Trial Outcomes & Findings for Nivolumab and Ipilimumab and Stereotactic Body Radiation Therapy in Treating Patients With Salivary Gland Cancers (NCT NCT03749460)
NCT ID: NCT03749460
Last Updated: 2023-12-29
Results Overview
Toxicities will be summarized as the number and percentage of patients with each type of toxicity, per Criteria for Adverse Events version 5.0
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
20 participants
Primary outcome timeframe
From start of treatment through up to 100 days after the completion of study treatment (up to 16 months total)
Results posted on
2023-12-29
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nivolumab and Ipilimumab and Stereotactic Body Radiation Therapy in Treating Patients With Salivary Gland Cancers
Baseline characteristics by cohort
| Measure |
Treatment (Nivolumab, Ipilimumab, SBRT)
n=20 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
56.4 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 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
|
20 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
|
8 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 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
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From start of treatment through up to 100 days after the completion of study treatment (up to 16 months total)Toxicities will be summarized as the number and percentage of patients with each type of toxicity, per Criteria for Adverse Events version 5.0
Outcome measures
| Measure |
Treatment (Nivolumab, Ipilimumab, SBRT)
n=20 Participants
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
|
|---|---|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Swollen Neck Sore
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Hypokalemia
|
3 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Infusion Related Reaction
|
5 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Insomnia
|
6 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Adrenal Insufficiency
|
3 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Allergic Reaction
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Anemia
|
2 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Anorexia
|
6 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Anxiety
|
2 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Arthralgia
|
2 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Arthritis
|
2 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Aspirational Pneumonitis
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Hyperthyroidism
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Back Pain
|
2 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Bilateral Upper Extremity Edema
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Non-Cardiac Chest Pain
|
3 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Chills
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Confusion
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Congestion
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Conjuctival Erythema
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Constipation
|
7 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Cough
|
5 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Dehydration
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Depression
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Diarrhea
|
5 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Dysphagia
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Drooling
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Dry Eyes
|
3 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Dry Mouth
|
3 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Dry Skin
|
2 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Dyspnea
|
4 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Ear Fullness
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Alkaline Phophate Increased
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Asparate Aminotransferase Increased
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Alanine Aminotransferase Increased
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Epistaxis
|
3 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Esophagitis
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Fall
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Fatigue
|
15 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Erythematous Pustular Rash
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Fistual Tract
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Flu Like Symptoms
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Fungal Infection
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
GERD
|
2 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Hair Loss
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Hallucinations
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Head/Neck Swelling
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Headache
|
4 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Hearing Loss
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Heartburn
|
2 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Hemoptysis
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Hot Flashes
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Hyperpigmented Skin
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Hypertension
|
2 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Hypoalbuminemia
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Hypocalcemia
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Hypothyroidism
|
5 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Increased Spine Pain
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Worsening Trismus
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Intermittent Palpatations
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Intermittent Abdominal Cramping
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Intermittent Dizziness
|
3 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Intermittent Facial Swelling
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Intermittent Hypertension
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Intermittent Maculopapular rash
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Intermittent Nasal Congestion
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Intermittent Rhinitis
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Joint Pain
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Ear Bleeding
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Facial Neuropathy
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Left Neck Discomfort
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Neck Pain
|
2 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Lower Extremity Edema
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Lung Infection (Pneumonia)
|
2 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Lymphedema
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Maculopapular Rash
|
4 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Mania
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Mental Fogginess
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Microcytic Anemia
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Mucositis
|
5 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Pustular Skin Rash
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Muscle Weakness
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Muscle Spams
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Myalgias
|
4 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Nausea
|
10 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Neck Tightness
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Neuropathy
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Night Sweats
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Non Pruritic Cheek Rash
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Otorrhea
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Skin Pain
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Facial Pain
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Pruritus
|
5 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Rash
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Renal Insufficiency
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Respiratory Infection
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Itchy Eyes
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Eye Pain
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Foot Pain
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Right Knee Fracture
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Foot Edema
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Periorbital Edema
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Thoracic Pain
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Rhinorrhea
|
2 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Cancer Related Pain
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Right Leg Pain
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Sinus Congestion
|
2 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Skin Infection
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Sore Throat
|
2 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Hyperhidrosis
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Swollen Joints
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Taste Changes
|
3 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Upper Respiratory Infection
|
2 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Urinary Frequency
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Urinary Tract Infection
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Vision Changes
|
2 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Vomiting
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Abdominal Pain
|
4 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Weight Loss
|
4 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Hoarseness
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Tinnitus
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Xerostomia
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Dyspepsia
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Right Rib Fracture
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Right Coracoid Fracture
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Oral Bleeding
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Hypotension
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 4 yearsClinical responses to the combination of nivolumab, ipilimumab and hypofractionated radiation will be based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. 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.
