression or unacceptable toxicity.
Nivolumab
Stereotactic Body Radiation Therapy (SBRT)
|
|---|---|---|
|
Percentage of Participants With Overall Response Rate
|
34.5 percentage of participants
Interval 19.9 to 52.7
|
29 percentage of participants
Interval 16.1 to 46.6
|
Adverse Events
Nivolumab 3mg/kg IV Every 2 Weeks
Serious events: 4 serious events
Other events: 21 other events
Deaths: 26 deaths
Stereotactic Body Radiotherapy & Nivolumab
Serious events: 3 serious events
Other events: 27 other events
Deaths: 27 deaths
Serious adverse events
| Measure |
Nivolumab 3mg/kg IV Every 2 Weeks
n=32 participants at risk
Nivolumab 3mg/kg IV every 2 weeks
Nivolumab
|
Stereotactic Body Radiotherapy & Nivolumab
n=33 participants at risk
Image Guided, Stereotactic Body Radiotherapy (27 Gy over 3 fractions given every other day) to a single lesion to start by study day 14 (study day 1 is day of first dose of Nivolumab).
Nivolumab 3mg/kg IV starting day 1 and then every 2 weeks thereafter. Treatment with Nivolumab will continue until progression or unacceptable toxicity.
Nivolumab
Stereotactic Body Radiation Therapy (SBRT)
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
3.1%
1/32 • Up tp 30 months
|
9.1%
3/33 • Up tp 30 months
|
|
Investigations
Alanine aminotransferase increased
|
3.1%
1/32 • Up tp 30 months
|
3.0%
1/33 • Up tp 30 months
|
|
Metabolism and nutrition disorders
Anorexia
|
3.1%
1/32 • Up tp 30 months
|
0.00%
0/33 • Up tp 30 months
|
|
Investigations
Aspartate aminotransferase increased
|
3.1%
1/32 • Up tp 30 months
|
3.0%
1/33 • Up tp 30 months
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/32 • Up tp 30 months
|
3.0%
1/33 • Up tp 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/32 • Up tp 30 months
|
3.0%
1/33 • Up tp 30 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/32 • Up tp 30 months
|
3.0%
1/33 • Up tp 30 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/32 • Up tp 30 months
|
3.0%
1/33 • Up tp 30 months
|
|
General disorders
Death NOS
|
6.2%
2/32 • Up tp 30 months
|
9.1%
3/33 • Up tp 30 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/32 • Up tp 30 months
|
3.0%
1/33 • Up tp 30 months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/32 • Up tp 30 months
|
3.0%
1/33 • Up tp 30 months
|
|
Gastrointestinal disorders
Dysphagia
|
9.4%
3/32 • Up tp 30 months
|
6.1%
2/33 • Up tp 30 months
|
|
General disorders
Fatigue
|
3.1%
1/32 • Up tp 30 months
|
0.00%
0/33 • Up tp 30 months
|
|
General disorders
Fever
|
9.4%
3/32 • Up tp 30 months
|
0.00%
0/33 • Up tp 30 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
3.1%
1/32 • Up tp 30 months
|
0.00%
0/33 • Up tp 30 months
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
3.1%
1/32 • Up tp 30 months
|
0.00%
0/33 • Up tp 30 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
3.1%
1/32 • Up tp 30 months
|
6.1%
2/33 • Up tp 30 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.1%
1/32 • Up tp 30 months
|
0.00%
0/33 • Up tp 30 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.2%
2/32 • Up tp 30 months
|
0.00%
0/33 • Up tp 30 months
|
|
Vascular disorders
Hypotension
|
9.4%
3/32 • Up tp 30 months
|
0.00%
0/33 • Up tp 30 months
|
|
Infections and infestations
Lung infection
|
6.2%
2/32 • Up tp 30 months
|
0.00%
0/33 • Up tp 30 months
|
|
Infections and infestations
Meningitis
|
3.1%
1/32 • Up tp 30 months
|
0.00%
0/33 • Up tp 30 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/32 • Up tp 30 months
|
3.0%
1/33 • Up tp 30 months
|
|
Gastrointestinal disorders
Oral hemorrhage
|
3.1%
1/32 • Up tp 30 months
|
0.00%
0/33 • Up tp 30 months
|
|
General disorders
Pain
|
6.2%
2/32 • Up tp 30 months
|
3.0%
1/33 • Up tp 30 months
|
|
Gastrointestinal disorders
Pancreatitis
|
9.4%
3/32 • Up tp 30 months
|
0.00%
0/33 • Up tp 30 months
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/32 • Up tp 30 months
|
3.0%
1/33 • Up tp 30 months
|
|
Cardiac disorders
Pericardial tamponade
|
0.00%
0/32 • Up tp 30 months
|
3.0%
1/33 • Up tp 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.1%
1/32 • Up tp 30 months
|
3.0%
1/33 • Up tp 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.1%
1/32 • Up tp 30 months
|
0.00%
0/33 • Up tp 30 months
|
|
Cardiac disorders
Sinus tachycardia
|
3.1%
1/32 • Up tp 30 months
|
0.00%
0/33 • Up tp 30 months
|
|
Infections and infestations
Skin infection
|
0.00%
0/32 • Up tp 30 months
|
3.0%
1/33 • Up tp 30 months
|
|
General disorders
Sudden death NOS
|
3.1%
1/32 • Up tp 30 months
|
3.0%
1/33 • Up tp 30 months
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/32 • Up tp 30 months
|
3.0%
1/33 • Up tp 30 months
|
|
Investigations
White blood cell decreased
|
0.00%
0/32 • Up tp 30 months
|
3.0%
1/33 • Up tp 30 months
|
Other adverse events
| Measure |
Nivolumab 3mg/kg IV Every 2 Weeks
n=32 participants at risk
Nivolumab 3mg/kg IV every 2 weeks
Nivolumab
|
Stereotactic Body Radiotherapy & Nivolumab
n=33 participants at risk
Image Guided, Stereotactic Body Radiotherapy (27 Gy over 3 fractions given every other day) to a single lesion to start by study day 14 (study day 1 is day of first dose of Nivolumab).
