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Tyrosine Kinase Inhibitor

Cabozantinib + Immunotherapy for Kidney Cancer (COSMIC-313 Trial)

Phase 3
Waitlist Available
Research Sponsored by Exelixis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) renal cell carcinoma with a clear-cell component
Intermediate- or poor-risk RCC as defined by International Metastatic RCC Database Consortium (IMDC) criteria
Must not have
Prior systemic anticancer therapy for unresectable locally advanced or metastatic RCC including investigational agents
Active infection requiring systemic treatment, acute or chronic hepatitis B or C infection, known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or known positive test for tuberculosis infection where there is clinical or radiographic evidence of active myobacterial infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial

Summary

This trial is testing a new cancer drug, cabozantinib, to see if it is better than the current standard of care for advanced or metastatic renal cell carcinoma.

Who is the study for?
This trial is for adults with advanced or metastatic kidney cancer that hasn't been treated before. They should have a certain level of fitness (KPS ≥ 70%) and measurable disease. People can't join if they've had recent surgeries, live vaccines, other cancers within 3 years, autoimmune diseases needing treatment in the last two years, or are on high-dose steroids.
What is being tested?
The study tests Cabozantinib combined with Nivolumab and Ipilimumab against a placebo plus Nivolumab and Ipilimumab in patients with kidney cancer. It's randomized and double-blinded, meaning neither doctors nor patients know who gets the real drug versus placebo.
What are the potential side effects?
Possible side effects include liver problems, fatigue, diarrhea, skin reactions from Cabozantinib; immune-related issues like colitis or pneumonitis from Nivolumab/Ipilimumab; as well as potential infusion reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney cancer cannot be cured with surgery or radiation and has spread.
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My kidney cancer is considered intermediate or poor risk.
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I am 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:
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I have had treatment for advanced kidney cancer that couldn't be surgically removed.
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I do not have any active infections needing treatment, including hepatitis, HIV/AIDS, or tuberculosis.
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I do not have any serious recent illnesses affecting my heart, stomach, or lungs.
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I have had symptoms or treatment for an autoimmune disease in the last 2 years.
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I have fully healed from any major surgery over 4 weeks ago and any minor surgery over 10 days ago.
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I haven't had radiation for bone metastasis in the last 2 weeks or any other radiation in the last 4 weeks.
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I haven't taken high-dose steroids or other immune-weakening drugs in the last 2 weeks.
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I am currently taking blood thinners or platelet inhibitors.

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 2022 Phase 2 trial • 45 Patients • NCT02101736
95%
HYPOTHYROIDISM
73%
DIARRHEA
55%
WEIGHT LOSS
50%
FATIGUE
41%
ALANINE AMINOTRANSFERASE INCREASED
41%
Neutrophil Count Decreased
41%
ASPARTATE AMINOTRANSFERASE INCREASED
41%
VOMITING
41%
ANOREXIA
41%
NAUSEA
36%
PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME
36%
HEADACHE
36%
PAIN IN EXTREMITY
36%
HYPERTENSION
32%
PROTEINURIA
32%
PAIN
27%
White Blood Cell Count Decreased
27%
ABDOMINAL PAIN
23%
Decreased Platelet Count
23%
PLATELET COUNT DECREASE
23%
HYPONATREMIA
23%
Platelet Count Decreased
23%
Skin Hypopigmentation
23%
Renal & Urinary Disorders - Other, Ketonuria
23%
HAIR COLOR CHANGE
18%
HEMOGLOBIN INCREASED
18%
HYPOKALEMIA
18%
Upper Respiratory Infection
18%
HYPOPHOSPHATEMIA
18%
Alopecia
18%
Hyperkalemia
14%
Rash Acneiform
14%
Pruritis
14%
Rash Maculopapular
14%
HYPOGLYCEMIA
14%
HYPERGLYCEMIA
14%
BILIRUBIN INCREASED
14%
ACNEIFORM RASH
14%
Cough
14%
Blood Bilirubin Increased
14%
DIZZINESS
14%
Skin And Subcutaneous Disorders - Other, Achromotricia
14%
CONSTIPATION
14%
Fever
9%
Papulopustular Rash
9%
ALKALINE PHOSPHATASE INCREASED
9%
LIPASE INCREASED
9%
Creatinine Increased
9%
Back Pain
9%
ABSOLUTE NEUTROPHIL COUNT DECREASED
9%
Paresthesia
9%
TUMOR PAIN
9%
Skin And Subcutaneous Tissue Disorders- Other, Rash Unspecified
9%
ORAL PAIN
9%
LYMPHOCYTE COUNT DECREASED
9%
NASAL CONGESTION
9%
WEIGHT GAIN
9%
HYPOCALCEMIA
9%
DRY SKIN
5%
Gastrointestinal Disorders - Other, Buccal Cyst
5%
Allergic Rhinitis
5%
Hypotension
5%
Muscle Weakness Lower Limb
5%
Skin And Subcutaneous Tissue Disorders- Other, Sore On Lips
5%
Musculoskeletal And Connective Tissue Disorders - Other, Extremity Cramps
5%
Skin And Subcutaneous Disorders - Other, Dry Skin Patches
5%
Hypertension
5%
SERUM AMYLASE INCREASED
5%
Behaviour Disturbance
5%
Investigations - Other, Eosinophilia
5%
Sore Throat
5%
JOINT RANGE OF MOTION DECREASED
5%
Joint Range Of Motion Decreased
5%
HEMATURIA
5%
ANXIETY
5%
Hypermagnesemia
5%
Rash Ezcematoid
5%
Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis
5%
Scalp Pain
5%
DIFFICULTY WALKING, BACK PAIN, BOWEL/BLADDER URGENCY, LEGS GAVE OUT, AND PARESTHESIAS
5%
Psychiatric Disorders - Other, Mood Swings
5%
URINARY URGENCY
5%
Sinus Tachycardia
5%
Periodontal Disease
5%
Peripheral Sensory Neuropathy
5%
Scalp Lesion
5%
Myalgia
5%
Tooth Infection
5%
RASH
5%
Gastrointestinal Disorders - Other, Dental Pain
5%
Peripheral Motor Neuropathy
5%
Tachycardia
5%
URINARY FREQUENCY
5%
Conjunctivitis
5%
Neuropathy
5%
Sinusitis
5%
Syncope
5%
Activated Partial Thromboplastin Time Prolonged
5%
Breast Pain
5%
INSOMNIA
5%
Infections And Infestations - Other, Gi Viral Infection
5%
Stomach Pain
5%
TENDONITIS
5%
SKIN INFECTION
5%
HYPOMAGNESEMIA
5%
Muscle Weakness Upper Limb
5%
Skin And Subcutaneous Tissue Disorders - Other, Skin Color Change
5%
Skin And Subcutaneous Tissue Disorders- Other, Blister/Bug Bite On Finger
5%
Surgical & Medical Procedures - Other, Dental Extractions
5%
Investigations - Other, International Normalized Ration Increased
5%
Skin And Subcutaneous Tissue Disorders- Other, Erythema
5%
Infections And Infestations - Other, Covid-19
5%
Investigations - Other, Increased Mean Corpuscular Volume
5%
Skin And Subcutaneous Tissue Disorders- Other, Transient Erythema
5%
SUBJECT WAS ADMITTED TO THE HOSPITAL ON 10/24/20 WITH GRADE 2 WEIGHT LOSS THAT THE PHYSICIAN FELT NE
5%
Injury, Poisoning And Procedural Complications - Other, Ankle Injury
5%
Injury, Poisoning And Procedural Complications- Other, Scalp Laceration
5%
Skin And Subcutaneous Tissue Disorders- Other, New Freckles/Moles
5%
SINUS BRADYCARDIA
5%
HYPERTHYROIDISM
5%
Creatine Phosphokinase Increased
5%
Skin And Subcutaneous Tissue Disorders - Other: Blue Lips (Not Cyanosis)
5%
Urine Discoloration
5%
SPINAL CORD COMPRESSION
5%
ANEMIA
5%
PARONYCHIA
5%
BRUISING
5%
HYPOALBUMINEMIA
5%
Ear And Labyrinth Disorders - Other, Impacted Cerumen
5%
Ear Pain
5%
Elevated Amylase
5%
Facial Pain
5%
Gastrointestinal Disorders - Other, Stomatitis
5%
Hoarseness
5%
Laryngitis
5%
Leg Pain
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
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort B
Cohort A

Awards & Highlights

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: Experimental ArmExperimental Treatment3 Interventions
Cabozantinib + nivolumab + ipilimumab (4 doses) followed by cabozantinib + nivolumab
Group II: Control ArmActive Control3 Interventions
Cabozantinib-matched placebo + nivolumab + ipilimumab (4 doses) followed by cabozantinib-matched placebo + nivolumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib
2020
Completed Phase 2
~1760
Nivolumab
2014
Completed Phase 3
~5220
Ipilimumab
2014
Completed Phase 3
~3140

Find a Location

Who is running the clinical trial?

ExelixisLead Sponsor
120 Previous Clinical Trials
19,275 Total Patients Enrolled

Media Library

Cabozantinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03937219 — Phase 3
Kidney Cancer Research Study Groups: Experimental Arm, Control Arm
Kidney Cancer Clinical Trial 2023: Cabozantinib Highlights & Side Effects. Trial Name: NCT03937219 — Phase 3
Cabozantinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03937219 — Phase 3
~135 spots leftby Nov 2025
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