๐ฌIn plain words
What the trial is, and whether it could suit you
The goal of this study is to evaluate the safety of the experimental drug, CUE-102, and establish the recommended dose of CUE-102 for participants with Recurrent Glioblastoma (GBM).
The name of the study drug involved in this study is:
-CUE-102 (a type of fusion protein)
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* Have HLA-A\*0201 genotype as determined by genomic testing performed locally;
* Have histologically confirmed World Health Organization (WHO) Grade 4 glioblastoma, other WHO grade 4 malignant glioma or molecular GBM (based on the 2021 WHO Classification) at first recurrence. Patients with gliosarcoma are NOT eligible;
* Be willing and able to provide written informed consent/assent for the trial;
* Be โฅ 18 years of age on day of signing informed consent;
* Have a Karnofsky performance status (KPS) โฅ 70 (Appendix A);
* Participants must be at least 4 weeks from start of last chemotherapy cycle (at least 6 weeks for nitrosoureas and at least 1 week for metronomic dosing) and at least 4 weeks or 5 half-lives (whichever is shorter) for any prior investigational agent. There is no minimal time from cessation of Optune TTF nor for prior cancer vaccine therapy.
* MRI within 14 days prior to registration. MRIs should include vascular imaging when possible. Corticosteroid dose must be stable or decreasing for at least 5 days prior to the scan. If steroids are added or the steroid dose is increased between the date of the screening MRI scan and the start of treatment, a new baseline MRI or CT is required;
* Patients must have fully completed initial radiation therapy with or without daily temozolomide including 60 Gy in 30 fractions, 59.4 Gy in 1.8 Gy per fraction or equivalent;
* At least 12 weeks from completion of radiotherapy +/- temozolomide. Patients \< 12 weeks from the completion of radiation therapy may be eligible if they have either of the following: 1) histopathologic confirmation of recurrent tumor; or 2) new contrast enhancing disease outside the primary radiation field. Participants who have received investigational therapies as a component of treatment for newly diagnosed GBM as long as remaining eligibility criteria are satisfied;
* Participants must have recovered to grade 0 or 1 or pre-treatment baseline from clinically significant toxic effects of prior therapy (exceptions include alopecia, laboratory values listed per inclusion criteria, and lymphopenia, which is common after therapy with temozolomide);
* Participants must meet the following organ and marrow function as defined below, all screening labs should be performed within 14 days of registration:
* Absolute neutrophil count (ANC) โฅ1,500 /mcL
* Platelets โฅ100,000 / mcL
* Hemoglobin โฅ9 g/dL or โฅ5.6 mmol/L (Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks)
* Serum creatinine โค 1.5 X institutional ULN OR
* Measured or calculated creatinine clearance (CrCl) โฅ45 mL/min for participant with creatinine levels \> 1.5 X institutional ULN (CrCl should be calculated per institutional standard, GFR can also be used in place of creatinine or CrCl)
* Serum total bilirubin โค 1.5 X institutional ULN OR
* Direct bilirubin โค institutional ULN for participants with total bilirubin levels \> 1.5 X institutional ULN
* AST (SGOT) and ALT (SGPT) โค 3.0 X institutional ULN OR โค 5 X institutional ULN for participants with Gilberts syndrome
* International Normalized Ratio (INR) OR Prothrombin Time (PT) and Activated Partial Thromboplastin Time (aPTT) โค1.5 X institutional ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants
* Resting baseline oxygen saturation by pulse oximetry โฅ92% at rest
* Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must have a negative urine or serum pregnancy within 72 hours prior to enrollment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required;
--Women in the following categories are not considered WOCBP:
* Premenarchal
* Premenopausal female with 1 of the following:
* Documented hysterectomy
* Documented bilateral salpingectomy
* Documented bilateral oophorectomy
* Note: Documentation can come from the site personnel's review of the participant's medical records, medical examination, or medical history interview.
* Postmenopausal female
* A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
-----A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy (HRT). However, in the absence of 12 months of amenorrhea, confirmation with two FSH measurements in the postmenopausal range is required.
* Females on HRT and whose menopausal status is in doubt will be required to use one of the non-hormonal highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status before study enrollment.
* Women of child-bearing potential (WOCBP; see definition above), must agree to use a highly effective method of contraception consistently and correctly as described below during study treatment and for 120 days after study treatment discontinuation or the initiation of other cancer therapy (whichever is shorter);
* Highly Effective Contraceptive Methods That Are User Dependent a (Failure rate of \< 1% per year when used consistently and correctly.)
* Combined (estrogen- and progestogen- containing) hormonal contraception
* i. Oral
* ii. Intravaginal
* iii. Transdermal
* iv. Injectable
* Progestogen-only hormonal contraception
* v. Oral
* vi. Injectable
* Highly Effective Methods That Have Low User Dependency (Failure rate of \<1% per year when used consistently and correctly)
* Progestogen- only contraceptive implant
* Intrauterine hormone-releasing system (IUS) Intrauterine device (IUD)
* Bilateral tubal occlusion
* Vasectomized partner