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Checkpoint Inhibitor
Nivolumab for Bladder Cancer
Phase 2
Recruiting
Led By Sangeeta Goswami
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
Patient will have a tumor harboring genomic mutation of ARID1A. ARID1A mutation testing will be performed as standard of care
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 is testing whether nivolumab can help control urothelial cancer that has spread to other parts of the body, specifically in patients with aberrations in the ARID1A gene.
Who is the study for?
This trial is for adults with metastatic urothelial cancer and a specific genetic change (ARID1A mutation). Participants must have had prior treatment failure, be in good physical condition (ECOG PS 0 or 1), and have measurable disease. They cannot join if they've received certain immune therapies before, have active infections like hepatitis B/C, uncontrolled medical conditions, HIV/AIDS, untreated brain metastases, or are on high-dose steroids.Check my eligibility
What is being tested?
The trial tests the effectiveness of Nivolumab—an immunotherapy drug—on patients whose cancer has spread and who show ARID1A mutations. It also examines how CXCL13 expression levels might influence responses to this treatment. The study includes diagnostic biomarker analysis to tailor therapy based on individual tumor characteristics.See study design
What are the potential side effects?
Nivolumab may cause immune-related side effects such as inflammation in various organs including lungs and intestines, skin rash, hormone gland problems (like thyroid dysfunction), liver inflammation, kidney issues, infusion reactions during administration of the drug and potential complications from activating the immune system.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tumor has an ARID1A mutation.
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I am fully active or can carry out light work.
Select...
My kidney function, measured by creatinine levels or clearance, is within the required range.
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My condition worsened or came back after treatment.
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)
Other outcome measures
Overall survival
Progression free survival (PFS)
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%
Nasopharyngitis
8%
Lacrimation increased
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Chills
7%
Hyperkalaemia
7%
Bronchitis
7%
Hypertension
7%
Blood alkaline phosphatase increased
7%
Hyperglycaemia
7%
Dehydration
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Hypotension
5%
Pain
5%
Malaise
5%
Rash maculo-papular
5%
Musculoskeletal chest 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%
Cancer pain
1%
Pneumothorax
1%
Atrial flutter
1%
Bone pain
1%
Small intestinal haemorrhage
1%
Confusional state
1%
Bronchial obstruction
1%
Femur fracture
1%
Hypercalcaemia
1%
Syncope
1%
Superior vena cava syndrome
1%
Neoplasm progression
1%
Pericardial effusion malignant
1%
Circulatory collapse
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 & relatlimab)Experimental Treatment3 Interventions
Participants found to be eligible to take part in this study, you will receive nivolumab and relatlimab by vein over about 30 minutes on Day 1 of every 28-day study cycle (about every 4 weeks).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Relatlimab
2018
Completed Phase 2
~1120
Nivolumab
FDA approved
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,985 Previous Clinical Trials
1,789,087 Total Patients Enrolled
Sangeeta GoswamiPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your neutrophil count is at least 1500 per microliter within the last 7 days before starting the treatment.I haven't had cancer treatment or experimental therapy in the last 28 days.Your platelet count is at least 100,000 per microliter of blood, as measured within 7 days before starting the study.My tumor has an ARID1A mutation.My cancer is in the bladder, urethra, ureter, or renal pelvis and cannot be removed by surgery.I haven't had any active cancer in the last 3 years, except for certain curable types.Your white blood cell count is at least 2000 cells per microliter.I have tested positive for hepatitis B or C.I am fully active or can carry out light work.I finished palliative radiotherapy at least 2 weeks ago and have measurable cancer outside the treated area.Your hemoglobin levels are at least 9.0 grams per deciliter, as checked within a week before starting the study.My brain cancer has been treated, stable for 4 weeks, and I'm not on high-dose steroids.My cancer can be measured on scans according to specific criteria.My side effects from previous cancer treatments have mostly gone away, except for possible nerve pain, hair loss, or tiredness.I have had platinum-based chemotherapy for advanced urothelial cancer or cannot have it.Your bilirubin levels should be within a certain range, unless you have a condition called Gilbert Syndrome, in which case a slightly higher level is allowed.Your AST and ALT levels in your blood are not more than 3 times the upper limit of normal, or not more than 5 times the upper limit of normal if you have cancer that has spread to your liver. These levels were checked within 7 days before starting the study.My kidney function, measured by creatinine levels or clearance, is within the required range.I have an autoimmune disease but it's under control or not expected to worsen.I can provide a sample of my tumor for testing, either from a past surgery or a new biopsy.I have been treated with drugs targeting immune system checkpoints.My condition worsened or came back after treatment.I haven't taken high-dose steroids or immunosuppressants in the last 14 days.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (nivolumab & relatlimab)
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 clinical indications are most typically addressed with Nivolumab?
"Nivolumab is a widely used therapeutic intervention for malignant neoplasms, but it can also be beneficial in treating a number of other conditions such as unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."
Answered by AI
What is the aggregate number of participants in this investigation?
"The recruitment period for this trial has already reached completion, as the study was initially posted on November 1st 2022 and last updated August 18th 2022. If you are still interested in participating in medical studies, there are currently 3635 trials searching patients with locally advanced ureter urothelial carcinoma and 718 clinical evaluations involving Nivolumab that require enrolment."
Answered by AI
Are there any open enrollments for this clinical experiment?
"This research project is no longer accepting candidates; it was first posted on the 1st of November 2022 and last edited on August 18th. For those searching for other trials, there are 3635 studies actively enrolling patients with locally advanced ureter urothelial carcinoma and 718 clinical trials seeking participants to test Nivolumab."
Answered by AI
Has anything like this clinical trial been conducted previously?
"As of now, 718 studies examining Nivolumab are being conducted in 2355 cities and 49 countries. This research began back in 2012 by Ono Pharmaceutical Co. Ltd., involving 659 trial subjects over the course of Phase 1 & 2 drug approval testing. Since then, a further 262 trials have taken place."
Answered by AI
Are there any severe side-effects associated with Nivolumab treatment?
"There is limited data available on Nivolumab's safety, which warrants a rating of 2. While there has been no evidence presented to support its efficacy, some studies have provided insight into the drug's potential risks."
Answered by AI
Has the efficacy of Nivolumab been evaluated in other clinical tests?
"Currently, 82 Phase 3 trials are underway for Nivolumab with a total of 718 research projects taking place worldwide. Basel, BE is home to several of these studies while 40280 other sites are also running their own investigations into the drug's efficacy."
Answered by AI
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