Glioblastoma MultiformePhase 1NCT05083754
Carmustine Wafer in Combination With Retifanlimab and Radiation With/Without Temozolomide in Subjects With Glioblastoma
A Phase 1 study testing Retifanlimab, Temozolomide and Radiation Therapy in people with Glioblastoma Multiforme, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
The purpose of the study is to evaluate the safety and survival of carmustine wafers and radiation and retifanlimab with or without temozolomide (TMZ) in newly-diagnosed adult subjects with glioblastoma multiform after carmustine wafer placement. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- Retifanlimab, Temozolomide and Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2022to Jan 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly-diagnosed adults with WHO (World Health Organization) Grade IV Glioblastoma or gliosarcoma based on histopathological or molecular criteria who had carmustine wafers placed at resection
- No prior treatment for GBM other than surgical resection and carmustine wafer placement (Patients who had a biopsy prior to resection are allowed)
- Post-operative MRI or CT scan within 72 hours (preferably 24 hours) of surgical resection
- Substantial recovery from surgical resection
- On a stable or decreasing dose of steroids
- Karnofsky Performance Status of ≥ 60
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- Clinically appropriate for concomitant temozolomide plus radiation therapy (RT) based on institutional guidelines
- Age ≥18 years
- Ensure that pregnant or lactating females are not enrolled and that contraceptive requirements are in accordance with applicable and recent requirements.
- Men must agree to take appropriate precautions to avoid fathering children (with at least 99% certainty) from screening through 180 days after the last dose of retifanlimab
- Must have normal organ and marrow function on routine laboratory tests
- Ability to understand and the willingness to sign a written informed consent document
- Subjects must be willing and able to comply with scheduled visits, treatment schedule, study procedures, and other requirements of the study
Who cannot join
- Recurrent glioblastoma (GBM) or progression of lower grade tumor
- Central nervous system (CNS) hemorrhage of Grade > 1 on baseline MRI scan, unless subsequently documented to have resolved
- Any known metastatic extracranial or leptomeningeal disease
- Intent to use other anti-neoplastic medications/treatments including the Optune® device
- Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
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- Active, known or suspected autoimmune disease, with the following exceptions: Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis or alopecia) not requiring systemic treatment (subjects with a history of flares requiring systemic treatment are excluded), or other autoimmune conditions not expected to recur in the absence of an external trigger are permitted to enroll
- Subjects with history of life-threatening toxicity, including hypersensitivity reaction, related to prior immunoglobulin treatment for another condition (except those considered unlikely to re-occur, with written approval of study PI) or any other study drug component
- History or evidence upon physical/neurological examination of other central nervous system condition (e.g., seizures, abscess) unrelated to cancer, unless adequately controlled by medication or considered not potentially interfering with protocol treatment
- Surgical procedure < 7 days prior to study treatment (No restriction for insertion of a central venous access device)
- Unable to swallow oral medication or any gastrointestinal disease or surgical procedure that may seriously impact the absorption of temozolomide
- Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, totally excised melanoma of stage IIA or lower, low or intermediate-grade localized prostate cancer (Gleason score ≤ 7), and curatively-treated carcinoma in situ of the cervix, breast, or bladder.
- Known history of any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection, and/or detectable virus
- Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- Evidence of interstitial lung disease, history of interstitial lung disease, or active, noninfectious pneumonitis.
- Palliative radiation therapy administered within 1 week of first dose of study treatment or radiation therapy in the thoracic region that is > 30 Gy within 6 months of the first dose of study treatment. Note: Participants must have recovered from all radiation-related toxicities (to Grade >1 or baseline), not require corticosteroids for this purpose, and not have had radiation pneumonitis.
- Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline (with the exception of any grade of alopecia and anemia not requiring transfusion support).
- Participants with specified abnormal laboratory values at screening
- Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (> 10 mg/day of prednisone or equivalent).
- Physiologic corticosteroid replacement therapy at doses ≤ 10 mg/day of prednisone or equivalent for adrenal or pituitary insufficiency and in the absence of active autoimmune disease is permitted.
- Participants with asthma that requires intermittent use of bronchodilators, inhaled steroids, or local steroid injections may participate.
- Participants using topical, ocular, intra-articular, or intranasal steroids (with minimal systemic absorption) may participate.
- Brief courses of corticosteroids for prophylaxis (e.g., contrast dye allergy) or study treatment-related standard premedication is permitted.
