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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
No Placebo-Only Group
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
Secondary study objectives
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 study objectives
Exploratory Biomarker analysis
Side effects data
From 2024 Phase 3 trial • 529 Patients • NCT0201771780%
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%
Tinnitus
10%
Cushingoid
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~5220
Temozolomide
2010
Completed Phase 3
~1880
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbIndustry Sponsor
2,681 Previous Clinical Trials
4,124,958 Total Patients Enrolled
Dwight OwenLead Sponsor
5 Previous Clinical Trials
158 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.
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