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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
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My cancer is advanced, cannot be surgically removed, and affects the urinary or reproductive organs.
Select...
I am 18 years old or older.
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate
Secondary outcome measures
Duration of Response
Immune related objective response rate
Objective Response Rate for all rare GU tumor types
+3 moreSide effects data
From 2022 Phase 3 trial • 541 Patients • NCT0204153357%
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%
Pyrexia
21%
Neutropenia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Bronchitis
7%
Chills
7%
Hypertension
7%
Hyperkalaemia
7%
Dehydration
7%
Hyperglycaemia
7%
Blood alkaline phosphatase increased
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Rash maculo-papular
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Malignant pleural effusion
2%
Sepsis
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Small intestinal haemorrhage
1%
Confusional state
1%
Pneumothorax
1%
Atrial flutter
1%
Femur fracture
1%
Bone pain
1%
Cancer pain
1%
Neoplasm progression
1%
Pericardial effusion malignant
1%
Circulatory collapse
1%
Hypercalcaemia
1%
Bronchial obstruction
1%
Superior vena cava syndrome
1%
Syncope
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
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
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
~4750
Ipilimumab
2014
Completed Phase 3
~2620
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,848 Total Patients Enrolled
2 Trials studying Germ Cell Tumors
545 Patients Enrolled for Germ Cell Tumors
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,400 Total Patients Enrolled
1 Trials studying Germ Cell Tumors
Bradley A McGregor, MDPrincipal InvestigatorDana-Farber Cancer Institute
1 Previous Clinical Trials
24 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to use birth control or abstain from sex during and after treatment for 120 days.You have had serious allergic reactions to certain types of medications made from antibodies or proteins.You are allergic to any part of the nivolumab or ipilimumab drug.I can provide a tumor sample and am willing to have a biopsy before treatment, unless it's unsafe.My organs are functioning well.You have a measurable disease as determined by a specific set of guidelines within the 28 days before joining the study.I have tested positive for HIV/AIDS.I haven't had chemotherapy, hormone therapy, or experimental treatments in the last 3 weeks.I have not used immune checkpoint inhibitors for certain cancers.I've taken low-dose steroids for nausea or pain but can start the study within 2 weeks.I haven't had any stomach or throat hole issues or stomach tears in the last 6 months.I need special feeding methods due to GI blockage symptoms.I haven't had radiotherapy in the last 14 days, except for one session to ease symptoms.My cancer has spread to my brain, spinal cord, or leptomeninges.I haven't had certain cancers besides my current one in the last 5 years.I haven't taken high-dose steroids or immunosuppressants for an autoimmune disease in the last 6 months.I have a history of lung scarring or inflammation not caused by infections.I have not had a stroke or mini-stroke in the last 3 months.I have had a stem cell or organ transplant in the past.I have been active and able to care for myself within the last 28 days.My cancer is advanced, cannot be surgically removed, and affects the urinary or reproductive organs.I have serious blood vessel problems.I do not have a bleeding disorder or significant blood clotting issues.I have had symptoms from a deep vein clot or lung clot.I have not had major surgery in the last 4 weeks.I don't have severe side effects from previous cancer treatments.I am currently being treated for an infection.You have air in your belly that can't be explained by a recent medical procedure.I have an ongoing or chronic hepatitis B infection.I have an active hepatitis C infection.Your heart's QTcF interval is too long.My adrenal glands are not working properly and it's not under control.I am 18 years old or older.I have a serious heart condition.I have a serious wound or ulcer that is not healing.I haven't taken any antibiotics by mouth or IV in the last 2 weeks.I have taken a pregnancy test in the last 28 days and it was negative.I haven't taken any immune-weakening medications in the last 2 weeks.I haven't taken high-dose steroids or immunosuppressants in the last 2 weeks.I understand and can follow the study's procedures.My high blood pressure is not well-controlled.
Research Study Groups:
This trial has the following groups:- Group 1: Nivolumab+Ipilimumab
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are they currently enrolling people in this clinical trial?
"The latest information from clinicaltrials.gov is that this trial is still open for recruitment. The listing was first posted on December 28th, 2017 and has been edited most recently on July 5th, 2022."
Answered by AI
How many individuals are included in this research project?
"One hundred patients that meet the pre-stated inclusion criteria are necessary for this clinical trial to move forward. If you are interested, Emory University in Atlanta, Georgia and MD Anderson Cancer Center in Houston, Texas are two of many sites participating in this study."
Answered by AI
Does Nivolumab carry a high risk for adverse effects?
"At the moment, there is not enough information to rate Nivolumab's efficacy. However, it has been given a score of 2 in regards to safety because Phase 2 trials have shown that it is safe for human use."
Answered by AI
In how many places is this experiment being conducted?
"At the time of writing this, patients are being enrolled at Winship Cancer Institute (Atlanta, GA), Emory University, MD Anderson Cancer Center (Houston, TX), Beth Israel Deaconess Medical Center (Boston, MA), and 6 other locations."
Answered by AI
What type of cancer does Nivolumab target?
"Nivolumab is a common treatment for previous anti-angiogenic therapy and other conditions like malignant neoplasms, unresectable melanoma, and squamous cell carcinoma."
Answered by AI
How does this study compare to others that have used Nivolumab?
"Nivolumab was first studied in 2009 at Texas Children's Hospital. In the years since, there have been a total of 362 completed clinical trials worldwide. Right now, 796 different medical studies are actively recruiting patients; a significant number of these active trials are based out of Atlanta, Georgia."
Answered by AI
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