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AZD8701 + Durvalumab for Solid Cancers
Study Summary
This trial is testing a new drug, AZD8701, to see if it is safe and effective in treating certain types of solid tumors. The drug will be tested alone and in combination with another drug, durvalumab.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 867 Patients • NCT03084471Trial Design
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- You have a serious heart condition.You need to provide a recent or past sample of your tumor for the study.You have a current or past history of uncontrolled autoimmune or inflammatory disorders, or other serious health problems that are not being treated.You weigh more than 35 kilograms.You have symptoms or a confirmed test for COVID-19 in the last 4 weeks.You have had an organ transplant from a donor.You have received treatments targeting OX40 or CD357 (GITR) in the 90 days before joining the study.Your blood albumin level is higher than 30 grams per liter.You have a disease that is not getting better with usual treatments, or there are no standard treatments available for your disease, and joining a clinical trial is the best choice for your next treatment based on how you have responded to previous treatments.You have already received a specific type of treatment for your non-small lung cancer.You are able to perform daily activities with little to no help.You are taking medication to prevent blood clotting, like warfarin.You had a different type of cancer in the past, but it was treated and hasn't come back for at least 5 years, or it was non-melanoma skin cancer, or it was carcinoma in situ that was treated and has not come back.You have a tumor that can be measured by a CT scan or MRI, and it was checked within the last 28 days before starting treatment.If you have triple negative breast cancer, you have not had a specific type of treatment before.You are expected to live for more than 12 weeks.You have not had severe side effects from previous immunotherapy, especially in your nervous system or eyes.You are still experiencing serious side effects from previous cancer treatment.You have received a large amount of radiation therapy to the bone marrow in the last 4 weeks.You have a confirmed diagnosis of certain types of cancers, including head and neck, triple-negative breast, lung, kidney, stomach, esophageal, skin, cervical, or small cell cancers, or have shown improvement from previous treatment with anti-PD-(L)1 medication.You have not been treated with PD(L)1 medication before for clear cell renal cancer.You had a serious case of Covid-19 and needed medical care.You had a bad reaction to a previous immunotherapy treatment that made you stop taking it forever.
- Group 1: Monotherapy
- Group 2: Combination Therapy
- 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 there a history of research surrounding the efficacy of AZD8701?
"AZD8701 was initially researched in 2010 by the professionals at City of Hope. The drug has been tested in 106 different trials so far, and currently there are 333 ongoing studies that have begun recruiting patients; most notably sites located around Madison, Wisconsin."
How many healthcare centers are currently executing this experiment?
"At the moment, 11 different medical centres are conducting this clinical trial. While there is a site in Madison, Toronto and Houston, 8 additional sites exist to make travel requirements more manageable for participants."
To what extent is the patient pool for this trial being expanded?
"Indeed, according to clinicialtrials.gov, this medical research project is actively enrolling patients after being initially published on August 18th 2020. 153 participants are required for completion of the trial and will be recruited from 11 different clinical sites."
Does this research project accept older adults as participants?
"The eligibility requirements for this clinical trial necessitate that potential participants are at least 18 years of age and no older than 101."
What risks do individuals face when taking AZD8701?
"As this is an early testing stage (Phase 1), and there is limited clinical data available to verify safety or efficacy, AZD8701 was awarded a score of 1."
In what contexts is AZD8701 commonly prescribed?
"AZD8701 is mainly used to treat late-stage, inoperable non-small cell lung cancer. It may also be prescribed for patients with metastatic ureteral carcinoma or other advanced directives."
What key outcomes are being sought in this research project?
"According to the trial's sponsor, AstraZeneca, the primary metric of success will be assessing Maximum Tolerated Dose (or Optimal/Maximum Feasible Dosage) and RP2D of AZD8701 when administered as monotherapy or in combination with Durvalumab. This evaluation period extends from screening until 105 days following the last dose. Secondary objectives include examining Plasma and Urine concentrations of AZD8701 through Non-Compartmental Analysis (NCA), serum concentration levels for Durvalumab when combined with AZD8701, alongside Time To Maximum Concentration values both on their own and"
Are new participants being sought out for this clinical trial?
"Per clinicaltrials.gov, this investigation is currently recruiting individuals to participate in the research study. The trial opened on August 18th 2020 and was last amended on October 27th 2022."
What is the eligibility criteria for participation in this research endeavor?
"This clinical trial is recruiting 153 individuals aged 18 to 101 who have been diagnosed with melanoma. To be eligible, patients must weigh more than 35 kilograms and demonstrate an ECOG performance status of 0-1. Furthermore, they ought to possess the capacity to provide informed consent as well as meet other criteria such as not having received prior PD(L)1 treatment (for certain cancers). This study consists of two parts: Monotherapy involving AZD8701 and Combined Therapy with both AZD8701 and Durvalumab being administered. Male and female participants capable of conceiving are required to use effective contraception methods during the duration of the"
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