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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

Must not have

Tumor invading or encasing any major blood vessels

Interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity

Timeline

Screening 3 weeks

Treatment Varies

Follow Up study start date to study end date, up to 24 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

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

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My tumor is growing into or around major blood vessels.

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I have lung disease that causes symptoms or could affect lung-related side effects from treatment.

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I haven't taken high-dose steroids or immunosuppressants in the last 2 weeks.

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I have tested positive for HIV/AIDS.

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I have previously been treated with cabozantinib or similar drugs.

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My lung scans show cavities or endobronchial disease.

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I have an autoimmune disease.

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I am currently taking blood thinners.

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I have been treated with specific immune system targeting drugs.

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I haven't had radiation for bone metastasis in the last 2 weeks, other radiation in 4 weeks, or radionuclide treatment in 6 weeks.

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I have had a stem cell or solid organ transplant in the past.

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I have tested positive for hepatitis B or C.

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I have not received a live vaccine in the last 30 days.

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I do not have any severe illnesses that are not under control.

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I cannot swallow whole pills.

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

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

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

Primary study objectives

Disease Control Rate (DCR)

Secondary study objectives

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%

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

Papulopustular Rash

ALKALINE PHOSPHATASE INCREASED

LIPASE INCREASED

Creatinine Increased

Back Pain

ABSOLUTE NEUTROPHIL COUNT DECREASED

Paresthesia

TUMOR PAIN

Skin And Subcutaneous Tissue Disorders- Other, Rash Unspecified

ORAL PAIN

LYMPHOCYTE COUNT DECREASED

NASAL CONGESTION

WEIGHT GAIN

HYPOCALCEMIA

DRY SKIN

Gastrointestinal Disorders - Other, Buccal Cyst

Allergic Rhinitis

Hypotension

Muscle Weakness Lower Limb

Skin And Subcutaneous Tissue Disorders- Other, Sore On Lips

Musculoskeletal And Connective Tissue Disorders - Other, Extremity Cramps

Skin And Subcutaneous Disorders - Other, Dry Skin Patches

Hypertension

SERUM AMYLASE INCREASED

Behaviour Disturbance

Investigations - Other, Eosinophilia

Sore Throat

Joint Range Of Motion Decreased

HEMATURIA

ANXIETY

Hypermagnesemia

Rash Ezcematoid

Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis

Scalp Pain

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

Psychiatric Disorders - Other, Mood Swings

URINARY URGENCY

Sinus Tachycardia

Periodontal Disease

Peripheral Sensory Neuropathy

Scalp Lesion

Myalgia

Tooth Infection

RASH

Gastrointestinal Disorders - Other, Dental Pain

JOINT RANGE OF MOTION DECREASED

Peripheral Motor Neuropathy

Tachycardia

URINARY FREQUENCY

Conjunctivitis

Neuropathy

Sinusitis

Syncope

Activated Partial Thromboplastin Time Prolonged

Breast Pain

INSOMNIA

Infections And Infestations - Other, Gi Viral Infection

Stomach Pain

TENDONITIS

SKIN INFECTION

HYPOMAGNESEMIA

Muscle Weakness Upper Limb

Skin And Subcutaneous Tissue Disorders - Other, Skin Color Change

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

Surgical & Medical Procedures - Other, Dental Extractions

Investigations - Other, International Normalized Ration Increased

Skin And Subcutaneous Tissue Disorders- Other, Erythema

Infections And Infestations - Other, Covid-19

Investigations - Other, Increased Mean Corpuscular Volume

Skin And Subcutaneous Tissue Disorders- Other, Transient Erythema

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

Injury, Poisoning And Procedural Complications - Other, Ankle Injury

Injury, Poisoning And Procedural Complications- Other, Scalp Laceration

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

SINUS BRADYCARDIA

HYPERTHYROIDISM

Creatine Phosphokinase Increased

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

Urine Discoloration

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: 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

~5220

Cabozantinib

2020

Completed Phase 2

~1760