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Checkpoint Inhibitor

Subcutaneous vs Intravenous Nivolumab for Kidney Cancer (CheckMate-67T Trial)

Phase 3
Recruiting
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Intolerance or progression on or after the last treatment regimen received and within 6 months prior to randomization on the study
Advanced RCC (not amenable to curative surgery or radiation therapy) or metastatic RCC (Stage IV)
Must not have
Active, known, or suspected autoimmune disease
Prior treatment with an programmed death receptor-1 (anti-PD-1), programmed death ligand-1 (anti-PD-L1), or cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial will compare the effects of two ways of administering the drug nivolumab in patients who have a certain type of kidney cancer that has come back or spread.

Who is the study for?
This trial is for adults with advanced or metastatic clear cell renal cell carcinoma who've had no more than two prior treatments. They must have a Karnofsky performance status of at least 70, measurable disease by RECIST v1.1, and agree to use contraception if needed. Exclusions include untreated brain metastases, active autoimmune diseases, certain HIV conditions, recent live vaccines, other cancers within 2 years, and previous treatment with specific immune-targeting drugs.
What is being tested?
The study compares the levels and effects of Nivolumab when given as a subcutaneous injection (under the skin) versus intravenously (into a vein). Participants will be randomly assigned to one of these methods to assess drug efficacy and safety in those previously treated for kidney cancer that has spread.
What are the potential side effects?
Nivolumab can cause immune-related side effects such as inflammation in organs like lungs or intestines, skin reactions, hormone gland problems (like thyroid), liver issues; also fatigue, weakness, rash may occur. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My last cancer treatment didn’t work or caused side effects, and it was within the last 6 months.
Select...
My kidney cancer cannot be cured with surgery or radiation, or it has spread to other parts.
Select...
My kidney cancer has been confirmed to have clear cell features, possibly with sarcomatoid traits.
Select...
I have had 2 or fewer previous systemic treatments.
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I am mostly able to care for myself but may not be able to do active work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have an autoimmune disease.
Select...
I have previously been treated with drugs targeting immune system checkpoints.
Select...
I have brain metastases that haven't been treated and are causing symptoms.
Select...
I do not have another cancer needing treatment or any cancer active in the last 2 years.

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

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Arm DExperimental Treatment1 Intervention
Group II: Arm CExperimental Treatment1 Intervention
Group III: Arm AExperimental Treatment1 Intervention
Group IV: Arm BActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,682 Previous Clinical Trials
4,124,389 Total Patients Enrolled

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04810078 — Phase 3
Renal Cell Carcinoma Research Study Groups: Arm A, Arm B, Arm C, Arm D
Renal Cell Carcinoma Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT04810078 — Phase 3
Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04810078 — Phase 3
~112 spots leftby Sep 2025
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