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Checkpoint Inhibitor
Nivolumab for Cancer
Phase 2
Recruiting
Led By Funda Meric-Bernstam
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
All subjects must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial will study nivolumab as a treatment for patients with solid tumors that have RID1A mutations and CXCL13 expression. Nivolumab is an immunotherapy that may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Who is the study for?
Adults with solid tumors that can't be removed by surgery or have spread, which also have ARID1A mutation and CXCL13 expression. They should not have serious medical issues, autoimmune diseases, recent immunosuppressive treatments, active infections like hepatitis B/C or HIV, brain metastases requiring steroids, or a history of certain cancers within the last 3 years.Check my eligibility
What is being tested?
The trial is testing Nivolumab's effectiveness on patients with specific genetic markers in their tumors. It's a phase II study to see if this drug can help the immune system fight cancer and prevent tumor growth.See study design
What are the potential side effects?
Nivolumab may cause immune-related side effects such as inflammation in various organs, potential lung problems (pneumonitis), skin reactions, hormone gland issues (like thyroid dysfunction), and infusion-related reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer can be measured on scans according to specific criteria.
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I am fully active or can carry out light work.
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My kidney function, measured by creatinine levels or clearance, is within the required range.
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My tumor has an ARID1A mutation.
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My cancer cannot be removed by surgery and has an ARID1A mutation.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 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)
Overall survival (OS)
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%
Hypertension
7%
Chills
7%
Hyperkalaemia
7%
Dehydration
7%
Hyperglycaemia
7%
Blood alkaline phosphatase increased
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Rash maculo-papular
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%
Cancer pain
1%
Small intestinal haemorrhage
1%
Confusional state
1%
Pneumothorax
1%
Atrial flutter
1%
Femur fracture
1%
Bone pain
1%
Neoplasm progression
1%
Pericardial effusion malignant
1%
Circulatory collapse
1%
Hypercalcaemia
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)Experimental Treatment1 Intervention
Patients receive nivolumab IV over 30 minutes on day 1. Cycles 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
FDA approved
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,287 Total Patients Enrolled
Funda Meric-BernstamPrincipal InvestigatorM.D. Anderson Cancer Center
7 Previous Clinical Trials
12,836 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have previously been treated with specific immune-targeting cancer drugs.My cancer can be measured on scans according to specific criteria.I haven't had active cancer in the last 3 years, except for certain curable types.I haven't taken high-dose steroids or immunosuppressants in the last 14 days.I am fully active or can carry out light work.I can provide a sample of my tumor for testing, either from a past surgery or a new biopsy.My kidney function, measured by creatinine levels or clearance, is within the required range.My tumor has an ARID1A mutation.My cancer cannot be removed by surgery and has an ARID1A mutation.I am 18 years old or older.I have an autoimmune disease but it's under control or not expected to worsen.I haven't had cancer treatment or experimental therapy in the last 28 days.My side effects from previous cancer treatments have mostly gone away, except for possible nerve pain, hair loss, or tiredness.I finished any palliative radiotherapy at least 2 weeks ago and have measurable cancer outside the treated area.My brain cancer has been stable for 4 weeks after treatment, and I haven't needed high doses of steroids.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (nivolumab)
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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 is the current size of the patient pool for this research?
"Affirmative. Clinicaltrials.gov demonstrates that this clinical trial, which was initially released on November 1st 2021, is actively recruiting patients. Approximately 30 people must be recruited from a single medical centre."
Answered by AI
Are there associated risks to using Nivolumab as a healthcare treatment?
"Nivolumab has been rated a 2 on our safety scale since it is in Phase 2; thus, there are some reports regarding its security but none attesting to its efficacy."
Answered by AI
Have any previous studies utilized Nivolumab as a treatment option?
"Currently, there are 718 studies that have been launched to investigate Nivolumab with 82 of them in their terminal Phase 3. This includes 40280 different research sites around the world – many located in Basel, BE."
Answered by AI
What conditions is Nivolumab usually prescribed to treat?
"Nivolumab is traditionally implemented to treat malignant neoplasms, as well as a range of other illnesses such as metastatic esophageal adenocarcinoma and unresectable melanoma."
Answered by AI
Is this an unprecedented clinical investigation?
"Ono Pharmaceutical Co. Ltd first initiated research of nivolumab in 2012 and completed a 659-person trial that same year, granting the drug Phase 1 & 2 regulatory approval soon after. Currently, 718 studies are actively assessing its efficacy across 49 different nations with 2355 cities participating in this medical endeavor."
Answered by AI
Are there vacancies for this medical experiment at the moment?
"Indeed, the clinical trial is open for recruitment as seen on clinicaltrials.gov and first posted on November 1st 2021. The most recent update was made in August 18th 2022 with a goal of finding 30 participants at one site."
Answered by AI
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