← Back to Search

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
Measurable disease per RECIST 1.1 as determined by the Investigator. Measurable disease must be outside the radiation field if radiation therapy was previously administered
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 23 months after first subject randomized
Awards & highlights

COSMIC-313 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.Check my eligibility
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.See study design
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.

COSMIC-313 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My kidney cancer cannot be cured with surgery or radiation and has spread.
Select...
My cancer can be measured and is not in an area treated by radiation.
Select...
My organs and bone marrow are working well.
Select...
My kidney cancer is considered intermediate or poor risk.
Select...
I am able to care for myself but may not be able to do active work.

COSMIC-313 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 23 months after first subject randomized
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 23 months after first subject randomized for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Duration of Progression-Free Survival (PFS) per RECIST 1.1 as determined by blinded independent radiology committee (BIRC)
Secondary outcome measures
Duration of Overall Survival (OS)

Side effects data

From 2022 Phase 2 trial • 45 Patients • NCT02101736
95%
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%
PAIN IN EXTREMITY
36%
PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME
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%
DIZZINESS
14%
BILIRUBIN INCREASED
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%
ALKALINE PHOSPHATASE INCREASED
9%
ORAL PAIN
9%
TUMOR PAIN
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%
RASH
5%
Peripheral Sensory Neuropathy
5%
SINUS BRADYCARDIA
5%
HEMATURIA
5%
HYPERTHYROIDISM
5%
Sore Throat
5%
Hypertension
5%
ANXIETY
5%
Myalgia
5%
SPINAL CORD COMPRESSION
5%
Gastrointestinal Disorders - Other, Buccal Cyst
5%
Hoarseness
5%
Peripheral Motor Neuropathy
5%
Investigations - Other, Eosinophilia
5%
Stomach Pain
5%
Gastrointestinal Disorders - Other, Dental Pain
5%
SUBJECT WAS ADMITTED TO THE HOSPITAL ON 10/24/20 WITH GRADE 2 WEIGHT LOSS THAT THE PHYSICIAN FELT NE
5%
Gastrointestinal Disorders - Other, Stomatitis
5%
Surgical & Medical Procedures - Other, Dental Extractions
5%
Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis
5%
TENDONITIS
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

COSMIC-313 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
~1080
Nivolumab
2014
Completed Phase 3
~4750
Ipilimumab
2014
Completed Phase 3
~2640

Find a Location

Who is running the clinical trial?

ExelixisLead Sponsor
116 Previous Clinical Trials
17,246 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this new Cabozantinib research build on other existing studies?

"879 clinical trials are currently underway to study cabozantinib. Of these, 96 are in phase 3. Some of the trials for cabozantinib originate out of Pittsburgh, but there are 46877 total locations running trials for this medication."

Answered by AI

Is Cabozantinib more harmful than other cancer treatments?

"Cabozantinib's safety is well-supported by clinical data, so it received a score of 3."

Answered by AI

Are there any available positions for patients in this trial?

"No, this research is not recruiting patients at the moment. The most recent update on clinicaltrials.gov was from October 31st, 2022 and stated that the trial is no longer looking for participants. There are currently 3544 other trials that are actively enrolling patients though."

Answered by AI

What are the standard treatments that Cabozantinib is used for?

"Cabozantinib can be used to treat otherwise inoperable melanoma, squamous cell carcinoma, and cases where there is a high risk of recurrence."

Answered by AI

Are there numerous hospitals participating in this experiment within the confines of our state?

"Exelixis Clinical Site #64 in Fairfax, Exelixis Clinical Site #69 in Scarborough, and Exelixis Clinical Site #7A in Boston are just a few of the 36 locations where patients can enroll for this clinical trial."

Answered by AI

How many participants are allowed to join this research project?

"This particular clinical trial is not currently looking for new participants. The posting was first published on June 25th, 2019 but the most recent edit occurred on October 31st, 2022. However, there are 2665 and 879 other trials respectively for patients with carcinoma and Cabozantinib that are presently recruiting."

Answered by AI
~146 spots leftby Mar 2025