Trial of Anti-Tim-3 in Combination With Anti-PD-1 and SRS in Recurrent GBM (NCT03961971) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Trial of Anti-Tim-3 in Combination With Anti-PD-1 and SRS in Recurrent GBM
United States16 participantsStarted 2020-02-18
Plain-language summary
This phase I trial studies the side effects of stereotactic radiosurgery with MBG453 and spartalizumab in treating patients with recurrent glioblastoma multiforme (GBM). Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor to more precisely target the cancer. Monoclonal antibodies, such as MBG453 and spartalizumab may interfere with the ability of tumor cells to grow and spread. Giving stereotactic radiosurgery together with immunotherapy may be a better treatment for GBM.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patients must provide written informed consent prior to any screening procedures.
✓. Age 18 years or older.
✓. Willing and able to comply with scheduled visits, treatment plan and laboratory tests
✓. Must have WHO Grade IV Glioblastoma or gliosarcoma based on histopathological OR molecular criteria
✓. Patients tumor target (GTV) should be ≤ 5 cm.
✓. a) Must have received first-line multimodal therapy with surgery (resection or biopsy) followed by radiation and Temozolomide (unless known MGMT promoter unmethylated) AND b) Must have completed at least 21 days of combination and Temozolomide therapy (unless known MGMT promoter unmethylated. . An interval of at least 12 weeks after the end of combination radiation therapy + Temozolomide is required unless there is: i.) Histopathologic confirmation of recurrent tumor, or ii) new enhancement on MRI outside of the radiotherapy treatment field. (\*NOTE: Patients treated with Optune device or who received Gliadel wafers placed during the first surgery are eligible.
✓. Must have no more than 2 recurrences of either GBM or gliosarcoma. Recurrence must be confirmed by diagnostic biopsy/surgery with local pathology review OR contrast-enhanced MRI measurable by RANO criteria. (\*NOTE: Patients diagnosed with WHO Grade III that undergo surgical resection and are found to have WHO Grade IV or gliosarcoma are considered eligible).
What they're measuring
1
Number of participants with serious adverse events (SAE) graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) version 5.0
Timeframe: Up to 12 weeks after first dose of study treatment
Trial details
NCT IDNCT03961971
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
✓. Prior gamma knife, stereotactic radiosurgery, or other focal high-dose radiotherapy is allowed but the subject must have either histopathologic confirmation of recurrent tumor, or new enhancement on MRI outside of the radiotherapy treatment field
Exclusion criteria
✕. History of other malignancy, unless the patient has been disease-free for at ≥5 years. Curatively treated basal or squamous cell carcinoma of the skin, totally excised melanoma of stage IIA or lower, low or intermediate-grade localized prostate cancer (Gleason sum ≤7), and curatively-treated carcinoma in situ of the cervix, breast, or bladder are allowed regardless.
✕. Any known metastatic extracranial or leptomeningeal disease.
✕. Evidence of acute intracranial / intra-tumoral hemorrhage
✕. History of organ or hematopoietic stem cell (HSC) transplant
✕. Receiving greater than 4 mg dexamethasone/day (or equivalent amount of an alternative corticosteroid) for a minimum of 5 days prior to screening visit. Subjects with an autoimmune condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study entry \*NOTE: Inhaled or topical steroids, and adrenal replacement steroid doses \> 10 mg daily prednisone or equivalent, are permitted in the absence of active autoimmune disease
✕. Prior treatment with immune-modulating therapy, other than steroids.
✕. Pregnant or nursing (lactating) women
✕. Known positive history of HIV, active Hepatitis B, and/or active Hepatitis C infection.