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Targeted Therapy

Genetic-Guided Therapy for Kidney Cancer

Phase 2

Recruiting

Led By Brian I Rini, MD

Research Sponsored by Vanderbilt-Ingram Cancer Center

Eligibility Criteria Checklist

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

Must have

Women of childbearing potential (WOCBP) is defined as any female who has experienced menarche who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or is not postmenopausal

Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 years of age in the absence of other biological or physiological causes

Must not have

Has preexisting gastrointestinal or non-gastrointestinal fistula

Active infection requiring infusional treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Summary

This trial is testing whether using genetic testing to select the optimal treatment regimen works in treating patients with advanced kidney cancer.

Who is the study for?

Adults with advanced or metastatic clear cell renal cell carcinoma, who haven't had systemic therapy for RCC and have a Karnofsky performance status of >=70%. Participants need measurable lesions per RECIST 1.1, adequate organ function, and must consent to genetic testing of their tumor tissue. Women must not be pregnant and agree to contraception.

What is being tested?

The trial is testing if genetic testing can help choose better treatment for kidney cancer that has spread. It compares two FDA-approved treatments: one combines two immunotherapies (nivolumab plus ipilimumab) via IV infusions; the other pairs nivolumab infusion with an oral pill (cabozantinib).

What are the potential side effects?

Possible side effects include immune-related reactions affecting organs, high blood pressure from cabozantinib, fatigue, skin issues from immunotherapy drugs, liver enzyme changes, and potential complications in patients with existing heart conditions.

Eligibility Criteria

Inclusion Criteria

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

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I am a woman who can still have children and have not had surgery to remove my reproductive organs.

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I am a woman over 45 and have not had a period for 12 months due to menopause.

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My kidney cancer has been confirmed to have clear cells.

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My screening results put me in either Cluster 1/2 or 4/5.

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I am able to care for myself but may not be able to do active work.

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I have not received any systemic therapy for kidney cancer before.

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My liver functions within normal limits, except for Gilbert's syndrome.

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My kidneys work well enough, with a creatinine clearance rate of at least 30 mL/min.

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My kidney cancer has spread to other parts of my body.

Exclusion Criteria

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

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I have a preexisting abnormal connection between two body parts.

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I am currently receiving treatment through an IV for an infection.

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I am currently experiencing significant bleeding.

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I have high levels of protein in my urine.

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I do not have severe heart problems or recent heart attacks.

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I cannot take pills by mouth or have a severe gut problem affecting drug absorption.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall response rate (Arm 2)

Heart rate

Secondary study objectives

Depth of response > 80%

Incidence of immune-related adverse events

Progression free survival

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.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (nivolumab, cabozantinib)Experimental Treatment2 Interventions

Patients receive nivolumab IV on day 1 and cabozantinib PO QD. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (ipilimumab, nivolumab)Experimental Treatment2 Interventions

INDUCTION: Patients receive ipilimumab and nivolumab IV on day 1. Cycles repeat every 21 days for 4 cycles. MAINTENANCE: Patients receive nivolumab IV on day 1. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cabozantinib

FDA approved

Ipilimumab

FDA approved

Nivolumab

FDA approved

0 / 15Eligibility criteria met