Your session is about to expire
← Back to Search
Kinase Inhibitor
Surgery + Immunotherapy + Targeted Therapy for Kidney Cancer (Cyto-KIK Trial)
Phase 2
Recruiting
Led By Mark N Stein, MD
Research Sponsored by Mark Stein
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years at the time of consent
Radiographically consistent with metastatic renal cell carcinoma (with subsequent pathologic confirmation of renal cell carcinoma with a clear cell component) OR histological/cytological evidence of metastatic renal cell carcinoma with a clear cell component
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years after completion of treatment
Awards & highlights
Cyto-KIK Trial Summary
This trial will test if using immunotherapy and targeted therapy before removing the kidney will increase the number of people who are free of any visible kidney cancer.
Who is the study for?
Adults with kidney cancer that has spread, who haven't had treatment for metastatic renal cell carcinoma. They must be in good physical condition (ECOG 0-1), have a measurable tumor, and agree to use two forms of contraception if of childbearing potential. Excluded are those with recent significant bleeding or radiation therapy, active or progressive other cancers, certain heart conditions, uncontrolled hypertension, brain metastases, major surgery within the last 8 weeks, systemic infections within the last month or on immunosuppressants.Check my eligibility
What is being tested?
The trial is testing whether combining nivolumab (an immunotherapy drug) and cabozantinib (a targeted therapy) before surgically removing the kidney can clear visible signs of kidney cancer more effectively than current treatments. Participants will receive these drugs prior to undergoing cytoreductive nephrectomy.See study design
What are the potential side effects?
Nivolumab may cause immune-related side effects like inflammation in various organs including lungs and intestines; skin rash; liver problems; hormonal gland issues; and infusion reactions. Cabozantinib might lead to high blood pressure; tiredness; nausea; mouth sores; hand-foot syndrome where hands or feet become swollen and painful.
Cyto-KIK Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My kidney cancer has spread, and tests show it's the clear cell type.
Select...
My kidney tumor can be measured by standard criteria.
Select...
I have not received any treatment for advanced kidney cancer.
Cyto-KIK Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years after completion of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years after completion of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants with a Complete Response
Secondary outcome measures
Median Size Reduction of the Primary Tumor
Overall Survival
Progression Free Survival (PFS)
+2 moreSide effects data
From 2022 Phase 2 trial • 45 Patients • NCT0210173695%
HYPOTHYROIDISM
73%
DIARRHEA
55%
WEIGHT LOSS
50%
FATIGUE
41%
VOMITING
41%
NAUSEA
41%
ASPARTATE AMINOTRANSFERASE INCREASED
41%
ANOREXIA
41%
ALANINE AMINOTRANSFERASE INCREASED
41%
Neutrophil Count Decreased
36%
HEADACHE
36%
PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME
36%
PAIN IN EXTREMITY
36%
HYPERTENSION
32%
PAIN
32%
PROTEINURIA
27%
ABDOMINAL PAIN
27%
White Blood Cell Count Decreased
23%
Platelet Count Decreased
23%
Skin Hypopigmentation
23%
HAIR COLOR CHANGE
23%
Renal & Urinary Disorders - Other, Ketonuria
23%
PLATELET COUNT DECREASE
23%
HYPONATREMIA
23%
Decreased Platelet Count
18%
HYPOPHOSPHATEMIA
18%
HYPOKALEMIA
18%
Alopecia
18%
Hyperkalemia
18%
Upper Respiratory Infection
18%
HEMOGLOBIN INCREASED
14%
BILIRUBIN INCREASED
14%
DIZZINESS
14%
Pruritis
14%
ACNEIFORM RASH
14%
Fever
14%
Rash Maculopapular
14%
CONSTIPATION
14%
HYPERGLYCEMIA
14%
HYPOGLYCEMIA
14%
Blood Bilirubin Increased
14%
Cough
14%
Rash Acneiform
14%
Skin And Subcutaneous Disorders - Other, Achromotricia
