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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
Histologically confirmed diagnosis of urothelial carcinoma of the bladder. Variant histology is acceptable if there is a predominant urothelial component.
Patients ineligible for cisplatin based on any of the following criteria: Estimated or calculated creatinine clearance ≥ 30ml/min but < 60 ml/min, Grade 2 or above audiometric hearing loss (per CTCAE v4.0), Grade 2 or above peripheral neuropathy (per CTCAE v4.0), Availability of tumor specimen block or 30 unstained slides from diagnosis of muscle-invasive disease. Patients with fewer than 30 slides available may be enrolled after discussion with the Principal Investigator, Karnofsky performance status ≥ 70%, Medically appropriate candidate for radical cystectomy, as per MSK Attending Urologic Oncologist, Age ≥ 18 years.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 60 days after completion of neoadjuvant nivolumab or nivolumab in combination with ipilimumab for cisplatin-ineligible mibc, without delays due to treatment-related toxicities or progressive disease
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 below
Select...
My bladder cancer diagnosis is mainly urothelial.
Select...
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.
Select...
I have a confirmed high-grade cancer in my upper urinary tract.
Select...
My bladder cancer is invasive but hasn't spread beyond my bladder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 60 days after completion of neoadjuvant nivolumab or nivolumab in combination with ipilimumab for cisplatin-ineligible mibc, without delays due to treatment-related toxicities or progressive disease
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 60 days after completion of neoadjuvant nivolumab or nivolumab in combination with ipilimumab for cisplatin-ineligible mibc, without delays due to treatment-related toxicities or progressive disease for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
number of patients who proceed to radical cystectomy and pelvic lymph node dissection (RC-PLND)

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533
57%
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%
Neutropenia
21%
Pyrexia
19%
Hypomagnesaemia
19%
Headache
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Insomnia
15%
Thrombocytopenia
14%
Rash
14%
Hyponatraemia
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Pruritus
12%
Hypokalaemia
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Muscular weakness
10%
Dry skin
10%
Alopecia
10%
Chest pain
10%
Hypoalbuminaemia
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Upper respiratory tract infection
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Hypertension
7%
Chills
7%
Bronchitis
7%
Blood alkaline phosphatase increased
7%
Dehydration
7%
Hyperglycaemia
7%
Hyperkalaemia
7%
Lymphocyte count decreased
7%
Anxiety
6%
Leukopenia
6%
Hypophosphataemia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Dry mouth
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Hypotension
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Myocardial infarction
3%
Metastases to central nervous system
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Embolism
2%
Malignant pleural effusion
2%
Sepsis
2%
Cardiac failure
2%
General physical health deterioration
2%
Atrial fibrillation
2%
Adrenal insufficiency
1%
Superior vena cava syndrome
1%
Syncope
1%
Confusional state
1%
Pneumothorax
1%
Neoplasm progression
1%
Lung cancer metastatic
1%
Cancer pain
1%
Bronchial obstruction
1%
Performance status decreased
1%
Ileus
1%
Pericardial effusion
1%
Colitis
1%
Atrial flutter
1%
Small intestinal obstruction
1%
Pancytopenia
1%
Gastrointestinal haemorrhage
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Hypercalcaemia
1%
Bone pain
1%
Pericardial effusion malignant
1%
Circulatory collapse
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

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
~2670
Nivolumab
2014
Completed Phase 3
~4750
Radical cystectomy
2002
Completed Phase 2
~100

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,929 Previous Clinical Trials
597,173 Total Patients Enrolled
Min Yuen Teo, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
24 Total Patients Enrolled

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03520491 — Phase 2
Bladder Cancer Research Study Groups: Cohort 1, Cohort 3, Cohort 2, Cohort U (UTUC patients) is independent from Cohorts 1 - 3. ( who are cisplatin-ineligible)
Bladder Cancer Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT03520491 — Phase 2
Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03520491 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you provide an overview of the existing research involving Nivolumab?

"Nivolumab was initially trialled in 2009 at Texas Children's Hospital, and 366 trials have been completed since. At present, 765 active clinical studies are utilizing this medication; many of these experiments taking place near Commack, New jersey."

Answered by AI

Are there vacancies for participants in this medical experiment?

"Affirmative. According to clinicaltrials.gov, this scientific experiment is actively recruiting participants and was initially posted on April 25th 2018 with a recent update on February 1st 2022. 45 individuals need to be enrolled at 7 medical sites."

Answered by AI

What is the current participant count for this clinical investigation?

"Correct. Information hosted on clinicaltrials.gov confirms that this medical trial is presently enrolling participants, with the initial post date being April 25th 2018 and a recent update taking place February 1st 2022. 45 patients are required from seven different locations for the study's completion."

Answered by AI

What conditions is Nivolumab used to ameliorate?

"Nivolumab is the most common drug prescribed to patients suffering from anti-angiogenic therapy. It also has applications in treating malignant neoplasms, unresectable melanoma, and squamous cell carcinoma."

Answered by AI

What adverse effects have been documented with Nivolumab treatments?

"With some clinical data confirming its safety, nivolumab received a score of 2. Notably, there is yet to be any evidence suggesting efficacy in humans."

Answered by AI

How many Canadian health care sites are hosting this research initiative?

"Seven medical facilities are enrolling patients for this clinical trial. Primary sites include Memorial Sloan Kettering Commack, Memoral Sloan Kettering Monmouth and the iconic Memorial Sloan Kettering Cancer Center in New york City. The other four locations can be found on the study's official website."

Answered by AI
~5 spots leftby Jan 2025