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Triple Drug Therapy for Kidney Cancer
Phase 1 & 2
Recruiting
Led By Eric Jonasch, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Confirmed diagnosis of clear cell RCC
No prior systemic therapy for advanced RCC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion and average of 1 year.
Awards & highlights
Study Summary
This trial will test if a combination of three drugs can help control advanced renal cell carcinoma.
Who is the study for?
Adults with Stage IV metastatic renal cell carcinoma who have not had prior systemic therapy for advanced RCC. Participants must have adequate organ function, be willing to use contraception, and able to provide consent. Excluded are those with recent major surgery, active autoimmune diseases, or conditions requiring immunosuppressants.Check my eligibility
What is being tested?
The trial is testing a combination of three drugs: Ciforadenant (an adenosine A2a receptor antagonist), Ipilimumab, and Nivolumab in patients with advanced renal cell carcinoma to see if this mix can control the disease better than current treatments.See study design
What are the potential side effects?
Potential side effects include immune-related reactions affecting organs like the liver or intestines, skin rash, hormone gland problems (like thyroid issues), infusion reactions during drug administration, fatigue, and possible increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with clear cell renal cell carcinoma.
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I have not received any systemic therapy for advanced kidney cancer.
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My kidney cancer is at stage IV.
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I have provided a sample of my tumor that has not been treated with radiation.
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I am 18 years old or older.
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I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion and average of 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion and average of 1 year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To establish the objective response rate (ORR)
Side effects data
From 2017 Phase 3 trial • 1289 Patients • NCT0128560938%
Alopecia
36%
Anaemia
32%
Nausea
31%
Decreased appetite
31%
Diarrhoea
30%
Fatigue
25%
Constipation
23%
Neutropenia
20%
Dyspnoea
19%
Vomiting
19%
Pyrexia
18%
Rash
17%
Asthenia
17%
Cough
16%
Pruritus
16%
Thrombocytopenia
16%
Arthralgia
15%
Peripheral sensory neuropathy
14%
Myalgia
13%
Insomnia
13%
Neuropathy peripheral
11%
Hypokalaemia
10%
Platelet count decreased
9%
Pain in extremity
9%
Weight decreased
9%
Leukopenia
8%
Alanine aminotransferase increased
8%
Hyponatraemia
8%
Pneumonia
8%
Haemoglobin decreased
7%
Neutrophil count decreased
7%
Dizziness
7%
Malignant neoplasm progression
7%
Aspartate aminotransferase increased
7%
Bone pain
7%
Haemoptysis
7%
Back pain
6%
Headache
6%
Hypomagnesaemia
6%
Stomatitis
5%
Abdominal pain upper
5%
Oedema peripheral
5%
White blood cell count decreased
5%
Chest pain
5%
Dehydration
5%
Abdominal pain
4%
Febrile neutropenia
4%
Paraesthesia
4%
Musculoskeletal pain
3%
Colitis
2%
Death
2%
Lung infection
2%
Pulmonary embolism
2%
Mucosal inflammation
1%
Lung neoplasm malignant
1%
Multi-organ failure
1%
Cerebrovascular accident
1%
Lung abscess
1%
General physical health deterioration
1%
Interstitial lung disease
1%
Liver function test abnormal
1%
Sudden death
1%
Chronic obstructive pulmonary disease
1%
Metastases to central nervous system
1%
Blood creatinine increased
1%
Atrial fibrillation
1%
Cardio-respiratory arrest
1%
Confusional state
1%
Intestinal perforation
1%
Pulmonary haemorrhage
1%
Drug hypersensitivity
1%
Infection
1%
Pneumothorax
1%
Renal failure
1%
Lower respiratory tract infection
1%
Pain
1%
Respiratory failure
1%
Syncope
1%
Hyperglycaemia
1%
Sepsis
1%
Acute kidney injury
1%
Hypersensitivity
1%
Urinary tract infection
1%
Disease progression
1%
Pneumonitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
10 MG/KG Ipilimumab + Paclitaxel/ Carbop
Placebo + Paclitaxel/ Carboplatin
Trial Design
1Treatment groups
Experimental Treatment
Group I: Ipilimumab, Nivolumab, and CiforadenantExperimental Treatment3 Interventions
To help control advanced renal cell carcinoma.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2014
Completed Phase 3
~2620
Nivolumab
2014
Completed Phase 3
~4750
Ciforadenant
2016
Completed Phase 1
~510
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,450 Total Patients Enrolled
Eric Jonasch, MDPrincipal InvestigatorM.D. Anderson Cancer Center
9 Previous Clinical Trials
428 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Women who can have babies must have a negative pregnancy test within 24 hours before starting the treatment.I have been diagnosed with clear cell renal cell carcinoma.I haven't had any cancer treatment, including immune or targeted therapies, in the last 6 months.I cannot take pills by mouth or have a severe gut problem affecting drug absorption.I haven't had major surgery in the last 28 days.I have or might have COVID-19.I have had minor surgery recently.I have not received any systemic therapy for advanced kidney cancer.I am currently experiencing significant bleeding.My kidney cancer is at stage IV.I have provided a sample of my tumor that has not been treated with radiation.I am 18 years old or older.I am willing to have bone and brain scans now and in the future if needed.My organs are functioning well enough for treatment.You have at least one specific type of lesion that can be measured according to certain guidelines.I am fully active or can carry out light work.I am currently receiving treatment through an IV for an infection.My brain metastasis is stable and hasn't changed in the last 2 weeks.I am a man, not sterile, and will use birth control during and after the treatment for 31 weeks.I have an autoimmune disease.I have had radiosurgery or radiotherapy within the last 14 days.I haven't taken steroids or immunosuppressants in the last 14 days.
Research Study Groups:
This trial has the following groups:- Group 1: Ipilimumab, Nivolumab, and Ciforadenant
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 there any vacancies remaining in this experiment?
"Per the data hosted on clinicaltrials.gov, this specific research study is not presently recruiting patients as it was last updated November 23rd 2022 after being initially posted February 28th 2023. However, there are currently 2,586 other trials that people can consider enrolling in at this time."
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