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Checkpoint Inhibitor
Nivolumab +/− Ipilimumab Before Surgery for Bladder Cancer
Phase 2
Recruiting
Led By Min Yuen Teo, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For UROTHELIAL CARCINOMA OF THE UPPER URINARY TRACT (URETER OR RENAL PELVIS) (Cohort U): Histologically confirmed high grade urothelial carcinoma of the upper tract and/or radiographically visible tumor stage T2-T4a N0/x M0 disease with positive selective urinary cytology. Hydronephrosis associated with tumor on imaging or biopsy will be considered invasive by definition. (Variant histology is acceptable if there is a predominant urothelial component)
Be older than 18 years old
Must not have
Unstable angina.
History of myocardial infarction within 6 months.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Summary
This trial is testing if two immunotherapy drugs can help treat bladder cancer before surgery.
Who is the study for?
This trial is for adults with bladder cancer who can't have chemotherapy. They must have a certain type of bladder cancer that hasn't spread beyond the pelvis and be fit for surgery. People with prior systemic cancer treatments, active autoimmune diseases needing steroids, recent heart attacks or strokes, HIV/AIDS, or those unwilling to use contraception are excluded.
What is being tested?
The study tests if immunotherapy drugs Nivolumab alone or combined with Ipilimumab are safe before surgery without delaying it. The goal is to see if these drugs shrink the tumor to aid surgical success in bladder cancer patients.
What are the potential side effects?
Potential side effects include immune-related reactions affecting organs, skin rash, fatigue, digestive issues like diarrhea, liver inflammation indicated by abnormal blood tests and hormone gland problems such as thyroid dysfunction.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a confirmed high-grade cancer in my upper urinary tract.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have unstable chest pain.
Select...
I have had a heart attack in the last 6 months.
Select...
I have moderate to severe heart failure.
Select...
I have tested positive for HIV/AIDS.
Select...
I am not pregnant or breastfeeding.
Select...
I have a serious wound or fracture that is not healing.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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%
Cushingoid
10%
Tinnitus
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
Trial Design
4Treatment groups
Experimental Treatment
Group I: Cohort U (UTUC patients) is independent from Cohorts 1 - 3. ( who are cisplatin-ineligible)Experimental Treatment3 Interventions
Ipilimumab 3 mg/kg and Nivolumab 1 mg/kg on day 1, of each cycle, followed by Nivolumab 3 mg/kg on day 22 and Ipilimumab 3mg/kg and Nivolumab 1mg/kg on day 45.
Group II: Cohort 3Experimental Treatment3 Interventions
Ipilimumab 3 mg/kg on day 1 each cycle and Nivolumab 1 mg/kg on day 1 of each cycle for a total of 3 cycles. Each cycle will be three weeks long and treatment will occur during weeks 0, 3, and 6.
Group III: Cohort 2Experimental Treatment3 Interventions
Ipilimumab 3 mg/kg and Nivolumab 1 mg/kg on day 1 of each cycle, followed by Nivolumab 3 mg/kg on day 22 of each cycle for a total of 2 cycles. Each cycle will be six weeks long. Ipilimumab and Nivolumab will occur on weeks 0 and 6 while Nivolumab alone will occur on weeks 3 and 9.
Group IV: Cohort 1Experimental Treatment2 Interventions
Nivolumab 3 mg/kg on day 1 of each cycle for a total of 5 cycles. Each cycle will be two weeks long and treatment will occur during weeks 0, 2, 4, 6, and 8.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2014
Completed Phase 3
~3140
Nivolumab
2014
Completed Phase 3
~5220
Radical cystectomy
2002
Completed Phase 2
~100
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,956 Previous Clinical Trials
595,511 Total Patients Enrolled
Min Yuen Teo, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
24 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've had chemotherapy for bladder cancer, including treatments to boost my immune system.My bladder cancer diagnosis is mainly urothelial.I am a male willing to use contraception during and for 31 weeks after treatment.You are being held against your will for treatment of a mental or physical illness.You have a positive test for hepatitis B or hepatitis C, showing that you have an ongoing infection.I have had a stroke in the last 6 months.I have an autoimmune disease but it's under control without strong medication.I have unstable chest pain.I have had a heart attack in the last 6 months.I have a bleeding or clotting disorder but am on a stable dose of blood thinners.I haven't taken specific immune therapies for cancer, but IL-2 is okay.You are not eligible if you have moderate to severe kidney function, hearing loss, peripheral neuropathy, or if there is not enough tumor tissue available for testing. You must also be fit for surgery, be at least 18 years old, and have a certain level of physical ability.Before joining the study, your blood tests need to show specific levels of white blood cells, platelets, bilirubin, and liver enzymes. If you are taking blood-thinning medication, your dose should be consistent.I have moderate to severe heart failure.I received BCG therapy for bladder cancer less than 6 weeks ago.I have tested positive for HIV/AIDS.I am not pregnant or breastfeeding.I have a confirmed high-grade cancer in my upper urinary tract.My bladder cancer is invasive but hasn't spread beyond my bladder.I haven't had any active cancer in the last 2 years, except for early stage cancer that's been cured or doesn't need treatment.I have not had major surgery in the last 28 days, except for bladder tumor removal.I have a serious wound or fracture that is not healing.I have not had bladder radiotherapy for my muscle-invasive bladder cancer.I am using birth control during and for 23 weeks after the study.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1
- Group 2: Cohort 3
- Group 3: Cohort 2
- Group 4: Cohort U (UTUC patients) is independent from Cohorts 1 - 3. ( who are cisplatin-ineligible)
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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