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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

Must not have

Prior treatment with an anti-programmed death (PD)-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

Prior systemic treatment with VEGF or VEGF receptor targeted therapy (including, but not limited to, Sunitinib, Pazopanib, Axitinib, Tivozanib, and Bevacizumab)

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

No Placebo-Only Group

Pivotal Trial

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.

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.

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 below

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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.

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My kidney cancer diagnosis includes clear-cell features.

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My tumor sample is ready and suitable for the study's requirements.

Exclusion Criteria

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

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I have previously been treated with specific immunotherapy drugs.

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I have previously been treated with drugs targeting blood vessel growth in cancer.

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to june 2017, approximately 31 months) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

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 study objectives

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 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.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

~3140

Nivolumab

2014

Completed Phase 3

~5220