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Avelumab Combinations for Triple Negative Breast Cancer (InCITe Trial)
InCITe Trial Summary
This trial is studying avelumab in combination with two other drugs to treat triple negative breast cancer.
InCITe Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowInCITe Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.InCITe Trial Design
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Who is running the clinical trial?
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- I have not received any vaccines within 28 days before starting the study drugs, except for inactivated ones.My breast cancer is at stage IV or has come back in the same area and cannot be surgically removed.I have received an organ or stem cell transplant.I have had pancreatitis, eye vein blockage, or take blood thinners.I do not have significant infections like HIV or hepatitis.My heart, liver, kidneys, and blood are all functioning well.My thyroid condition is treated and under control.I use corticosteroids or immunosuppressants only under certain conditions.I don't have lasting side effects from past treatments, severe allergies to monoclonal antibodies, or a history of severe allergic reactions.I am 18 years old or older.I agree to use two forms of birth control if I can have children.I do not have severe lung problems, uncontrolled heart or blood pressure issues.I have had more than one treatment with checkpoint inhibitors for my advanced cancer.I have had more than 2 chemotherapy treatments for my cancer after it spread.I am willing to undergo a biopsy for the study.I haven't had cancer other than breast cancer in the last 5 years.My cancer's PD-L1 status is known.I have brain metastases but meet certain criteria for this trial.I have stopped my cancer treatment for a specific time before joining.I have an autoimmune disease that might worsen with immune-stimulating treatments.I have a muscle disorder that causes high levels of creatine kinase.I am fully active or have some restrictions but can still care for myself.I have previously been treated with sacituzumab govitecan.
- Group 1: CLOSED TO ENROLLMENT: Arm II (anti-OX40 antibody PF-04518600, avelumab)
- Group 2: Arm B (avelumab, sacituzumab govitecan)
- Group 3: Arm A (avelumab, binimetinib, liposomal doxorubicin)
- Group 4: Arm C (avelumab, liposomal doxorubicin)
- Group 5: CLOSED TO ENROLLMENT: Arm III (utomilumab, avelumab)
- Group 6: CLOSED TO ENROLLMENT: Arm I (binimetinib, avelumab)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Is this particular experiment the inaugural iteration of its type?
"Since 1997, Alfacell has spearheaded research on Binimetinib. After the first study's completion in that same year involving 300 participants, this drug was granted Phase 3 approval. Currently there are 562 active trials for Binimetinib occuring 69 countries and 2472 cities worldwide."
How many medical centers are actively conducting this investigation?
"Seven medical centres are recruiting participants for this trial, including University of California San Francisco in San Francisco, Mayo Clinic Rochester and the University of Alabama Birmingham. Additionally there are 4 other sites enrolling patients as well."
Is there any availability for participants in this medical trial?
"According to the clinicaltrials.gov website, this study is currently enrolling participants and has been modified as recently as June 2nd 2022 from its original post date of July 8th 2019."
Could you outline the potential perils of Binimetinib administration?
"The safety of Binimetinib is rated as a 2 on our team's assessment scale, indicative of its Phase 2 trial status and the absence of efficacy data."
What other experiments have been conducted to explore Binimetinib's therapeutic potential?
"Currently, 562 medical studies are in progress that investigate Binimetinib. 137 of those active research projects have reached the Phase 3 stage. While most clinical trials for this drug take place in Cambridge, England, there is additionally a global network of 31696 locations conducting tests and gathering data on its effects."
What is the size of the participant group for this clinical investigation?
"Affirmative. According to the information hosted on clinicaltrials.gov, this medical trial is presently recruiting participants and has been since July 8th 2019 with a most recent update made June 2nd 2022. 150 individuals are being accepted from 7 different facilities."
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