Trial Outcomes & Findings for Cytokine Microdialysis for Real-Time Immune Monitoring in Glioblastoma Patients Undergoing Checkpoint Blockade (NCT NCT03493932)
NCT ID: NCT03493932
Last Updated: 2024-07-24
Results Overview
The proportion of patients that have a rise in interferon gamma levels within the tumor microenvironment of 4 pg/ml or higher before the first dose of Nivolumab as compared to the 5th day after treatment with Nivolumab.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
21 participants
Primary outcome timeframe
Day 8
Results posted on
2024-07-24
Participant Flow
Participant milestones
| Measure |
Experimental: Nivolumab and BMS-986016
Nivolumab: OPDIVO is a human programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.
BMS-986016: Anti-Lymphocyte Activation Gene-3 antibody undergoing clinical evaluation by Bristol-Myers Squibb
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cytokine Microdialysis for Real-Time Immune Monitoring in Glioblastoma Patients Undergoing Checkpoint Blockade
Baseline characteristics by cohort
| Measure |
Experimental: Nivolumab and BMS-986016
n=13 Participants
Nivolumab: OPDIVO is a human programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.
BMS-986016: Anti-Lymphocyte Activation Gene-3 antibody undergoing clinical evaluation by Bristol-Myers Squibb
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 8The proportion of patients that have a rise in interferon gamma levels within the tumor microenvironment of 4 pg/ml or higher before the first dose of Nivolumab as compared to the 5th day after treatment with Nivolumab.
Outcome measures
| Measure |
Recurrent Glioblastoma Patients
n=13 Participants
Nivolumab: OPDIVO is a human programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.
BMS-986016: Anti-Lymphocyte Activation Gene-3 antibody undergoing clinical evaluation by Bristol-Myers Squibb
|
|---|---|
|
Increase of Interferon Gamma Levels
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 8The number of patients with any adverse events that are directly attributable to placement of the microdialysis catheter. Specifically, intracranial hemorrhage, intracranial infection, wound infection, or new neurological deficit attributable to location of microdialysis catheter placement were to be captured
Outcome measures
| Measure |
Recurrent Glioblastoma Patients
n=13 Participants
Nivolumab: OPDIVO is a human programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.
BMS-986016: Anti-Lymphocyte Activation Gene-3 antibody undergoing clinical evaluation by Bristol-Myers Squibb
|
|---|---|
|
Microdialysis Catheter
|
13 Participants
|
PRIMARY outcome
Timeframe: Day 8The safety of the combination of nivolumab and BMS-986016 in recurrent glioblastoma patients
Outcome measures
| Measure |
Recurrent Glioblastoma Patients
n=13 Participants
Nivolumab: OPDIVO is a human programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.
BMS-986016: Anti-Lymphocyte Activation Gene-3 antibody undergoing clinical evaluation by Bristol-Myers Squibb
|
|---|---|
|
Drug Safety
|
117 events attributed to nivolumab/BMS-98601
|
Adverse Events
Recurrent Glioblastoma Patients
Serious events: 13 serious events
Other events: 1 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Recurrent Glioblastoma Patients
n=13 participants at risk
Nivolumab: OPDIVO is a human programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.
BMS-986016: Anti-Lymphocyte Activation Gene-3 antibody undergoing clinical evaluation by Bristol-Myers Squibb
|
|---|---|
|
General disorders
Death
|
7.7%
1/13 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Recurrent Glioblastoma Patients
n=13 participants at risk
Nivolumab: OPDIVO is a human programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.
BMS-986016: Anti-Lymphocyte Activation Gene-3 antibody undergoing clinical evaluation by Bristol-Myers Squibb
|
|---|---|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
7.7%
1/13 • 1 year
|
|
Blood and lymphatic system disorders
White blood cell decreased
|
7.7%
1/13 • 1 year
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
7.7%
1/13 • 1 year
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
7.7%
1/13 • 1 year
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.7%
1/13 • 1 year
|
|
Blood and lymphatic system disorders
Elevated WBC count
|
7.7%
1/13 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
7.7%
1/13 • 1 year
|
|
Blood and lymphatic system disorders
ALC low
|
7.7%
1/13 • 1 year
|
|
Endocrine disorders
Hypothyroidism
|
7.7%
1/13 • 1 year
|
|
Endocrine disorders
Hyperglycemia
|
7.7%
1/13 • 1 year
|
|
Endocrine disorders
Abnormal thyroid function tests
|
7.7%
1/13 • 1 year
|
|
Endocrine disorders
Cushingoid
|
7.7%
1/13 • 1 year
|
|
Endocrine disorders
Adrenal insufficiency
|
7.7%
1/13 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.7%
1/13 • 1 year
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
7.7%
1/13 • 1 year
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
7.7%
1/13 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.7%
1/13 • 1 year
|
|
Metabolism and nutrition disorders
Alkalosis
|
7.7%
1/13 • 1 year
|
|
Investigations
