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Monoclonal Antibodies
Atezolizumab + Bevacizumab for Rare Cancers
Phase 2
Waitlist Available
Led By Daniel M Halperin
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Liver and kidney function within specified limits
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
Study Summary
This trial is studying how well atezolizumab and bevacizumab work in treating patients with rare solid tumors.
Who is the study for?
This trial is for patients with rare solid tumors like certain types of lung, anal, cervical, and other cancers. Participants must have measurable disease growth, adequate liver/kidney function, and be able to follow the study plan. They should not have severe allergies or autoimmune diseases, recent cancer treatments or investigational therapies within 28 days prior to the study.Check my eligibility
What is being tested?
The trial tests how well atezolizumab (an immunotherapy drug) combined with bevacizumab (a drug that inhibits blood vessel growth in tumors) works against various rare solid tumors. It's a phase II study focusing on the effectiveness of these monoclonal antibodies in stopping tumor growth.See study design
What are the potential side effects?
Potential side effects include immune-related reactions such as inflammation in organs; infusion reactions; increased risk of infections; possible bleeding issues due to interference with blood vessel formation; fatigue; and allergic responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver and kidney are working well.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Change in targeted clinical laboratory test results
Change in targeted vital signs
Duration of response
+4 moreOther outcome measures
Predictive and prognostic biomarkers in blood and tumor tissue
Side effects data
From 2021 Phase 1 & 2 trial • 24 Patients • NCT0301035865%
Infusion related reaction
59%
Neutrophil count decreased
41%
Upper respiratory infection
29%
Aspartate aminotransferase increased
29%
Platelet count decreased
24%
Alanine aminotransferase increased
18%
Sinusitis
18%
Urinary tract infection
12%
Tooth infection
6%
Bronchial infection
6%
Acute Coronary Syndrome
6%
Febrile neutropenia
6%
Sepsis
6%
Infections and infestations - Other, specify
6%
Nail infection
6%
Rhinitis infective
6%
Tumor lysis syndrome
6%
Infusion Related Reaction
6%
Wound infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 2 and MTD (800 mg Entospletinib Daily)
Phase 1, Dose 1 (400 mg Entospletinib Daily)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (atezolizumab, bevacizumab)Experimental Treatment4 Interventions
Patients receive atezolizumab and bevacizumab IV over 60 minutes on day 1. Courses 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
Bevacizumab
2013
Completed Phase 4
~5280
Atezolizumab
2017
Completed Phase 3
~5860
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,534 Total Patients Enrolled
7 Trials studying Vulvar Squamous Cell Carcinoma
1,038 Patients Enrolled for Vulvar Squamous Cell Carcinoma
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,669 Total Patients Enrolled
2 Trials studying Vulvar Squamous Cell Carcinoma
429 Patients Enrolled for Vulvar Squamous Cell Carcinoma
Daniel M HalperinPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not been excluded due to previous treatments or medications.I do not have autoimmune diseases, organ transplants, serious lung, infectious, or heart conditions.My cancer type matches the specific criteria listed.My liver and kidney are working well.Your blood clotting tests are within certain levels.I haven't received any cancer treatment in the last 28 days.My cancer can be measured by specific criteria and has grown after radiation.My cancer type does not match any of the excluded types listed.I have high blood pressure, heart issues, or bleeding problems.Your blood counts need to be within a certain range for white blood cells, platelets, and hemoglobin.You have had serious allergic reactions to certain medications.I am fully active or restricted in physically strenuous activity but can do light work.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (atezolizumab, bevacizumab)
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.
Is recruitment currently underway for this research endeavor?
"Unfortunately, no more candidates are being sought for this trial. It was initially posted on March 3rd 2017 and last edited July 26th 2022. However, there are 4,971 trials seeking participants with neuroendocrine carcinomas and 621 studies actively recruiting for Pharmacological Study at the moment."
Answered by AI
What conditions are commonly addressed by pharmacological investigations?
"Pharmacological Study can be used to treat non-small cell lung carcinoma, postoperative cases, and recurrent forms of non-squamous non-small cell lung cancer."
Answered by AI
What is the current sample size of this research project?
"This clinical trial is no longer actively seeking out participants. First posted on March 3rd 2017, the study was last updated in July 26th of 2022. If you're searching for other studies, 4971 trials are presently recruiting those with neuroendocrine carcinomas and 621 Pharmacological Studies have active enrolment periods."
Answered by AI
Has the Pharmacological Study been given official clearance by the FDA?
"Although the efficacy of this pharmacological study is yet to be proven, there is evidence supporting its safety. Therefore our team assigned it a rating of 2 on the scale from 1 to 3."
Answered by AI
What other investigations have been conducted to evaluate the efficacy of Pharmacological Study?
"Currently, 621 trials are underway for the Pharmacological Study. Of those active studies, 142 have reached Phase 3. Most of these research projects are concentrated in Taibei, Taiwan but 31793 different sites around the world offer this treatment as well."
Answered by AI
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