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Monoclonal Antibodies
Nivolumab + Temozolomide for Lung & Neuroendocrine Cancers
Phase 2
Waitlist Available
Led By Dwight Owen, MD, MS
Research Sponsored by Dwight Owen
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 the time from allocation to the first documented disease progression within the cns according to recist 1.1, assessed up to 3 years
Awards & highlights
Study Summary
This trial is testing nivolumab and temozolomide to see if they're effective in treating small-cell lung cancer and neuroendocrine cancer.
Who is the study for?
This trial is for adults with recurrent or unresponsive small-cell lung cancer, or advanced neuroendocrine tumors. Participants must have measurable disease progression and be able to take oral medication. They should not have had certain treatments like temozolomide before, and those with serious health conditions such as active hepatitis, CNS metastases, or autoimmune diseases are excluded.Check my eligibility
What is being tested?
The trial tests the combination of nivolumab (an immunotherapy drug) and temozolomide (a chemotherapy drug) on patients. Nivolumab may boost the immune system's response against cancer cells while temozolomide aims to stop tumor growth by killing cells or preventing their division.See study design
What are the potential side effects?
Potential side effects include typical reactions from immunotherapy such as fatigue, skin issues, inflammation in organs; and from chemotherapy like nausea, hair loss, blood cell count changes. Each patient's experience can vary based on individual health factors.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the time from allocation to the first documented disease progression within the cns according to recist 1.1, assessed up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the time from allocation to the first documented disease progression within the cns according to recist 1.1, assessed up 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
Objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
Secondary outcome measures
Central nervous system (CNS) PFS
Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Overall survival (OS) of patients
+1 moreOther outcome measures
Exploratory Biomarker analysis
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%
Blood alkaline phosphatase increased
7%
Chills
7%
Hypertension
7%
Dehydration
7%
Hyperkalaemia
7%
Hyperglycaemia
7%
Lymphocyte count decreased
7%
Anxiety
6%
Leukopenia
6%
Hypophosphataemia
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%
Sepsis
2%
Malignant pleural effusion
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%
Pericardial effusion malignant
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Circulatory collapse
1%
Bone pain
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: Treatment (nivolumab, temozolomide)Experimental Treatment2 Interventions
Patients receive nivolumab IV on day 1 of a 28 day cycle. Patients also receive temozolomide PO on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Temozolomide
2010
Completed Phase 3
~1930
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,459 Total Patients Enrolled
Dwight OwenLead Sponsor
4 Previous Clinical Trials
134 Total Patients Enrolled
Dwight Owen, MD, MSPrincipal InvestigatorOhio State University Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have active hepatitis B or hepatitis C.You have advanced neuroendocrine tumor or carcinoma, and have shown signs of disease progression in the past year.You are able to perform daily activities without any major issues.Your white blood cell count is at least 1,500 per microliter.If you didn't respond to the first chemotherapy treatment or your condition got worse less than 90 days after the treatment ended, you cannot participate in Cohort 1.Your blood clotting time is within the normal range or is controlled with medication.You are allergic to nivolumab or temozolomide.Your blood clotting time is within a certain range, unless you are taking medication that affects blood clotting.You have a tumor that can be measured using specific guidelines for evaluating tumor size.You have been treated with temozolomide before.You have had active tuberculosis (TB) in the past.In the second group, it's okay to take a medicine called somatostatin, as long as you've been taking the same amount for at least 2 months.You have received a certain type of immunotherapy called checkpoint inhibitors, but only if it was given with chemotherapy as your first treatment. Another type of immunotherapy called CTLA-4 therapy is not allowed.You have symptoms from cancer that has spread to your brain or spinal cord.You have received chemotherapy, targeted therapy, or radiation within 2 weeks before the study starts, and you have not fully recovered from any side effects.You have another type of cancer that is getting worse or needs treatment.You have a condition where your immune system attacks your own body and have been treated with strong medications in the last 2 years.You currently have an infection that needs treatment with medication throughout your body.You have been diagnosed with HIV.You have been diagnosed with advanced small cell lung cancer and have not improved after receiving platinum-based chemotherapy with immunotherapy.For Group 1: You had one round of chemotherapy, and then your disease came back more than 90 days after the treatment ended.You are expected to live for at least 3 more months.Your AST and ALT levels in your blood are not too high, unless you have liver metastases, in which case they can be a little higher but still not too high.Your kidney function is good, and your creatinine levels are within normal limits.Your platelet count must be at least 100,000 per microliter within the past 28 days before starting the treatment.Your bilirubin levels in your blood should be within a certain range, which can be checked with a blood test.You have a condition that weakens your immune system, or you are taking medications that lower your body's ability to fight off infections.Your albumin level is at least 2.5 mg/dL within 28 days of starting the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (nivolumab, temozolomide)
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.
How many participants are currently taking part in this clinical experiment?
"This clinical trial has ended its recruitment period, commencing on December 31st 2018 and closing April 27th 2022. For those seeking alternate studies related to neuroendocrine carcinomas, there are 4773 active trials; alternatively 915 separate medical experiments for Nivolumab remain open for enrollment."
Answered by AI
Is this experiment the inaugural investigation of its kind?
"Currently, 915 sites across 2430 cities and 51 nations are running Nivolumab trials. The first clinical study of this drug was conducted in 2002 by Schering-Plough, with 60 participants partaking in a Phase 2 trial. Since then, 546 other experiments have been administered."
Answered by AI
In what circumstances is Nivolumab commonly prescribed?
"Nivolumab is often used to treat cancer, but can also be utilized in cases of unresectable melanoma, squamous cell carcinoma, and high risk of recurrence."
Answered by AI
To what degree does Nivolumab pose a hazard to those using it?
"Although Phase 2 trials do not yet have evidence to support their efficacy, Nivolumab has demonstrated enough safety for Power's team to give it a score of two."
Answered by AI
Are there any vacancies currently available for this trial?
"Per the data recorded on clinicaltrials.gov, this research trial is not recruiting any further participants at present. Initially posted in December 2018 and last updated in April 2022, it has concluded its recruitment phase but there are still 5688 other trials actively seeking volunteers."
Answered by AI
Have any other scholarly reports focused on Nivolumab been released?
"Presently, 915 clinical studies are being conducted concerning Nivolumab; 105 of these trials have progressed to the third phase. While most research is taking place in Houston, TX, there are over 44 thousand sites conducting experiments with this medication globally."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What site did they apply to?
Ohio State University Comprehensive Cancer Center-COHORT 1
What portion of applicants met pre-screening criteria?
Met criteria
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