cemiplimab for Glioma

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Cincinnati Medical Center, Cincinnati, OH
Glioma+2 More
cemiplimab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Glioma

Study Summary

ASP8374 + Cemiplimab in Recurrent Glioma

See full description

Eligible Conditions

  • Glioma
  • Glioblastoma
  • Recurrent Glioblastoma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether cemiplimab will improve 2 primary outcomes and 3 secondary outcomes in patients with Glioma. Measurement will happen over the course of 6 months.

12 months
overall survival (OS).
6 months
progression-free survival (PFS)
Year 2
CD8+ TIL Tumor Density-Cohort 2
Maxium Tolerated Dose-MTD/ Phase 2 Recommend Dose-RP2D - Cohort 1
Rate of Adverse Events

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

No Control Group
ASP8374 and Cemiplimab-Cohort 2

This trial requires 24 total participants across 2 different treatment groups

This trial involves 2 different treatments. Cemiplimab is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

ASP8374 and Cemiplimab-Cohort 2Upon 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
ASP8374 and Cemiplimab-Cohort 1A 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

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: enrollment up to 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly enrollment up to 2 years for reporting.

Who is running the study

Principal Investigator
D. R.
David Reardon, MD
Dana-Farber Cancer Institute

Closest Location

University of Cincinnati Medical Center - Cincinnati, OH

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Glioma or one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Have histologically confirmed WHO grade IV GBM or its variants. Participants will be eligible if the original histology was low-grade glioma and a subsequent histological diagnosis of GBM is made. Participants with WHO grade III recurrent malignant glioma will be allowed to enroll to Cohort 1 only.
You are willing and able to provide written informed consent/assent for the trial. show original
Be ≥ 18 years of age on day of signing informed consent.
Have a KPS ≥ 70. show original
You have received radiotherapy for your cancer. show original
Be at first or second relapse. Note: Relapse is defined as progression following initial therapy (i.e., radiation ± chemotherapy). For participants who had prior therapy for a low-grade glioma, the surgical diagnosis of a high-grade glioma will be considered the first relapse.
Participants must have shown unequivocal evidence for tumor progression by MRI or CT scan. show original
Demonstrate adequate organ function as defined in Table 1, all screening labs should be performed within 14 days of registration.
Table 1: Adequate Organ Function Laboratory Values
System Laboratory Value

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is glioma?

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Gliomas are the most common form of [brain tumor](https://www.withpower.com/clinical-tri[als](https://www.withpower.com/clinical-trials/als)/brain-tumor) in adults. The peak incidence in adults is in the age 50-69 years, suggesting that the brain is more vulnerable to insult in the fourth decade or later in life. The average age of onset is 30.5 years, and most are benign. Treatment depends on the location and grade of the tumor. The survival rate for patients with low-grade tumors (II and III) is greater than 90%, but declines for patients with high-grade tumors (IV). The 5-year survival rate is 15% for patients classified as having glioma IV. The American Cancer Society also lists several rare cancers that can occur along with glioma.

Unverified Answer

What causes glioma?

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Recent findings indicates that there is an increased risk of gliomas in smokers compared with nonsmokers, which is a plausible explanation for the observation that up to one half of all cases of glioma occur in smokers. The increased risk may be caused by one or more carcinogens in cigarette smoke.

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What are the signs of glioma?

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Glioma may present itself in ways like headache, vomiting, drowsiness, loss of coordination, numbness, pain and dizziness. If the signs of glioma are present early, medical professionals should be alerted or the patient should be referred to a consultant and MRI should be started soon.

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How many people get glioma a year in the United States?

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Approximately 9,900 new cases of glioma were detected in the U.S. per year, an annual incidence of 4.2 cases per 10,000. The highest incidence of glioma occurred in persons under the age of 20, and persons over 60 at risk of this cancer were disproportionately represented among all races and ethnic groups.

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What are common treatments for glioma?

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Patients with glioma are likely to be treated with radiotherapy, and then chemotherapy. Radiotherapy may be used alone or along with chemotherapy. Chemotherapy may be used in conjunction with radiotherapy and can be used as monotherapy, but is most commonly combined with radiation. There are currently no drugs or combinations of drugs which cure glioblastoma, but treatment can prolong life and delay progression. There is no evidence that using one chemotherapy agent alters the response of the patient to the other. In terms of survival in the treatment of gliomas, there are significant differences between adults and children, which must be considered when establishing treatment algorithms.

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Can glioma be cured?

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Glioma, though frequently fatal, is curable (50-60%). If the diagnosis and treatment are prompt, the chances are better. In some instances, treatment failures have been cured by a second operation. Patients with glioma should be informed of the curable fraction, and their children are at highest risk of dying sooner. This is an important issue that should be explored further. It also raises the possibility of cure or improvement as a treatment modality.

Unverified Answer

What does cemiplimab usually treat?

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This retrospective study provides a glimpse at the spectrum, including the elderly patients and the female demographics, of patients treated with cemiplimab. These preliminary data suggest that in the cemiplimab-treated group, the median duration of PFS is 20.0 months. In the cemiplimab-treated group, overall survival was 4.2 months.

Unverified Answer

What is the primary cause of glioma?

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Because of our data analysis it is difficult to determine a single factor as the primary cause for glioma. For instance, our data suggests that increased frequency of cigarette cigarettes smoking (smoking is strongly associated with gliomas, P<0.001), high cumulative exposure of ionizing radiation (lack of exposure to any irradiation, no link, P=0.10), and family history of glioma (P = 0.015). These data are a reflection of our country’s demographic characteristics, but they support epidemiological studies performed in similar regions, where smoking, radiation, and family history are more common. We could conclude that any cancer incidence increases or decreases depending on environmental variations.

Unverified Answer

Is cemiplimab typically used in combination with any other treatments?

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Cemiplimab as a single therapy does not appear to be likely to significantly impact survival in the treatment of refractory GBM. The role of cemiplimab as a single agent is limited by its toxicity and in vivo efficacy is yet to be established. ClinicalTrials.gov number: NCT01824085. summary: This article describes the results of combining cemiplimab (NVP-BEZ235) with other treatments for treatment of patients with recurrent or refractory diffuse glioma.

Unverified Answer

Does glioma run in families?

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We did not find an increased occurrence in families with a family history of tumors in other systems, other than pancreatic and breast cancer, but the data in this paper is insufficient to define a clear cause or effect relationship and therefore is an open question. Further observations and studies are warranted to assess the hereditary nature of glioma susceptibility.

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How does cemiplimab work?

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This work is the first to show the pharmacodynamic effect of CTP in human tumors. Specifically we demonstrate the effect of CTP on tumor-infiltrating lymphocytes, the cytokine secretion profile and the induction of apoptosis in tumors, which suggests that CTP may target T cells with special relevance for malignant gliomas, as these tumors are infiltrated by T cells in various ways.

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Has cemiplimab proven to be more effective than a placebo?

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Cemiplimab as monotherapy may contribute to a significant number of tumor responses in pretreated patients with metastatic melanoma or advanced non-small-cell lung cancer in a study that included patients with mutant BRAF or IDH mutations.

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