Outcome measures
| Measure |
Treatment (Nivolumab, Ipilimumab, SBRT)
n=20 Participants
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
|
|---|---|
|
Objective Response Rate (ORR)
Stable Disease
|
6 Participants
|
|
Objective Response Rate (ORR)
Progressive Disease
|
10 Participants
|
|
Objective Response Rate (ORR)
Partial Response
|
4 Participants
|
SECONDARY outcome
Timeframe: From the date of study enrollment, until disease progression or death, assessed up to 4 yearsPFS estimate will be calculated using the Kaplan-Meier method. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesion
Outcome measures
| Measure |
Treatment (Nivolumab, Ipilimumab, SBRT)
n=20 Participants
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
|
|---|---|
|
Progression-free Survival (PFS)
|
7.2 Months
Interval 2.52 to 18.24
|
SECONDARY outcome
Timeframe: From the date of study enrollment, until disease progression or death, assessed up to 4 yearsOS estimate will be calculated using the Kaplan-Meier method.
Outcome measures
| Measure |
Treatment (Nivolumab, Ipilimumab, SBRT)
n=20 Participants
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
|
|---|---|
|
Overall Survival (OS)
|
25 months
Interval 18.72 to 31.08
|
Adverse Events
Treatment (Nivolumab, Ipilimumab, SBRT)
Serious events: 3 serious events
Other events: 20 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Treatment (Nivolumab, Ipilimumab, SBRT)
n=20 participants at risk
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
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Right Rib Fracture
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Musculoskeletal and connective tissue disorders
Right Coracoid Fracture
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Endocrine disorders
Adrenal Insufficiency
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
General disorders
Oral Bleeding
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infection
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Vascular disorders
Hypotension
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
Other adverse events
| Measure |
Treatment (Nivolumab, Ipilimumab, SBRT)
n=20 participants at risk
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
|
|---|---|
|
Skin and subcutaneous tissue disorders
Hair Loss
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Gastrointestinal disorders
Abdominal Pain
|
20.0%
4/20 • Number of events 7 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Endocrine disorders
Adrenal Insufficiency
|
15.0%
3/20 • Number of events 3 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Renal and urinary disorders
Renal Insufficiency
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Immune system disorders
Allergic Reaction
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Blood and lymphatic system disorders
Anemia
|
10.0%
2/20 • Number of events 2 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Metabolism and nutrition disorders
Anorexia
|
30.0%
6/20 • Number of events 6 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Psychiatric disorders
Anxiety
|
10.0%
2/20 • Number of events 2 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
2/20 • Number of events 2 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Infection
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
10.0%
2/20 • Number of events 2 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Aspirational Pneumonia
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Endocrine disorders
Hyperthyroidism
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
10.0%
2/20 • Number of events 2 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
General disorders
Bilateral Upper Extremity Edema
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Musculoskeletal and connective tissue disorders
Non-Cardiac Chest Pain
|
15.0%
3/20 • Number of events 4 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
General disorders
Chills
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
15.0%
3/20 • Number of events 7 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Psychiatric disorders
Confusion
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Congestion
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Infections and infestations
Conjuctival Erythema
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Gastrointestinal disorders
Constipation
|
35.0%
7/20 • Number of events 7 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
5/20 • Number of events 5 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Psychiatric disorders
Depression
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
5/20 • Number of events 6 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Gastrointestinal disorders
Dysphagia
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Nervous system disorders
Drooling
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Eye disorders
Dry Eyes
|
15.0%
3/20 • Number of events 3 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Gastrointestinal disorders
Dry Mouth
|
15.0%
3/20 • Number of events 3 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
10.0%
2/20 • Number of events 2 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
4/20 • Number of events 4 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Ear and labyrinth disorders
Ear Fullness
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Investigations
Alkaline Phosphate Increased
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Investigations
Aspartate Aminotransferase Increased
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Investigations
Alanine Aminotransferase Increased
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Gastrointestinal disorders
Esophagitis
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Injury, poisoning and procedural complications
Fall
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
General disorders
Fatigue
|
75.0%
15/20 • Number of events 16 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Skin and subcutaneous tissue disorders
Erythematous-Pustular Rash
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Skin and subcutaneous tissue disorders
Fistula Tract
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
General disorders
Flu Like Symptoms
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Infections and infestations
Fungal Infection
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Gastrointestinal disorders
GERD
|
10.0%
2/20 • Number of events 2 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Psychiatric disorders
Hallucinations
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
General disorders
Head/Neck Swelling
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Nervous system disorders
Headache
|
20.0%
4/20 • Number of events 4 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Ear and labyrinth disorders
Hearing Loss
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Gastrointestinal disorders
Heartburn
|
10.0%
