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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 below

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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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

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 • NCT02017717

80%

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%

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

0 / 8Eligibility criteria met