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Checkpoint Inhibitor

Nivolumab + Radiation Therapy +/- Ipilimumab for Brain Metastasis from Lung Cancer

Phase 1 & 2
Waitlist Available
Led By Jing Li
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have a performance status of 0 or 1 on the ECOG performance scale
Female subjects of childbearing potential should have a negative pregnancy test and be willing to use birth control
Must not have
Recent use of monoclonal antibodies or anti PD1/PD-L1 therapies
Diagnosis of severe active scleroderma, lupus, or other rheumatologic/autoimmune diseases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month after radiation to 3 years
Awards & highlights

Summary

This trial is testing the side effects and best dose of nivolumab when given with stereotactic radiosurgery or whole brain radiotherapy, with or without ipilimumab, to treat patients with non-small cell lung cancer that has spread to the brain.

Who is the study for?
This trial is for adults with non-small cell lung cancer that has spread to the brain. They must have at least one treatable brain lesion, be in good physical condition (ECOG 0 or 1), and meet certain blood and biochemical criteria. Women of childbearing age need a negative pregnancy test and agree to birth control; men must use contraception too. Those who've had prior treatments may qualify under specific conditions.
What is being tested?
The study is testing how well patients respond to Nivolumab combined with either stereotactic radiosurgery or whole-brain radiotherapy, with or without Ipilimumab. It aims to find the safest doses while assessing how these therapies affect tumor growth in the brain from lung cancer.
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs, fatigue, skin issues, hormone gland problems like thyroid dysfunction, infusion reactions during treatment administration, and potential worsening of pre-existing autoimmune diseases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am not pregnant and agree to use birth control.
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My cancer has spread to my brain, as confirmed by an MRI.
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My lung cancer diagnosis was confirmed through a lab test.
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I have a brain lesion larger than 0.3 cm that can be treated with radiation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have recently used monoclonal antibodies or anti PD1/PD-L1 therapies.
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I have been diagnosed with a severe active form of scleroderma, lupus, or another similar autoimmune disease.
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I have a known infection of HIV, hepatitis B, or hepatitis C.
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I have another cancer that is getting worse, cancer in my brain's coverings, or an active infection.
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I have not had a live vaccine or severe side effects from radiation or brain toxicity recently.
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I cannot or do not want to undergo an MRI of my brain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month after radiation to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month after radiation to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
RP2D of nivolumab in combination with ipilimumab defined as the probability of > 15% intracranial or > 30% extracranial DLT (Phase I)
Recommended phase 2 dose (RP2D) of nivolumab defined as the probability of > 15% intracranial or > 30% extracranial dose limiting toxicities (DLT) (Phase I)
Secondary study objectives
Neurocognitive changes assessed by the Hopkins Verbal Learning Revised (HVLT-R) total recall test (Phase II)

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717
80%
Fatigue
70%
Diarrhoea
70%
Headache
40%
Vomiting
40%
Aspartate aminotransferase increased
40%
Rash maculo-papular
40%
Alanine aminotransferase increased
40%
Lipase increased
30%
Partial seizures
30%
Hemiparesis
30%
Gait disturbance
30%
Fall
30%
Cough
30%
Dry skin
30%
Amylase increased
30%
Nausea
30%
Confusional state
20%
Malignant neoplasm progression
20%
Pyrexia
20%
Candida infection
20%
Mucosal infection
20%
Decreased appetite
20%
Back pain
20%
Dysphonia
20%
Hypotension
20%
Colitis
20%
Hyperthyroidism
20%
Oedema peripheral
20%
Muscular weakness
20%
Hypothyroidism
10%
Cushingoid
10%
Tinnitus
10%
Diabetic ketoacidosis
10%
Procedural haemorrhage
10%
Blood bilirubin increased
10%
Bradycardia
10%
Sinus tachycardia
10%
Hyperglycaemia
10%
Hypocalcaemia
10%
Neck pain
10%
Brain oedema
10%
Hydrocephalus
10%
Lethargy
10%
Seizure
10%
Hypertension
10%
Palpitations
10%
Cheilitis
10%
Presyncope
10%
Face oedema
10%
Oedema
10%
Conjunctivitis
10%
Enterocolitis infectious
10%
Oral candidiasis
10%
Pneumonia
10%
Sinusitis
10%
Staphylococcal infection
10%
Blood alkaline phosphatase increased
10%
Spinal pain
10%
Tremor
10%
Dizziness
10%
Dysarthria
10%
Urinary retention
10%
Dyspnoea exertional
10%
Nasal congestion
10%
Pneumonitis
10%
Dermatitis
10%
Erythema
10%
Rash
10%
Klebsiella infection
10%
Hypomagnesaemia
10%
Syncope
10%
Haemorrhage intracranial
10%
Pancreatitis
10%
Cholecystitis
10%
Upper respiratory tract infection
10%
Acute kidney injury
10%
Dermatitis bullous
10%
Lymphopenia
10%
Optic nerve disorder
10%
Visual impairment
10%
Dehydration
10%
Hypokalaemia
10%
Scoliosis
10%
Cognitive disorder
10%
Memory impairment
10%
Hallucination
10%
Insomnia
10%
Irritability
10%
Urinary incontinence
10%
Dyspnoea
10%
Dermatitis acneiform
10%
Pelvic venous thrombosis
10%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: Arm N1+I3
Cohort 2: Arm B
Part A Cohort 1c: Arm N3+RT+TMZ
Part A Cohort 1d: Arm N3+RT
Part B Cohort 1c: Arm N3+RT+TMZ
Part B Cohort 1d: Arm N3+RT
Cohort 1: Arm N3
Cohort 1b: Arm N3+I1
Cohort 2: Arm N3

Trial Design

4Treatment groups
Experimental Treatment
Group I: Group D (nivolumab, ipilimumab, WBRT)Experimental Treatment5 Interventions
GROUP D: Patients receive nivolumab as in Group A and ipilimumab as in Group C. Patients undergo WBRT once daily for 10 days.
Group II: Group C (nivolumab, ipilimumab, SRS)Experimental Treatment5 Interventions
Patients receive nivolumab as in Group A and ipilimumab IV over 90 minutes every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo SRS once the day after nivolumab administration.
Group III: Group B (nivolumab, WBRT)Experimental Treatment4 Interventions
Patients then receive nivolumab as in Group A. Patients undergo WBRT once daily for 10 days.
Group IV: Group A (nivolumab, SRS)Experimental Treatment4 Interventions
Patients receive nivolumab IV over 90 minutes every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo SRS once the day after nivolumab administration.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Radiosurgery
2021
Completed Phase 2
~440
Cognitive Assessment
2011
Completed Phase 2
~1420
Ipilimumab
2014
Completed Phase 3
~3140
Nivolumab
2014
Completed Phase 3
~5220
Whole-Brain Radiotherapy
2012
Completed Phase 2
~150

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,039 Previous Clinical Trials
1,799,621 Total Patients Enrolled
Jing LiPrincipal InvestigatorM.D. Anderson Cancer Center
8 Previous Clinical Trials
51,652 Total Patients Enrolled

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02696993 — Phase 1 & 2
Non-Small Cell Lung Cancer Research Study Groups: Group C (nivolumab, ipilimumab, SRS), Group A (nivolumab, SRS), Group D (nivolumab, ipilimumab, WBRT), Group B (nivolumab, WBRT)
Non-Small Cell Lung Cancer Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT02696993 — Phase 1 & 2
Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02696993 — Phase 1 & 2
~2 spots leftby Dec 2024
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