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Monoclonal Antibodies
ASP8374 + Cemiplimab for Recurrent Brain Cancer
Phase 1
Waitlist Available
Led By David A Reardon, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At first or second relapse
Previous first line therapy with at least radiotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up enrollment up to 2 years
Awards & highlights
Study Summary
This trial is testing the safety and efficacy of a drug combo of ASP8374 and cemiplimab for people with recurrent malignant glioma.
Who is the study for?
This trial is for adults over 18 with recurrent malignant glioma, either WHO grade IV GBM or variants, or grade III (Cohort 1 only). They must have a Karnofsky performance status of ≥70 and show tumor progression. Participants need adequate organ function and should be at their first or second relapse after radiotherapy. Pregnant women and those with certain medical conditions or treatments are excluded.Check my eligibility
What is being tested?
The study tests the combination of ASP8374 with cemiplimab in two parts: finding the safest high dose (Part 1) and assessing its effect before surgery (Part 2). It aims to establish safety and effectiveness against recurrent brain tumors.See study design
What are the potential side effects?
While specific side effects aren't listed, similar trials often involve risks like immune reactions, inflammation in various organs, fatigue, allergic responses to drug components, infection risk increase due to immunosuppression, bleeding complications, and potential interference with other medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition has worsened for the first or second time after improving.
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I have received radiotherapy as my first treatment.
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I am 18 years old or older.
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I am able to care for myself but may not be able to do active work.
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I am not pregnant.
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My organs are functioning well.
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My brain tumor is confirmed to be a high-grade glioma.
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I am mostly able to care for myself and carry out daily activities.
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I have received radiotherapy as my first treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ enrollment up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~enrollment up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
CD8+ TIL Tumor Density-Cohort 2
Maxium Tolerated Dose-MTD/ Phase 2 Recommend Dose-RP2D - Cohort 1
Secondary outcome measures
Rate of Adverse Events
overall survival (OS).
progression-free survival (PFS)
Trial Design
2Treatment groups
Experimental Treatment
Group I: ASP8374 and Cemiplimab-Cohort 2Experimental Treatment2 Interventions
Upon determination of the MTD/RP2D of ASP8374 plus cemiplimab in Cohort 1, a dose expansion will be performed in which eligible participants who are candidates for surgical resection will enroll to Cohort 2 and will be randomized into one of two treatment groups (2A-2B).
Group 2A: IV ASP8374 plus cemiplimab within 14± 5 days prior to surgery at the MTD/RP2D established in Cohort 1.
Group 2B: No immune checkpoint therapy prior to surgery.
Post-operatively, all Cohort 2 participants will receive ASP8374 plus cemiplimab every 3 weeks administered at the MTD/RP2D established by Cohort 1
Group II: ASP8374 and Cemiplimab-Cohort 1Experimental Treatment2 Interventions
A 3+3 dose escalation design will be used to determine maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of ASP8374 when combined with cemiplimab.
Participants will receive ASP8374 and Cemiplimab every 3 weeks for up to 2 years. ASP8374 will be available until October 31, 2022. Subjects may continue treatment with cemiplimab alone after that date.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ASP8374
2017
Completed Phase 1
~180
cemiplimab
2016
Completed Phase 2
~570
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,934 Total Patients Enrolled
23 Trials studying Glioblastoma
1,012 Patients Enrolled for Glioblastoma
Regeneron PharmaceuticalsIndustry Sponsor
616 Previous Clinical Trials
379,831 Total Patients Enrolled
Astellas Pharma IncIndustry Sponsor
691 Previous Clinical Trials
232,200 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am using or willing to use effective birth control during and for 4 months after the study.You are willing and able to read and sign a form that says you agree to participate in the trial.My condition has worsened for the first or second time after improving.You are currently or planning to participate in a study that involves testing a new drug or medical device.I have an active tuberculosis infection.I have been diagnosed with an immune system disorder.I have received radiotherapy as my first treatment.My tumor is mainly in my brainstem or spinal cord.Your MRI or CT scan shows clear signs that your tumor is growing.I haven't had significant bleeding or blood clotting issues in the last year.I have had targeted radiation therapy for my condition.My cancer has returned once or twice after initial treatment.It's been over 3 weeks since my last surgery or 1 week since my biopsy.My brain tumor is confirmed to be a high-grade glioma or has progressed from a low-grade glioma to GBM.I have another cancer that needed treatment in the last 2 years.I am 18 years old or older.I am able to care for myself but may not be able to do active work.I don't have any health issues that could affect the trial's results or my participation.I am currently on medication for an infection.I haven't had severe bleeding in the last 6 months.I am not pregnant.My organs are functioning well.I have recovered from major side effects of my previous treatments.I had a CT or MRI with contrast within the last 14 days.I am scheduled for a surgery that my doctor says I need.I have a confirmed case of non-infectious lung inflammation.I have been diagnosed with HIV.I need to take a moderate or high dose of steroids within a week of signing up.It's been over 12 weeks since I finished radiation therapy, or my cancer has gotten worse since then.Enough time has passed since my last cancer treatment.You are allergic to any of the study medications.My brain tumor is confirmed to be a high-grade glioma.My recent tests show my organs are functioning well.I have not received a live vaccine in the last 30 days.I have not needed treatment for an autoimmune disease in the last 2 years.I have been treated with drugs targeting VEGF or VEGFR.My cancer has spread to the lining of my brain or other parts of my body.I have not taken drugs to suppress my immune system in the last 6 months.I have an active Hepatitis B or C infection.I have been treated with the drug idelalisib before.I am 18 years old or older.I am mostly able to care for myself and carry out daily activities.Your organs must be functioning properly, and your blood work must show normal values.I have been treated with specific immune-targeting drugs before.I'm sorry, this criterion is incomplete. Can you please provide more information or context?I have received radiotherapy as my first treatment.
Research Study Groups:
This trial has the following groups:- Group 1: ASP8374 and Cemiplimab-Cohort 1
- Group 2: ASP8374 and Cemiplimab-Cohort 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Food and Drug Administration given cemiplimab their stamp of approval?
"As cemiplimab is a Phase 1 trial, with only minimal evidence of safety and efficacy, it was given an evaluation score of 1."
Answered by AI
In how many separate sites has this clinical trial been organized?
"This trial is running out of Brigham and Women's Hospital in Boston, Massachusetts, the Hospital of University Pennsylvania and Abramson Cancer Center Philadelphia (both located in Pennsylvania) as well as the University of Cincinnati Medical Centre from Ohio plus 4 other sites."
Answered by AI
Are there still openings for this research program?
"The information from clinicaltrials.gov suggests that this medical trial is not presently recruiting participants, as the last update was on September 22nd 2022. However, there are 1666 other trials actively searching for patients at present."
Answered by AI
How many participants have joined the research thus far?
"Unfortunately, this trial is not taking on new patients at the present time. It was first posted to clinicaltrials.gov on March 9th 2022 and last updated September 22nd of the same year. However, there are 1610 other trials recruiting for glioblastoma and 56 studies involving cemiplimab that are currently enrolling participants."
Answered by AI
What medical conditions is cemiplimab commonly employed to address?
"Cemiplimab is a viable therapeutic approach for patients afflicted with an ALK gene mutation, who have set in place advanced directives, and those suffering from dangerous neoplasms."
Answered by AI
To what extent has cemiplimab been tested in clinical trials prior to this one?
"cemiplimab's clinical research first began at City of Hope in 2010, with 8 completed studies since then. At the moment, over 50 medical centres are running active trials; many of these being located in Boston, MA."
Answered by AI
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