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MEDI4736 for Bladder Cancer (BISCAY Trial)
BISCAY Trial Summary
This trial is for patients with bladder cancer who have progressed on prior treatment. It is designed to study the safety and tolerability of multiple agents as monotherapy or in combination.
BISCAY Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowBISCAY 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 2023 Phase 3 trial • 713 Patients • NCT02125461BISCAY Trial Design
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Who is running the clinical trial?
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- My treatment is in the 2nd or 3rd round.You have been diagnosed with an autoimmune disease, inflammatory bowel disease (IBD), primary immunodeficiency, or have had an organ transplant that requires medication to suppress your immune system within the past two years.My cancer has a FGFR3 mutation or fusion.I haven't taken immunosuppressive drugs in the last 28 days.My blood tests show normal white blood cells, neutrophils, and platelets.My brain or spinal cancer is stable and I haven't needed steroids for 4 weeks.I have heart issues or uncontrolled blood pressure.I haven't taken specific cancer drugs or strong drug metabolism modifiers recently.I do not have an active infection like TB, HBV, HCV, or HIV. If I had HBV or HCV, it's either resolved or my tests for the virus are negative.I have eye conditions like macular degeneration or retinal disease.I have ongoing issues with nausea, vomiting, or have had part of my bowel removed.I haven't had a blood transfusion in the last 4 months.I have not been treated with specific cancer drugs like Nitrosourea, mitomycin C, or Wee1 inhibitors recently.I am not taking medication that interacts with CYP3A4 enzymes.I am currently using herbal supplements.I haven't taken any blood cell growth factors in the last 14 days.I have ongoing nausea or a long-term stomach/intestine condition.I have not had heart disease in the last 6 months.I have not taken any mTOR inhibitor medications.I have kidney disease or a condition affecting my kidney's acid levels.I have had eye problems like retinal issues or high eye pressure.I have been treated with specific cancer drugs within the last 6 weeks.I have been treated with a PARP inhibitor like olaparib before.I have a history of myelodysplastic syndrome or acute myeloid leukemia.I have a history of lung conditions that needed steroid treatment.I am not using effective birth control or am breastfeeding.My tumor has specific genetic changes.I had major surgery less than 4 weeks ago.My previous chemotherapy for early-stage cancer did not work within the last year.My bladder cancer has spread to other parts of my body.I do not have any severe or uncontrolled illnesses.I am not taking strong medication that affects liver enzymes.I haven't had cancer treatments or study drugs in the last 4 weeks.My diabetes is not well-managed.I still have side effects from previous cancer treatments.I have been treated with a MEK, Ras, or Raf inhibitor before.I am 25 years old or older.My cancer has a harmful change in DNA repair genes.I haven't had a live vaccine in the last 30 days.I haven't taken certain drugs that affect liver transporters or enzymes recently.I have not had minor surgery within the last 14 days.I had a heart condition where my heart's pumping ability was reduced but have since recovered.I am not currently on chemotherapy, immunotherapy, biologic, or hormonal therapy.
- Group 1: Module A: AZD4547 Monotherapy
- Group 2: Module A: MEDI4736 (durvalumab) + AZD4547
- Group 3: Module B: MEDI4736 (durvalumab) + Olaparib
- Group 4: Module C: MEDI4736 (durvaluamb) + AZD1775
- Group 5: Module D: MEDI4736 (durvalumab) monotherapy
- Group 6: Module E: MEDI4736 (durvalumab) + Vistusertib
- Group 7: Module F: MEDI4736 (durvaluamb) + AZD9150
- Group 8: Module G: MEDI4736 + Selumetinib
- 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
What medical purpose does MEDI4736 serve?
"MEDI4736 is widely used to treat numerous diseases and can be prescribed as a pharmacotherapy option for primary peritoneal cancer, neurofibroma, and further conditions."
What potential risks do patients face when taking MEDI4736?
"MEDI4736's safety is rated 1 on our scale given the limited clinical evidence of both efficacy and security present in this Phase 1 study."
What is the scope of healthcare facilities currently engaging in this clinical trial?
"Currently, the trial is enrolling patients at 10 different centres across America. These include locations in Los Angeles, Nashville and New york City with additional sites dispersed throughout the nation. To make participating a little easier on yourself, consider joining a clinical site near you to reduce travel demands."
How many participants are being monitored as part of this medical investigation?
"This clinical trial is no longer recruiting participants. It was initially listed on October 3rd 2016 and its last update occurred 17 days later. For those seeking out similar studies, 315 trials are presently searching for patients with urinary bladder cancer while 526 other medical experiments are actively looking for individuals eligible to receive MEDI4736."
Has there been a precedent established for this kind of clinical trial?
"Research of MEDI4736 commenced in 2005, when AstraZeneca sponsored the first trial with 98 participants. Following this study, Phase 1 drug approval was granted. At present, 526 live studies are being conducted in 65 nations and 1952 cities worldwide."
What results should we anticipate from this research endeavor?
"The primary outcome for this trial is the transformation in haematology parameters from baseline, which will be monitored at screening, on Day 1 of Cycle 1 and every 12 weeks until Cycle 7. Then onwards it will be tracked every 16 weeks relative to first dose administration. Secondary outcomes include plasma concentration levels of MEDI4736 (durvalumab) and AZD9150 as well as anti-drug antibodies (ADA), neutralising ADA's produced against MEDI4736 with concentrations adjusted depending upon data trends."
Is this investigation presently enrolling participants?
"It is reported that this experiment, first posted on October 3rd 2016 and last amended on October 17th 2022, is not currently recruiting patients. Nonetheless, there are 841 different studies which are actively accepting participants at the present moment."
Has there been prior research conducted with MEDI4736?
"MEDI4736 was initially studied in 2005 at a Research Site. To date, 259 trials have been completed and there are currently 526 active ones across the world; many of which take place in Los Angeles, California."
Does this medical experiment have an age restriction, and if so what is it?
"This medical trial is seeking participants between 18 and 130 years old. Separately, there are 35 subsets of the study tailored to people under the age of majority, while 826 studies focus on those over 65."
Who qualifies to participate in this medical research?
"Eligibility requirements for this clinical trial mandate that applicants have a diagnosis of urinary bladder cancer and lie within the age range between 18 to 130. In total, 156 patients are needed across all sites."
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