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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
Must not have
Prior systemic treatment including neoadjuvant or adjuvant therapy <6 months from protocol initiation is not allowed including an immune checkpoint inhibitor or TKI
Inability to swallow oral medication; or the presence of a poorly controlled gastrointestinal disorder that could significantly affect the absorption of oral study drug
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had any cancer treatment, including immune or targeted therapies, in the last 6 months.
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I cannot take pills by mouth or have a severe gut problem affecting drug absorption.
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I have or might have COVID-19.
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I am currently experiencing significant bleeding.
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I am currently receiving treatment through an IV for an infection.
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I have an autoimmune disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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%
0%
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: 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
Nivolumab
2015
Completed Phase 3
~4010
Ipilimumab
2015
Completed Phase 3
~3420
Ciforadenant
2016
Completed Phase 1
~510

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,068 Previous Clinical Trials
1,802,605 Total Patients Enrolled
Eric Jonasch, MDPrincipal InvestigatorM.D. Anderson Cancer Center
10 Previous Clinical Trials
547 Total Patients Enrolled

Media Library

Ciforadenant (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05501054 — Phase 1 & 2
Kidney Cancer Research Study Groups: Ipilimumab, Nivolumab, and Ciforadenant
Kidney Cancer Clinical Trial 2023: Ciforadenant Highlights & Side Effects. Trial Name: NCT05501054 — Phase 1 & 2
Ciforadenant (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05501054 — Phase 1 & 2
~13 spots leftby Nov 2026
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