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Relatlimab + Nivolumab + Chemotherapy for Lung Cancer
Study Summary
This trial is testing if a new cancer treatment is more effective and has a better safety profile than the current standard of care.
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 2023 Phase 1 & 2 trial • 62 Patients • NCT03310619Trial Design
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Who is running the clinical trial?
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- My cancer has specific mutations (EGFR, ALK, ROS-1, BRAF V600E) treatable with targeted therapy.I have previously been treated with specific immunotherapy drugs.I am fully active or have some restrictions but can still care for myself.I haven't received any systemic anti-cancer treatments for my advanced cancer.My lung cancer is confirmed to be advanced or has come back and is either SQ or NSQ type.My cancer can be measured on scans.My cancer has spread to the lining of my brain and spinal cord.To learn more about participating in a clinical trial with Bristol-Myers Squibb, please visit www.BMSStudyConnect.com.I have brain metastases that have not been treated.I do not have any other cancers needing treatment or that were active in the last 2 years.
- Group 1: Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT))
- Group 2: Part 1: Arm B (Nivolumab + Relatlimab Dose 2 + PDCT))
- Group 3: Part 2: Arm C (Nivolumab + Relatlimab Dose 2 + PDCT)
- Group 4: Part 2: Arm D (Nivolumab + PDCT)
- 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
Can you share any other relevant research that has been done on Relatlimab?
"Relatlimab was first studied in 1997 and, 2624 clinical trials later, is still being researched. Right now, 2289 medical studies are actively recruiting patients; a significant portion of these trials taking place near Natrona Heights, Pennsylvania."
Are there any vacancies in this research project for new participants?
"That is accurate. The clinical trial, which began recruiting on February 17th 2021, is still looking for patients. So far, 49 sites have been utilized in the search for 420 individuals."
What autoimmune diseases does Relatlimab commonly help manage?
"Relatlimab is used to fight cancerous neoplasms. In addition, it can be employed to treat other conditions such as melanoma that cannot be removed by surgery, squamous cell carcinoma, and locally advanced nonsquamous non-small cell lung cancer."
What is the projected or estimated number of people who will enroll in this clinical trial?
"To run this clinical trial, we need 420 volunteers that fit the predetermined patient profile. Those who participate can do so from different hospitals, such as Allegheny Valley Hospital located in Natrona Heights, Pennsylvania or Duke University Medical Center situated in Durham, North carolina."
What are the parameters of success for this experiment?
"The primary outcome that will be observed and compared over a 10 to 21-month period is the Overall Response Rate (ORR) as measured by RECIST v1.1. This study's secondary outcomes include the Duration of Response (DoR), Treatment Related Adverse Events (TRAEs), and PFS in biomarker subgroups, all as defined by Part 2 of this trial."
When will Relatlimab be available for public use?
"Since this is a Phase 2 trial, meaning that while there is some safety data it has not been proven effective, we have given Relatlimab a score of 2."
Is this trial also taking place in other locations besides this city?
"Enrollment for this trial is currently happening at 49 different locations, which include cities such as Natrona Heights, Durham and Athens. Travel can be a burden, so please enroll at the location that is most convenient for you."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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