A Phase 1/2 interventional study of M032 and Pembrolizumab in Glioblastoma Multiforme, Anaplastic Astrocytoma and Gliosarcoma, sponsored by University of Alabama at Birmingham. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-22.
Sponsored by University of Alabama at Birmingham · Phase 1/2, Interventional, and Treatment
This Phase I (Cohort I and Cohort II) and Phase II trial is designed to confirm the safety and tolerability of Pembrolizumab when given in conjunction with M032, an Oncolytic Herpes Simplex Virus (oHSV) that expresses IL-12 and perform the Phase II portion using a Recommended Phase 2 Dose (RP2D) of M032 (provided by the Phase I) when given in conjunction with Pembrolizumab for recurrent malignant glioma (glioblastoma multiforme, anaplastic astrocytoma, or glio-sarcoma).
Phase I/Cohort I:
For the Phase I portion of this trial, patients whose malignant gliomas recur after undergoing initial surgical resection, standard of care radiotherapy (60Gy) and standard of care temozolomide chemotherapy and who are candidates for, and would bene-fit from, a surgical debulking. Patients whose tumors have unmethylated MGMT promoters who have completed radiation therapy will also be eligible, regardless of whether or not they received temozolomide, since some centers are not using temozolomide in these patients. M032 will initially be administered directly into the tumor bed at the time of craniotomy and immediately after resection of the tumor. Patients will be treated with a total dose of 1 x 106 pfu of M032 initially and then subsequently with each dose of Pembrolizumab. If one toxicity occurs at a given dose level, that cohort will be increased to six patients. If two or more toxicities occur at the 1 x 106 pfu dose level, then a new cohort will be enrolled at 1 x 105 pfu, using the same approach. If two or more toxicities occur at the 1 x 105 pfu dose level, then the Data Safety and Monitoring Board (DSMB) will be consulted to determine if a stopping rule should be invoked or consideration of dose de-escalation to 1 x 104 pfu be considered. The highest safe dose will be considered the starting dose for
Phase I/Cohort II. Details of initial dose administration of M032. Patients must be candidates for a resection of the enhancing portion of the recurrent tumor; they will undergo craniotomy, with additional burr holes as needed, and then stereotactic placement of up to 4 infusion catheters. Planned catheter tip locations will include: a) > 2.5 cm from a cortical surface; b) > 1 cm from an ependymal surface or the margin of the planned resection cavity; and c) if possible, > 0.5 cm from a sulcus. This will minimize loss of dose into the subarachnoid or intra-ventricular space during subsequent M032 inoculations.
Only after catheters have been successfully placed (with Rickham reservoirs used to cap off catheters and hold them in place for the remainder of surgery) will patients will then undergo resection of the enhancing portion of the tumor. Subsequent to the resection but prior to dural closure, M032 will be administered if no ventricular entry has occurred during the resection. M032 will be administered by by multiple free hand injections into the resected tumor bed, using approximately equal volumes at each site (6 ml total). Each inoculation will be administered \~1 cm apart and delivered into the resected tumor bed over 1 minute and at a 1 cm depth (28G, 1/2-inch needle fitted to a 1-cc tuberculin syringe), where possible. Injections will be placed with careful avoidance of penetration of the ventricular system or any significant vascular structures, and any of the already-placed catheters. Intraoperative ultrasound will be used as needed to define positions of structures or catheters to avoid. After each inoculation the needle will be left in place for up to two minutes before removal and, after removal, the entry site will be covered with hemostatic agent. Both of these measures should minimize reflux of inoculum back into the tumor cavity. Before closing the dura, a fifth catheter will be left in place and then anchored with a Rickham in the tumor resection cavity to allow later access for CSF collection. This Rickham will not be used for M032 administration. The surgical procedure will then be completed in standard fashion. If ventricular entry has occurred during surgery, no M032 will be administered intraoperatively. Instead, a post-operative CT scan will be obtained on Day 1, and the initial M032 dose will be administered as outlined below, using all catheters felt to be appropriately positioned adjacent to the tumor cavity without violating the constraints of the exclusion criteria.
