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Retifanlimab for Merkel Cell Carcinoma
Study Summary
This trial is testing a new drug for people with advanced Merkel cell cancer. The goal is to see if it is safe and if it works.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 2 trial • 94 Patients • NCT03597295Trial Design
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Who is running the clinical trial?
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- I am not taking any medications that are not allowed in this study.I do not have any active infections, including hepatitis.I haven't taken any cancer drugs or joined any clinical studies in the last 21 days.I have recovered from previous cancer treatments, except for possible anemia or hair loss.Your test results are not within the specified range according to the study guidelines.There needs to be a sample of your tumor tissue available for central pathology review.I can carry out all my usual activities without help.You have a disease that can be measured using specific guidelines.My Merkel cell carcinoma has spread or returned and cannot be treated with surgery or radiation.I have received treatments like chemotherapy or PD-1/PD-L1 therapy for Merkel Cell Carcinoma.You are allergic to another type of medication called monoclonal antibody, and standard treatments like antihistamines and corticosteroids don't work to control your allergy.My cancer has spread to my brain or the coverings of my brain.I have not had another type of cancer in the last 3 years.I haven't had radiation therapy in the last 2 weeks or high-dose chest radiation in the last 6 months.I do not have serious lung, heart, stomach, or autoimmune diseases.I have not received a live vaccine in the last 28 days.
- Group 1: Retifanlimab: Chemotherapy: Naïve
- Group 2: Retifanlimab: Chemotherapy: Refractory
- 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 Retifanlimab acquired regulatory clearance from the FDA?
"Our assessment of the safety profile for Retifanlimab was a 2, as there is evidence to suggest it is safe but no clinical trials that support its efficacy."
What prior investigations have been conducted concerning Retifanlimab?
"As of now, 26 active trials are exploring the efficacy of Retifanlimab with 3 in Phase 3. While A CORU�A and Virginia have a significant concentration of studies, 810 sites across the world are running these tests."
Is this the inaugural trial for such a protocol?
"Since its initial study, conducted in 2016 and sponsored by Incyte Corporation, retifanlimab has undergone extensive testing. After being granted Phase 1 approval following the first trial involving 325 patients, there are currently 26 active studies for this drug across 117 cities in 43 nations."
What objectives are the researchers hoping to achieve with this investigation?
"This clinical trial aims to assess the Objective Response Rate of chemotherapy-naive patients with advanced/metastatic MCC using RECIST v1.1, as Determined by independent Central Radiographic Review (ICR), over a period extending from Baseline up to approximately 8 months. Other metrics that are being evaluated include Disease Control Rate, tmax of INCMGA00012, and Cmax of INCMGA00012."
How many healthcare facilities are currently administering this clinical trial?
"Numerous medical centres are engaging in the recruitment of patients for this study, including Norton Cancer Institute (Louisville), Stanford Cancer Institute (Palo Alto), and McGill University Health Centre/Glen Site/Cedars Cancer Centre (Montreal). Additionally, 16 other sites have also signed on."
Are additional volunteers being welcomed into this medical experiment?
"As indicated on clinicaltrials.gov, this particular medical study is no longer actively enrolling patients. However, there are currently 2503 other trials which require participants and can be accessed from the same website. The trial was initially posted on February 25th 2019, but has since been closed off to new candidates as of September 29th 2022."
How many individuals are currently enrolled in this clinical research?
"This research endeavour is now closed for recruitment. It was first announced on February 25th 2019, with the last update made on September 29th 2022. For other trials related to carcinoma or merkel cell, 2477 are available; alternatively 26 studies recruiting participants for Retifanlimab are currently active."
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