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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
Must not have
Known or suspected metastatic disease
Active Hepatitis B or Hepatitis C infection or any other active infection requiring intravenous therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 months
Awards & highlights
No Placebo-Only Group
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.
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.
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.
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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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My cancer has spread to other parts of my body.
Select...
I do not have an active Hepatitis B or C infection or any other infection needing IV treatment.
Select...
I have been treated with cabozantinib before.
Select...
I am currently taking blood thinners.
Select...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
To assess the effect of treatment on markers of vascular normalization in pre-treatment biopsies and treated tumors.
Other study objectives
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%
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%
PLATELET COUNT DECREASE
23%
HYPONATREMIA
23%
Decreased Platelet Count
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
9%
TUMOR PAIN
9%
Papulopustular Rash
9%
ALKALINE PHOSPHATASE INCREASED
9%
LIPASE INCREASED
9%
Creatinine Increased
9%
Back Pain
9%
ABSOLUTE NEUTROPHIL COUNT DECREASED
9%
Paresthesia
9%
Skin And Subcutaneous Tissue Disorders- Other, Rash Unspecified
9%
ORAL PAIN
9%
LYMPHOCYTE COUNT DECREASED
9%
NASAL CONGESTION
9%
WEIGHT GAIN
9%
HYPOCALCEMIA
9%
DRY SKIN
5%
Allergic Rhinitis
5%
Hypotension
5%
Muscle Weakness Lower Limb
5%
Hypertension
5%
SERUM AMYLASE INCREASED
5%
Investigations - Other, Eosinophilia
5%
Sore Throat
5%
HEMATURIA
5%
ANXIETY
5%
Hypermagnesemia
5%
Rash Ezcematoid
5%
Scalp Pain
5%
DIFFICULTY WALKING, BACK PAIN, BOWEL/BLADDER URGENCY, LEGS GAVE OUT, AND PARESTHESIAS
5%
Psychiatric Disorders - Other, Mood Swings
5%
URINARY URGENCY
5%
Sinus Tachycardia
5%
Periodontal Disease
5%
Peripheral Sensory Neuropathy
5%
Scalp Lesion
5%
Myalgia
5%
Tooth Infection
5%
RASH
5%
Gastrointestinal Disorders - Other, Dental Pain
5%
Peripheral Motor Neuropathy
5%
Tachycardia
5%
URINARY FREQUENCY
5%
Conjunctivitis
5%
Neuropathy
5%
Sinusitis
5%
Syncope
5%
Activated Partial Thromboplastin Time Prolonged
5%
Breast Pain
5%
JOINT RANGE OF MOTION DECREASED
5%
INSOMNIA
5%
Gastrointestinal Disorders - Other, Buccal Cyst
5%
Skin And Subcutaneous Disorders - Other, Dry Skin Patches
5%
Investigations - Other, International Normalized Ration Increased
5%
Musculoskeletal And Connective Tissue Disorders - Other, Extremity Cramps
5%
Joint Range Of Motion Decreased
5%
Behaviour Disturbance
5%
Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis
5%
Skin And Subcutaneous Tissue Disorders- Other, Sore On Lips
5%
Infections And Infestations - Other, Gi Viral Infection
5%
Stomach Pain
5%
TENDONITIS
5%
SKIN INFECTION
5%
HYPOMAGNESEMIA
5%
Muscle Weakness Upper Limb
5%
Skin And Subcutaneous Tissue Disorders - Other, Skin Color Change
5%
Skin And Subcutaneous Tissue Disorders- Other, Blister/Bug Bite On Finger
5%
Surgical & Medical Procedures - Other, Dental Extractions
5%
Skin And Subcutaneous Tissue Disorders- Other, Erythema
5%
Infections And Infestations - Other, Covid-19
5%
Investigations - Other, Increased Mean Corpuscular Volume
5%
Skin And Subcutaneous Tissue Disorders- Other, Transient Erythema
5%
SUBJECT WAS ADMITTED TO THE HOSPITAL ON 10/24/20 WITH GRADE 2 WEIGHT LOSS THAT THE PHYSICIAN FELT NE
5%
Injury, Poisoning And Procedural Complications - Other, Ankle Injury
5%
Injury, Poisoning And Procedural Complications- Other, Scalp Laceration
5%
Skin And Subcutaneous Tissue Disorders- Other, New Freckles/Moles
5%
SINUS BRADYCARDIA
5%
HYPERTHYROIDISM
5%
Creatine Phosphokinase Increased
5%
Skin And Subcutaneous Tissue Disorders - Other: Blue Lips (Not Cyanosis)
5%
Urine Discoloration
5%
SPINAL CORD COMPRESSION
5%
ANEMIA
5%
PARONYCHIA
5%
BRUISING
5%
HYPOALBUMINEMIA
5%
Ear And Labyrinth Disorders - Other, Impacted Cerumen
5%
Ear Pain
5%
Elevated Amylase
5%
Facial Pain
5%
Gastrointestinal Disorders - Other, Stomatitis
5%
Hoarseness
5%
Laryngitis
5%
Leg Pain
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
100%
80%
60%
40%
20%
0%
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
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
~1760
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 postive
- Group 2: HLA-A2 negative
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.
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