GlioblastomaPhase 1NCT04826393
ASP8374 + Cemiplimab in Recurrent Glioma
A Phase 1 study testing ASP8374 and cemiplimab in people with Glioblastoma and Recurrent Glioblastoma, run by Dana-Farber Cancer Institute at 4 sites in United States.
Trial summary
This study is looking at the safety and efficacy of the drug combination of ASP8374 with cemiplimab in people with recurrent malignant glioma. The study will be conducted in two parts, the first portion of the study will be to establish the highest dose of ASP8374 that can be given safely with cemiplimab and will be… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Recurrent Glioblastoma
- What is being tested?
- ASP8374 and cemiplimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 4 sitesUnited States
- Study dates
- 9 Mar 2022to 1 Jan 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Be willing and able to provide written informed consent/assent for the trial.
- Be ≥ 18 years of age on day of signing informed consent.
- Have a Karnofsky performance status (KPS) ≥ 70 (Appendix A).
- Previous first line therapy with at least radiotherapy.
- 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.
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- Participants must have shown unequivocal evidence for tumor progression by MRI or CT scan.
- 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
- Hematological Absolute neutrophil count (ANC) ≥1,500 /mcL Platelets ≥100,000 / mcL Hemoglobin ≥9 g/dL or ≥5.6 mmol/L without transfusion or EPO dependency (within 7 days of assessment)
- Renal Serum creatinine OR measured or calculated a creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 X institutional upper limit of normal (ULN) OR
- ≥60 mL/min for participant with creatinine levels > 1.5 X institutional ULN a Creatinine clearance should be calculated per institutional standard.
- Hepatic Serum total bilirubin ≤ 1.5 X institutional ULN OR Direct bilirubin ≤ institutional ULN for participants with total bilirubin levels > 1.5 institutional ULN AST (SGOT) and ALT (SGPT) ≤ 2.5 X institutional ULN OR
- ≤ 5 X institutional ULN for participants with Gilberts syndrome Albumin >2.5 mg/dL
- Coagulation International Normalized Ratio (INR) or Prothrombin Time (PT) Activated Partial Thromboplastin Time (aPTT) ≤1.5 X institutional ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants ≤1.5 X institutional ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
- Contrast enhanced CT or MRI within 14 days prior to registration. NOTE: For Cohort 2 participants only: due to the fact that the screening MRI will not be used for response purposes, participants may be registered if the screening scan is >14 days from registration with prospective approval from Overall PI, Dr. David Reardon (for prospectively approved circumstances, an eligibility exception will not need to be filed).
- An interval of at least 3 weeks (to registration) between prior surgical resection or one week for stereotactic biopsy.
- An interval of at least 12 weeks from the completion of radiation therapy to registration unless there is unequivocal histologic confirmation of tumor progression or radiographic progression outside of the prior radiation field.
- Participants must have recovered to grade 0 or 1 or pre-treatment baseline from clinically significant toxic effects of prior therapy (exceptions include but not limited to alopecia, laboratory values not listed per inclusion criteria, and lymphopenia which is common after therapy with temozolomide).
- From start of study therapy, the following time periods must have elapsed:
- 5 half-lives from any small molecule investigational agent
- 4 weeks from cytotoxic therapy (except 23 days for temozolomide, 6 weeks from nitrosoureas, and 7 days from daily administered agents)
- 6 weeks from antibodies, or 4 weeks (or 5 half-lives, whichever is shorter) from other anti-tumor therapies
- No wash-out period required for prior TTF or vaccine therapies
- Participants must be planned to undergo surgery that is clinically indicated as determined by their care providers (Cohort 2 only).
- Female participant of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to registration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL and estradiol < 20 pg/mL or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment she considered not of child bearing potential.
- Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must use highly effective contraception during study treatment and for 120 days after study discontinuation. Highly effective contraception is defined as either:
- i. True Abstinence: When this is in line with the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- ii. Sterilization: Surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment (as described in item 12 above).
- iii. Male Partner Sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). For female participants on the study, the vasectomized male partner should be the sole partner for that participant.
- Use of a combination of any two of the following:
- Placement of an intrauterine device (IUD) or intrauterine system (IUS)
- Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository
- Appropriate hormonal contraceptives (including any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent - including oral, subcutaneous, intrauterine, or intramuscular agents)
- Male participants should agree to use adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of therapy.
Who cannot join
- Current or planned participation in a study of an investigational agent or using an investigational device.
- Has a diagnosis of immunodeficiency.
- Has tumor primarily localized to the brainstem or spinal cord.
- Has presence of diffuse leptomeningeal disease or extracranial disease.
- Has received systemic immunosuppressive treatments, aside from systemic corticosteroids as described in Section 3.2.7, (such as methotrexate, chloroquine, azathioprine, etc.) within six months of registration.
- Has received anti-VEGF or anti-VEGFR targeted agents (e.g. bevacizumab, cediranib, aflibercept, vandetanib, XL-184, sunitinib, etc.).
