Study Summary
This trial is testing a combination of drugs to treat melanoma. The drugs are cabozantinib and pembrolizumab.
Eligible Conditions
- Advanced Metastatic Melanoma
Treatment Effectiveness
Phase-Based Effectiveness
Phase 1 & 2
Study Objectives
2 Primary · 3 Secondary · Reporting Duration: Initiation of treatment up to 2 years
Year 2
Determine disease control rate (DCR) according to RECIST v1.1 criteria
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
Radiologic progression-free survival (PFS) per RECIST v1.1
Summarize overall survival (OS) with the method of Kaplan-Meier
Trial Safety
Phase-Based Safety
Side Effects for
Cohort A
78%WEIGHT LOSS
74%GAIT DISTURBANCE
65%Joint Pain
65%White Blood Cell Count Decreased
57%ABSOLUTE NEUTROPHIL COUNT INCREASED
43%BUN INCREASED
43%Skin Blisters
43%HEADACHE
43%Blood Bilirubin Increased
39%BLURRED VISION
39%HOT FLASHES
39%Chest Pain
35%Panic Attack
35%Total Protein Level Increased
26%SKIN INFECTION
26%HEMATURIA
26%FLUSHING
26%Toothache
26%DYSGEUSIA
22%ABDOMINAL PAIN
22%Emotional Lability
22%Neutrophil Count Decreased
17%ABSOLUTE NEUTROPHIL COUNT DECREASED
17%Cold Sore
17%Dyspnea
17%Muscle Weakness Lower Limb
17%HYPOTHYROIDISM
17%CONSTIPATION
17%WEIGHT GAIN
17%HYPOALBUMINEMIA
17%Urobilinogen Increased
13%PAIN IN EXTREMITY
13%PARONYCHIA
13%ALANINE AMINOTRANSFERASE DECREASED
13%WHITE BLOOD CELL INCREASED
13%DEHYDRATION
13%TUMOR PAIN
13%URINARY URGENCY
13%Decreased Platelet Count
13%Myalgia
13%Vitamin D Deficiency
13%DIARRHEA
13%BILIRUBIN INCREASED
13%HYPERGLYCEMIA
13%HYPOMAGNESEMIA
13%PROTEINURIA
13%HYPOPIGMENTATION
13%Hypermagnesemia
13%Tinnitus
9%DRY MOUTH
9%ANOREXIA
9%HYPOCALCEMIA
9%HYPOGLYCEMIA
9%HYPONATREMIA
9%Dislocation
9%Flatulence
9%Gastrointestinal Disorders - Other, Dental Pain
9%Suicidal Ideation
9%Tooth Infection
9%White Blood Cell Count Increased
9%SINUS BRADYCARDIA
9%VERTIGO
9%DYSPEPSIA
9%ORAL PAIN
9%VOMITING
9%LYMPHOCYTE COUNT DECREASED
9%ERYTHEMA
9%MACULOPAPULAR RASH
9%HYPERTENSION
9%Facial Pain
9%Neck Pain
9%Sinus Tachycardia
9%Skin And Subcutaneous Tissue Disorders- Other, Erythema
9%Urine White Blood Cell Increased
4%ABSCESS
4%ORAL DYSESTHESIA
4%PANCREATITIS
4%FATIGUE
4%EDEMA LIMBS
4%ALANINE AMINOTRANSFERASE INCREASED
4%PLATELET COUNT DECREASE
4%HYPOPHOSPHATEMIA
4%ANXIETY
4%INSOMNIA
4%URINARY FREQUENCY
4%URINARY TRACT INFECTION
4%IRREGULAR MENSTRUATION
4%NASAL CONGESTION
4%ACNEIFORM RASH
4%CALLUS OF FOOT
4%DRY SKIN
4%HAIR COLOR CHANGE
4%PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME
4%TINEA PEDIS
4%Back Pain
4%Dental Caries
4%Depression
4%Epistaxis
4%Hemorrhoids
4%Hyperkalemia
4%Investigations - Other, Eosinophilia
4%Metabolism Other - Decreased Vitamin D
4%Pale Skin
4%Peripheral Motor Neuropathy
4%Rash Acneiform
4%Skin And Subcutaneous Tissue Disorders - Other, Skin Color Change
4%Skin And Subcutaneous Tissue Disorders- Other, Sore On Lips
4%Tooth Extraction
4%Tremor
4%PALPITATIONS
4%HYPERTHYROIDISM
4%BLOATING
4%NAUSEA
4%PAIN
4%ABSOLUTE LYMPHOCYTE COUNT INCREASED
4%ALKALINE PHOSPHATASE INCREASED
4%ASPARTATE AMINOTRANSFERASE INCREASED
4%HEMOGLOBIN INCREASED
4%LIPASE INCREASED
4%SERUM AMYLASE INCREASED
4%THYROID STIMULATING HORMONE INCREASED
4%HYPOKALEMIA
4%DIZZINESS
4%URINARY RETENTION
4%BULLOUS DERMATITIS
4%RASH
4%Alopecia
4%Arthralgia
4%Concentration Impairment
4%Cough
4%Fever
4%Laryngeal Inflammation
4%Muscle Pain
4%Muscle Weakness
4%Paresthesia
4%Platelet Count Decreased
4%Productive Cough
4%Rash Maculopapular
4%Tachycardia
4%Upper Respiratory Infection
4%Wound Infection
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Trial Design
1 Treatment Group
Cabozantinib and pembrolizumab
1 of 1
Experimental Treatment
39 Total Participants · 1 Treatment Group
Primary Treatment: Cabozantinib · No Placebo Group · Phase 1 & 2
Cabozantinib and pembrolizumabExperimental Group · 2 Interventions: Cabozantinib, Pembrolizumab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib
FDA approved
Pembrolizumab
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: initiation of treatment up to 2 years
Who is running the clinical trial?
ExelixisIndustry Sponsor
110 Previous Clinical Trials
17,909 Total Patients Enrolled
5 Trials studying Melanoma
295 Patients Enrolled for Melanoma
University of IowaOTHER
424 Previous Clinical Trials
879,530 Total Patients Enrolled
1 Trials studying Melanoma
39 Patients Enrolled for Melanoma
Yousef ZakhariaLead Sponsor
4 Previous Clinical Trials
137 Total Patients Enrolled
Yousef Zakharia, MDPrincipal Investigator - University of Iowa
University of Iowa Chemical Dependency Center, University of Iowa Hospitals & Clinics
4 Previous Clinical Trials
137 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You cannot have received any treatment for advanced melanoma, except for BRAF and/or MEK inhibitors, which you stopped taking at least 2 weeks ago.
Frequently Asked Questions
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." - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
Unverified Answer