9%
TUMOR PAIN
9%
ORAL PAIN
9%
ALKALINE PHOSPHATASE INCREASED
9%
WEIGHT GAIN
9%
NASAL CONGESTION
9%
Skin And Subcutaneous Tissue Disorders- Other, Rash Unspecified
9%
ABSOLUTE NEUTROPHIL COUNT DECREASED
9%
LIPASE INCREASED
9%
LYMPHOCYTE COUNT DECREASED
9%
HYPOCALCEMIA
9%
DRY SKIN
9%
Back Pain
9%
Creatinine Increased
9%
Papulopustular Rash
9%
Paresthesia
5%
INSOMNIA
5%
Peripheral Sensory Neuropathy
5%
HYPERTHYROIDISM
5%
Hypertension
5%
ANXIETY
5%
Sore Throat
5%
Myalgia
5%
SPINAL CORD COMPRESSION
5%
Gastrointestinal Disorders - Other, Stomatitis
5%
Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis
5%
Peripheral Motor Neuropathy
5%
Investigations - Other, Eosinophilia
5%
SINUS BRADYCARDIA
5%
Surgical & Medical Procedures - Other, Dental Extractions
5%
SUBJECT WAS ADMITTED TO THE HOSPITAL ON 10/24/20 WITH GRADE 2 WEIGHT LOSS THAT THE PHYSICIAN FELT NE
5%
Stomach Pain
5%
HEMATURIA
5%
Gastrointestinal Disorders - Other, Buccal Cyst
5%
Gastrointestinal Disorders - Other, Dental Pain
5%
TENDONITIS
5%
RASH
5%
Hoarseness
5%
DIFFICULTY WALKING, BACK PAIN, BOWEL/BLADDER URGENCY, LEGS GAVE OUT, AND PARESTHESIAS
5%
Musculoskeletal And Connective Tissue Disorders - Other, Extremity Cramps
5%
Facial Pain
5%
HYPOMAGNESEMIA
5%
Allergic Rhinitis
5%
Activated Partial Thromboplastin Time Prolonged
5%
Leg Pain
5%
Muscle Weakness Lower Limb
5%
Muscle Weakness Upper Limb
5%
Psychiatric Disorders - Other, Mood Swings
5%
Scalp Lesion
5%
Scalp Pain
5%
Sinus Tachycardia
5%
Sinusitis
5%
Skin And Subcutaneous Tissue Disorders- Other, Blister/Bug Bite On Finger
5%
Skin And Subcutaneous Tissue Disorders- Other, Erythema
5%
Skin And Subcutaneous Tissue Disorders- Other, Sore On Lips
5%
Skin And Subcutaneous Tissue Disorders- Other, Transient Erythema
5%
Syncope
5%
Tachycardia
5%
Urine Discoloration
5%
JOINT RANGE OF MOTION DECREASED
5%
ANEMIA
5%
PARONYCHIA
5%
BRUISING
5%
SERUM AMYLASE INCREASED
5%
SKIN INFECTION
5%
HYPOALBUMINEMIA
5%
URINARY FREQUENCY
5%
URINARY URGENCY
5%
Behaviour Disturbance
5%
Breast Pain
5%
Conjunctivitis
5%
Creatine Phosphokinase Increased
5%
Ear And Labyrinth Disorders - Other, Impacted Cerumen
5%
Ear Pain
5%
Elevated Amylase
5%
Hypermagnesemia
5%
Hypotension
5%
Infections And Infestations - Other, Covid-19
5%
Infections And Infestations - Other, Gi Viral Infection
5%
Injury, Poisoning And Procedural Complications - Other, Ankle Injury
5%
Injury, Poisoning And Procedural Complications- Other, Scalp Laceration
5%
Investigations - Other, Increased Mean Corpuscular Volume
5%
Investigations - Other, International Normalized Ration Increased
5%
Laryngitis
5%
Localized Edema
5%
Lung Infection
5%
Metabolism And Nutrition Disorders - Other, Decreased Oral Intake
5%
Metabolism Other - Decreased Vitamin D
5%
Metbolism And Nutrition Disorders - Other, Hyperchloremia
5%
Mucositis Oral
5%
Neuropathy
5%
Periodontal Disease
5%
Rash Ezcematoid
5%
Skin And Subcutaneous Disorders - Other, Dry Skin Patches
5%
Skin And Subcutaneous Tissue Disorders - Other, Skin Color Change
5%
Skin And Subcutaneous Tissue Disorders - Other: Blue Lips (Not Cyanosis)
5%
Skin And Subcutaneous Tissue Disorders- Other, New Freckles/Moles
5%
Tooth Infection
5%
Joint Range Of Motion Decreased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort B
Cohort A
Cyto-KIK Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment with cabozantinib and nivolumab with nephrectomyExperimental Treatment3 Interventions
All study participants will receive the same study medications, cabozantinib and nivolumab. The study drug, nivolumab, will be administered through an IV infusion every 4 weeks and cabozantinib will be administered orally daily. Initially participants will receive study treatment for 12 weeks. The cabozantinib will then be stopped prior to the nephrectomy. Initially patients enrolled on the study will be assigned to cohort 1.