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- Requires treatment with moderate or high dose systemic corticosteroids defined as dexamethasone > 2 mg/day or bioequivalent for at least 3 consecutive days within 7 days of registration.
- Has received prior interstitial brachytherapy or stereotactic radiosurgery (Cohort 2 only).
- Has history of known coagulopathy that increases risk of bleeding or a history of clinically significant hemorrhage within 12 months of registration.
- Has a known history of active TB (Bacillus Tuberculosis).
- Has gastrointestinal bleeding or any other hemorrhage/bleeding event CTCAE Grade > 3 within 6 months of registration.
- Has a known additional malignancy that is progressing or requires active treatment within 2 years of registration. Exceptions include malignancies treated with surgery alone including but not limited to basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. See Section 5.4.3 for additional information on allowed corticosteroid dosing.
- Has confirmed history or any evidence of active non-infectious pneumonitis.
- Has an active infection requiring systemic therapy.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator. Examples include but are not limited to symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding or expecting to conceive within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment. It is unknown whether ASP8374 and/or cemiplimab is excreted in human milk or may have adverse effects on a fetus in utero. Since many drugs are excreted in human milk, and because of the potential for serious adverse reactions in the nursing infant or fetus, these participants are not eligible for enrollment.
- Has received prior therapy with an anti-TIGIT, anti-PD-1, anti-PD-L1, anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab), or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
- Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
- Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
- Has received a live vaccine within 30 days prior to registration.
- Has a known hypersensitivity to any of the study therapy products.
- Has been previously treated with the PI3K inhibitor idelalisib.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
Columbia University Medical Center
New York, New York, 10032
Hospital of the University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: Phase Ib Trial of ASP8374 and Cemiplimab in Recurrent Malignant Glioma Patients
This study is looking at the safety and efficacy of the drug combination of ASP8374 with cemiplimab in people with recurrent malignant glioma.
The study will be conducted in two parts, the first portion of the study will be to establish the highest dose of ASP8374 that can be given safely with cemiplimab and will be used as the recommended dose of ASP8374 in combination with cemiplimab for the second portion of the study. The second portion of the study will be to compare the effect of having ASP8374 in combination with cemiplimab prior to surgery.
The names of the study drugs involved in this study are:
- ASP8374
- Cemiplimab
Read the detailed description
This is a multicenter, randomized, open-label, phase Ib trial of ASP8374 plus cemiplimab among recurrent malignant glioma participants.
Initially, eligible participants will enroll to Cohort 1 which will determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of ASP8374 when combined with cemiplimab among recurrent malignant glioma participants using a 3+3 design.
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.
The U.S. Food and Drug Administration (FDA) has not approved ASP8374 as a treatment for any disease. The U.S. Food and Drug Administration (FDA) has not approved cemiplimab for recurrent malignant glioma but it has been approved for other uses.
The research study procedures include: screening for eligibility, then study treatment including evaluations and follow up visits. Participants will receive study treatment for up to two years and will be followed for their tumor's response, whether or not their disease gets worse, and for side effects.
It is expected that about 24 people will take part in this research study. At least 6 in cohort 1 and 18 in cohort 2.
Pharmaceutical company Astellas is supporting this research study by providing study funding and study drug, ASP8374 and Regeneron is supporting this research by providing study drug cemiplimab.
- Conditions
- Glioblastoma, Recurrent Glioblastoma
- Being tested
- ASP8374, cemiplimab
- Keywords
- Glioblastoma, Recurrent Glioblastoma, Glioma, Grade 3
- Medical subject headings
- Glioblastoma, Glioma, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP8374Drug
every 3 weeks by intravenous infusion
cemiplimabDrug
Also called Libtayo
intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| ASP8374 and Cemiplimab-Cohort 1 | Experimental | 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. Receives: Drug: ASP8374; Drug: cemiplimab |
| ASP8374 and Cemiplimab-Cohort 2 | Experimental | 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 Receives: Drug: ASP8374; Drug: cemiplimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maxium Tolerated Dose-MTD/ Phase 2 Recommend Dose-RP2D - Cohort 1
primary endpoint for Cohort 1 will be determination of the MTD/RP2D of ASP8374 when administered with cemiplimab among recurrent malignant glioma participants.
Measured: Enrollment up to 2 years
CD8+ TIL Tumor Density-Cohort 2
CD8+ TIL density from tumors obtained from participants randomized to the neoadjuvant study arm (2A) will be compared to tumor CD8+ TIL density obtained from control participants enrolled on Arm 2B who do not receive neoadjuvant therapy.
Measured: Enrollment up to 2 years
Secondary outcomes (3)
Rate of Adverse Events
Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: Enrollment up to 2 years
progression-free survival (PFS)
Assessed by Response Assessment in Neuro-Oncology (RANO)1 and Immunotherapy RANO (iRANO) guidelines.
Measured: 6 months
overall survival (OS).
