Trial Outcomes & Findings for Nivolumab, Ipilimumab, and Short-course Radiotherapy in Adults With Newly Diagnosed, MGMT Unmethylated Glioblastoma (NCT NCT03367715)
NCT ID: NCT03367715
Last Updated: 2022-07-01
Results Overview
Survival rate is defined as the percentage of participants who survived at 1 year (from either the date of diagnosis or the start of treatment for a disease)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
1 year
Results posted on
2022-07-01
Participant Flow
Participant milestones
| Measure |
Nivolumab + Ipilimumab + Short-course Radiation Therapy
within 6 weeks of the first diagnostic surgery for glioblastoma, all subjects will initiate study treatment on Day 1
Nivolumab: study treatment on Day 1 with one dose of nivolumab 3 mg/kg
Ipilimumab: study treatment on Day 1 with one dose of ipilimumab 1mg/kg
Radiation Therapy (RT): total dose of 30 Gy, given in 5 consecutive fractions of 6 Gy each fraction.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nivolumab, Ipilimumab, and Short-course Radiotherapy in Adults With Newly Diagnosed, MGMT Unmethylated Glioblastoma
Baseline characteristics by cohort
| Measure |
Nivolumab + Ipilimumab + Short-course Radiation Therapy
n=10 Participants
within 6 weeks of the first diagnostic surgery for glioblastoma, all subjects will initiate study treatment on Day 1
Nivolumab: study treatment on Day 1 with one dose of nivolumab 3 mg/kg
Ipilimumab: study treatment on Day 1 with one dose of ipilimumab 1mg/kg
Radiation Therapy (RT): total dose of 30 Gy, given in 5 consecutive fractions of 6 Gy each fraction.
|
|---|---|
|
Age, Continuous
|
56 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 1 yearSurvival rate is defined as the percentage of participants who survived at 1 year (from either the date of diagnosis or the start of treatment for a disease)
Outcome measures
| Measure |
Nivolumab + Ipilimumab + Short-course Radiation Therapy
n=10 Participants
within 6 weeks of the first diagnostic surgery for glioblastoma, all subjects will initiate study treatment on Day 1
Nivolumab: study treatment on Day 1 with one dose of nivolumab 3 mg/kg
Ipilimumab: study treatment on Day 1 with one dose of ipilimumab 1mg/kg
Radiation Therapy (RT): total dose of 30 Gy, given in 5 consecutive fractions of 6 Gy each fraction.
|
|---|---|
|
1-year Overall Survival (OS)
|
80 percentage of participants
|
SECONDARY outcome
Timeframe: 3 yearsMedian survival rate of evaluable participants will be reported in months of survival
Outcome measures
| Measure |
Nivolumab + Ipilimumab + Short-course Radiation Therapy
n=10 Participants
within 6 weeks of the first diagnostic surgery for glioblastoma, all subjects will initiate study treatment on Day 1
Nivolumab: study treatment on Day 1 with one dose of nivolumab 3 mg/kg
Ipilimumab: study treatment on Day 1 with one dose of ipilimumab 1mg/kg
Radiation Therapy (RT): total dose of 30 Gy, given in 5 consecutive fractions of 6 Gy each fraction.
|
|---|---|
|
Median Overall Survival (OS)
|
16.85 months
Interval 4.49 to 32.89
|
SECONDARY outcome
Timeframe: 3 yearsThe length of time during and after the treatment that a patient lives with the disease but it does not get worse.
Outcome measures
| Measure |
Nivolumab + Ipilimumab + Short-course Radiation Therapy
n=10 Participants
within 6 weeks of the first diagnostic surgery for glioblastoma, all subjects will initiate study treatment on Day 1
Nivolumab: study treatment on Day 1 with one dose of nivolumab 3 mg/kg
Ipilimumab: study treatment on Day 1 with one dose of ipilimumab 1mg/kg
Radiation Therapy (RT): total dose of 30 Gy, given in 5 consecutive fractions of 6 Gy each fraction.
|
|---|---|
|
Median Progression Free Survival (PFS)
|
5.92 months
Interval 1.48 to 13.93
|
Adverse Events
Nivolumab + Ipilimumab + Short-course Radiation Therapy
Serious events: 7 serious events
Other events: 10 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Nivolumab + Ipilimumab + Short-course Radiation Therapy
n=10 participants at risk
within 6 weeks of the first diagnostic surgery for glioblastoma, all subjects will initiate study treatment on Day 1
Nivolumab: study treatment on Day 1 with one dose of nivolumab 3 mg/kg
Ipilimumab: study treatment on Day 1 with one dose of ipilimumab 1mg/kg
Radiation Therapy (RT): total dose of 30 Gy, given in 5 consecutive fractions of 6 Gy each fraction.