Pembrolizumab treatment and subsequent treatments of M032. Starting at week four, patients will undergo treatment on the same day, and every three weeks thereafter, with intra-venous infusion of 200mg of Pembrolizumab (for dosing detail, see Section 5.2.1). A total of 3 combined doses of Pembrolizumab and M032 will be given. Patients will then undergo treatment with inoculation of the calculated total dose of M032 as follows: each total dose (1 x 105 pfu for dose level one, 1 x 106 pfu for dose level two) directly into the remaining tumor bed at the time of craniotomy and immediately after resection for a particular dose level will be divided into up to four aliquots depending on the number of catheters available for inoculation. Each aliquot will be 1ml in total volume, consisting of 0.5 ml of M032 and will be infused over two minutes after puncture of each individual reservoir with a 22-24 g needle (using sterile techniques, after sterile preparation of the overlying scalp), followed by 0.5 ml of preservative free saline.
Determination of the suitability of each reservoir/catheter for inoculation will be made by the PI before each dosing and will include known patency status of each catheter, location of catheter tip and degree of adherence to the placement guidelines described above; 3) concerns for associated neurotoxicity related to M032 and/or inflammation in area of a particular reservoir/catheter tip; and 4) availability of other catheters for inoculation. Catheters whose reservoir(s) are closely associated with overlying scalp infections/inflammation will not be injected. Each catheter will be gently aspirated after the Rickham has been accessed but prior to M032 inoculation; catheters from which CSF can be aspirated will not be inoculated to avoid inoculation into the CSF space. The MRI obtained immediately prior to assessment (see schedule, below) will be used to help inform the decision-making above. If there is any question regarding reservoir/catheter suitability, an additional CT or MRI may be obtained prior to inoculation at the PI's discretion.
Combined Pembrolizumab and M032 treatments at each dose level will be repeated at three-week intervals for up to three cycles total, or until unacceptable toxicity or tumor progression occurs. Patients who are responding to treatment may be considered for additional dosing after the trial period has been completed.
The first two patients treated will not require any waiting period between enrollments. If one of the two should develop a toxicity, the third and subsequent (up to six) patients at that level will not be enrolled until seven weeks from the initial dose of M032 and three weeks from the first combined dose of Pembrolizumab and M032 has transpired for the initial two patients and every patient thereafter, to allow adequate duration of time for development of potential dose limiting toxicities in each treated patient before treating the next patient at that level.
Patients will undergo and then subsequently with each dose of Pembrolizumab; i If one toxicity occurs at a given dose level, that cohort will be increased to 6 patients. If 2 or more toxicities occur at the tested dose level, then with the approval of the DSMB, the dose will be de-escalated by one log and a new cohort enrolled with similar rules at the level. If 2 or more toxicities occur at the de-escalated dose level, then the DSMB will be consulted to determine if a stopping rule should be invoked or consideration of further dose de-escalation should be considered. The investigators anticipate as few as four patients (given two or more DLTs initially) and as many as 12 (only one DLT at each dose level). However, based on experience with M032 and Pembrolizumab, the investigators expect that this combination will not pro-duce any dose-limiting toxicities (DLTs).
Phase I/Cohort II: Having established for the safety and tolerability of M032 in conjunction with Pembrolizumab in patients with recurrent Malignant Glioma (MG), the trial will immediately transition into a Phase I Cohort II study of Pembrolizumab and M032 in patients with newly diagnosed MG. Patients who are previously untreated but suspected of having a high grade glioma by MRI and are eligible for craniotomy and resection will be offered participation in this two-Cohort trial. As in Phase I Cohort I, for the Phase I/Cohort II, consented subjects will have safe gross total resection, implantation of up to four Rickham catheters in the peritumoral brain and M032 injected into the wall of the resection cavity as described above.