- Has an active infection requiring systemic antibiotics or antifungal treatment
- History of organ transplant, including allogeneic stem cell transplantation
- Known allergy or hypersensitivity to any component of retifanlimab or formulation components
- Has received a live vaccine within 28 days of the planned start of study drug (Note: Examples of live vaccines include but are not limited to measles, mumps, rubella, chicken pox/zoster, yellow fever, rabies, Bacillus of Calmette and Guerin (BCG), and typhoid vaccine. Inactivated seasonal influenza vaccines and COVID-19 vaccine(s) are permitted and do not require a 4-week waiting period before starting study treatment; however, intranasal influenza vaccines are live attenuated vaccines and are not allowed.)
- Patients who are taking Probiotic dietary supplements
- Patients with uncontrolled intercurrent illness
- Patients with psychiatric illness/social situations (e.g. prisoners/involuntarily incarcerated individuals) that would limit compliance with study requirements
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Medical Institution
Baltimore, Maryland, 21287
Lawrence Kleinberg, MD, 410-614-2597, kleinla@jhmi.edu
Stella Krawiec, MA, 410-502-1962, skrawie1@jhmi.edu
About this study
Official title: A Randomized, Open-label Pilot Trial to Evaluate the Safety and Efficacy of Carmustine Wafer in Combination With Retifanlimab and Standard Radiation With or Without Temozolomide in Newly-Diagnosed Adult Subjects With Glioblastoma
The purpose of the study is to evaluate the safety and survival of carmustine wafers and radiation and retifanlimab with or without temozolomide (TMZ) in newly-diagnosed adult subjects with glioblastoma multiform after carmustine wafer placement.
- Conditions
- Glioblastoma Multiforme
- Being tested
- Retifanlimab, Temozolomide, Radiation Therapy
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RetifanlimabDrug
Also called INCMGA00012
Anti-PD-1 Therapy
TemozolomideDrug
Anti-PD-1 Therapy
Radiation TherapyRadiation
Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| Arm A- Retifanlimab and Radiation Therapy | Experimental | Participants will receive Retifanlimab and Radiation Therapy. Receives: Drug: Retifanlimab; Radiation: Radiation Therapy |
| Arm B- Retifanlimab, Radiation Therapy and Temozolomide | Experimental | Participants will receive Retifanlimab, Radiation Therapy and Temozolomide. Receives: Drug: Retifanlimab; Drug: Temozolomide; Radiation: Radiation Therapy |
| Arm C- Radiation Therapy and Temozolomide | Other | Participants will receive Radiation Therapy and Temozolomide which is the Standard of Care. Receives: Drug: Temozolomide; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of combination retifanlimab and radiation with and without temozolomide as assessed by number of participants who experience adverse events
Number of participants who experience grade 1 or higher adverse events, as defined by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).
Measured: Up to 2 years
Feasibility of combination retifanlimab and radiation with and without temozolomide as assessed by number of participants who experience adverse events
Number of participants who experience grade 1 or higher adverse events, as defined by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).
Measured: Up to 2 years
Maximum Tolerated Dose (MTD) as determined by number of participants with dose limiting toxicities (DLT)
Maximum tolerated dose will be determined by the maximum dose at which the least number of participants experience dose-limiting toxicity. The dose limiting toxicity is defined using the Common Terminology Criteria for Adverse Events (CTCAE).
Measured: Up to 2 years
Secondary outcomes (4)
Safety as assessed by number of treatment-emergent adverse events in patients on combination refitanlimab and standard of care (SOC) with newly diagnosed glioblastoma after treatment with carmustine wafers
Number of participants who experience grade 1 or higher adverse events, as defined by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)
Measured: Up to 2 years
Progression Free Survival
Proportion of participants who achieve progression free survival who are treated with retifanlimab with or without temozolomide after carmustine placement
Measured: Up to 2 years
Overall Response Rate
Proportion of participants with measurable disease at baseline and have been re-evaluated after at least 1 cycle of therapy with observed reduction in tumor burden as defined by RECIST (Response evaluation criteria in solid tumors) and iRECIST criteria after 2 doses of nivolumab and ipilimumab.
Measured: Upt to 2 years
Overall Survival
Proportion of participants who achieve survival with methylated or unmethylated methylguanine-DNA-methyltransferase (MGMT)
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start31 Aug 2022
- Primary completionJan 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Incyte Corporation
- Responsible party
- Sponsor
- Investigators
- Lawrence Kleinberg, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05083754
- Sponsor's protocol ID
- J21103
- Other IDs
- IRB00291102
- Status last verified
- Jan 2026
- First submitted
- 6 Oct 2021
- Last updated
- 9 Jan 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label Pilot Trial to Evaluate the Safety and Efficacy of Carmustine Wafer in Combination With Retifanlimab and Standard Radiation With or Without Temozolomide in Newly-Diagnosed Adult Subjects With Glioblastoma
- ClinicalTrials.gov ID
- NCT05083754
- Acronym / sponsor ID
- J21103
- Conditions
- Glioblastoma Multiforme
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Incyte Corporation
- Study start
- 31 Aug 2022 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 19 Oct 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.