|
|---|---|
|
Investigations
Alanine Aminotransferase Increased
|
60.0%
6/10 • 3 years
Regular investigator assessment
|
|
Investigations
Aspartate Aminotransferase Increased
|
40.0%
4/10 • 3 years
Regular investigator assessment
|
|
Gastrointestinal disorders
Diarrhea
|
30.0%
3/10 • 3 years
Regular investigator assessment
|
|
Nervous system disorders
Dizziness
|
20.0%
2/10 • 3 years
Regular investigator assessment
|
|
Nervous system disorders
Encephalopathy
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
20.0%
2/10 • 3 years
Regular investigator assessment
|
|
Nervous system disorders
Headache
|
20.0%
2/10 • 3 years
Regular investigator assessment
|
|
Nervous system disorders
Paresthesia
|
20.0%
2/10 • 3 years
Regular investigator assessment
|
|
Nervous system disorders
Seizure
|
20.0%
2/10 • 3 years
Regular investigator assessment
|
Other adverse events
| Measure |
Nivolumab + Ipilimumab + Short-course Radiation Therapy
n=10 participants at risk
within 6 weeks of the first diagnostic surgery for glioblastoma, all subjects will initiate study treatment on Day 1
Nivolumab: study treatment on Day 1 with one dose of nivolumab 3 mg/kg
Ipilimumab: study treatment on Day 1 with one dose of ipilimumab 1mg/kg
Radiation Therapy (RT): total dose of 30 Gy, given in 5 consecutive fractions of 6 Gy each fraction.
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
Psychiatric disorders
Agitation
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
Investigations
Alkaline phosphatase increased
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
5/10 • 3 years
Regular investigator assessment
|
|
Psychiatric disorders
Anxiety
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
Investigations
Blood lactate dehydrogenase increased
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
Injury, poisoning and procedural complications
Bruising (Injection Site)
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
Nervous system disorders
Central Nervous System Necrosis
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
Musculoskeletal and connective tissue disorders
Chest Wall Pain
|
20.0%
2/10 • 3 years
Regular investigator assessment
|
|
Psychiatric disorders
Confusion
|
30.0%
3/10 • 3 years
Regular investigator assessment
|
|
Eye disorders
Conjunctivitis
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
Psychiatric disorders
Creatinine Increased
|
20.0%
2/10 • 3 years
Regular investigator assessment
|
|
Psychiatric disorders
Delirium
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
Psychiatric disorders
Depression
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
Eye disorders
Dry eye
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
Gastrointestinal disorders
Dry Mouth
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
Nervous system disorders
Dysarthria
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
Nervous system disorders
Dysgeusia
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
Gastrointestinal disorders
Dysphagia
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
Eye disorders
Eye disorder, other; Diplopia
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
Nervous system disorders
Facial nerve disorder
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
Injury, poisoning and procedural complications
Fall
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
General disorders
Fatigue
|
30.0%
3/10 • 3 years
Regular investigator assessment
|
|
Gastrointestinal disorders
Flatulence
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
20.0%
2/10 • 3 years
Regular investigator assessment
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
40.0%
4/10 • 3 years
Regular investigator assessment
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
20.0%
2/10 • 3 years
Regular investigator assessment
|
|
Vascular disorders
Hypotension
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
Psychiatric disorders
Insomnia
|
20.0%
2/10 • 3 years
Regular investigator assessment
|
|
Investigations
Lipase increased
|
20.0%
2/10 • 3 years
Regular investigator assessment
|
|
General disorders
Localized Edema
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
Blood and lymphatic system disorders
Lymphocyte Count Decreased
|
70.0%
7/10 • 3 years
Regular investigator assessment
|
|
Blood and lymphatic system disorders
Lymphocyte count increased
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
Gastrointestinal disorders
Nausea
|
20.0%
2/10 • 3 years
Regular investigator assessment
|
|
Eye disorders
Oculomotor nerve disorder
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
General disorders
Pain
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
Skin and subcutaneous tissue disorders
Papulopustular Rash
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
Blood and lymphatic system disorders
Platelet Count Decreased
|
40.0%
4/10 • 3 years
Regular investigator assessment
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
Nervous system disorders
Pyramidal Tract Syndrome
|
20.0%
2/10 • 3 years
Regular investigator assessment
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
Skin and subcutaneous tissue disorders
Rash Maculopapular
|
50.0%
5/10 • 3 years
Regular investigator assessment
|
|
Psychiatric disorders
Restlessness
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
Investigations
Serum Amylase Increased
|
30.0%
3/10 • 3 years
Regular investigator assessment
|
|
Cardiac disorders
Sinus Bradycardia
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
Skin and subcutaneous tissue disorders
Skin + Subcutaneous tissue disorder (foot ulcer)
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
Nervous system disorders
Somnolence
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
Nervous system disorders
Tremor
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
Infections and infestations
Urinary tract infection
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
Renal and urinary disorders
Urinary urgency
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
Eye disorders
Watering Eyes
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
Investigations
Weight Loss
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
|
Blood and lymphatic system disorders
White Blood Cell Decreased
|
10.0%
1/10 • 3 years
Regular investigator assessment
|
Additional Information
Sylvia Kurz, MD, PhD
NYU Langone Health - Perlmutter Cancer Center
Phone: 212-731-6267
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place