Lymphocyte count decreased
|
7.7%
1/13 • 1 year
|
|
Investigations
Investigations - Other specify
|
7.7%
1/13 • 1 year
|
|
Investigations
GGT increased
|
7.7%
1/13 • 1 year
|
|
Investigations
CK increased
|
7.7%
1/13 • 1 year
|
|
Investigations
elevated total bilirubin
|
7.7%
1/13 • 1 year
|
|
Investigations
elevated AST
|
7.7%
1/13 • 1 year
|
|
Investigations
Alkaline phosphatase increased
|
7.7%
1/13 • 1 year
|
|
Investigations
Alanine aminotransferase increased
|
7.7%
1/13 • 1 year
|
|
General disorders
Fever
|
7.7%
1/13 • 1 year
|
|
General disorders
Fatigue
|
7.7%
1/13 • 1 year
|
|
General disorders
Chills
|
7.7%
1/13 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
1/13 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
7.7%
1/13 • 1 year
|
|
Gastrointestinal disorders
Hemorrhoids
|
7.7%
1/13 • 1 year
|
|
Gastrointestinal disorders
Fecal incontinence
|
7.7%
1/13 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
7.7%
1/13 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
7.7%
1/13 • 1 year
|
|
Gastrointestinal disorders
Anorectal infection
|
7.7%
1/13 • 1 year
|
|
Eye disorders
Blurred Vision
|
7.7%
1/13 • 1 year
|
|
Ear and labyrinth disorders
Vertigo
|
7.7%
1/13 • 1 year
|
|
Cardiac disorders
atrial fibrillation
|
7.7%
1/13 • 1 year
|
|
Cardiac disorders
Hypertension
|
7.7%
1/13 • 1 year
|
|
Congenital, familial and genetic disorders
Li Fraumeni Syndrome
|
7.7%
1/13 • 1 year
|
|
Infections and infestations
Upper respiratory infection
|
7.7%
1/13 • 1 year
|
|
Injury, poisoning and procedural complications
Fall
|
7.7%
1/13 • 1 year
|
|
Injury, poisoning and procedural complications
Wound dehisence of biopsy site
|
7.7%
1/13 • 1 year
|
|
Musculoskeletal and connective tissue disorders
extremity weakness
|
7.7%
1/13 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
7.7%
1/13 • 1 year
|
|
Psychiatric disorders
Insomnia
|
7.7%
1/13 • 1 year
|
|
Renal and urinary disorders
Urinary Incontinence
|
7.7%
1/13 • 1 year
|
|
Renal and urinary disorders
urinary urgency
|
7.7%
1/13 • 1 year
|
|
Reproductive system and breast disorders
benign prostate hypertrophy
|
7.7%
1/13 • 1 year
|
|
Vascular disorders
Flushing
|
7.7%
1/13 • 1 year
|
|
Vascular disorders
Hypertension
|
7.7%
1/13 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify - limited skin erythema only, asymptomatic
|
7.7%
1/13 • 1 year
|
|
Skin and subcutaneous tissue disorders
pruritis
|
7.7%
1/13 • 1 year
|
|
Skin and subcutaneous tissue disorders
Petechial rash
|
7.7%
1/13 • 1 year
|
|
Skin and subcutaneous tissue disorders
Macular rash
|
7.7%
1/13 • 1 year
|
|
Skin and subcutaneous tissue disorders
Papular erythematous rash on upper extremities
|
7.7%
1/13 • 1 year
|
|
Skin and subcutaneous tissue disorders
Folliculitis
|
7.7%
1/13 • 1 year
|
|
Skin and subcutaneous tissue disorders
rash
|
7.7%
1/13 • 1 year
|
|
Skin and subcutaneous tissue disorders
Pityrosporum folliculitis
|
7.7%
1/13 • 1 year
|
|
Skin and subcutaneous tissue disorders
sweating
|
7.7%
1/13 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
sore throat
|
7.7%
1/13 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.7%
1/13 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Congestion
|
7.7%
1/13 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
7.7%
1/13 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
7.7%
1/13 • 1 year
|
|
Nervous system disorders
balance instability
|
7.7%
1/13 • 1 year
|
|
Nervous system disorders
Cerebral edema
|
7.7%
1/13 • 1 year
|
|
Nervous system disorders
change with cognition "fuzzy cognition
|
7.7%
1/13 • 1 year
|
|
Nervous system disorders
Communicating hydrocephalus
|
7.7%
1/13 • 1 year
|
|
Nervous system disorders
Difficulty reading
|
7.7%
1/13 • 1 year
|
|
Nervous system disorders
Drowsiness
|
7.7%
1/13 • 1 year
|
|
Nervous system disorders
dysphasia
|
7.7%
1/13 • 1 year
|
|
Nervous system disorders
Edema, cerebral
|
7.7%
1/13 • 1 year
|
|
Nervous system disorders
Headache
|
7.7%
1/13 • 1 year
|
|
Nervous system disorders
intracranial edema
|
7.7%
1/13 • 1 year
|
|
Nervous system disorders
Intracranial Hemorrhage (CT)
|
7.7%
1/13 • 1 year
|
|
Nervous system disorders
Left facial droop
|
7.7%
1/13 • 1 year
|
|
Nervous system disorders
left facial weakness
|
7.7%
1/13 • 1 year
|
|
Nervous system disorders
left hemiparesis
|
7.7%
1/13 • 1 year
|
|
Nervous system disorders
Left lower quadrantanopsia
|
7.7%
1/13 • 1 year
|
|
Nervous system disorders
Left superior quadrantanopsia
|
7.7%
1/13 • 1 year
|
|
Nervous system disorders
Mental Fogginess- distraction
|
7.7%
1/13 • 1 year
|
|
Nervous system disorders
Paresthesia
|
7.7%
1/13 • 1 year
|
|
Nervous system disorders
Photophobia
|
7.7%
1/13 • 1 year
|
|
Nervous system disorders
Positive pronator drift test
|
7.7%
1/13 • 1 year
|
|
Nervous system disorders
Pre-syncope
|
7.7%
1/13 • 1 year
|
|
Nervous system disorders
Facial muscle weakness
|
7.7%
1/13 • 1 year
|
|
Nervous system disorders
Seizure
|
7.7%
1/13 • 1 year
|
|
Nervous system disorders
Short term memory difficulty
|
7.7%
1/13 • 1 year
|
|
Nervous system disorders
Somnolence
|
7.7%
1/13 • 1 year
|
|
Nervous system disorders
Stroke
|
7.7%
1/13 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place