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Monoclonal Antibodies

Nivolumab for Glioblastoma

Phase 2

Waitlist Available

Led By David Peereboom, MD

Research Sponsored by Case Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to six months after beginning treatment

Awards & highlights

Study Summary

This trial is testing an antibody to see if it will help the body's immune system attack glioblastoma tumors. Bevacizumab will also be given, which works on the blood vessels supplying the tumor. 90 people are expected to participate, with the trial lasting up to 3 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to six months after beginning treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to six months after beginning treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to six months after beginning treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Survival at 12 Months (OS-12)

Secondary outcome measures

Duration of Response

Overall Response Rate (ORR)

Overall Survival (OS)

+2 more

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533

57%

Nausea

54%

Anaemia

51%

Fatigue

39%

Decreased appetite

36%

Malignant neoplasm progression

32%

Constipation

31%

Diarrhoea

30%

Cough

29%

Vomiting

29%

Dyspnoea

25%

Oedema peripheral

24%

Back pain

21%

Pyrexia

21%

Neutropenia

19%

Headache

19%

Hypomagnesaemia

18%

Arthralgia

16%

Asthenia

16%

Dizziness

16%

Neutrophil count decreased

15%

Thrombocytopenia

15%

Insomnia

14%

Hyponatraemia

14%

Rash

14%

Weight decreased

14%

Platelet count decreased

13%

Blood creatinine increased

13%

White blood cell count decreased

12%

Hypokalaemia

12%

Pruritus

12%

Abdominal pain

12%

Pain in extremity

11%

Myalgia

11%

Alanine aminotransferase increased

11%

Aspartate aminotransferase increased

10%

Alopecia

10%

Dry skin

10%

Hypoalbuminaemia

10%

Muscular weakness

10%

Chest pain

10%

Dysgeusia

10%

Pneumonia

10%

Productive cough

Abdominal pain upper

Upper respiratory tract infection

Hypothyroidism

Mucosal inflammation

Peripheral sensory neuropathy

Lacrimation increased

Nasopharyngitis

Non-cardiac chest pain

Epistaxis

Haemoptysis

Stomatitis

Dysphonia

Bronchitis

Chills

Hypertension

Hyperkalaemia

Hyperglycaemia

Blood alkaline phosphatase increased

Dehydration

Lymphocyte count decreased

Anxiety

Hypophosphataemia

Leukopenia

Pleural effusion

Neuropathy peripheral

Pneumonitis

Oropharyngeal pain

Rash maculo-papular

Hypotension

Musculoskeletal chest pain

Malaise

Pain

Dry mouth

Urinary tract infection

Dyspepsia

Gamma-glutamyltransferase increased

Depression

Muscle spasms

Fall

Pulmonary embolism

Metastases to central nervous system

Myocardial infarction

Febrile neutropenia

Musculoskeletal pain

Chronic obstructive pulmonary disease

Malignant pleural effusion

Sepsis

General physical health deterioration

Adrenal insufficiency

Atrial fibrillation

Cardiac failure

Embolism

Hypercalcaemia

Neoplasm progression

Small intestinal haemorrhage

Femur fracture

Cancer pain

Confusional state

Pneumothorax

Circulatory collapse

Bone pain

Pericardial effusion malignant

Atrial flutter

Bronchial obstruction

Superior vena cava syndrome

Syncope

Performance status decreased

Pancytopenia

Colitis

Pericardial effusion

Gastrointestinal haemorrhage

Ileus

Small intestinal obstruction

Lung cancer metastatic

Respiratory tract infection

Respiratory failure

Tumour pain

Appendicitis

Skin infection

Ataxia

Seizure

100%

80%

60%

40%

20%

Study treatment Arm

Investigator Choice of Chemotherapy

Post Chemotherapy Optional Nivolumab

Nivolumab

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Nivolumab + Low Dose BevacizumabExperimental Treatment2 Interventions

nivolumab 240 mg IV and low dose bevacizumab 3mg/kg every 2 weeks until disease progression or unacceptable toxicity Nivolumab is to be administered first. The second infusion will be bevacizumab, and will start no sooner than 10 minutes after completion of the nivolumab infusion

Group II: Nivolumab + Standard Dose BevacizumabActive Control2 Interventions

nivolumab 240 mg IV and standard dose bevacizumab 10 mg/kg every 2 weeks until disease progression or unacceptable toxicity. Nivolumab is to be administered first. The second infusion will be bevacizumab, and will start no sooner than 10 minutes after completion of the nivolumab infusion

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

FDA approved

Bevacizumab

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor

452 Previous Clinical Trials

31,820 Total Patients Enrolled

15 Trials studying Glioblastoma

356 Patients Enrolled for Glioblastoma

David Peereboom, MDPrincipal InvestigatorCleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

9 Previous Clinical Trials

313 Total Patients Enrolled

9 Trials studying Glioblastoma

313 Patients Enrolled for Glioblastoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent could Nivolumab potentially be harmful to people?

"Taking Nivolumab's Phase 2 status into consideration, our team at Power have assigned it a score of 2 for safety. This indicates that the drug has some evidence in support of its security but not yet any proof to back up its efficacy."

Answered by AI

What medical conditions is Nivolumab generally employed to treat?

"Nivolumab is commonly prescribed to treat unresectable melanoma and has also been shown to be beneficial in treating squamous cell carcinoma, locally advanced nonsquamous non-small cell lung cancer, and high risk of recurrence."

Answered by AI

Could you shed light on any previous research involving Nivolumab?

"Presently, there are 1060 clinical trials investigating Nivolumab with 167 in Phase 3. Of these studies, 56612 locations across the world have been identified as test sites- Taibei among them."

Answered by AI

What is the capacity of enrollees to this research endeavor?

"No, this medical trial has concluded its recruitment process. It was originally made available on May 21st 2018 and last updated on the same day in 2021. There are presently 441 trials recruiting patients with glioblastoma and 1060 studies requiring Nivolumab volunteers."

Answered by AI

Is there still the opportunity for subjects to join this research initiative?

"According to clinicaltrials.gov, this trial is no longer in search of participants and has not been updated since May 21st 2021. Nonetheless, there are still 1,501 other trials available for enrolling patients at the present time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Nivolumab Plus Standard Dose Bevacizumab Versus Nivolumab Plus Low Dose Bevacizumab in GBM

2018. "Nivolumab Plus Standard Dose Bevacizumab Versus Nivolumab Plus Low Dose Bevacizumab in GBM". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03452579.