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Checkpoint Inhibitor

Nivolumab for Glioblastoma

Phase 1
Waitlist Available
Led By Sadhana Jackson, M.D.
Research Sponsored by National Institute of Neurological Disorders and Stroke (NINDS)
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 end of study
Awards & highlights

Study Summary

This trial is testing whether the combination of two drugs, nivolumab and BMS-986016, can help people with glioblastoma brain tumors that have returned.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of study
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Drug Safety
Increase of interferon gamma levels
Microdialysis safety

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
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Bronchitis
7%
Chills
7%
Hypertension
7%
Hyperkalaemia
7%
Hyperglycaemia
7%
Blood alkaline phosphatase increased
7%
Dehydration
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Musculoskeletal chest pain
5%
Malaise
5%
Pain
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Malignant pleural effusion
2%
Sepsis
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Hypercalcaemia
1%
Neoplasm progression
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Circulatory collapse
1%
Bone pain
1%
Pericardial effusion malignant
1%
Atrial flutter
1%
Bronchial obstruction
1%
Superior vena cava syndrome
1%
Syncope
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab

Trial Design

1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment2 Interventions
Recurrent Glioblastoma patients
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BMS-986016
2018
Completed Phase 2
~130
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)Lead Sponsor
1,339 Previous Clinical Trials
649,360 Total Patients Enrolled
8 Trials studying Glioblastoma
1,189 Patients Enrolled for Glioblastoma
Sadhana Jackson, M.D.Principal InvestigatorNational Institute of Neurological Disorders and Stroke (NINDS)
1 Previous Clinical Trials
7 Total Patients Enrolled

Media Library

BMS-986016 (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03493932 — Phase 1
Glioblastoma Research Study Groups: 1
Glioblastoma Clinical Trial 2023: BMS-986016 Highlights & Side Effects. Trial Name: NCT03493932 — Phase 1
BMS-986016 (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03493932 — Phase 1

Frequently Asked Questions

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

Is this research the pioneering effort of its kind?

"At this moment, Nivolumab has 719 active clinical trials in 49 countries and 2357 cities. Ono Pharmaceutical Co. Ltd started the first trial for this immunotherapy drug back in 2012; it involved 659 patients and successfully finished Phases 1 & 2 of approval testing. Subsequently, 252 additional studies have been completed thus far."

Answered by AI

What medical conditions are usually managed by administering Nivolumab?

"Nivolumab is a powerful treatment for malignant neoplasms, with applications in the management of unresectable melanoma, squamous cell carcinoma and metastatic esophageal adenocarcinoma."

Answered by AI

Could you please elucidate any additional research conducted on Nivolumab?

"Currently, 719 research projects exploring Nivolumab are actively running. Of these studies, 82 have already progressed to Phase 3 trials. While a majority of the investigations involving this treatment are based out of Zürich, BE, there are 40364 sites around the world engaging in related research."

Answered by AI

What are the potential hazards associated with ingesting Nivolumab?

"Given the limited clinical data surrounding nivolumab, our team of experts assigned it a rating of 1. This signifies that this drug is currently undergoing Phase 1 trials which assess its safety and efficacy."

Answered by AI

How many participants is this research project accepting at present?

"Affirmative. Records hosted on clinicaltrials.gov demonstrate that this experiment, which was initially posted on September 24th 2018, is presently seeking participants. Approximately 20 patients must be recruited from 1 medical facility."

Answered by AI

Are there opportunities still available to join this experimental trial?

"Affirmative. Data hosted on clinicaltrials.gov confirms that this medical study, which was initially posted in September of 2018, is actively recruiting patients. A total of 20 people will be accepted from a single location to participate in the trial."

Answered by AI
~3 spots leftby Apr 2025