Patients who are assigned to cohort 1 will be treated with cabozantinib until 21 days prior to surgery. A patient in cohort 1 will be evaluable for assessment of the cabozantinib washout interval ("evaluable patients") if they
complete at least 10 of the 14 scheduled cabozantinib doses in the two week period prior to stopping cabozantinib AND
have surgical resection of the primary tumor.
In cohort 2, subjects will receive cabozantinib until 14 days prior to nephrectomy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Cabozantinib
2020
Completed Phase 2
~1080
Find a Location
Who is running the clinical trial?
Mark SteinLead Sponsor
3 Previous Clinical Trials
101 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,640 Previous Clinical Trials
4,129,416 Total Patients Enrolled
ExelixisIndustry Sponsor
117 Previous Clinical Trials
19,503 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had a severe infection needing treatment in the last 28 days.I haven't had any serious wounds, ulcers, or bone fractures that haven't healed in the last 28 days.I have been treated with PD-1/PD-L1 or anti-CTLA-4 inhibitors before.I have not had my kidney removed due to cancer.I am currently on medication for an infection.I have not had serious stomach or intestine bleeding in the last 6 months.My cancer has spread to my digestive system or airways.My blood pressure is not controlled despite taking medication.I have an autoimmune disease that could come back or affect my organs.I haven't taken high-dose steroids or other immune-weakening drugs in the last 14 days.I do not have uncontrolled bleeding, high blood pressure, or heart disease.I have severe heart failure (NYHA Class III or IV).I have had an organ transplant.I have fully healed from any major surgery 1 month before starting the study treatment and from any minor surgery at least 10 days before.I am not pregnant and can prove it with a test, or I cannot have children due to surgery or menopause.I need blood thinners for my condition.My cancer has spread to my brain.I have lung lesions or disease in my airways.I am 18 years old or older.My kidney cancer has spread, and tests show it's the clear cell type.I have been mostly active and able to carry out all my pre-disease activities up to 28 days before signing up.I have coughed up a noticeable amount of blood recently.I haven't had radiation for bone metastasis in the last 2 weeks or any other radiation in the last 4 weeks.I have no active cancer needing treatment, except for certain skin, cervical, or bladder cancers.Your heart's electrical activity, measured as the QT interval, is too long.I have active cancer spread to my brain or the protective covering of my brain and spinal cord.Your blood clotting tests show a result that is more than 1.3 times the upper limit of normal.I cannot swallow pills.I understand and can follow the study's procedures.I have untreated low thyroid function.My kidney tumor can be measured by standard criteria.I have not received any treatment for advanced kidney cancer.My organ functions are within normal ranges as required.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment with cabozantinib and nivolumab with nephrectomy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Are enrollment opportunities still available for this research endeavor?
"The details posted on clinicaltrials.gov indicate that this medical trial is actively seeking participants, having been initially published on June 22nd 2020 and amended on March 22nd 2022."
Answered by AI
What other studies have investigated the benefits of Cabozantinib?
"At present, 90 out of the 794 active trials on Cabozantinib are in Phase 3. International locations have come together to form 43549 sites that oversee research for this medication and many of these centres are located within Basel, BE."
Answered by AI
What maladies have Cabozantinib been known to aid in managing?
"Cabozantinib has been proven to be a viable treatment option for people suffering from malignant neoplasms, unresectable melanoma, and squamous cell carcinoma."
Answered by AI
Is this experiment an unprecedented approach?
"At present, 794 live clinical studies for Cabozantinib are being conducted in 2553 cities and 53 countries. The initial trial with Exelixis sponsorship was established in 2012 and had 86 participants who completed the Phase 2 drug assessment stage. Since that time, 305 trials have been finished successfully."
Answered by AI
What is the participant cap for this clinical trial?
"To properly conduct the trial, 48 participants that meet the study eligibility criteria must be recruited. The sponsor of this research initiative is Bristol-Myers Squibb and it will take place in New york's Columbia University Irving Medical Center as well Cleveland Clinic in Ohio."
Answered by AI
Has Cabozantinib obtained regulatory approval from the FDA?
"Supported by initial safety-based evidence, Cabozantinib received a score of 2 on the 1 to 3 scale. While there is data noting its likely security, efficacy has yet to be proven in clinical trials."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger