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Tyrosine Kinase Inhibitor
Cabozantinib + Pembrolizumab for Melanoma
Phase 1 & 2
Recruiting
Led By Yousef Zakharia, MD
Research Sponsored by Yousef Zakharia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged 18 years and older
Histologically or cytologically confirmed unresectable in-transit (stage IIIc) or metastatic (stage IV) melanoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up initiation of treatment up to 2 years
Awards & highlights
Study Summary
This trial is testing a combination of drugs to treat melanoma. The drugs are cabozantinib and pembrolizumab.
Who is the study for?
Adults with advanced melanoma who can swallow pills, have measurable lesions, and haven't had certain treatments for their cancer recently. They must understand the study and agree to provide tissue samples. Women of childbearing age need a negative pregnancy test.Check my eligibility
What is being tested?
The trial is testing the combination of two drugs, Cabozantinib and Pembrolizumab, to see how safe they are together and if they work well against advanced melanoma.See study design
What are the potential side effects?
Possible side effects include immune system reactions that could affect organs, fatigue, skin changes, digestive issues like diarrhea or nausea, liver function changes, and potential increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My melanoma cannot be removed by surgery and is either stage IIIc or IV.
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I can provide previous biopsy samples for PD-L1 testing.
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I can swallow pills.
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I understand the study requirements and have signed the consent form.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ initiation of treatment up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~initiation of treatment up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1: Incidence of dose limiting toxicities using CTCAE, Version 4.03
Phase 2: Best overall response rate (ORR) (complete response (CR) + partial response (PR)) per RECIST v1.1
Secondary outcome measures
Determine disease control rate (DCR) according to RECIST v1.1 criteria
Radiologic progression-free survival (PFS) per RECIST v1.1
Summarize overall survival (OS) with the method of Kaplan-Meier
Side 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%
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%
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%
Hoarseness
5%
INSOMNIA
5%
HYPERTHYROIDISM
5%
Hypertension
5%
ANXIETY
5%
Sore Throat
5%
Myalgia
5%
SPINAL CORD COMPRESSION
5%
DIFFICULTY WALKING, BACK PAIN, BOWEL/BLADDER URGENCY, LEGS GAVE OUT, AND PARESTHESIAS
5%
Peripheral Sensory Neuropathy
5%
Gastrointestinal Disorders - Other, Stomatitis
5%
Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis
5%
Peripheral Motor Neuropathy
5%
Investigations - Other, Eosinophilia
5%
SINUS BRADYCARDIA
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%
HEMATURIA
5%
Gastrointestinal Disorders - Other, Buccal Cyst
5%
Gastrointestinal Disorders - Other, Dental Pain
5%
TENDONITIS
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 and pembrolizumabExperimental Treatment2 Interventions
Cabozantinib will be administered in the tablet form, at three dose levels: 40, 20 and 60 mg per day. Pembrolizumab will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib
FDA approved
Pembrolizumab
FDA approved
Find a Location
Who is running the clinical trial?
University of IowaOTHER
447 Previous Clinical Trials
879,660 Total Patients Enrolled
1 Trials studying Melanoma
39 Patients Enrolled for Melanoma
Yousef ZakhariaLead Sponsor
4 Previous Clinical Trials
133 Total Patients Enrolled
ExelixisIndustry Sponsor
117 Previous Clinical Trials
19,489 Total Patients Enrolled
5 Trials studying Melanoma
258 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have not had any cancer other than skin, cervical, or in situ cancers in the last 2 years.I haven't taken any tyrosine kinase inhibitor medication in the last 2 weeks.I have had treatments targeting PD-1, PD-L1, or PD-L2 for advanced melanoma, but not within the last 6 months if it was for preventing cancer return.I can care for myself and have a life expectancy of more than 12 weeks.I haven't been in a drug/device trial in the last 30 days, and I don't need other cancer treatments now.I am currently being treated for an infection.I need blood thinners or platelet inhibitors for my condition.I haven't had cancer treatment in the last 4 weeks or have recovered from its side effects.I haven't been treated for advanced melanoma, except possibly BRAF/MEK inhibitors.I haven't had recent radiation for bone metastasis or any radiation in the last 4 weeks.I am not taking more than 10 mg of prednisone or any immunosuppressive medication.I had a severe allergic reaction to a specific cancer treatment before.My melanoma cannot be removed by surgery and is either stage IIIc or IV.I can provide previous biopsy samples for PD-L1 testing.I have recovered from previous cancer treatment side effects, or they are stable and not serious.I have an autoimmune disease but it's controlled without strong medication, except for thyroid issues, vitiligo, or mild asthma.I am a woman who can have children and have a recent negative pregnancy test.I have stable brain metastases, no new brain tumors, and haven't taken steroids for 2 weeks.You must have at least one specific type of lesion that can be measured for the study.I have not received a live vaccine in the last 30 days.I can swallow pills.I had adjuvant therapy including anti-PD-1, but my last dose was over 6 months ago before my cancer spread.I understand the study requirements and have signed the consent form.I have been diagnosed with melanoma in the eye or mucous membranes.I have been treated with cabozantinib before.I have been diagnosed with HIV.I have or might have Hepatitis B or C.
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Cabozantinib and pembrolizumab
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the highest number of participants enrolled in this research?
"Affirmative, the clinical trial is presently accepting enrolment. The clinical trail was initially published on August 27th 2019 and its most recent update took place on August 19th 2022. 39 patients must be accepted at a single research institution to meet the requirements of this study."
Answered by AI
Has Cabozantinib been previously investigated in any other research studies?
"Currently, 1062 medical trials are being conducted to investigate the efficacy of Cabozantinib. Of these studies, 133 have reached Phase 3 and feature 42531 clinical locations across Houston, Texas."
Answered by AI
To what diseases is Cabozantinib typically administered?
"Cabozantinib, a common treatment for unresectable melanoma, has also been proven to alleviate symptoms of microsatellite instability high and reduce the risk of recurrence in certain diseases."
Answered by AI
Are there any open slots available to join this investigation?
"The details on clinicaltrials.gov indicate that this trial is presently enrolled participants. This research project was inaugurated on August 27th 2019, and has recently been revised as of August 19th 2022."
Answered by AI
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