Patients will be treated with a total dose of of M032 initially at the time of craniotomy as determined in Cohort I, above. They will then undergo treatment with standard fractionated radiation, and temozolomide as determined by treating physician. Starting at week four, patients will undergo treatment on the same day, and every three weeks thereafter, with intra-venous infusion of 200mg of Pembrolizumab (for dosing detail, see Section 5.2.1) and intratumoral M032 (via the Rickham-catheters placed at the periphery of the tumor cavity-the catheter left in the tumor cavity itself will not be used for M032 inoculation, but only to access CSF). Patients will then undergo treatment with inoculation of the calculated total dose of M032 for that dose level divided into up to four aliquots depending on the number of catheters available for inoculation. Each aliquot will be 1ml in total volume, consisting of 0.5 ml of M032 and will be infused over 2 minutes after puncture of each individual reservoir with a 22-24 g needle (using sterile techniques, after sterile preparation of the over-lying scalp).
Determination of the suitability of each reservoir/catheter for inoculation will be made by the PI before each dosing and will include known patency status of each catheter, location of catheter tip and degree of adherence to the placement guidelines described above; 3) concerns for associated neurotoxicity related to M032 and/or inflammation in area of a particular reservoir/catheter tip; and 4) availability of other catheters for inoculation. Catheters whose reservoir(s) are closely associated with overlying scalp infections/inflammation will not be injected. Each catheter will be gently aspirated after the Rickham has been accessed but prior to M032 inoculation; catheters from which CSF can be aspirated will not be inoculated to avoid inoculation into the CSF space. The MRI obtained immediately prior to assessment (see schedule, below) will be used to help inform the decision-making above. If there is any question regarding reservoir/catheter suitability, an additional CT or MRI may be obtained prior to inoculation at the PI's discretion.
Combined Pembrolizumab and M032 treatments at each dose level will be repeated at three-week intervals for up to three cycles total, or until unacceptable toxicity or tumor progression occurs. Patients who are responding to treatment may be considered for additional dosing after the trial period has been completed.
The first two patients treated will not require any waiting period between enrollments. If one of the two should develop a toxicity, the third and subsequent (up to six) patients at that level will not be enrolled until seven weeks from the initial dose of M032 and three weeks from the first combined dose of Pembrolizumab and M032 has transpired for the initial two patients and every patient thereafter, to allow adequate duration of time for development of potential dose limiting toxicities in each treated patient before treating the next patient at that level.
Patients will undergo and then subsequently with each dose of Pembrolizumab; i If one toxicity occurs at a given dose level, that cohort will be increased to 6 patients. If 2 or more toxicities occur at the tested dose level, then with the approval of the DSMB, the dose will be de-escalated by one log and a new cohort enrolled with similar rules at the level. If 2 or more toxicities occur at the deescalated dose level, then the DSMB will be consulted to determine if a stopping rule should be invoked or consideration of further dose de-escalation should be considered. The investigators anticipate as few as four patients (given two or more DLTs initially) and as many as 12 (only one DLT at each dose level). However, based on experience with M032 and Pembrolizumab, the investigators expect that this combination will not produce any dose-limiting toxicities (DLTs).
Phase II: Having established for the safety and tolerability of M032 in conjunction with Pembrolizumab in patients with newly-diagnosed MG, the trial will immediately transition into a Phase II study of Pembrolizumab and M032 in patients with newly diagnosed MG. Patients who are previously untreated but suspected of having a high grade glioma by MRI and are eligible for craniotomy and resection will be offered participation in this two-Cohort trial. Unlike the Phase I, patients will be eligible to receive Pembrolizumab and M032 every 3 weeks for up to one year. The Phase II design will employ the Simon two-stage optimal study design. It will be a single-arm open-label study of M032+ pembrolizumab and the primary endpoints of Over-all Survival at 12 months and 24 months, and Progression Free Survival rate at 6 months (PFS-6). In the first stage, 6 patients will be accrued. Data will be allowed to mature, and an interim analysis per-formed at that time. During this period, additional subjects may be accrued. If there are 2 or fewer responses in the initial 6 patients, further accrual to the study may be stopped. Otherwise, 10 additional patients will be accrued for a total of 16. The null hypothesis will be rejected if 11 or more responses are observed in 16 patients. This design yields a type I error rate of 0.05 and power of 80% when the PFS-6 is 75%. To allow for 25% unevaluable subjects, a maximum of 22 subjects will be enrolled.
2,132 studies on the registry are indexed under Glioblastoma; 464 are open to participants now.
This study's planned enrollment of 28 is below the median of 36 across 1,753 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Phase I/Cohort I: Participants are eligible to be included in the study only if all of the following criteria apply:
Patients must have or cytologically confirmed glioblastoma multiforme, anaplastic astrocytoma, or gliosarcoma, and is deemed a potential candidate for resection of the recurrent tumor.
Prior therapy: Patients must have failed external beam radio-therapy to the brain, and if eligible and tolerated, undergone appropriate treatment with temozolomide chemotherapy. All radiation and additional chemotherapies must have been completed at least 4 weeks prior to enrollment. Prior therapy with nitrosoureas must have been completed at least 6 weeks prior to enrollment.
Phase I/Cohort II or Phase II: Participants are eligible to be included in the study only if all of the following criteria apply:
Patient must have MRI findings consistent with probable malignant glioma, have no previous diagnosis of glioma, and have had either no history of any surgery for brain tumor. The exception to this requirement is that patients who have under-gone for diagnosis only and have not received any other treatment. All patients must be potential candidates for resection of the probably malignant glioma tumor.
Should a patient in Phase I/Cohort II or Phase II be found on final pathologic diagnosis to not have a glioblastoma multiforme, anaplastic astrocytoma, or gliosarcoma, he/she will receive no other doses of M032 other than that administered at the time of craniotomy, nor will he/she receive any doses of Pembrolizumab. He/she will be followed for evidence of toxicity of M032 only and will be considered off-study for all efficacy and other secondary endpoints.
All patients, whether in Phase I/Cohort II or Phase II shall also be required to meet the following eligibility and be subject to the exclusion criteria below:
Patients must have normal organ and marrow function as defined below:
Exclusion Criteria:
A Woman of Child Bearing Potential () who has a positive urine pregnancy test within 72 hours prior to allocation.(see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Has received prior therapy with an , anti-PD-L1, or antiPDL2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX40, CD137).
Has received prior systemic anti-cancer therapy including agents within 4 weeks prior to allocation.
Note: Participants must have recovered from all adverse events (AEs) due to previous thera-pies to ≤Grade 1 or baseline. Participants with ≤Grade 2 neuropathy may be eligible.
Note: If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.
Has received a within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
Is currently participating in or has participated in a study of an interventionally-directed investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent or if the agent is directed at analysis and not treatment (e.g., certain PET tracers, etc.).
Has a diagnosis of immunodeficiency or is receiving chronic systemic therapy (in dosing exceeding 2 mg daily of dexamethasone equivalent) or any other form of therapy within 7 days prior to the first dose of study drug.
Has a known additional that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
Has severe (≥Grade 3) to pembrolizumab and/or any of its .
Has active 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 (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pitu-tary insufficiency, etc.) is not considered a form of systemic treatment.
Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
Has an active infection requiring systemic therapy.
Has a known history of (HIV).
Has a known history of (defined as Hepatitis B surface anti-gen [HBsAg] reactive) or known active virus (defined as HCV RNA is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.
Has a known history of active Bacillus Tuberculosis (TB).
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
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 or father children within the projected duration of the study, starting with the screening vis-it through 120 days after the last dose of trial treatment.
Patients who have had chemotherapy, cytotoxic therapy, immunotherapy within 4 weeks prior to entering the study (6 weeks for nitrosoureas), surgical resection within 4 weeks prior to entering the study, or have received experimental viral therapy or gene therapy at any time (e.g., adenovirus, retrovirus or herpes virus protocol). However, this does not preclude re-treatment with M032 at a later date.
Patients who have not recovered from adverse events due to therapeutic interventions administered more than 4 weeks earlier.
History of allergic reactions attributed to compounds of similar biologic composition to M032 or to IL-12.
