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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 belowSelect...
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.
Select...
My condition worsened or didn't improve after treatment with specific cancer drugs.
Select...
My condition worsened or didn't improve after treatment with specific cancer drugs.
Select...
My cancer is not caused by a high level of microsatellite instability.
Select...
I've had a CT scan or MRI of all cancer sites within the last 28 days.
Select...
I have enough tissue samples from my cancer for testing.
Select...
I am 18 years old or older.
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My cancer's RAS and BRAF gene status is known.
Select...
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.
Select...
My diagnosis is advanced colorectal cancer that cannot be surgically removed.
Select...
My cancer is not caused by a high level of microsatellite instability.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ study start date to study end date, up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study start date to study end date, up to 24 months
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 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%
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%
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%
RASH
5%
INSOMNIA
5%
Peripheral Sensory Neuropathy
5%
HYPERTHYROIDISM
5%
SINUS BRADYCARDIA
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%
Hoarseness
5%
Gastrointestinal Disorders - Other, Buccal Cyst
5%
Peripheral Motor Neuropathy
5%
Investigations - Other, Eosinophilia
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%
TENDONITIS
5%
HEMATURIA
5%
Gastrointestinal Disorders - Other, Dental Pain
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
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
~1080
Find a Location
Who is running the clinical trial?
ExelixisIndustry Sponsor
117 Previous Clinical Trials
19,503 Total Patients Enrolled
Criterium, Inc.Industry Sponsor
16 Previous Clinical Trials
726 Total Patients Enrolled
University of Colorado, DenverLead Sponsor
1,732 Previous Clinical Trials
2,143,535 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My tumor is growing into or around major blood vessels.I have lung disease that causes symptoms or could affect lung-related side effects from treatment.I can have a biopsy on my cancer before starting the study drug.I haven't taken high-dose steroids or immunosuppressants in the last 2 weeks.I am fully active or restricted in physically strenuous activity but can do light work.I understand the study requirements and have signed the consent form.My colorectal cancer cannot be removed by surgery and has spread.I have tested positive for HIV/AIDS.I haven't had any cancer besides skin cancer or low-grade tumors in the past 2 years.You have had an allergic reaction or are hypersensitive to any of the ingredients in the study treatment.I have previously been treated with cabozantinib or similar drugs.I am 18 years old or older.I am fully active or can carry out light work.My condition worsened or didn't improve after treatment with specific cancer drugs.My condition worsened or didn't improve after treatment with specific cancer drugs.My cancer is not caused by a high level of microsatellite instability.I have not been treated with TAS-102 (Lonsurf).I agree to use birth control during and for 5 months after my nivolumab treatment.All my cancer sites were checked by CT scan or MRI within the last 28 days.I have recovered from previous treatment side effects, or they are minor and stable.You have a medical condition that can be measured by a specific assessment tool called RECIST v.1.1, as determined by the doctor in charge of the study.I've had a CT scan or MRI of all cancer sites within the last 28 days.My lung scans show cavities or endobronchial disease.I have an autoimmune disease.I have enough tissue samples from my cancer for testing.I am 18 years old or older.I have had EGFR inhibitor therapy for my left-sided, RAS wild-type tumor.I haven't had significant bleeding, like coughing up or vomiting blood, in the last 3 months.I have had EGFR inhibitor therapy for my left-sided, RAS wild-type tumor.My cancer's RAS and BRAF gene status is known.I agree to use birth control during and for 7 months after my nivolumab treatment.I haven't had chemotherapy or biological treatment in the last 3 weeks.My cancer's RAS and BRAF gene status is known.I haven't had major surgery in the last 2 weeks or minor surgery in the last 10 days.I am currently taking blood thinners.I have had significant bleeding from a tumor in my digestive system in the last 28 days.My recent tests show my organs and bone marrow are functioning well.I have been treated with specific immune system targeting drugs.I haven't had radiation for bone metastasis in the last 2 weeks, other radiation in 4 weeks, or radionuclide treatment in 6 weeks.My brain metastases have been treated and stable for over 4 weeks.I have not taken Lonsurf before.I have had a stem cell or solid organ transplant in the past.I have tested positive for hepatitis B or C.I have not received a live vaccine in the last 30 days.I do not have any severe illnesses that are not under control.My diagnosis is advanced colorectal cancer that cannot be surgically removed.I cannot swallow whole pills.My cancer is not caused by a high level of microsatellite instability.You have taken any experimental medication in the last 28 days before starting the study.
Research Study Groups:
This trial has the following groups:- Group 1: Cabozantinib 40 mg orally daily in combination with nivolumab 480 mg IV every 28 days.
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.
Is this a revolutionary medical research endeavor?
"Cabozantinib has been studied since 2012, with the initial trial sponsored by Exelixis and involving 86 participants. Following its success in Phase 2 trials, this medication is now being explored across 2553 cities in 53 countries - hosting a total of 794 live studies."
Answered by AI
Is the trial still accepting participants?
"This scientific experiment is actively searching for test subjects. It was initially posted to clinicaltrials.gov on June 23rd 2021, and recently revised on November 19th 2021."
Answered by AI
How many participants are currently enrolled in this research?
"Affirmative. According to information on clinicaltrials.gov, this experiment is currently looking for volunteers and has been since June 23rd 2021. 46 people are required across 5 sites and the trial was last updated on November 19th 2021."
Answered by AI
What precedent has been set regarding the utilization of Cabozantinib in clinical research?
"Currently, 794 investigations concerning cabozantinib exist and 90 of them are in the final stage. Although Basel, BE is the centre where most trials take place, there are 43554 other places that host research studies involving this drug."
Answered by AI
Are there a considerable number of medical facilities engaging in this research trial within North America?
"At present, this medical trial is being conducted in 5 different locations - three of which are located within Colorado (Colorado Springs, Greeley and Loveland) alongside two other sites. To reduce travel commitment should you wish to participate, it's recommended that you choose the location nearest to your own home."
Answered by AI
How has Cabozantinib been applied in medical practice?
"Cabozantinib has been successfully employed to treat malignancies, unresectable melanoma, and squamous cell carcinomas."
Answered by AI
What potential adverse effects can result from the use of Cabozantinib?
"Cabozantinib's safety has been somewhat established in a Phase 2 trial, resulting in it being assigned a score of 2. However, no efficacy data exists at this time."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What site did they apply to?
University of Colorado Hospital
UCHealth Memorial Hospital Central
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How responsive is this trial?
Most responsive sites:
- UCHealth Memorial Hospital Central: < 48 hours
Average response time
- < 2 Days
Typically responds via
Email
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