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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
CheckMate-67T 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.Check my eligibility
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.See study design
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.
CheckMate-67T Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Select...
I am mostly able to care for myself but may not be able to do active work.
CheckMate-67T Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time-averaged serum concentration over 28 days (Cavgd28)
Trough serum concentration at steady-state (Cminss)
Secondary outcome measures
Efficacy parameters: DCR by BICR at end of study
Efficacy parameters: DCR by BICR with a minimum of 12 months follow-up
Efficacy parameters: DOR by BICR at end of study
+30 moreSide effects data
From 2022 Phase 3 trial • 541 Patients • NCT0204153357%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Pyrexia
21%
Neutropenia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Nasopharyngitis
8%
Lacrimation increased
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Chills
7%
Dehydration
7%
Hyperkalaemia
7%
Bronchitis
7%
Hypertension
7%
Blood alkaline phosphatase increased
7%
Hyperglycaemia
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Hypotension
5%
Pain
5%
Musculoskeletal chest pain
5%
Malaise
5%
Rash maculo-papular
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Sepsis
2%
Malignant pleural effusion
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Cancer pain
1%
Pneumothorax
1%
Atrial flutter
1%
Bone pain
1%
Small intestinal haemorrhage
1%
Circulatory collapse
1%
Confusional state
1%
Bronchial obstruction
1%
Femur fracture
1%
Hypercalcaemia
1%
Syncope
1%
Pericardial effusion malignant
1%
Neoplasm progression
1%
Superior vena cava syndrome
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab
CheckMate-67T 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
2,646 Previous Clinical Trials
4,130,510 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My last cancer treatment didn’t work or caused side effects, and it was within the last 6 months.I haven't had a serious illness like COVID-19 in the last month.My kidney cancer cannot be cured with surgery or radiation, or it has spread to other parts.My kidney cancer has been confirmed to have clear cell features, possibly with sarcomatoid traits.I am HIV positive but have been on ART for at least 4 weeks and will continue treatment.I have an autoimmune disease.I have previously been treated with drugs targeting immune system checkpoints.I have brain metastases that haven't been treated and are causing symptoms.I have had 2 or fewer previous systemic treatments.I have not received a live vaccine in the last 30 days.I do not have another cancer needing treatment or any cancer active in the last 2 years.I am mostly able to care for myself but may not be able to do active work.My cancer can be measured by scans according to specific criteria.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A
- Group 2: Arm B
- Group 3: Arm C
- Group 4: Arm D
Awards:
This trial has 2 awards, including:- 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.
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.
What are Nivolumab and rHuPH20 used to treat?
"Nivolumab and rHuPH20 is most commonly used to treat different forms of cancer. However, it can also be used to treat other medical conditions such as unresectable melanoma, squamous cell carcinoma, and drug extravasation."
Answered by AI
Are Nivolumab and rHuPH20 new drugs being trialed?
"Nivolumab and rHuPH20 was first studied in the year 2010 at H. Lee Moffitt Cancer Center and Research Institute. To date there have been 284 completed clinical trials. There are presently 786 actively recruiting clinical trials, with a large number of these studies based in Chicago, Illinois."
Answered by AI
How many individuals are being administered the trial medication?
"The sponsor, Bristol-Myers Squibb, needs to recruit 454 patients that meet the clinical study's inclusion criteria from various medical centres. For example, Reading Hospital McGlinn Cancer Institute in Chicago, Illinois and Roswell Park Cancer Institute in Buffalo, New york are both participating in the trial."
Answered by AI
What is novel about this research?
"Nivolumab and rHuPH20 have been under medical scrutiny since 2010. The first clinical trial was funded by Medarex and took place in 2010. After the initial study, which involved 127 people, Nivolumab and rHuPH20 received Phase 1 drug approval. Currently, there are 786 live studies involving this medication across 2486 cities and 57 countries."
Answered by AI
Has the FDA given the okay to use Nivolumab and rHuPH20 together?
"Nivolumab and rHuPH20 have both received a 3 for safety. This is due to the fact that this is a Phase 3 trial, which provides clinical evidence for the efficacy of the medication as well as data supporting its safety from multiple rounds of testing."
Answered by AI
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