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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

Must not have

Prior treatment with any therapy on the PD-1/PD-L1 axis or anti-CTLA-4 inhibitors

Patients who had previously undergone nephrectomy for renal cancer are excluded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years after completion of treatment

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My kidney cancer has spread, and tests show it's the clear cell type.

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My kidney tumor can be measured by standard criteria.

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I have not received any treatment for advanced kidney cancer.

Exclusion Criteria

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

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I have been treated with PD-1/PD-L1 or anti-CTLA-4 inhibitors before.

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I have not had my kidney removed due to cancer.

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I am currently on medication for an infection.

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I have an autoimmune disease that could come back or affect my organs.

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I haven't taken high-dose steroids or other immune-weakening drugs in the last 14 days.

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I do not have uncontrolled bleeding, high blood pressure, or heart disease.

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I have severe heart failure (NYHA Class III or IV).

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I have had an organ transplant.

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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.

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My cancer has spread to my brain.

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I have lung lesions or disease in my airways.

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I have coughed up a noticeable amount of blood recently.

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I have active cancer spread to my brain or the protective covering of my brain and spinal cord.

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I cannot swallow pills.

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I have untreated low thyroid function.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years after completion of treatment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Percentage of Participants with a Complete Response

Secondary study objectives

Median Size Reduction of the Primary Tumor

Overall Survival

Progression Free Survival (PFS)

+2 more

Side effects data

From 2022 Phase 2 trial • 45 Patients • NCT02101736

95%

HYPOTHYROIDISM

73%

DIARRHEA

55%

WEIGHT LOSS

50%

FATIGUE

41%

Neutrophil Count Decreased

41%

ALANINE AMINOTRANSFERASE INCREASED

41%

ASPARTATE AMINOTRANSFERASE INCREASED

41%

VOMITING

41%

ANOREXIA

41%

NAUSEA

36%

HYPERTENSION

36%

HEADACHE

36%

PAIN IN EXTREMITY

36%

PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME

32%

PROTEINURIA

32%

PAIN

27%

White Blood Cell Count Decreased

27%

ABDOMINAL PAIN

23%

PLATELET COUNT DECREASE

23%

HYPONATREMIA

23%

Platelet Count Decreased

23%

Renal & Urinary Disorders - Other, Ketonuria

23%

Skin Hypopigmentation

23%

Decreased Platelet Count

23%

HAIR COLOR CHANGE

18%

Upper Respiratory Infection

18%

HEMOGLOBIN INCREASED

18%

HYPOKALEMIA

18%

HYPOPHOSPHATEMIA

18%

Alopecia

18%

Hyperkalemia

14%

HYPERGLYCEMIA

14%

Skin And Subcutaneous Disorders - Other, Achromotricia

14%

Pruritis

14%

HYPOGLYCEMIA

14%

Rash Maculopapular

14%

BILIRUBIN INCREASED

14%

ACNEIFORM RASH

14%

Cough

14%

Blood Bilirubin Increased

14%

DIZZINESS

14%

CONSTIPATION

14%

Rash Acneiform

14%

Fever

NASAL CONGESTION

TUMOR PAIN

Papulopustular Rash

ALKALINE PHOSPHATASE INCREASED

Creatinine Increased

Back Pain

ABSOLUTE NEUTROPHIL COUNT DECREASED

LIPASE INCREASED

Paresthesia

ORAL PAIN

LYMPHOCYTE COUNT DECREASED

Skin And Subcutaneous Tissue Disorders- Other, Rash Unspecified

WEIGHT GAIN

HYPOCALCEMIA

DRY SKIN

Hypotension

Joint Range Of Motion Decreased

Skin And Subcutaneous Disorders - Other, Dry Skin Patches

Hypertension

SERUM AMYLASE INCREASED

Muscle Weakness Upper Limb

Investigations - Other, Eosinophilia

ANXIETY

Hypermagnesemia

Rash Ezcematoid

Behaviour Disturbance

Scalp Pain

Psychiatric Disorders - Other, Mood Swings

Sinus Tachycardia

Periodontal Disease

Myalgia

Tooth Infection

JOINT RANGE OF MOTION DECREASED

Skin And Subcutaneous Tissue Disorders - Other, Skin Color Change

Skin And Subcutaneous Tissue Disorders- Other, Sore On Lips

URINARY FREQUENCY

Conjunctivitis

Sinusitis

Syncope

Activated Partial Thromboplastin Time Prolonged

Breast Pain

Peripheral Motor Neuropathy

Scalp Lesion

Sore Throat

Tachycardia

INSOMNIA

URINARY URGENCY

Allergic Rhinitis

Peripheral Sensory Neuropathy

HEMATURIA

RASH

Infections And Infestations - Other, Covid-19

Gastrointestinal Disorders - Other, Buccal Cyst

Investigations - Other, International Normalized Ration Increased

Infections And Infestations - Other, Gi Viral Infection

Gastrointestinal Disorders - Other, Dental Pain

Stomach Pain

SKIN INFECTION

HYPOMAGNESEMIA

Surgical & Medical Procedures - Other, Dental Extractions

Neuropathy

Investigations - Other, Increased Mean Corpuscular Volume

Skin And Subcutaneous Tissue Disorders- Other, New Freckles/Moles

TENDONITIS

SINUS BRADYCARDIA

HYPERTHYROIDISM

Creatine Phosphokinase Increased

SUBJECT WAS ADMITTED TO THE HOSPITAL ON 10/24/20 WITH GRADE 2 WEIGHT LOSS THAT THE PHYSICIAN FELT NE

Skin And Subcutaneous Tissue Disorders - Other: Blue Lips (Not Cyanosis)

Skin And Subcutaneous Tissue Disorders- Other, Transient Erythema

Muscle Weakness Lower Limb

Urine Discoloration

DIFFICULTY WALKING, BACK PAIN, BOWEL/BLADDER URGENCY, LEGS GAVE OUT, AND PARESTHESIAS

Injury, Poisoning And Procedural Complications - Other, Ankle Injury

Injury, Poisoning And Procedural Complications- Other, Scalp Laceration

Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis

Musculoskeletal And Connective Tissue Disorders - Other, Extremity Cramps

Skin And Subcutaneous Tissue Disorders- Other, Blister/Bug Bite On Finger

Skin And Subcutaneous Tissue Disorders- Other, Erythema

SPINAL CORD COMPRESSION

ANEMIA

PARONYCHIA

BRUISING

HYPOALBUMINEMIA

Ear And Labyrinth Disorders - Other, Impacted Cerumen

Ear Pain

Elevated Amylase

Facial Pain

Gastrointestinal Disorders - Other, Stomatitis

Hoarseness

Laryngitis

Leg Pain

Localized Edema

Lung Infection

Metabolism And Nutrition Disorders - Other, Decreased Oral Intake

Metabolism Other - Decreased Vitamin D

Metbolism And Nutrition Disorders - Other, Hyperchloremia

Mucositis Oral

100%

80%

60%

40%

20%

Study treatment Arm

Cohort B

Cohort A

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 1. complete at least 10 of the 14 scheduled cabozantinib doses in the two week period prior to stopping cabozantinib AND 2. 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

Cabozantinib

2020

Completed Phase 2

~2360

Nivolumab

2015

Completed Phase 3

~4010