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Tyrosine Kinase Inhibitor

Cabozantinib + Nivolumab for Colorectal Cancer

Phase 2
Waitlist Available
Led By Alexis Leal, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
Histologic or cytologic diagnosis of colorectal adenocarcinoma that is metastatic or unresectable
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study start date to study end date, up to 24 months
Awards & highlights

Study Summary

This trial is testing if a drug combo can help patients with a certain type of cancer that has spread and is hard to treat.

Who is the study for?
This trial is for adults with metastatic or unresectable colorectal adenocarcinoma that's microsatellite stable (MSS) or has proficient mismatch repair. They must have tried certain cancer treatments without success and be in good health otherwise. Women of childbearing potential and sexually active men must agree to use contraception during the study.Check my eligibility
What is being tested?
The trial tests a combination of Cabozantinib, a drug targeting cancer growth pathways, and Nivolumab, an immunotherapy drug, in patients who've had at least two other types of treatment for colorectal cancer. It aims to see if this combo is effective when others aren't.See study design
What are the potential side effects?
Possible side effects include fatigue, high blood pressure, hand-foot syndrome from Cabozantinib; Nivolumab may cause immune-related issues like inflammation in organs such as lungs or intestines, skin rash, and endocrine problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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My colorectal cancer cannot be removed by surgery and has spread.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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My condition worsened or didn't improve after treatment with specific cancer drugs.
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My condition worsened or didn't improve after treatment with specific cancer drugs.
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My cancer is not caused by a high level of microsatellite instability.
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I've had a CT scan or MRI of all cancer sites within the last 28 days.
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I have enough tissue samples from my cancer for testing.
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I am 18 years old or older.
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My cancer's RAS and BRAF gene status is known.
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I agree to use birth control during and for 7 months after my nivolumab treatment.
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My cancer's RAS and BRAF gene status is known.
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My diagnosis is advanced colorectal cancer that cannot be surgically removed.
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My cancer is not caused by a high level of microsatellite instability.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study start date to study end date, up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and study start date to study end date, up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disease Control Rate (DCR)
Secondary outcome measures
Exploratory Biomarker analysis - Tumor tissue
Exploratory Biomarker analysis - Whole Blood
Objective Response Rate (ORR)
+3 more

Side effects data

From 2022 Phase 2 trial • 45 Patients • NCT02101736
95%
HYPOTHYROIDISM
73%
DIARRHEA
55%
WEIGHT LOSS
50%
FATIGUE
41%
NAUSEA
41%
ASPARTATE AMINOTRANSFERASE INCREASED
41%
VOMITING
41%
ANOREXIA
41%
ALANINE AMINOTRANSFERASE INCREASED
41%
Neutrophil Count Decreased
36%
PAIN IN EXTREMITY
36%
HEADACHE
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%
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%
ORAL PAIN
9%
ALKALINE PHOSPHATASE INCREASED
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%
SPINAL CORD COMPRESSION
5%
Investigations - Other, Eosinophilia
5%
Hypertension
5%
ANXIETY
5%
Sore Throat
5%
Myalgia
5%
Peripheral Sensory Neuropathy
5%
Peripheral Motor Neuropathy
5%
SINUS BRADYCARDIA
5%
Hoarseness
5%
Gastrointestinal Disorders - Other, Dental Pain
5%
Stomach Pain
5%
HEMATURIA
5%
TENDONITIS
5%
Gastrointestinal Disorders - Other, Buccal Cyst
5%
Surgical & Medical Procedures - Other, Dental Extractions
5%
HYPERTHYROIDISM
5%
Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis
5%
Musculoskeletal And Connective Tissue Disorders - Other, Extremity Cramps
5%
DIFFICULTY WALKING, BACK PAIN, BOWEL/BLADDER URGENCY, LEGS GAVE OUT, AND PARESTHESIAS
5%
Gastrointestinal Disorders - Other, Stomatitis
5%
SUBJECT WAS ADMITTED TO THE HOSPITAL ON 10/24/20 WITH GRADE 2 WEIGHT LOSS THAT THE PHYSICIAN FELT NE
5%
RASH
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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Cabozantinib 40 mg orally daily in combination with nivolumab 480 mg IV every 28 days.Experimental Treatment2 Interventions
Cabozantinib is supplied as 20-mg tablets and will be administered orally at a dose of 40 mg/day. Nivolumab is supplied in 100 mg/Vial (10 mg/mL) vials and will be administered IV at a dose of 480 mg every 28 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Cabozantinib
2020
Completed Phase 2
~1760

Find a Location

Who is running the clinical trial?

ExelixisIndustry Sponsor
117 Previous Clinical Trials
19,486 Total Patients Enrolled
Criterium, Inc.Industry Sponsor
16 Previous Clinical Trials
726 Total Patients Enrolled
University of Colorado, DenverLead Sponsor
1,756 Previous Clinical Trials
2,166,433 Total Patients Enrolled

Media Library

Cabozantinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04963283 — Phase 2
Colorectal Cancer Research Study Groups: Cabozantinib 40 mg orally daily in combination with nivolumab 480 mg IV every 28 days.
Colorectal Cancer Clinical Trial 2023: Cabozantinib Highlights & Side Effects. Trial Name: NCT04963283 — Phase 2
Cabozantinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04963283 — Phase 2
~8 spots leftby Feb 2025