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Checkpoint Inhibitor
Immune Checkpoint Inhibitors + Temozolomide for Brain Cancer
Phase 2
Recruiting
Led By Mark R Gilbert, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Karnofsky greater than or equal to 70%
- Hemoglobin > 9.0 g/dL (may be transfused to achieve this level)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study calendar, last collection of qol questioner
Awards & highlights
Study Summary
This trial is studying the changes in immune cells in the blood of people with newly diagnosed GBM or gliosarcoma, who take ipilimumab and nivolumab, along with temozolomide.
Who is the study for?
Adults over 18 with newly diagnosed GBM or gliosarcoma who've had surgery to remove their tumor and completed initial chemo and radiation. They must be in good health, have a Karnofsky score of at least 70%, agree to use two forms of contraception, and not be pregnant or breastfeeding.Check my eligibility
What is being tested?
The trial is testing the combination of nivolumab and ipilimumab immunotherapies with temozolomide chemotherapy in patients with brain tumors. It aims to understand how these treatments affect immune cells in the blood. Treatment cycles last four weeks, including IV infusions and oral medication.See study design
What are the potential side effects?
Possible side effects include immune-related reactions that can affect various organs, infusion-related symptoms, fatigue, digestive issues like nausea or diarrhea, skin rashes, hormonal imbalances (endocrine issues), liver function changes, and increased risk for infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am mostly able to care for myself.
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My hemoglobin level is above 9.0 g/dL, or I can receive a transfusion to reach this.
Select...
I finished my chemoradiation treatment no more than 5 weeks ago.
Select...
I have been recently diagnosed with glioblastoma or gliosarcoma.
Select...
My organs and bone marrow are functioning well.
Select...
My kidney function is normal, with creatinine levels at or below 1.7 mg/dL.
Select...
I had surgery to remove almost all of a brain tumor located above the cerebellum.
Select...
I am aware of the need for birth control during and up to 6 months after the study if I am female, or my partner is, and participating.
Select...
I am 18 years old or older.
Select...
I am using a barrier method of contraception.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, day 1 of each cycle and 60 day and 100 day post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day 1 of each cycle and 60 day and 100 day post treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine if the outcomes, as measured by overall survival, is improved in patients with newly diagnosed glioblastoma when treatment with immune checkpoint inhibitors result in an immune response in peripheral blood T lymphocytes.
Secondary outcome measures
Determine if T cell response to immune checkpoint inhibitors measuring the change in the pre-treatment and post-treatment blood correlates with progression-free survival
Determine if in vitro peripheral blood T cell response to a stimulation paradigm including nivolumab and ipilimumab correlates with overall survival, evaluating 2 different dosing regimens of the ICIs.
Determine if in vitro peripheral blood T cell response to a stimulation paradigm including nivolumab and ipilimumab correlates with progression-free survival, evaluating 2 different dosing regimens of the ICIs.
+2 moreSide 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
2Treatment groups
Experimental Treatment
Group I: Arm 2Experimental Treatment3 Interventions
Nivolumab + Ipilimumab 3mg/kg + TMZ
Group II: Arm 1Experimental Treatment3 Interventions
Nivolumab + Ipilimumab 1mg/kg + TMZ
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TMZ
2007
Completed Phase 3
~1530
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,657 Previous Clinical Trials
40,933,609 Total Patients Enrolled
142 Trials studying Gliosarcoma
10,767 Patients Enrolled for Gliosarcoma
Mark R Gilbert, M.D.Principal InvestigatorNational Cancer Institute (NCI)
8 Previous Clinical Trials
3,401 Total Patients Enrolled
2 Trials studying Gliosarcoma
40 Patients Enrolled for Gliosarcoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am mostly able to care for myself.I have had immune therapy, like a vaccine or dendritic cell vaccine.You have had a serious allergic reaction to any type of antibody treatment in the past.You have an intrauterine device (IUD) inserted.My hemoglobin level is above 9.0 g/dL, or I can receive a transfusion to reach this.I have or had hepatitis.I am not taking more than 30 mg of cortisone or its equivalent daily.I finished my chemoradiation treatment no more than 5 weeks ago.I have conditions like vitiligo, thyroid issues managed with hormones, or controlled arthritis but no severe organ involvement.I do not have any uncontrolled illnesses that could interfere with the study.I am allergic to medications similar to nivolumab, ipilimumab, or temozolomide.I have been recently diagnosed with glioblastoma or gliosarcoma.My organs and bone marrow are functioning well.I have had cancer before, but it won't affect this treatment's safety or results.My kidney function is normal, with creatinine levels at or below 1.7 mg/dL.I had surgery to remove almost all of a brain tumor located above the cerebellum.I am aware of the need for birth control during and up to 6 months after the study if I am female, or my partner is, and participating.I do not have an active or history of severe autoimmune disease.My cancer is getting worse, as shown by tests or scans.I am not pregnant or breastfeeding.I am 18 years old or older.I am using a barrier method of contraception.I have had Gliadel wafer or local brachytherapy, but Tumor Treating Fields are okay.You are currently taking any experimental medications.You are using hormone-based birth control methods.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1
- Group 2: Arm 2
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 are the possible risks associated with Nivolumab?
"Given that this is a Phase 2 trial, and thus there is only some data supporting safety with no data supporting efficacy, our team at Power estimates the safety of Nivolumab to be a 2."
Answered by AI
What are the most common conditions that Nivolumab is used for?
"Nivolumab is not only commonly used to treat previous anti-angiogenic therapy, but it can also be employed against other maladies such as unresectable melanoma and squamous cell carcinoma."
Answered by AI
What is the extent of research on Nivolumab's effects?
"As of now, there are 796 ongoing clinical trials for Nivolumab with 86 in Phase 3. While many of the clinical trials for Nivolumab are based in Pittsburgh, Pennsylvania, there are 43300 total locations running trials for Nivolumab."
Answered by AI
Are investigators still recruiting participants for this research trial?
"The listings on clinicaltrials.gov show that this experiment is still recruiting patients. The trial was first advertised on December 8th, 2021 and the most recent update was on October 29th, 2022. A total of 48 people are needed for the study which is only happening at 1 location."
Answered by AI
Just to be clear, how many people are included in the experimental group for this project?
"Yes, that is correct. The clinical trial is presently seeking candidates, as indicated by the data on clinicaltrials.gov. This particular trial was initially posted on 12/8/2021 and was most recently edited on 10/29/2022. The recruitment goal for this trial is 48 participants from 1 site."
Answered by AI
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