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Avelumab + AVB-S6-500 for Bladder Cancer (COAXIN Trial)
COAXIN Trial Summary
This trial is testing a new cancer treatment combining avelumab and AVB-S6-500 to see if it is safe and effective for patients with advanced urothelial carcinoma.
COAXIN Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCOAXIN Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 2 trial • 19 Patients • NCT03006848COAXIN Trial Design
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- I haven't taken high-dose steroids or immunosuppressants in the last 28 days.My cancer progressed after platinum-based treatment.I am 18 years old or older.I have not received a live vaccine recently and do not plan to during the study.I have had an organ or stem-cell transplant.I haven't taken any cancer drugs or been in a trial for 28 days, but I may have had radiation for symptom relief.I have been treated with anti-PD-1 or PD-L1 drugs before.You have serious ongoing medical conditions like colitis, inflammatory bowel disease, pneumonia, lung fibrosis, or mental health issues including recent thoughts of self-harm. You also have abnormal lab results that could make it risky for you to participate in the study or make it difficult to interpret the results.My blood and organs are functioning well.I chose not to undergo platinum-based chemotherapy after discussing it with my doctor.I have a history of certain lung conditions or signs of lung inflammation on a CT scan.My cancer is advanced and cannot be surgically removed, or it has spread beyond its original location.I am a woman who is not postmenopausal or surgically sterile and have a recent negative pregnancy test.I have lasting side effects from past treatments, but they are mild.I cannot have cisplatin chemotherapy due to my health condition.I have had hepatitis B or untreated hepatitis C, but if I had hepatitis C, it's been treated.You must meet one of the following conditions:I can provide a sample of my tumor or am willing to have a biopsy.You have had severe allergic reactions to a certain type of medication called monoclonal antibodies or any other biologic drugs. You also have uncontrolled asthma.I haven't had cancer, except for some skin, cervical, or low-grade prostate cancers, in the last 3 years.I do not have untreated or worsening brain metastases.I have an autoimmune disease but don't need strong immune system-suppressing drugs, except for conditions like type 1 diabetes, vitiligo, psoriasis, or thyroid issues.I can take care of myself but might not be able to do heavy physical work.I am currently on medication for an infection.I haven't had any severe infections or been hospitalized for infection complications in the last 4 weeks.I have scarring from previous radiation treatments.My cancer returned or worsened within a year after finishing chemotherapy.
- Group 1: Avelumab + AVB-S6-500
- 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
Has the FDA sanctioned AVB-S6-500 for use in medical treatment?
"Our team's assessment puts the safety of AVB-S6-500 at a low score of 1, as this is an initial Phase 1 trial which has limited data regarding its efficacy and security."
Are there other scientific investigations utilizing AVB-S6-500?
"Currently, there are 111 active studies in relation to AVB-S6-500 with 10 trials at the critical Phase 3. Barcelona and South dakota host most of these clinical tests; however, investigations concerning AVB-S6-500 can also be found in 3678 separate locations."
What is the ultimate goal of this experiment?
"The main objective of this trial over a two-year period is to measure the incidence of dose limiting toxicities. Secondary metrics include overall survival, clinical benefit rate and progression free survival; all calculated respectively as the time between enrollment and death or date of last contact (or end of study), proportion of patients with response or stable disease on treatment, and interval from enrollment until disease deterioration, expiration or final contact (or dropout/end)."
Is recruitment still taking place for this research endeavor?
"Clinicialtrials.gov discloses that this research is not presently recruiting patients, despite having been initially posted on February 17th 2020 and recently edited November 21st 2022. Notwithstanding, there are 2,629 other studies actively looking for volunteers at the present moment."
Is this research a pioneering endeavor?
"Since 2014, AVB-S6-500 has remained an area of focus for research. After the inaugural 204 patient trial sponsored by EMD Serono Research & Development Institute, Inc., Phase 2 approval was granted. Currently there are 111 active studies in 1024 cities and 52 countries worldwide dedicated to this medication."
How many participants have registered for this investigation?
"This trial has ceased recruitment and was last updated on November 21st 2022. If you are exploring alternatives, there is a total of 2518 clinical trials recruiting patients with transitional cell carcinoma and 111 for the AVB-S6-500 medication currently in progress."
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