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Checkpoint Inhibitor
Nivolumab + Ipilimumab for Kidney Cancer
Phase 3
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Karnofsky Performance Status (KPS) of at least 70%
Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to june 2017, approximately 31 months)
Awards & highlights
Study Summary
This trial will compare the effectiveness of two different treatments for kidney cancer.
Who is the study for?
This trial is for adults with advanced or metastatic renal cell carcinoma who haven't had systemic therapy for it, except possibly one adjuvant/neoadjuvant therapy not targeting VEGF if recurrence was over 6 months ago. Participants must have a KPS of at least 70%, measurable disease, and provide tumor tissue samples. Exclusions include brain metastases, prior VEGF/VEGF receptor targeted therapies or immunotherapies, current CNS metastases, and certain autoimmune diseases.Check my eligibility
What is being tested?
The study compares the effectiveness of combining Nivolumab (an immune checkpoint inhibitor) with Ipilimumab (another immune-modulating drug) against Sunitinib monotherapy in untreated renal cell cancer patients. It looks at response rate to treatment, how long patients live without their disease getting worse, and overall survival rates.See study design
What are the potential side effects?
Potential side effects may include immune-related reactions such as inflammation in various organs like the intestines or liver; skin rash; endocrine issues like thyroid dysfunction; fatigue; and infusion-related reactions from the drugs being administered.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to care for myself but may not be able to do active work.
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My kidney cancer cannot be cured with surgery or radiation.
Select...
My kidney cancer diagnosis includes clear-cell features.
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My tumor sample is ready and suitable for the study's requirements.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to june 2017, approximately 31 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to june 2017, approximately 31 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Investigator-assessed Objective Response Rate(ORR) in Intermediate/Poor Risk Participants Per IRRC Using RECIST v1.1
Overall Survival (OS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)
Progression-Free Survival (PFS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)
Secondary outcome measures
Investigator-assessed Objective Response Rate(ORR) in Any Risk Participants Per IRRC Using RECIST v1.1
Overall Survival (OS) in Any Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)
Progression-Free Survival (PFS) in Any Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)
Side 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%
Hypomagnesaemia
19%
Headache
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Rash
14%
Hyponatraemia
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%
Muscular weakness
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
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%
Dehydration
7%
Hyperkalaemia
7%
Hyperglycaemia
7%
Chills
7%
Blood alkaline phosphatase increased
7%
Hypertension
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%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
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%
Sepsis
2%
Malignant pleural effusion
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Bone pain
1%
Pericardial effusion malignant
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Neoplasm progression
1%
Circulatory collapse
1%
Atrial flutter
1%
Bronchial obstruction
1%
Hypercalcaemia
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
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kgExperimental Treatment2 Interventions
Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Group II: Arm B: Sunitinib 50 mgActive Control3 Interventions
Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks
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
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,638 Previous Clinical Trials
4,127,124 Total Patients Enrolled
Ono Pharmaceutical Co. LtdIndustry Sponsor
154 Previous Clinical Trials
93,133 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am able to care for myself but may not be able to do active work.My kidney cancer cannot be cured with surgery or radiation.My kidney cancer diagnosis includes clear-cell features.I have previously been treated with specific immunotherapy drugs.I have kidney cancer and haven't had systemic therapy, except possibly one treatment that didn't target VEGF if my cancer returned 6+ months after.You have a measurable tumor according to specific guidelines.I have had or currently have cancer spread to my brain.I don't have an active autoimmune disease or need strong immune system medications.I have previously been treated with drugs targeting blood vessel growth in cancer.I haven't taken high-dose steroids or immunosuppressants in the last 14 days.My tumor sample is ready and suitable for the study's requirements.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
- Group 2: Arm B: Sunitinib 50 mg
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
How is Nivolumab most often employed?
"Nivolumab can be used to treat various forms of cancer, including malignant neoplasms, unresectable melanoma, and squamous cell carcinoma."
Answered by AI
Could you provide more information on the potential risks of Nivolumab?
"Given that this is a Phase 3 trial - meaning that there is evidence of efficacy as well as multiple rounds of data supporting safety - our team has given Nivolumab a safety score of 3."
Answered by AI
How many different locations are participating in this experiment?
"In addition to 96 other locations, this trial is enrolling patients at Local Institution - 0056 in Dallas, Texas, Local Institution - 0182 in Kelowna, British Columbia, and Local Institution - 0003 in Houston, Massachusetts."
Answered by AI
How many individuals are enrolling in this clinical trial in total?
"At the moment, this clinical trial is not enrolling patients. The study was first posted on October 16th, 2014 and was last updated on October 12th, 2022. However, there are presently 2652 trials actively recruiting patients with advanced renal cell carcinoma (arcc) and 829 trials for Nivolumab that are actively looking for patients."
Answered by AI
To the best of your knowledge, has this research been done before?
"Nivolumab has been researched since 2006 when it was first trialled by Pfizer. The Phase 2 drug approval came after the initial study in 2006, which only included 64 patients. In the present day, there are 829 live trials for Nivolumab being conducted in 51 countries and 2482 cities."
Answered by AI
Is this research project actively looking for new participants?
"Unfortunately, this particular trial is not looking for any more candidates at this time. It was originally posted on October 16th, 2014 but the most recent update was on October 12th, 2022. Although this study is not searching for candidates right now, there are 3481 other clinical trials that are."
Answered by AI
Are there previous examples of Nivolumab's efficacy?
"Nivolumab was first researched in 2006 at the University of Texas MD Anderson Cancer Center. So far, 593 clinical trials have completed. 829 more are recruiting patients right now; a large portion of these are based in Dallas, Texas."
Answered by AI
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