2/20 • Number of events 2 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Gastrointestinal disorders
Hemoptysis
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
General disorders
Hot Flashes
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Skin and subcutaneous tissue disorders
Hyperpigmented Skin
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Vascular disorders
Hypertension
|
10.0%
2/20 • Number of events 4 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Blood and lymphatic system disorders
Hypoalbuminemia
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Metabolism and nutrition disorders
hypocalcemia
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Endocrine disorders
Hypothyroidism
|
25.0%
5/20 • Number of events 5 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Musculoskeletal and connective tissue disorders
Increased Spine Pain
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Musculoskeletal and connective tissue disorders
Worsening Trismus
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Swollen Neck Sore
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
15.0%
3/20 • Number of events 4 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
25.0%
5/20 • Number of events 7 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Psychiatric disorders
Insomnia
|
30.0%
6/20 • Number of events 6 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Cardiac disorders
Intermittent Palpitations
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Gastrointestinal disorders
Intermittent Abdominal Cramping
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Nervous system disorders
Intermittent Dizziness
|
10.0%
2/20 • Number of events 2 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
General disorders
Intermittent Facial Swelling
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Cardiac disorders
Intermittent Hypertension
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Skin and subcutaneous tissue disorders
Intermittent Maculopapular Rash
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Intermittent Nasal Congestion
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Intermittent Rhinitis
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Musculoskeletal and connective tissue disorders
Joint Pain
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Ear and labyrinth disorders
Ear Bleeding
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Nervous system disorders
Facial Neuropathy
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Musculoskeletal and connective tissue disorders
Left Neck Discomfort
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
10.0%
2/20 • Number of events 2 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Vascular disorders
Lower Extremity Edema
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infection (Pneumonia)
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Vascular disorders
Lymphedema
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Skin and subcutaneous tissue disorders
Maculopapular Rash
|
20.0%
4/20 • Number of events 4 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Psychiatric disorders
Mania
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Nervous system disorders
Mental Fogginess
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Blood and lymphatic system disorders
Microcytic Anemia
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Gastrointestinal disorders
Mucositis
|
25.0%
5/20 • Number of events 6 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Skin and subcutaneous tissue disorders
Pustular Skin Rash
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Musculoskeletal and connective tissue disorders
Myalgias
|
20.0%
4/20 • Number of events 4 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
10/20 • Number of events 13 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Musculoskeletal and connective tissue disorders
Neck Tightness
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Nervous system disorders
Neuropathy
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
General disorders
Night Sweats
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Skin and subcutaneous tissue disorders
Non Pruritic Cheek Rash
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Ear and labyrinth disorders
Otorrhea
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Skin and subcutaneous tissue disorders
Skin Pain
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
General disorders
Facial Pain
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
30.0%
6/20 • Number of events 6 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Eye disorders
Itchy Eyes
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Eye disorders
Eye Pain
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Musculoskeletal and connective tissue disorders
Foot Pain
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Injury, poisoning and procedural complications
Right Knee Fracture
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
General disorders
Foot Edema
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
General disorders
Periorbital Edema
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Musculoskeletal and connective tissue disorders
Thoracic Pain
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
10.0%
2/20 • Number of events 2 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Gastrointestinal disorders
Cancer Related Pain
|
5.0%
1/20 • Number of events 2 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Musculoskeletal and connective tissue disorders
Right Leg Pain
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
10.0%
2/20 • Number of events 3 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Skin and subcutaneous tissue disorders
Skin Infection
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
10.0%
2/20 • Number of events 2 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Musculoskeletal and connective tissue disorders
Swollen Joints
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Gastrointestinal disorders
Taste Changes
|
15.0%
3/20 • Number of events 3 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
10.0%
2/20 • Number of events 2 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Renal and urinary disorders
Urinary Frequency
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Renal and urinary disorders
Urinary Tract Infection
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Eye disorders
Vision Changes
|
10.0%
2/20 • Number of events 2 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Metabolism and nutrition disorders
Weight Loss
|
20.0%
4/20 • Number of events 4 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Ear and labyrinth disorders
Tinnitus
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Gastrointestinal disorders
Xerostomia
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.0%
1/20 • Number of events 1 • Up to 4 years
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place