Tumor involvement which would require ventricular, brainstem, basal ganglia, or posterior fossa inoculation or would require access through a ventricle in order to deliver treatment.
History of encephalitis within the past 5 years, any history of multiple sclerosis or other CNS infection. Bacterial infections associated with previous cranial operations such as bone flap infections, cerebral abscesses, etc., that have been completely treated will not be exclusions for this trial
For Phase I, Cohort I: Required steroid increase within 2 weeks of scheduled M032 administration. All study candidates: When possible, the patient should be on a dexamethasone equivalent dose of ≤ 2mg daily at the time of treatment.
Active herpes lesion.
Concurrent therapy with any drug active against HSV (acyclovir, valacyclovir, penciclovir, famciclovir, ganciclovir, foscarnet, cidofovir).
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or any other medical condition that precludes surgery.
Patients with known history of allergic reaction to IV contrast material that is not amenable to pre-treatment by protocol.
Patients with pacemakers, ferro-magnetic aneurysm clips, metal infusion pumps, metal or shrapnel fragments or certain types of stents.
Receipt of Gliadel Therapy.
Receipt of Bevacizumab (Avastin) therapy within 4 weeks of scheduled M032 administration. (Receipt of Bevacizumab (Avastin) greater than 4 weeks of scheduled M032 administration does not exclude patient.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
To determine the safety and tolerability of M032 at the doses examined when given in combinations with pembrolizumab in patients with recurrent MG.
Drug: M032 · Drug: Pembrolizumab
To determine Overall Survival at 12 and 24 months, and Progression Free Survival at 6 months (PFS-6) in patients with newly diagnosed glioblastoma multiforme of M032 when given in combinations with pembrolizumab (while maintaining safety).
Drug: M032 · Drug: Pembrolizumab
Starting at week four, patients will undergo treatment on the same day, and every three weeks thereafter, with intravenous infusion of 200mg of Pembrolizumab . A total of 3 combined doses of Pembrolizumab and M032 will be given.
Starting at week four, patients will undergo treatment on the same day, and every three weeks thereafter, with intravenous infusion of 200mg of Pembrolizumab . A total of 3 combined doses of Pembrolizumab and M032 will be given.
Overall Survival at 12 and 24 months
Overall Survival at 12 and 24 months allows for a quantifiable outcome that should be straightforward to compare to historical data in this patient population.
Time frame: 12-24 months
Progression Free Survival at 6 months (PFS-6)
PFS-6 evaluates all treated patients at 6 months after baseline MRI and determines the percentage of patients who have not progressed by either imaging or neurologic evaluation. The iRA-NO criteria will be utilized to determine progression for this trial. PFS-6 will also be compared to historical controls for each cohort.
Time frame: 6 months
Overall Survival (OS)
OS will be determined for each cohort of patients and compared to historical controls for that cohort. .
Time frame: 3 years
Progression Free Survival (PFS)
PFS will be determined by MRI and neurologic evaluation using the iRANO criteria. PFS utilizes an historical approach to determining if progression has occurred and is helpful measure to compare this current study to historical studies. An important limitation in the assessment of PFS centers on the fact that patients may not get imaging or neurologic examinations done at an optimal or consistent time; as such, another approach, PFS-6, has been adopted in some studies. PFS-6 evaluates all treated patients at 6 months after baseline MRI and determines the percentage of patients who have not progressed by either imaging or neurologic evaluation. The iRANO criteria will be utilized to determine progression for this trial. PFS and OS will be compared to historical controls for each cohort.
Time frame: 3 years
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2022 (actual). Primary completion is estimated for Mar 2027, 60 months after the start.
Of 84 non-industry phase 1/2 interventional studies under Glioblastoma, half reached primary completion within 73 months of starting (the median), counting those still running; a quarter within 50 and three quarters within 102. This study's planned 60 months is below that.
Counting every sponsor, half of 137 studies reached it within 66 months; a quarter within 45 and three quarters within 100.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: IL-12-expressing HSV-1 NSC 733972
University of Alabama at Birmingham →