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Checkpoint Inhibitor
Atezolizumab + Tivozanib for Sarcoma
Phase 1 & 2
Recruiting
Led By Brian Ramnaraign, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a combination of two drugs to see if it improves outcomes in cancer patients with tumors that don't respond well to other treatments.
Who is the study for?
Adults over 18 with certain advanced 'cold' tumors not responsive to immunotherapy, including specific cancers of the bile duct, gallbladder, breast (HR-negative HER2-positive), neuroendocrine system (grade 2 or 3), ovary (high grade serious/endometrioid), pancreas, soft tissue sarcoma, prostate (castrate-resistant), and vulvar. Participants must have had prior treatment failure and be in good physical condition with a life expectancy of at least 12 weeks. They should not have multiple cancers or HIV/hepatitis B unless stable on therapy.
What is being tested?
The trial is testing Atezolizumab combined with Tivozanib in patients whose tumors are considered immunologically 'cold' and typically don't respond well to checkpoint inhibitor therapy alone. The goal is to see if blocking VEGF can enhance the immune response against these types of cancer.
What are the potential side effects?
Potential side effects include typical reactions related to immune therapies such as fatigue, diarrhea, skin rash or itching. There may also be risks associated with blood vessel growth inhibition like high blood pressure or abnormal protein levels in urine.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Objective response rate (ORR)
Secondary study objectives
Disease control rate (DCR)
Overall survival (OS)
Progression free survival (PFS)
Side effects data
From 2014 Phase 3 trial • 277 Patients • NCT0107601025%
Hypertension
14%
Diarrhoea
13%
Fatigue
12%
Asthenia
10%
Palmar-plantar erythrodysaesthesia syndrome
6%
Dysphonia
6%
Cough
6%
Decreased appetite
6%
Dyspnoea
2%
Renal cancer
2%
Neoplasm progression
2%
Anaemia
1%
Bronchitis
1%
Respiratory failure
1%
Bone pain
1%
Cardio-respiratory arrest
1%
Hypoglycaemia
1%
Jaundice cholestatic
1%
Ischaemic stroke
1%
Pathological fracture
1%
Head injury
1%
Apnoea
1%
Pneumothorax
1%
General physical health deterioration
1%
Hypokalaemia
1%
Metastases to soft tissue
1%
Cerebral infarction
1%
Metastases to pleura
1%
Transient ischaemic attack
1%
Metastases to the mediastinum
1%
Pleural effusion
1%
Hypercalcaemia
1%
Bile duct stone
1%
Cholangitis
1%
Acute myocardial infarction
1%
Aortic aneurysm
1%
Pulmonary embolism
1%
Death
1%
Multi-organ failure
1%
Pelvic venous thrombosis
1%
Body temperature increased
1%
Cardiopulmonary failure
1%
Myocardial infarction
1%
Cardiac failure
1%
Arteriosclerosis coronary artery
1%
Delusional disorder, somatic type
1%
Pleurisy
1%
Sepsis
1%
Myxoedema
1%
Pancreatitis acute
1%
Vena cava thrombosis
1%
Skin lesion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sorafenib Crossover to Tivozanib
First Line Tivozanib
First Line Sorafenib
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Atezolizumab + TivozanibExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tivozanib
2010
Completed Phase 3
~810
Atezolizumab
2016
Completed Phase 3
~5860
Find a Location
Who is running the clinical trial?
Aveo Oncology PharmaceuticalsUNKNOWN
University of FloridaLead Sponsor
1,409 Previous Clinical Trials
767,430 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,565 Previous Clinical Trials
570,027 Total Patients Enrolled
Brian Ramnaraign, MDPrincipal InvestigatorUniversity of Florida
Jonathan Chatzkel, MDPrincipal InvestigatorUniversity of Florida
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a previous transplant of stem cells or an organ.I have had at least one treatment for my advanced or metastatic cancer that cannot be surgically removed.My cancer has a high number of genetic changes.If I need a new biopsy, it will be from a tumor site that is not the only site being measured for disease.I have had leptomeningeal disease.I can swallow pills.I have not had any cancer other than the one specified in the last 5 years.My blood and organs are functioning well.I have pain from my cancer that isn't relieved by medication.You have advanced or incurable cancer that has spread to other parts of the body. This includes specific types of cancer such as bile duct or gallbladder cancer, metastatic breast cancer, neuroendocrine cancer, ovarian cancer, pancreatic adenocarcinoma, soft tissue sarcoma, prostate cancer, and vulvar cancer.I haven't taken any antibiotics by mouth or IV in the last 2 weeks.I am mostly active and can carry out all self-care but unable to carry out any work activities.I am 18 years old or older.I cannot stop taking my current medications that are not allowed with the study treatment.I have not had a severe infection in the last 4 weeks.I have not had major surgery in the last 4 weeks.My tumor is MSI-H or dMMR.I have previously been treated with CD137 agonists or immune checkpoint inhibitors.I am currently being treated for an autoimmune disease.My heart's electrical activity is normal and I don't have heart disease.I haven't had cancer treatment in the last 28 days.My cancer is at stage IV and considered 'immunogenically cold' or incurable.I am currently on medication for hepatitis B.I agree to use birth control as advised by my doctor.I have not received a live virus vaccine recently.I am mostly active and can carry out all my self-care activities without help.I have been on a stable blood thinner regimen for at least 2 weeks.I have high blood pressure that isn't controlled by medication.I have had lung scarring or inflammation.I have high calcium levels in my blood that are causing symptoms.I frequently need procedures to remove excess fluid from my chest or abdomen.I am using highly effective birth control to prevent pregnancy during and after the study.I haven't taken any immune-boosting drugs in the last 4 weeks.I have tissue samples or slides available for research.I have active tuberculosis.I have only one type of cancer.I am not pregnant or breastfeeding.I haven't taken any immune-weakening drugs in the last 2 weeks.I do not have HIV, or if positive, I am stable on treatment with good immune function and undetectable viral load.I have been treated with VEGFR inhibitors before.I am not using or cannot use birth control.I have brain metastases that have been treated and are now stable.I haven't had major heart problems in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Atezolizumab + Tivozanib
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.