Assessed by Response Assessment in Neuro-Oncology (RANO)1 and Immunotherapy RANO (iRANO) guidelines.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start9 Mar 2022
- Primary completion31 Oct 2022
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals, Astellas Pharma Inc
- Responsible party
- Principal investigator, David Reardon, MD, Dana-Farber Cancer Institute
- Investigators
- David A Reardon, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04826393
- Sponsor's protocol ID
- 21-054
- Status last verified
- Oct 2025
- First submitted
- 30 Mar 2021
- Last updated
- 22 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib Trial of ASP8374 and Cemiplimab in Recurrent Malignant Glioma Patients
- ClinicalTrials.gov ID
- NCT04826393
- Acronym / sponsor ID
- 21-054
- Conditions
- Glioblastoma, Recurrent Glioblastoma
- Keywords
- Glioblastoma, Recurrent Glioblastoma, Glioma, Grade 3
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals, Astellas Pharma Inc
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is looking at the safety and efficacy of the drug combination of ASP8374 with cemiplimab in people with recurrent malignant glioma.
The study will be conducted in two parts, the first portion of the study will be to establish the highest dose of ASP8374 that can be given safely with cemiplimab and will be used as the recommended dose of ASP8374 in combination with cemiplimab for the second portion of the study. The second portion of the study will be to compare the effect of having ASP8374 in combination with cemiplimab prior to surgery.
The names of the study drugs involved in this study are:
- ASP8374
- Cemiplimab
Detailed description
This is a multicenter, randomized, open-label, phase Ib trial of ASP8374 plus cemiplimab among recurrent malignant glioma participants.
Initially, eligible participants will enroll to Cohort 1 which will determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of ASP8374 when combined with cemiplimab among recurrent malignant glioma participants using a 3+3 design.
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.
The U.S. Food and Drug Administration (FDA) has not approved ASP8374 as a treatment for any disease. The U.S. Food and Drug Administration (FDA) has not approved cemiplimab for recurrent malignant glioma but it has been approved for other uses.
The research study procedures include: screening for eligibility, then study treatment including evaluations and follow up visits. Participants will receive study treatment for up to two years and will be followed for their tumor's response, whether or not their disease gets worse, and for side effects.
It is expected that about 24 people will take part in this research study. At least 6 in cohort 1 and 18 in cohort 2.
Pharmaceutical company Astellas is supporting this research study by providing study funding and study drug, ASP8374 and Regeneron is supporting this research by providing study drug cemiplimab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASP8374 and Cemiplimab-Cohort 1 | Experimental | Drug: ASP8374, Drug: cemiplimabA 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. |
| ASP8374 and Cemiplimab-Cohort 2 | Experimental | Drug: ASP8374, Drug: cemiplimabUpon 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (36 listed)
- 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.
- Be willing and able to provide written informed consent/assent for the trial.
- Be ≥ 18 years of age on day of signing informed consent.
- Have a Karnofsky performance status (KPS) ≥ 70 (Appendix A).
- Previous first line therapy with at least radiotherapy.
Key exclusion criteria (24 listed)
- Current or planned participation in a study of an investigational agent or using an investigational device.
- Has a diagnosis of immunodeficiency.
- Has tumor primarily localized to the brainstem or spinal cord.
- Has presence of diffuse leptomeningeal disease or extracranial disease.
- Has received systemic immunosuppressive treatments, aside from systemic corticosteroids as described in Section 3.2.7, (such as methotrexate, chloroquine, azathioprine, etc.) within six months of registration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASP8374every 3 weeks by intravenous infusion | Drug | ASP8374 and Cemiplimab-Cohort 1, ASP8374 and Cemiplimab-Cohort 2 |
| cemiplimabAlso: Libtayointravenous infusion | Drug | ASP8374 and Cemiplimab-Cohort 1, ASP8374 and Cemiplimab-Cohort 2 |
Primary outcome
Maxium Tolerated Dose-MTD/ Phase 2 Recommend Dose-RP2D - Cohort 1
Time frame: Enrollment up to 2 years
primary endpoint for Cohort 1 will be determination of the MTD/RP2D of ASP8374 when administered with cemiplimab among recurrent malignant glioma participants.
CD8+ TIL Tumor Density-Cohort 2
Time frame: Enrollment up to 2 years
CD8+ TIL density from tumors obtained from participants randomized to the neoadjuvant study arm (2A) will be compared to tumor CD8+ TIL density obtained from control participants enrolled on Arm 2B who do not receive neoadjuvant therapy.
3 secondary outcomes
Rate of Adverse Events
Time frame: Enrollment up to 2 years
progression-free survival (PFS)
Time frame: 6 months
overall survival (OS).
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2025.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David A Reardon, MD principal investigator
Dana-Farber Cancer Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ASP8374 and cemiplimab in people with Glioblastoma and Recurrent Glioblastoma, run by Dana-Farber Cancer Institute at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 36 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maxium Tolerated Dose-MTD/ Phase 2 Recommend Dose-RP2D - Cohort 1 (time frame: Enrollment up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2025.