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Cancer Vaccine
Dendritic Cell Vaccine + Cabozantinib for Kidney Cancer
Phase 2
Recruiting
Led By Jodi Maranchie, MD
Research Sponsored by Jodi Maranchie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female subjects of childbearing potential must not be pregnant at screening
18 years or older (male or female) with an ECOG performance status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 months
Awards & highlights
Study Summary
This trial is studying how well a dendritic cell vaccine works when given with cabozantinib in treating patients with solid tumors that have spread to other parts of the body.
Who is the study for?
This trial is for adults with clear cell renal cancer that hasn't spread and can be surgically removed. Participants must understand the study, agree to use contraception, not be pregnant, have good organ function, an ECOG status of 0 or 1 (fully active or restricted in physically strenuous activity but ambulatory), and must have HLA-A2+ if receiving the vaccine.Check my eligibility
What is being tested?
The study tests a combination treatment: a personalized dendritic cell vaccine alongside oral cabozantinib medication. The goal is to see how well patients' immune systems respond to this combo and what side effects might occur.See study design
What are the potential side effects?
Potential side effects include those common to immunotherapies such as flu-like symptoms, injection site reactions, fatigue; and for cabozantinib: nausea, diarrhea, high blood pressure, hand-foot syndrome (redness and pain on palms/soles).
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not pregnant and can become pregnant.
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I am 18 or older and can care for myself with minimal assistance.
Select...
My kidney cancer is confirmed, has not spread, and can be surgically removed.
Select...
I am HLA-A2 positive and will receive a vaccine.
Select...
I understand the study requirements and have signed the consent form.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Characterize the safety profile of interventional therapy.
To estimate the probability of immune response for the combination treatment of an autologous DC1/peptide vaccine targeting tumor-associated blood vessel antigens with concomitant oral cabozantinib.
Secondary outcome measures
To assess the effect of treatment on markers of vascular normalization in pre-treatment biopsies and treated tumors.
Other outcome measures
To assess TCRA/B repertoire evenness (oligoclonality), convergence (antigenic focus) and compartmentalization (tumor vs. blood) in patients at baseline vs. on treatment
To assess further indicators of VN.
To assess immune cell composition and "fitness" within vs. outside of tumor-associated TLS
+5 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%
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
2Treatment groups
Experimental Treatment
Active Control
Group I: HLA-A2 postiveExperimental Treatment2 Interventions
The study will include 21 participants over the 18 years of age with newly diagnosed, clinically localized clear cell renal cell carcinoma, planned for surgical resection with curative intent. Participants receiving vaccine much be HLA-A2 positive.
Group II: HLA-A2 negativeActive Control1 Intervention
Up to 21 additional participants who screen as HLA-A2 negative will be enrolled as non-treatment controls. These participants will not be required to undergo blood collection or study procedures
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib
2020
Completed Phase 2
~1080
Find a Location
Who is running the clinical trial?
Jodi MaranchieLead Sponsor
1 Previous Clinical Trials
42 Total Patients Enrolled
Jodi Maranchie, MDPrincipal InvestigatorUPMC Department of Urology
Walter Storkus, PhDStudy DirectorUniversity of Pittsburgh
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to other parts of my body.I am not on strong immune system suppressing drugs, except for low-dose steroids for hormone issues.I haven't had radiation for bone metastasis in the last 2 weeks or any other radiation in the last 4 weeks.I do not have an active Hepatitis B or C infection or any other infection needing IV treatment.I am not pregnant and can become pregnant.I am 18 or older and can care for myself with minimal assistance.My recent tests show my organs and bone marrow are working well.I have been treated with cabozantinib before.I haven't had cancer treatment in the last 4 weeks.I am currently taking blood thinners.My kidney cancer is confirmed, has not spread, and can be surgically removed.I am HLA-A2 positive and will receive a vaccine.I understand the study requirements and have signed the consent form.I have not had a blood transfusion in the last two weeks.I haven't taken any kinase inhibitor medication in the last two weeks.You have uncontrolled or recent significant illnesses, including heart, stomach, or lung conditions, severe bleeding, or major blood vessel involvement, serious wounds, recent major surgery, certain heart rhythm abnormalities, pregnancy or breastfeeding, inability to swallow pills, severe liver problems, or other active cancers.
Research Study Groups:
This trial has the following groups:- Group 1: HLA-A2 negative
- Group 2: HLA-A2 postive
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.
Are there any openings left in this research endeavor?
"According to the records hosted on clinicaltrials.gov, this medical study is not recruiting patients currently; its initial posting was December 1st 2022 and it was last amended October 7th 2022. However, 463 other studies are actively seeking participants presently."
Answered by AI
Is this an unprecedented research endeavor?
"Presently, there are 109 active studies concerning the drug cabozantinib in 45 countries and 1315 cities. Exelixis' initial trial involving 86 subjects dates back to 2012, where it achieved Phase 2 approval status. Since then, 55 trials have concluded their research objectives successfully."
Answered by AI
Are there any other studies that have looked into Cabozantinib's efficacy?
"As of the present, 109 clinical trials are underway to research Cabozantinib. Of these active studies, 11 have reached Phase 3. While a majority of the trials for Cabozantinib take place in Cordoba and Calabria, there are 6849 medical sites across the world that are running experiments with this medication."
Answered by AI
Is Cabozantinib considered a safe option for human use?
"Our experts at Power assigned cabozantinib a safety rating of 2, as this is still in the second phase of clinical trials and only preliminary evidence has been gathered regarding its efficacy."
Answered by AI
How many participants are currently being treated as part of this scientific research project?
"Unfortunately, this clinical trial is closed to new patients. It was initially published on December 1st 2022 and last amended on October 7th of the same year. If you are seeking other studies, 354 research projects related to carcinoma renal cell remain open as well as 109 trials for cabozantinib that still welcome participants."
Answered by AI
In what maladies is Cabozantinib employed therapeutically?
"As a common treatment for anti-VEGF, Cabozantinib can also be impactful in treating advanced renal cell carcinoma (ARCC), adrenal medulla, and high risk patients."
Answered by AI
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