Trial Outcomes & Findings for Avelumab With Hypofractionated Radiation Therapy in Adults With Isocitrate Dehydrogenase (IDH) Mutant Glioblastoma (NCT NCT02968940)
NCT ID: NCT02968940
Last Updated: 2022-06-29
Results Overview
Subjects are evaluable for DLTs (defined in section 5.2.1.2) if they have received at least one dose of Avelumab, have completed HFRT per protocol and have completed safety assessments over the entire DLT evaluation period (days 1 through 28).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
Day 28
Results posted on
2022-06-29
Participant Flow
Participant milestones
| Measure |
Avelumab and Hypofractionated Radiation Therapy(HFRT)
* Avelumab 10 mg/kg intravenously (IV) every 2 weeks.
* Hypofractionated radiation therapy to a total dose of 30 Gy, delivered in 6 Gy per fraction for 5 consecutive daily fractions
Avelumab: Avelumab 10 mg/kg intravenously (IV) every 2 weeks
Hypofractionated radiation therapy (HFRT): Hypofractionated radiation therapy to a total dose of 30 Gy, delivered in 6 Gy per fraction for 5 consecutive daily fractions
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Avelumab With Hypofractionated Radiation Therapy in Adults With Isocitrate Dehydrogenase (IDH) Mutant Glioblastoma
Baseline characteristics by cohort
| Measure |
Avelumab and Hypofractionated Radiation Therapy(HFRT)
n=6 Participants
* Avelumab 10 mg/kg intravenously (IV) every 2 weeks.
* Hypofractionated radiation therapy to a total dose of 30 Gy, delivered in 6 Gy per fraction for 5 consecutive daily fractions
Avelumab: Avelumab 10 mg/kg intravenously (IV) every 2 weeks
Hypofractionated radiation therapy (HFRT): Hypofractionated radiation therapy to a total dose of 30 Gy, delivered in 6 Gy per fraction for 5 consecutive daily fractions
|
|---|---|
|
Age, Continuous
|
45 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 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
|
0 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
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 28Subjects are evaluable for DLTs (defined in section 5.2.1.2) if they have received at least one dose of Avelumab, have completed HFRT per protocol and have completed safety assessments over the entire DLT evaluation period (days 1 through 28).
Outcome measures
| Measure |
Avelumab and Hypofractionated Radiation Therapy(HFRT)
n=6 Participants
* Avelumab 10 mg/kg intravenously (IV) every 2 weeks.
* Hypofractionated radiation therapy to a total dose of 30 Gy, delivered in 6 Gy per fraction for 5 consecutive daily fractions
Avelumab: Avelumab 10 mg/kg intravenously (IV) every 2 weeks
Hypofractionated radiation therapy (HFRT): Hypofractionated radiation therapy to a total dose of 30 Gy, delivered in 6 Gy per fraction for 5 consecutive daily fractions
|
|---|---|
|
Number of Dose Limiting Toxicities
|
0 Events meeting DLT Criteria
|
PRIMARY outcome
Timeframe: Month 6PFS, defined as the time between treatment initiation and first occurrence of disease progression or death, will be censored at last follow-up if the patient remained alive without disease progression
Outcome measures
| Measure |
Avelumab and Hypofractionated Radiation Therapy(HFRT)
n=6 Participants
* Avelumab 10 mg/kg intravenously (IV) every 2 weeks.
* Hypofractionated radiation therapy to a total dose of 30 Gy, delivered in 6 Gy per fraction for 5 consecutive daily fractions
Avelumab: Avelumab 10 mg/kg intravenously (IV) every 2 weeks
Hypofractionated radiation therapy (HFRT): Hypofractionated radiation therapy to a total dose of 30 Gy, delivered in 6 Gy per fraction for 5 consecutive daily fractions
|
|---|---|
|
Median Progression-free Survival (PFS6)
|
4.2 Months
Interval 1.4 to 5.7
|
SECONDARY outcome
Timeframe: Month 12OS will be determined from the time of treatment initiation until the time of death, with OS being censored at last follow-up if the patient remained alive
Outcome measures
| Measure |
Avelumab and Hypofractionated Radiation Therapy(HFRT)
n=6 Participants
* Avelumab 10 mg/kg intravenously (IV) every 2 weeks.
