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Checkpoint Inhibitor
Cabozantinib + Atezolizumab for Prostate Cancer
Phase 2
Recruiting
Led By Umang Swami
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male subjects must agree to use a condom during intercourse for the duration of study therapy
Effective castration with serum testosterone levels =< 0.5 ng/mL (=<1.7 nmol/L)
Must not have
Known brain metastases or cranial epidural disease
Requirement for hemodialysis or peritoneal dialysis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from trial initiation and death of any cause, assessed up to 5 years
Awards & highlights
Summary
This trial is testing whether cabozantinib and atezolizumab can shrink tumors in patients with metastatic castrate-resistant prostate cancer.
Who is the study for?
Men aged 18+ with metastatic castration-resistant prostate cancer that has spread and progressed despite hormone therapy. They must have certain blood, liver, and kidney function levels, agree to contraception use, not have had certain recent treatments or other cancers within 3 years, no severe illnesses or infections, and be able to follow the study plan.Check my eligibility
What is being tested?
The AtezoCab trial is testing if combining cabozantinib (a drug blocking enzymes for cell growth) with atezolizumab (an immunotherapy antibody) can shrink tumors in patients with advanced prostate cancer compared to current standard treatments.See study design
What are the potential side effects?
Potential side effects include immune-related reactions affecting organs, fatigue, digestive issues like nausea or diarrhea, skin rash, high blood pressure from cabozantinib; similar effects plus potential infusion reactions from atezolizumab.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree to use a condom during sex while on the study.
Select...
My testosterone levels are very low, meeting the castration criteria.
Select...
I can take care of myself and perform daily activities.
Select...
My cancer has spread above my lower abdomen but can't be measured by scans.
Select...
My condition worsened after treatment with a new hormone therapy.
Select...
My platelet count is at least 100,000 without recent transfusions.
Select...
My kidney function, measured by creatinine levels, is within the normal range.
Select...
My prostate cancer is confirmed without being a small cell type.
Select...
I am a man aged 18 or older.
Select...
My cancer has spread and worsened despite hormone therapy.
Select...
My white blood cell count is healthy without needing medication.
Select...
I have a sample of my tumor available for testing.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have brain metastases or cranial epidural disease.
Select...
I require dialysis.
Select...
I have had a solid organ or bone marrow transplant.
Select...
I have had leptomeningeal disease.
Select...
I do not have any other cancer that needs treatment.
Select...
I am currently being treated for an infection.
Select...
I haven't had major surgery in the last 4 weeks and don't expect to need one during the study.
Select...
I have a history of lung scarring or inflammation not caused by infections.
Select...
I have a serious wound, ulcer, or bone fracture that isn't healing.
Select...
I am currently taking blood thinners or platelet inhibitors.
Select...
I do not have hepatitis, HIV/AIDS, or tuberculosis.
Select...
My cancer can be measured and is located above my lower back area.
Select...
I do not have any severe, uncontrolled health problems.
Select...
I have not had chemotherapy for advanced prostate cancer after hormone therapy failed.
Select...
I have previously been treated with cabozantinib, CD137 agonists, or immune checkpoint inhibitors.
Select...
I have high calcium levels in my blood that are causing symptoms.
Select...
I haven't taken any immune-boosting drugs in the last 4 weeks or 5 half-lives of the drug.
Select...
My liver function is significantly impaired.
Select...
I frequently need procedures to remove excess fluid from my chest or abdomen.
Select...
I have untreated or symptomatic thyroid issues.
Select...
I haven't had radiation for bone metastasis in the last 2 weeks or any radiation in the last 4 weeks.
Select...
I have a condition that prevents my body from absorbing nutrients properly.
Select...
