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REGN4018 + Cemiplimab for Ovarian Cancer
Study Summary
This trial is studying REGN4018, given alone or together with cemiplimab, to see how well it works in treating patients with solid tumors that have spread (metastatic) or cannot be removed by surgery (unresectable).
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.Trial Design
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Who is running the clinical trial?
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- My organs and bone marrow are working well.I have a history of heart issues as described in the study details.My high blood pressure is under control with stable medication.I have been diagnosed with advanced ovarian, peritoneal, or fallopian tube cancer.I have been treated with a therapy targeting MUC16 before.I have an untreated brain tumor or cancer that has spread to my brain or spinal cord.I have no standard treatment options left.You are expected to live for at least 3 more months.I have ovarian cancer resistant to platinum therapy, treated with 1-4 platinum-based therapies and a PARP inhibitor or bevacizumab.I have recently been treated with PD-1/PD-L1 inhibitors.My condition worsened after my last treatment.I have undergone more than 4 chemotherapy treatments.Your CA-125 blood test shows a level that is at least twice as high as the normal range.I have had platinum-based treatment or cannot tolerate it.
- Group 1: Combination Therapy
- Group 2: Monotherapy
- 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
What is the most frequent purpose for taking REGN4018?
"REGN4018 is an effective treatment for the alk gene mutation, as well as advance directives and malignant neoplasms."
What goals does this experiment seek to achieve?
"The main objective of this study, which will last for around 62 weeks, is to assess the number of patients that experience laboratory abnormalities (grade 3 or worse according to CTCAE) as a result of REGN4018 monotherapy. Additionally, the study hopes to gain information on secondary objectives such as DOR based on iRECIST for REGN4018 with cemiplimab in the Dose Escalation and Dose Expansion Phases, the presence or absence of anti-drug antibodies against REGN4018 in the same phases, and changes from baseline in physical functioning as measured by EORTC QLQ"
Are there any patients still needed for this research?
"Yes, this study is still looking for participants. The listing on clinicaltrials.gov says that the trial was originally posted on 5/21/2018 and was edited as recently as 10/11/2022. Up to 554 people will be accepted at 13 different locations."
Are there any other research centers conducting this experiment?
"There are 13 hospitals enrolling patients for this study, which include locations in Nashville, Hilliard and Oklahoma City. The other 10 sites are located throughout the country. If you choose to enroll in this study, try to select a hospital near you to limit travel demands."
How many individuals are participating in this clinical trial?
"In order to carry out this clinical trial, we need 554 patients that fit the bill in terms of our specified inclusion criteria. If you're interested, you may be able to participate from locations such as Sarah Cannon Research Institute in Nashville, Tennessee or The General Hospital Corporation d/b/a Massachusetts General Hospital in Hilliard, Ohio."
What other scientific papers have been published that mention REGN4018?
"City of Hope first researched REGN4018 in 2010 and, since then, 6 studies have completed. Of the 59 ongoing trials, a considerable number are based in Nashville, Tennessee."
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