* Hypofractionated radiation therapy to a total dose of 30 Gy, delivered in 6 Gy per fraction for 5 consecutive daily fractions
Avelumab: Avelumab 10 mg/kg intravenously (IV) every 2 weeks
Hypofractionated radiation therapy (HFRT): Hypofractionated radiation therapy to a total dose of 30 Gy, delivered in 6 Gy per fraction for 5 consecutive daily fractions
|
|---|---|
|
Median Overall Survival (OS)
|
10.1 Months
Interval 6.8 to 12.0
|
SECONDARY outcome
Timeframe: Month 12PFS, defined as the time between treatment initiation and first occurrence of disease progression or death, will be censored at last follow-up if the patient remained alive without disease progression
Outcome measures
| Measure |
Avelumab and Hypofractionated Radiation Therapy(HFRT)
n=6 Participants
* Avelumab 10 mg/kg intravenously (IV) every 2 weeks.
* Hypofractionated radiation therapy to a total dose of 30 Gy, delivered in 6 Gy per fraction for 5 consecutive daily fractions
Avelumab: Avelumab 10 mg/kg intravenously (IV) every 2 weeks
Hypofractionated radiation therapy (HFRT): Hypofractionated radiation therapy to a total dose of 30 Gy, delivered in 6 Gy per fraction for 5 consecutive daily fractions
|
|---|---|
|
Median Progression-free Survival (PFS12)
|
4.2 Months
Interval 1.4 to 5.7
|
Adverse Events
Avelumab and Hypofractionated Radiation Therapy(HFRT)
Serious events: 5 serious events
Other events: 6 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Avelumab and Hypofractionated Radiation Therapy(HFRT)
n=6 participants at risk
* Avelumab 10 mg/kg intravenously (IV) every 2 weeks.
* Hypofractionated radiation therapy to a total dose of 30 Gy, delivered in 6 Gy per fraction for 5 consecutive daily fractions
Avelumab: Avelumab 10 mg/kg intravenously (IV) every 2 weeks
Hypofractionated radiation therapy (HFRT): Hypofractionated radiation therapy to a total dose of 30 Gy, delivered in 6 Gy per fraction for 5 consecutive daily fractions
|
|---|---|
|
Nervous system disorders
Edema cerebral
|
50.0%
3/6 • 12 months
regular investigator assessment
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
33.3%
2/6 • 12 months
regular investigator assessment
|
|
Nervous system disorders
Encephalopathy
|
16.7%
1/6 • 12 months
regular investigator assessment
|
|
General disorders
Infusion related reaction
|
16.7%
1/6 • 12 months
regular investigator assessment
|
|
Vascular disorders
Other, radiation vasculopathy
|
16.7%
1/6 • 12 months
regular investigator assessment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.7%
1/6 • 12 months
regular investigator assessment
|
Other adverse events
| Measure |
Avelumab and Hypofractionated Radiation Therapy(HFRT)
n=6 participants at risk
* Avelumab 10 mg/kg intravenously (IV) every 2 weeks.
* Hypofractionated radiation therapy to a total dose of 30 Gy, delivered in 6 Gy per fraction for 5 consecutive daily fractions
Avelumab: Avelumab 10 mg/kg intravenously (IV) every 2 weeks
Hypofractionated radiation therapy (HFRT): Hypofractionated radiation therapy to a total dose of 30 Gy, delivered in 6 Gy per fraction for 5 consecutive daily fractions
|
|---|---|
|
Investigations
White blood cell decreased
|
66.7%
4/6 • 12 months
regular investigator assessment
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6 • 12 months
regular investigator assessment
|
|
Reproductive system and breast disorders
Vaginal dryness
|
16.7%
1/6 • 12 months
regular investigator assessment
|
|
Renal and urinary disorders
Urinary urgency
|
16.7%
1/6 • 12 months
regular investigator assessment
|
|
Infections and infestations
Urinary tract infection
|
33.3%
2/6 • 12 months
regular investigator assessment
|
|
Renal and urinary disorders
Urinary retention
|
16.7%
1/6 • 12 months
regular investigator assessment
|
|
Renal and urinary disorders
Urinary incontinence
|
16.7%
1/6 • 12 months
regular investigator assessment
|
|
Nervous system disorders
Spasticity
|
16.7%
1/6 • 12 months
regular investigator assessment
|
|
Nervous system disorders
Somnolence
|
16.7%
1/6 • 12 months
regular investigator assessment
|
|
Skin and subcutaneous tissue disorders
Sun burn
|
16.7%
1/6 • 12 months
regular investigator assessment
|
|
Cardiac disorders
Sinus tachycardia
|
16.7%
1/6 • 12 months
regular investigator assessment
|
|
Nervous system disorders
Sinus pain
|
16.7%
1/6 • 12 months
regular investigator assessment
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
16.7%
1/6 • 12 months
regular investigator assessment
|
|
Cardiac disorders
Sinus bradycardia
|
16.7%
1/6 • 12 months
regular investigator assessment
|
|
Nervous system disorders
Seizure
|
16.7%
1/6 • 12 months
