Your session is about to expire
← Back to Search
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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate (ORR)
Secondary outcome measures
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%
Bile duct stone
1%
Head injury
1%
Hypercalcaemia
1%
Ischaemic stroke
1%
Apnoea
1%
General physical health deterioration
1%
Bone pain
1%
Metastases to soft tissue
1%
Cardio-respiratory arrest
1%
Metastases to pleura
1%
Metastases to the mediastinum
1%
Pneumothorax
1%
Transient ischaemic attack
1%
Bronchitis
1%
Jaundice cholestatic
1%
Respiratory failure
1%
Hypoglycaemia
1%
Pleural effusion
1%
Hypokalaemia
1%
Cerebral infarction
1%
Cholangitis
1%
Pathological fracture
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
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
2017
Completed Phase 3
~5860
Find a Location
Who is running the clinical trial?
Aveo Oncology PharmaceuticalsUNKNOWN
University of FloridaLead Sponsor
1,341 Previous Clinical Trials
715,638 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
568,114 Total Patients Enrolled
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Am I eligible to participate in this investigation?
"29 individuals with neuroendocrine tumors aged 18-99 are eligible for the research. Patients must have a preexisting history of systemic treatment, an Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2, not more than one other malignancy at time of enrollment, no active Hepatitis b infection or HIV unless on stable antiretroviral medication and CD4 count ≥200/uL and undetectable viral load; WOCBP must use effective contraception throughout trial duration plus 160 days following last dose of study drug to minimize risk of pregnancy; diagnosis consistent with stage IV "immunogenically cold"
Answered by AI
How many participants are receiving treatment in this trial?
"Affirmative. According to the records hosted on clinicaltrials.gov, this scientific experiment is presently recruiting participants after being first posted on November 3rd 2021 and updated lastly on November 28th 2022. 29 patients need to be recruited from a solitary location."
Answered by AI
Is there still room for participants in this experiment?
"Affirmative. According to the clinicaltrials.gov website, this trial is presently recruiting individuals for participation. Initially posted on November 3rd 2021 and last modified on November 28th 2022, 29 patients are being sought from one medical facility."
Answered by AI
What therapeutic applications is Tivozanib primarily utilized for?
"Tivozanib is primarily used to treat small cell lung cancer, yet it can also be employed as a neoadjuvant systemic therapy or for the treatment of KRN 951 and malignant neoplasms."
Answered by AI
Does this clinical research represent an unprecedented approach?
"Presently, 354 clinical studies for Tivozanib are running in 1695 cities and 74 countries. The drug's journey began with a trial initiated by Hoffmann-La Roche back in 2008; the Phase 2 study enrolled 720 participants. Since then, 102 trials have already been concluded."
Answered by AI
Is eligibility for this research study limited to individuals aged 18 or over?
"As mentioned in the requirements for enrollment, this trial is open to patients between 18 and 99 years of age."
Answered by AI
Who else is applying?
What state do they live in?
New Jersey
Texas
California
How old are they?
18 - 65
What site did they apply to?
University of Florida
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger