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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
Must not have
Treatment with any chemotherapy, radiation therapy, biologics for cancer, or investigational therapy within 28 days of first administration of study treatment. Prior palliative radiotherapy must have been completed at least 2 weeks prior to study drug administration
Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (RNA) or hepatitis C antibody (HCV antibody) indicating acute or chronic infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
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.
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.
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.
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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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't had cancer treatment or experimental therapy in the last 28 days.
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I have tested positive for hepatitis B or C.
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My brain cancer has been treated, stable for 4 weeks, and I'm not on high-dose steroids.
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I have been treated with drugs targeting immune system checkpoints.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Objective response rate (ORR)
Overall survival (OS)
Other study objectives
Overall survival
Progression free survival (PFS)
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
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.
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
2019
Completed Phase 2
~1150
Nivolumab
FDA approved
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,072 Previous Clinical Trials
1,803,196 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.