regular investigator assessment
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
2/6 • 12 months
regular investigator assessment
|
|
Nervous system disorders
Pyramidal tract syndrome
|
33.3%
2/6 • 12 months
regular investigator assessment
|
|
Psychiatric disorders
Psychosis
|
16.7%
1/6 • 12 months
regular investigator assessment
|
|
Investigations
Platelet count decreased
|
33.3%
2/6 • 12 months
regular investigator assessment
|
|
General disorders
Pain
|
16.7%
1/6 • 12 months
regular investigator assessment
|
|
General disorders
Non-cardiac chest pain
|
16.7%
1/6 • 12 months
regular investigator assessment
|
|
Nervous system disorders
Paresthesia
|
33.3%
2/6 • 12 months
regular investigator assessment
|
|
Gastrointestinal disorders
Nausea
|
66.7%
4/6 • 12 months
regular investigator assessment
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
1/6 • 12 months
regular investigator assessment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • 12 months
regular investigator assessment
|
|
Nervous system disorders
Memory impairment
|
16.7%
1/6 • 12 months
regular investigator assessment
|
|
Endocrine disorders
Hypothyroidism
|
16.7%
1/6 • 12 months
regular investigator assessment
|
|
Vascular disorders
Hypotension
|
16.7%
1/6 • 12 months
regular investigator assessment
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
16.7%
1/6 • 12 months
regular investigator assessment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.7%
1/6 • 12 months
regular investigator assessment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
16.7%
1/6 • 12 months
regular investigator assessment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
16.7%
1/6 • 12 months
regular investigator assessment
|
|
Vascular disorders
Hypertension
|
16.7%
1/6 • 12 months
regular investigator assessment
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • 12 months
regular investigator assessment
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
16.7%
1/6 • 12 months
regular investigator assessment
|
|
Gastrointestinal disorders
Tongue sores
|
16.7%
1/6 • 12 months
regular investigator assessment
|
|
General disorders
Fever
|
16.7%
1/6 • 12 months
regular investigator assessment
|
|
Injury, poisoning and procedural complications
Fall
|
33.3%
2/6 • 12 months
regular investigator assessment
|
|
Nervous system disorders
Facial nerve disorder
|
16.7%
1/6 • 12 months
regular investigator assessment
|
|
General disorders
Edema limbs
|
16.7%
1/6 • 12 months
regular investigator assessment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
1/6 • 12 months
regular investigator assessment
|
|
Nervous system disorders
Dysphasia
|
16.7%
1/6 • 12 months
regular investigator assessment
|
|
Nervous system disorders
Dysgeusia
|
16.7%
1/6 • 12 months
regular investigator assessment
|
|
Nervous system disorders
Dysarthria
|
16.7%
1/6 • 12 months
regular investigator assessment
|
|
Psychiatric disorders
Depression
|
33.3%
2/6 • 12 months
regular investigator assessment
|
|
Vascular disorders
Deep vein thrombosis
|
16.7%
1/6 • 12 months
regular investigator assessment
|
|
Investigations
Creatinine increased
|
16.7%
1/6 • 12 months
regular investigator assessment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
2/6 • 12 months
regular investigator assessment
|
|
Gastrointestinal disorders
Constipation
|
33.3%
2/6 • 12 months
regular investigator assessment
|
|
Nervous system disorders
Concentration impairment
|
16.7%
1/6 • 12 months
regular investigator assessment
|
|
Nervous system disorders
Cognitive disturbance
|
16.7%
1/6 • 12 months
regular investigator assessment
|
|
General disorders
Chills
|
16.7%
1/6 • 12 months
regular investigator assessment
|
|
Investigations
CD4 lymphocytes decreased
|
50.0%
3/6 • 12 months
regular investigator assessment
|
|
Eye disorders
Blurred vision
|
16.7%
1/6 • 12 months
regular investigator assessment
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
2/6 • 12 months
regular investigator assessment
|
|
Psychiatric disorders
Anxiety
|
33.3%
2/6 • 12 months
regular investigator assessment
|
|
Infections and infestations
Anorectal infection
|
16.7%
1/6 • 12 months
regular investigator assessment
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
2/6 • 12 months
regular investigator assessment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
2/6 • 12 months
regular investigator assessment
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
2/6 • 12 months
regular investigator assessment
|
|
Gastrointestinal disorders
Abdominal Pain
|
16.7%
1/6 • 12 months
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