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Odronextamab + Cemiplimab for Aggressive B-Cell Lymphoma (CLIO-1 Trial)
CLIO-1 Trial Summary
This trial is studying cemiplimab and REGN1979 to see how well they work in treating patients with lymphoma. The study will last 6-12 months, and participants will be monitored for 6 months after treatment.
CLIO-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCLIO-1 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 2023 Phase 2 trial • 138 Patients • NCT03132636CLIO-1 Trial Design
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Who is running the clinical trial?
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- My organs are working well.I do not have an uncontrolled infection like HIV or hepatitis.You are pregnant or currently breastfeeding.My bone marrow is working well.I have a history of or currently have a brain or nervous system condition.I am fully active or can carry out light work.I am sexually active and not willing to use birth control during the study.I have been treated with idelalisib before.I have been treated with a PD-1/PD-L1 inhibitor and it worked for me.I have an autoimmune disease treated with immune-suppressing drugs in the last 2 years.You are expected to live for at least 6 more months.You must meet all the other requirements and restrictions listed in the study protocol.My lymphoma is not responding to treatment and there are no standard treatments left for me.I have a tumor that can be measured and is larger than 1.5 cm.My cancer involves the brain or nervous system.I have had a stem cell transplant from a donor.
- Group 1: Dose escalation phase
- Group 2: Dose expansion phase
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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 any precedents of research involving cemiplimab?
"At this time, 58 separate clinical trials are undergoing research on cemiplimab with 4 in the late stages of development. While Barcelona and California have a significant number of ongoing studies for cemiplimab, there are 1978 different sites conducting these tests worldwide."
Is enrollment for this trial still open?
"As detailed on clinicaltrials.gov, the initial post for this trial was made in November of 2016 and last edited in September 2022; however, it is not currently seeking participants. Fortunately, there are 1776 other medical studies accepting patients at present."
At how many venues can participants access this experiment?
"At the present moment, 9 distinct clinical sites are enrolling patients into this trial. These centres can be found in Lebanon, Baltimore and Grand Rapids as well as other nearby locations to reduce potential travel burdens for participants if they choose to take part."
Has cemiplimab received the green light from the Food and Drug Administration?
"Cemiplimab's safety has yet to be fully established due to its Phase 1 trial status, and thus it recieved a score of 1."
What is the current enrollment rate for this clinical research trial?
"At the present time, this clinical trial is not recruiting. It was initially posted on 11th January 2016 and last updated on 20th September 2022. Alternately, if you are seeking other studies there are 1718 trials actively looking for lymphoma patients while 58 of such trials require participants with cemiplimab."
What medical conditions is cemiplimab regularly used to treat?
"Through the use of cemiplimab, it is possible to address alk gene mutation, anticipate medical decisions through advance directives, and combat malignant neoplasms."
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