My cancer pain is not managed with current treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from trial initiation and death of any cause, assessed up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from trial initiation and death of any cause, assessed up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease control rate
Secondary outcome measures
Incidence of adverse events (AEs)
Overall survival
PSA levels
+2 moreSide effects data
From 2019 Phase 2 trial • 13 Patients • NCT0231543085%
Fatigue
77%
Nausea
62%
Dysgeusia
62%
Vomiting
54%
Alkaline Phosphatase Increased
54%
Aspartate Aminotransferase Increased
54%
Mucositis Oral
54%
Abdominal Pain
46%
Hypertension
46%
Anorexia
38%
Alanine Aminotransferase Increased
38%
Thromboembolic Event
38%
Anemia
38%
Diarrhea
38%
Constipation
38%
Cough
38%
Weight Loss
38%
Dyspnea
31%
Hypomagnesemia
31%
Back Pain
31%
Lipase Increased
31%
Hypoalbuminemia
23%
Hypophosphatemia
23%
Hyperglycemia
23%
Dizziness
23%
Palmar-Plantar Erythrodysesthesia Syndrome
23%
Alopecia
23%
Hypothyroidism
23%
Pain In Extremity
23%
Oral Pain
23%
Pain
23%
Headache
15%
Activated Partial Thromboplastin Time Prolonged
15%
Sore Throat
15%
Myalgia
15%
Bloating
15%
White Blood Cell Decreased
15%
Insomnia
15%
Dry Mouth
15%
Dyspepsia
15%
Dehydration
15%
Hypocalcemia
15%
Dry Skin
15%
Flushing
15%
Peripheral Sensory Neuropathy
15%
Abdominal Distension
15%
Platelet Count Decreased
8%
Allergic Rhinitis
8%
Generalized Muscle Weakness
8%
Creatinine Increased
8%
Hyponatremia
8%
Flank Pain
8%
Bone Pain
8%
Gastroesophageal Reflux Disease
8%
Chest Pain - Cardiac
8%
Vertigo
8%
Neutrophil Count Decreased
8%
Arthralgia
8%
Syncope
8%
Proteinuria
8%
Pleural Effusion
8%
Nasal Congestion
8%
Pleuritic Pain
8%
Hoarseness
8%
Nail Discoloration
8%
Ventricular Tachycardia
8%
Tinnitus
8%
Gastrointestinal Pain
8%
Floaters
8%
Dysphagia
8%
Blood Bilirubin Increased
8%
Lung Infection
8%
Fever
8%
Depression
8%
Hypersomnia
8%
Hypotension
8%
Productive Cough
8%
Memory Impairment
8%
Anxiety
8%
Cardiac Troponin I Increased
8%
Urinary Incontinence
8%
Pancreatitis
8%
Upper Respiratory Infection
8%
Bruising
8%
Weight Gain
8%
Skin Induration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cabozantinib
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (cabozantinib, atezolizumab)Experimental Treatment2 Interventions
Patients receive cabozantinib PO QD on days 1-21 and atezolizumab IV over 30-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2017
Completed Phase 3
~5860
Cabozantinib S-malate
2013
Completed Phase 2
~470
Find a Location
Who is running the clinical trial?
University of UtahLead Sponsor
1,110 Previous Clinical Trials
1,788,523 Total Patients Enrolled
8 Trials studying Prostate Cancer
5,349 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,368 Total Patients Enrolled
566 Trials studying Prostate Cancer
529,005 Patients Enrolled for Prostate Cancer
Umang SwamiPrincipal InvestigatorHuntsman Cancer Institute/ University of Utah
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread, but I don't have pain or loss of function from it.I haven't had a live vaccine within 30 days before starting the study treatment.I have brain metastases or cranial epidural disease.I have not had a severe infection in the last 4 weeks.I require dialysis.I have had treatment for any painful cancer spots before joining.I haven't had cancer treatment in the last 4 weeks.I have had leptomeningeal disease.I do not have any other cancer that needs treatment.I am currently being treated for an infection.I haven't had major surgery in the last 4 weeks and don't expect to need one during the study.I agree to use a condom during sex while on the study.I have a history of lung scarring or inflammation not caused by infections.I can take care of myself and perform daily activities.I have a serious wound, ulcer, or bone fracture that isn't healing.I am currently taking blood thinners or platelet inhibitors.My cancer has spread above my lower abdomen but can't be measured by scans.I do not have hepatitis, HIV/AIDS, or tuberculosis.My condition worsened after treatment with a new hormone therapy.My platelet count is at least 100,000 without recent transfusions.I have had a solid organ or bone marrow transplant.My kidney function, measured by creatinine levels, is within the normal range.My cancer can be measured and is located above my lower back area.My testosterone levels are very low, meeting the castration criteria.I have recovered from side effects of previous cancer treatments.I do not have any severe, uncontrolled health problems.I have not had chemotherapy for advanced prostate cancer after hormone therapy failed.I have previously been treated with cabozantinib, CD137 agonists, or immune checkpoint inhibitors.I haven't taken any kinase inhibitor medication in the last 2 weeks.My prostate cancer is confirmed without being a small cell type.I am a man aged 18 or older.My cancer has spread and worsened despite hormone therapy.I have high calcium levels in my blood that are causing symptoms.I haven't taken any immune-boosting drugs in the last 4 weeks or 5 half-lives of the drug.My liver function is significantly impaired.I frequently need procedures to remove excess fluid from my chest or abdomen.I have untreated or symptomatic thyroid issues.I haven't had radiation for bone metastasis in the last 2 weeks or any radiation in the last 4 weeks.My liver function tests are within acceptable limits despite having liver metastases.I have a condition that prevents my body from absorbing nutrients properly.My white blood cell count is healthy without needing medication.I have a sample of my tumor available for testing.I understand and can follow the study's requirements.My cancer pain is not managed with current treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (cabozantinib, atezolizumab)
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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