Nivolumab 3mg/kg IV starting day 1 and then every 2 weeks thereafter. Treatment with Nivolumab will continue until progression or unacceptable toxicity.
Nivolumab
Stereotactic Body Radiation Therapy (SBRT)
|
|---|---|---|
|
Investigations
Activated partial thromboplastin time prolonged
|
6.2%
2/32 • Up tp 30 months
|
0.00%
0/33 • Up tp 30 months
|
|
Investigations
Alanine aminotransferase increased
|
6.2%
2/32 • Up tp 30 months
|
9.1%
3/33 • Up tp 30 months
|
|
Investigations
Alkaline phosphatase increased
|
12.5%
4/32 • Up tp 30 months
|
18.2%
6/33 • Up tp 30 months
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
16/32 • Up tp 30 months
|
54.5%
18/33 • Up tp 30 months
|
|
Investigations
Aspartate aminotransferase increased
|
9.4%
3/32 • Up tp 30 months
|
15.2%
5/33 • Up tp 30 months
|
|
Investigations
Blood bilirubin increased
|
12.5%
4/32 • Up tp 30 months
|
6.1%
2/33 • Up tp 30 months
|
|
Investigations
Creatinine increased
|
6.2%
2/32 • Up tp 30 months
|
9.1%
3/33 • Up tp 30 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
3.1%
1/32 • Up tp 30 months
|
9.1%
3/33 • Up tp 30 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
43.8%
14/32 • Up tp 30 months
|
36.4%
12/33 • Up tp 30 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.2%
2/32 • Up tp 30 months
|
3.0%
1/33 • Up tp 30 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
31.2%
10/32 • Up tp 30 months
|
30.3%
10/33 • Up tp 30 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
25.0%
8/32 • Up tp 30 months
|
21.2%
7/33 • Up tp 30 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
21.9%
7/32 • Up tp 30 months
|
15.2%
5/33 • Up tp 30 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/32 • Up tp 30 months
|
6.1%
2/33 • Up tp 30 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/32 • Up tp 30 months
|
6.1%
2/33 • Up tp 30 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
31.2%
10/32 • Up tp 30 months
|
30.3%
10/33 • Up tp 30 months
|
|
Investigations
INR increased
|
9.4%
3/32 • Up tp 30 months
|
3.0%
1/33 • Up tp 30 months
|
|
Investigations
Lipase increased
|
18.8%
6/32 • Up tp 30 months
|
21.2%
7/33 • Up tp 30 months
|
|
Investigations
Lymphocyte count decreased
|
65.6%
21/32 • Up tp 30 months
|
66.7%
22/33 • Up tp 30 months
|
|
Investigations
Neutrophil count decreased
|
9.4%
3/32 • Up tp 30 months
|
12.1%
4/33 • Up tp 30 months
|
|
Investigations
Platelet count decreased
|
0.00%
0/32 • Up tp 30 months
|
9.1%
3/33 • Up tp 30 months
|
|
Investigations
Serum amylase increased
|
12.5%
4/32 • Up tp 30 months
|
9.1%
3/33 • Up tp 30 months
|
|
Investigations
White blood cell decreased
|
12.5%
4/32 • Up tp 30 months
|
27.3%
9/33 • Up tp 30 months
|
Additional Information
Dr. Sean McBride, MD, MPH
Memorial Sloan Kettering Cancer Center
Phone: 646-608-2450
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place