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PD-L1 Inhibitor
Atezolizumab + Cabozantinib for Pancreatic Cancer
Phase 2
Recruiting
Led By Rachna Shroff, MD
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Stage IV pancreatic adenocarcinoma, confirmed by histology or cytology
Adequate organ and marrow function based upon meeting specific laboratory criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, at 9 weeks, at end of treatment (approx. 6 months), and after disease progression
Awards & highlights
Study Summary
This trial is testing a combination of two drugs to treat pancreatic cancer. The drugs will be given to patients with cancer that has spread and who have not responded to other treatments. The goal is to see if the combination is safe and works better than other treatments.
Who is the study for?
Adults over 18 with stage IV pancreatic adenocarcinoma that has spread and is resistant to certain chemotherapies. They must have measurable disease, be in good physical condition (ECOG ≤1), and recovered from previous treatments' side effects. Participants need functioning organs/marrow, can't be pregnant or breastfeeding, must use contraception, and not have had specific prior treatments like cabozantinib or immune therapies.Check my eligibility
What is being tested?
The trial tests a combination of Cabozantinib + Atezolizumab for metastatic pancreatic cancer patients who haven't responded to standard treatments. It measures how well the treatment works (response rate), controls the disease, extends life without progression, overall survival time, safety/tolerability and examines immune changes before/after treatment.See study design
What are the potential side effects?
Potential side effects include liver problems, high blood pressure, fatigue, mouth sores; hand-foot syndrome; diarrhea; decreased appetite; nausea; vomiting; weight loss; voice changes or hoarseness may occur. If any of these effects persist or worsen tell your doctor promptly.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My pancreatic cancer is at stage IV.
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My blood tests show my organs and bone marrow are working well.
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I have recovered from side effects of previous treatments, with only mild symptoms remaining.
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I am fully active and can carry on all my pre-disease activities without restriction.
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It has been over two weeks since my last cancer treatment.
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I've had a bad reaction or my cancer got worse on treatments like fluoropyrimidine or gemcitabine.
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I am 18 years old or older.
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My cancer spread within 6 months after adjuvant therapy, counting as one prior treatment.
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I am not pregnant and either am not able to become pregnant or have confirmed I am in menopause.
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My cancer can be measured on scans taken within the last 28 days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, at 9 weeks, at end of treatment (approx. 6 months), and after disease progression
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, at 9 weeks, at end of treatment (approx. 6 months), and after disease progression
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate or Stable Disease
Secondary outcome measures
Adverse Event
Disease Control Rate
Immune System Effects
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Cabozantinib 40mg + Atezolizumab 1200mgExperimental Treatment1 Intervention
Cabozantinib 40 mg, tablets, oral administration, once daily, continuously. Atezolizumab 1200 mg, administered intravenously, on Day 1 of every 21 day cycle.
Find a Location
Who is running the clinical trial?
University of ArizonaLead Sponsor
514 Previous Clinical Trials
148,242 Total Patients Enrolled
Rachna Shroff, MDPrincipal InvestigatorUniversity of Arizona
1 Previous Clinical Trials
20 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active and can carry on all my pre-disease activities without restriction.I have previously been treated with specific immune therapies.I haven't taken any kinase inhibitor medication in the last 28 days.I have pain from my cancer that isn't relieved by treatment.I have a history of HIV/AIDS or tested positive for tuberculosis.I have not had a live vaccine recently and do not plan to get one soon.My liver is not working well.I haven't had cancer treatment in the last 2 weeks.I am 18 years old or older.I cannot swallow pills.I haven't had radiation for bone metastasis in the last 2 weeks or any other radiation in the last 4 weeks.I haven't taken any strong immune system suppressing drugs in the last 2 weeks.I have recovered from side effects of previous treatments, with only mild symptoms remaining.It has been over two weeks since my last cancer treatment.I have high calcium levels in my blood that are causing symptoms.I have been treated with cabozantinib before.I have a serious wound, ulcer, or bone fracture that isn't healing.My heart's electrical activity (QTcF) is not over 500 ms.I haven't taken any immune-boosting drugs recently.I have symptoms of underactive thyroid that aren't treated.You have had serious, severe allergic reactions to certain substances.I have had a previous transplant of stem cells or an organ.I have not had major surgery in the last 4 weeks.I've had a bad reaction or my cancer got worse on treatments like fluoropyrimidine or gemcitabine.My cancer spread within 6 months after adjuvant therapy, counting as one prior treatment.I have a history of specific lung conditions or signs of lung inflammation on a CT scan.I am not pregnant and either am not able to become pregnant or have confirmed I am in menopause.My blood tests show my organs and bone marrow are working well.I am currently being treated for an infection.You are known to have an allergy to certain ingredients.My pancreatic cancer is at stage IV.You currently have or have had an autoimmune disease or immune deficiency, with some specific exceptions.My brain metastases have been treated and are stable.I am currently taking blood thinners.I do not have any severe ongoing illnesses like heart or stomach issues.I frequently need procedures to remove excess fluid from my chest or abdomen.I do not have any other cancer that needs treatment right now.My cancer can be measured on scans taken within the last 28 days.
Research Study Groups:
This trial has the following groups:- Group 1: Cabozantinib 40mg + Atezolizumab 1200mg
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.
Could you enlighten me on the potential dangers of combining Cabozantinib and Atezolizumab?
"Cabozantinib + Atezolizumab has been assigned a score of 2, as there is some data available for safety but none to demonstrate its efficacy."
Answered by AI
What health concerns are typically addressed by the combination of Cabozantinib and Atezolizumab?
"Cabozantinib + Atezolizumab is routinely used to combat small cell lung cancer in addition to previously treated malignancies such as anti-VEGF, and individuals deemed higher risk."
Answered by AI
Does this research represent a pioneering exploration of its kind?
"Since the original 2008 trial, conducted by Hoffmann-La Roche and involving 720 participants, cabozantinib + atezolizumab has been approved for phase 2 drug use. Currently, it is being examined in 447 trials across 1911 cities and 75 nations."
Answered by AI
How many participants are being accepted into this medical experiment?
"Affirmative. The records on clinicaltrials.gov make it clear that this experimental study is actively recruiting, having initially been posted on October 12th 2021 and last updated December 3rd 2021. Consequently, the trial requires 29 participants to be sourced from 1 medical centre."
Answered by AI
Are applications for participation being accepted currently in this experiment?
"Indeed, corroborated by clinicaltrials.gov, this medical trial is currently seeking participants. This experiment was initially posted on October 12th 2021 and it's latest update came through December 3rd of that same year. 29 patients are needed to join the study at a single center."
Answered by AI
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