Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Nivolumab and Ipilimumab and Stereotactic Body Radiation Therapy in Treating Patients With Salivary Gland Cancers · Source last updated 2023-12-29
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From start of treatment through up to 100 days after the completion of study treatment (up to 16 months total)
What was measured
Toxicities will be summarized as the number and percentage of patients with each type of toxicity, per Criteria for Adverse Events version 5.0
Groups in this outcome
Treatment (Nivolumab, Ipilimumab, SBRT)
Patients receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks for up to 12 courses and then every 4 weeks for an additional 8 courses in the absence of disease progression or unacceptable toxicity. Patients also receive ipilimumab IV over 60 minutes on day 1. Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Beginning week 3, patients undergo 3 fractions of stereotactic body radiation therapy every other day in the absence of disease progression or unacceptable toxicity.
Nivolumab: Given IV
Ipilimumab: Given IV
Stereotactic Body Radiation Therapy: Undergo SBRT
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
Treatment (Nivolumab, Ipilimumab, SBRT)
20
Reported measurements
Adrenal Insufficiency
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
3
Not reported
Not reported
Not reported
Not reported
Allergic Reaction
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Anemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
2
Not reported
Not reported
Not reported
Not reported
Anorexia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
6
Not reported
Not reported
Not reported
Not reported
Anxiety
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
2
Not reported
Not reported
Not reported
Not reported
Arthralgia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
2
Not reported
Not reported
Not reported
Not reported
Arthritis
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
2
Not reported
Not reported
Not reported
Not reported
Aspirational Pneumonitis
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Hyperthyroidism
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Back Pain
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
2
Not reported
Not reported
Not reported
Not reported
Bilateral Upper Extremity Edema
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Non-Cardiac Chest Pain
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
3
Not reported
Not reported
Not reported
Not reported
Chills
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Confusion
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Congestion
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Conjuctival Erythema
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Constipation
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
7
Not reported
Not reported
Not reported
Not reported
Cough
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
5
Not reported
Not reported
Not reported
Not reported
Dehydration
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Depression
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Diarrhea
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
5
Not reported
Not reported
Not reported
Not reported
Dysphagia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Drooling
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Dry Eyes
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
3
Not reported
Not reported
Not reported
Not reported
Dry Mouth
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
3
Not reported
Not reported
Not reported
Not reported
Dry Skin
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
2
Not reported
Not reported
Not reported
Not reported
Dyspnea
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
4
Not reported
Not reported
Not reported
Not reported
Ear Fullness
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Alkaline Phophate Increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Asparate Aminotransferase Increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Alanine Aminotransferase Increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Epistaxis
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
3
Not reported
Not reported
Not reported
Not reported
Esophagitis
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Fall
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Fatigue
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
15
Not reported
Not reported
Not reported
Not reported
Erythematous Pustular Rash
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Fistual Tract
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Flu Like Symptoms
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Fungal Infection
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
GERD
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
2
Not reported
Not reported
Not reported
Not reported
Hair Loss
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Hallucinations
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Head/Neck Swelling
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Headache
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
4
Not reported
Not reported
Not reported
Not reported
Hearing Loss
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Heartburn
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
2
Not reported
Not reported
Not reported
Not reported
Hemoptysis
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Hot Flashes
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Hyperpigmented Skin
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Hypertension
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
2
Not reported
Not reported
Not reported
Not reported
Hypoalbuminemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Hypocalcemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Hypothyroidism
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
5
Not reported
Not reported
Not reported
Not reported
Increased Spine Pain
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Worsening Trismus
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Swollen Neck Sore
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Hypokalemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
3
Not reported
Not reported
Not reported
Not reported
Infusion Related Reaction
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
5
Not reported
Not reported
Not reported
Not reported
Insomnia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
6
Not reported
Not reported
Not reported
Not reported
Intermittent Palpatations
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Intermittent Abdominal Cramping
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Intermittent Dizziness
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
3
Not reported
Not reported
Not reported
Not reported
Intermittent Facial Swelling
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Intermittent Hypertension
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Intermittent Maculopapular rash
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Intermittent Nasal Congestion
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Intermittent Rhinitis
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Joint Pain
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Ear Bleeding
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Facial Neuropathy
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Left Neck Discomfort
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Neck Pain
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
2
Not reported
Not reported
Not reported
Not reported
Lower Extremity Edema
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Lung Infection (Pneumonia)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
2
Not reported
Not reported
Not reported
Not reported
Lymphedema
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Maculopapular Rash
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
4
Not reported
Not reported
Not reported
Not reported
Mania
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Mental Fogginess
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Microcytic Anemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Mucositis
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
5
Not reported
Not reported
Not reported
Not reported
Pustular Skin Rash
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Muscle Weakness
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Muscle Spams
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Myalgias
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
4
Not reported
Not reported
Not reported
Not reported
Nausea
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
10
Not reported
Not reported
Not reported
Not reported
Neck Tightness
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Neuropathy
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Night Sweats
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Non Pruritic Cheek Rash
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Otorrhea
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Skin Pain
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Facial Pain
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Pruritus
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
5
Not reported
Not reported
Not reported
Not reported
Rash
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Renal Insufficiency
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Respiratory Infection
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Itchy Eyes
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Eye Pain
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Foot Pain
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Right Knee Fracture
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Foot Edema
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Periorbital Edema
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Thoracic Pain
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Rhinorrhea
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
2
Not reported
Not reported
Not reported
Not reported
Cancer Related Pain
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Right Leg Pain
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Sinus Congestion
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
2
Not reported
Not reported
Not reported
Not reported
Skin Infection
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Sore Throat
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
2
Not reported
Not reported
Not reported
Not reported
Hyperhidrosis
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Swollen Joints
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Taste Changes
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
3
Not reported
Not reported
Not reported
Not reported
Upper Respiratory Infection
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
2
Not reported
Not reported
Not reported
Not reported
Urinary Frequency
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Urinary Tract Infection
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Vision Changes
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
2
Not reported
Not reported
Not reported
Not reported
Vomiting
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Abdominal Pain
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
4
Not reported
Not reported
Not reported
Not reported
Weight Loss
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
4
Not reported
Not reported
Not reported
Not reported
Hoarseness
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Tinnitus
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Xerostomia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Dyspepsia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Right Rib Fracture
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Right Coracoid Fracture
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Oral Bleeding
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Hypotension
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Nivolumab, Ipilimumab, SBRT)
1
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
3
title
Adrenal Insufficiency
categories
measurements
group Id
OG000
value
1
title
Allergic Reaction
categories
measurements
group Id
OG000
value
2
title
Anemia
categories
measurements
group Id
OG000
value
6
title
Anorexia
categories
measurements
group Id
OG000
value
2
title
Anxiety
categories
measurements
group Id
OG000
value
2
title
Arthralgia
categories
measurements
group Id
OG000
value
2
title
Arthritis
categories
measurements
group Id
OG000
value
1
title
Aspirational Pneumonitis
categories
measurements
group Id
OG000
value
1
title
Hyperthyroidism
categories
measurements
group Id
OG000
value
2
title
Back Pain
categories
measurements
group Id
OG000
value
1
title
Bilateral Upper Extremity Edema
categories
measurements
group Id
OG000
value
3
title
Non-Cardiac Chest Pain
denoms
counts
group Id
OG000
value
20
units
Participants
description
Toxicities will be summarized as the number and percentage of patients with each type of toxicity, per Criteria for Adverse Events version 5.0
groups
description
Patients receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks for up to 12 courses and then every 4 weeks for an additional 8 courses in the absence of disease progression or unacceptable toxicity. Patients also receive ipilimumab IV over 60 minutes on day 1. Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Beginning week 3, patients undergo 3 fractions of stereotactic body radiation therapy every other day in the absence of disease progression or unacceptable toxicity.
Nivolumab: Given IV
Ipilimumab: Given IV
Stereotactic Body Radiation Therapy: Undergo SBRT
id
OG000
title
Treatment (Nivolumab, Ipilimumab, SBRT)
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
From start of treatment through up to 100 days after the completion of study treatment (up to 16 months total)
title
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Triangle