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REGN6569 + Cemiplimab for Advanced Solid Cancer
Study Summary
This trial is evaluating the safety and efficacy of REGN6956 as monotherapy and in combination with cemiplimab. The primary objective is to assess the safety and tolerability of the combination. Secondary objectives include assessing the preliminary efficacy of the combination as measured by objective response rate, disease control rate, duration of response, progression-free survival, and overall survival.
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 3 trial • 608 Patients • NCT03257267Trial Design
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Who is running the clinical trial?
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- I've been on more than 10 mg of prednisone or equivalent daily for the last 2 weeks.I have had a stem cell or organ transplant.I haven't taken any biologic therapy recently as per the study's timeline.I have not received a live vaccine within 4 weeks or a COVID-19 vaccine within 1 week before starting the study medication.I do not have an uncontrolled HIV, hepatitis B or C, or an immunodeficiency.I can provide tissue samples from my cancer before and during treatment.My cancer is an advanced head and neck cancer that cannot be surgically removed.My cancer is in an advanced stage and cannot be removed by surgery.I have had lung inflammation not caused by infection in the last 5 years, but any from radiation has healed.I have never received immune checkpoint blockade therapy.I have an autoimmune disease treated with strong medication in the last 5 years.I have tried all approved treatments for my condition with no success.I have been treated with GITR-targeted therapy before.
- Group 1: Dose Escalation
- Group 2: Dose Expansion
- 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 there numerous locations in the US hosting this trial?
"Eight medical centres are currently participating in this trial. These include the Regeneron Research Facility located in Los Angeles, H.Lee Moffitt Cancer Center and Research Institute in Tampa, and Angeles Clinic and Research Institute - Clinic/Outpatient Facility based out of Grand Rapids."
Has REGN6569 attained licensure from the Federal Drug Administration?
"Due to the limited clinical data attesting its efficacy and safety, REGN6569 received a score of 1 out of 3."
Does this research endeavor have slots available for prospective participants?
"According to the clinicaltrials.gov portal, this medical trial is currently open for enrollment and was published on October 5th 2020 with its most recent edit occurring June 20th 2022."
Are there any recorded investigations into the efficacy of REGN6569?
"REGN6569 was first explored at City of Hope 10 years ago, and has since gone through 6 clinical trials. At the moment, there are 56 active studies being conducted in various locations across Los Angeles."
What is the primary aim of this clinical experiment?
"This medical trial will monitor primary and secondary outcomes over a period of 30 months, with the main objective being to evaluate Incidence and severity of adverse events. Secondary objectives include assessing Drug concentrations for both cemiplimab and REGN6569 in serum samples during Dose escalation periods as well as Duration of Response (DOR)."
What is the sample size for this research experiment?
"To conduct this experiment, 85 volunteers who meet the eligibility requirements must partake. These participants can join from multiple locations such as Regeneron Research Facility in Los Angeles, California and H.Lee Moffitt Cancer Center and Research Institute in Tampa, Florida."
What illnesses does REGN6569 typically address?
"REGN6569 is a powerful drug for mitigating the effects of alk gene mutation. It can also lessen the burden associated with conditions such as advanced directives, malignant neoplasms, and metastatic cutaneous squamous cell carcinoma."
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