Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month after radiation to 3 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I am not pregnant and agree to use birth control.
Select...
My cancer has spread to my brain, as confirmed by an MRI.
Select...
My lung cancer diagnosis was confirmed through a lab test.
Select...
I have a brain lesion larger than 0.3 cm that can be treated with radiation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month after radiation to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month after radiation to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Intracranial progression free survival (PFS) (Phase II)
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 outcome measures
Neurocognitive changes assessed by the Hopkins Verbal Learning Revised (HVLT-R) total recall test (Phase II)
Side effects data
From 2022 Phase 3 trial • 541 Patients • NCT0204153357%
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
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
2016
Completed Phase 2
~460
Cognitive Assessment
2011
Completed Phase 2
~1320
Ipilimumab
2014
Completed Phase 3
~2620
Nivolumab
2014
Completed Phase 3
~4750
Whole-Brain Radiotherapy
2012
Completed Phase 2
~150
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,757 Total Patients Enrolled
Jing LiPrincipal InvestigatorM.D. Anderson Cancer Center
8 Previous Clinical Trials
51,652 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have recently used monoclonal antibodies or anti PD1/PD-L1 therapies.I have recently undergone chemotherapy or targeted therapy.I have been diagnosed with a severe active form of scleroderma, lupus, or another similar autoimmune disease.I am not using high-dose dexamethasone, do not have specific tumor mutations, am not allergic to study drugs, and have not had recent CNS surgery.I do not have any health issues that could affect the trial's results.I have a known infection of HIV, hepatitis B, or hepatitis C.I have another cancer that is getting worse, cancer in my brain's coverings, or an active infection.I am fully active or restricted in physically strenuous activity but can do light work.I am not pregnant and agree to use birth control.My cancer has spread to my brain, as confirmed by an MRI.I agree to use birth control.My lung cancer diagnosis was confirmed through a lab test.I have had radiation therapy to areas other than my current cancer site.I have had brain radiation within safe limits.I have not had a live vaccine or severe side effects from radiation or brain toxicity recently.Your blood and body chemistry need to be within certain levels.I cannot or do not want to undergo an MRI of my brain.I have a brain lesion larger than 0.3 cm that can be treated with radiation.
Research Study Groups:
This trial has the following groups:- Group 1: Group C (nivolumab, ipilimumab, SRS)
- Group 2: Group A (nivolumab, SRS)
- Group 3: Group D (nivolumab, ipilimumab, WBRT)
- Group 4: Group B (nivolumab, WBRT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What other research efforts have been undertaken concerning Nivolumab?
"Presently, Nivolumab is being studied in 765 different clinical trials. 86 of these investigations are Phase 3 studies and they can be found at 42755 locations, with many situated around Pittsburgh Pennsylvania."
Answered by AI
In what circumstances have healthcare professionals traditionally prescribed Nivolumab?
"Nivolumab is commonly prescribed to tackle anti-angiogenic therapy and has been seen as a possible treatment for malignant neoplasms, melanoma that cannot be surgically removed, and squamous cell carcinoma."
Answered by AI
What is the current capacity of this research endeavor?
"Affirmative. According to the clinicaltrials.gov website, this research is still in search of volunteers. The trial was originally published on December 16th 2016 and most recently modified on June 14th 2022; it requires 88 participants from 1 medical facility for completion."
Answered by AI
Are there still openings for participants in this clinical research?
"This medical trial, which was made available to the public on December 16th 2016, is still searching for participants according to clinicaltrials.gov's records. Its last review took place June 14th 2022."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger