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Ceralasertib + Durvalumab for Melanoma (MONETTE Trial)
MONETTE Trial Summary
This trial is testing a new drug for people with melanoma that has spread or can't be removed surgically, and who have already tried a different kind of treatment.
MONETTE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowMONETTE 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 2022 Phase 3 trial • 867 Patients • NCT03084471MONETTE Trial Design
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Who is running the clinical trial?
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- I have had an organ transplant and take drugs to suppress my immune system.You have a disease that can be measured according to a specific standard.I can provide both an old and a new sample of my tumor.I have never stopped a CPI treatment due to severe side effects.It has been at least 14 days since my last dose of anti-PD-(L)1 or BRAF/MEK inhibitor.My melanoma cannot be removed by surgery and is of a specific type (skin, acral, or mucosal).I do not have serious heart problems like heart failure, unstable chest pain, or dangerous irregular heartbeats.I tested positive for COVID-19 and haven't fully recovered.My liver, kidneys, or bone marrow are not working well.I've had 1-2 treatments with specific immune therapies for my advanced cancer and it has progressed despite these treatments.I agree to provide 3 tumor biopsies for the study.I have been diagnosed with uveal melanoma.I had cancer before, but it was treated successfully over 3 years ago.I haven't had severe side effects from previous immunotherapy.I do not have an active infection or hepatitis that needs treatment.
- Group 1: Main study: Ceralasertib + Durvalumab
- Group 2: Main study: Ceralasertib
- Group 3: Biopsy Sub-study: Ceralasertib + Durvalumab
- Group 4: Biopsy study: Ceralasertib
- 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
Are new participants being enrolled in this experiment at this time?
"The study is still open and recruiting patients, as seen on clinicaltrials.gov. This trial was initially posted on 8/11/2022 and was most recently updated on 10/21/2022."
Could you please explain the risks associated with Ceralasertib?
"Ceralasertib is still being tested for efficacy in Phase 2 trials, but there is some data supporting its safety--we've given it a score of 2."
Does this research project restrict its participants to people under a certain age?
"This study is looking for patients aged 18 to 130. In contrast, 60 trials focus on individuals younger than 18 while 1121 are geared towards people over the age of 65."
How do I sign up for this clinical trial?
"This clinical trial is looking for 195 patients that have been diagnosed with melanoma. The study has specific age, treatment, and health requirements that potential participants must meet in order to be eligible. Some of these include being 18 years or older, having received immunotherapy in the past, and having a life expectancy of at least 3 months from the proposed start date of the trial. If you think you may qualify and are interested in participating, please reach out to the research team for more information."
In how many different hospitals is this study being run today?
"There are 11 sites where this study is enrolling patients. To help participants, they have chosen locations in Sacramento, Toronto and San Francisco as well as other cities to make it more convenient."
What are some other examples of Ceralasertib being studied in a medical capacity?
"There are presently 353 Ceralasertib clinical trials underway. Of these, 51 have progressed to Phase 3 testing. Although the majority of these studies are based in Cordoba and Texas, there are a total of 13157 locations running trials for this treatment worldwide."
How many people are enrolling in this research project?
"Yes, the data available on clinicaltrials.gov affirms that this trial is still recruiting patients. This research was first made public on August 11th, 2022 and has since been updated on October 21st, 2022. So far, 195 individuals have been accepted across 11 sites."
What are the primary goals of this clinical trial?
"The purpose of this ongoing clinical trial is to observe the Main study's ORR (objective response rate) and the Biopsy sub-study's changes in PD-L1 and pRAD50 (tumour tissue samples that change following exposure to ceralasertib). The trial length is 28 days per cycle."
What are Ceralasertib's most popular applications?
"Ceralasertib is commonly used to treat unresectable stage iii non-small cell lung cancer. This drug can also be effective in treating other conditions, such as previously untreated metastatic ureter urothelial carcinoma and advance directives."
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