The purpose of the study is to evaluate the safety and survival of carmustine wafers and radiation and retifanlimab with or without temozolomide (TMZ) in newly-diagnosed adult subjects with glioblastoma multiform after carmustine wafer placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A- Retifanlimab and Radiation Therapy | Experimental | Drug: Retifanlimab, Radiation: Radiation TherapyParticipants will receive Retifanlimab and Radiation Therapy. |
| Arm B- Retifanlimab, Radiation Therapy and Temozolomide | Experimental | Drug: Retifanlimab, Drug: Temozolomide, Radiation: Radiation TherapyParticipants will receive Retifanlimab, Radiation Therapy and Temozolomide. |
| Arm C- Radiation Therapy and Temozolomide | Other | Drug: Temozolomide, Radiation: Radiation TherapyParticipants will receive Radiation Therapy and Temozolomide which is the Standard of Care. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Newly-diagnosed adults with WHO (World Health Organization) Grade IV Glioblastoma or gliosarcoma based on histopathological or molecular criteria who had carmustine wafers placed at resection
- No prior treatment for GBM other than surgical resection and carmustine wafer placement (Patients who had a biopsy prior to resection are allowed)
- Post-operative MRI or CT scan within 72 hours (preferably 24 hours) of surgical resection
- Substantial recovery from surgical resection
- On a stable or decreasing dose of steroids
Key exclusion criteria (30 listed)
- Recurrent glioblastoma (GBM) or progression of lower grade tumor
- Central nervous system (CNS) hemorrhage of Grade > 1 on baseline MRI scan, unless subsequently documented to have resolved
- Any known metastatic extracranial or leptomeningeal disease
- Intent to use other anti-neoplastic medications/treatments including the Optune® device
- Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results
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 |
|---|---|---|
| RetifanlimabAlso: INCMGA00012Anti-PD-1 Therapy | Drug | Arm A- Retifanlimab and Radiation Therapy, Arm B- Retifanlimab, Radiation Therapy and Temozolomide |
| TemozolomideAnti-PD-1 Therapy | Drug | Arm B- Retifanlimab, Radiation Therapy and Temozolomide, Arm C- Radiation Therapy and Temozolomide |
| Radiation TherapyStandard of Care | Radiation | Arm A- Retifanlimab and Radiation Therapy, Arm B- Retifanlimab, Radiation Therapy and Temozolomide, Arm C- Radiation Therapy and Temozolomide |
Primary outcome
Safety of combination retifanlimab and radiation with and without temozolomide as assessed by number of participants who experience adverse events
Time frame: Up to 2 years
Number of participants who experience grade 1 or higher adverse events, as defined by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).
Feasibility of combination retifanlimab and radiation with and without temozolomide as assessed by number of participants who experience adverse events
Time frame: Up to 2 years
Number of participants who experience grade 1 or higher adverse events, as defined by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).
Maximum Tolerated Dose (MTD) as determined by number of participants with dose limiting toxicities (DLT)
Time frame: Up to 2 years
Maximum tolerated dose will be determined by the maximum dose at which the least number of participants experience dose-limiting toxicity. The dose limiting toxicity is defined using the Common Terminology Criteria for Adverse Events (CTCAE).
4 secondary outcomes
Safety as assessed by number of treatment-emergent adverse events in patients on combination refitanlimab and standard of care (SOC) with newly diagnosed glioblastoma after treatment with carmustine wafers
Time frame: Up to 2 years
Progression Free Survival
Time frame: Up to 2 years
Overall Response Rate
Time frame: Upt to 2 years
Overall Survival
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
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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.
Lawrence Kleinberg, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Retifanlimab, Temozolomide and Radiation Therapy in people with Glioblastoma Multiforme, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site 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 13 inclusion and 30 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: looking for participants now, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lawrence Kleinberg, MD (410-614-2597, kleinla@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of combination retifanlimab and radiation with and without temozolomide as assessed by number of participants who experience adverse events (time frame: Up to 2 years). The study lists 3 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 9 Jan 2026.