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Checkpoint Inhibitor

Nivolumab + Ipilimumab for Genitourinary Cancers

Phase 2

Waitlist Available

Led By Bradley A McGregor, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Unresectable advanced or metastatic ACC, non-urothelial bladder/upper tract cancer, non-adenocarcinoma prostate cancer, penile cancer, treatment refractory germ-cell tumor or a high grade neuroendocrine carcinoma/small cell carcinoma of any genitourinary site

Age ≥ 18 years at the time of consent

Must not have

Significant vascular disease

Evidence of bleeding diathesis or significant coagulopathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up imaging will occur every 6-12 weeks study entry up until disease progression (up to 24 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying a combination of two drugs, Nivolumab and Ipilimumab, as a possible treatment for rare genitourinary cancers. Bladder and upper tract carcinomas with variant histology, adrenocortical carcinoma, other rare genitourinary carcinomas, and any genitourinary carcinoma with neuroendocrine differentiation are being studied. Given preliminary results, the study is being tested in additional patients with bladder or upper tract carcinoma with variant histology at this time.

Who is the study for?

Adults (18+) with advanced rare genitourinary tumors, including certain types of bladder, prostate, penile cancer, and others. Participants must have good organ function, no recent serious illnesses or surgeries, and not be on immunosuppressive drugs. Women who can bear children must test negative for pregnancy and agree to contraception.

What is being tested?

The trial is testing a combination of Nivolumab and Ipilimumab as treatment options for patients with specific genitourinary cancers that are either unresectable or metastatic. The study focuses on those whose conditions haven't improved with standard treatments.

What are the potential side effects?

Potential side effects include immune-related reactions like inflammation in various organs, skin rash, hormone gland problems (like thyroid), digestive issues such as diarrhea or liver inflammation; fatigue; infusion reactions; possible increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is advanced, cannot be surgically removed, and affects the urinary or reproductive organs.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have serious blood vessel problems.

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I do not have a bleeding disorder or significant blood clotting issues.

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I have had symptoms from a deep vein clot or lung clot.

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I have tested positive for HIV/AIDS.

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I have not used immune checkpoint inhibitors for certain cancers.

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I haven't had any stomach or throat hole issues or stomach tears in the last 6 months.

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I need special feeding methods due to GI blockage symptoms.

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I don't have severe side effects from previous cancer treatments.

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My cancer has spread to my brain, spinal cord, or leptomeninges.

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I haven't had certain cancers besides my current one in the last 5 years.

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I haven't taken high-dose steroids or immunosuppressants for an autoimmune disease in the last 6 months.

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I have a history of lung scarring or inflammation not caused by infections.

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I have had a stem cell or organ transplant in the past.

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I am currently being treated for an infection.

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I have an ongoing or chronic hepatitis B infection.

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I have an active hepatitis C infection.

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My adrenal glands are not working properly and it's not under control.

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I have a serious heart condition.

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I have a serious wound or ulcer that is not healing.

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I haven't taken any antibiotics by mouth or IV in the last 2 weeks.

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I haven't taken high-dose steroids or immunosuppressants in the last 2 weeks.

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My high blood pressure is not well-controlled.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ imaging will occur every 6-12 weeks study entry up until disease progression (up to 24 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~imaging will occur every 6-12 weeks study entry up until disease progression (up to 24 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and imaging will occur every 6-12 weeks study entry up until disease progression (up to 24 months) 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

Secondary study objectives

Duration of Response

Immune related objective response rate

Objective Response Rate for all rare GU tumor types

+3 more

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

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: Nivolumab+IpilimumabExperimental Treatment2 Interventions

* Nivolumab and Ipilimumab are administered intravenously every 3 weeks for a total of 4 maximum doses. After combination therapy, nivolumab will be administered as monotherapy every 4 weeks. * Doses are determined per protocol.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2014

Completed Phase 3

~5220

Ipilimumab

2014

Completed Phase 3

~3140