Advanced GlioblastomaPhase 2/3NCT07605364
Testing the Addition of an Anti-Cancer Drug, Mycophenolate Mofetil, to the Usual Treatment (Radiation Therapy and Temozolomide) for Advanced Brain Cancer
A Phase 2/3 study testing Intensity-Modulated Radiation Therapy, Hypofractionated Radiation Therapy and Temozolomide (TMZ) in people with Advanced Glioblastoma, run by Alliance for Clinical Trials in Oncology.
Trial summary
This phase II/III trial tests how well adding mycophenolate mofetil, to the usual treatment with intensity-modulated radiation therapy and temozolomide works for the treatment of glioblastoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Glioblastoma
- What is being tested?
- Intensity-Modulated Radiation Therapy, Hypofractionated Radiation Therapy and Temozolomide (TMZ)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 422 participants
- Where
- No sites listed yet
- Study dates
- 10 Jun 2026to 5 Jan 2031
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed primary glioblastoma by World Health Organization (WHO) 2021 criteria
- No spinal cord glioblastoma
- No leptomeningeal disease
- No extracranial metastatic disease
- Patient is a candidate for first-line standard of care chemoradiation per treating physician(s)
- No prior treatment for glioblastoma other than resection (i.e. prior chemotherapy, radiation therapy, or other therapies such as laser ablation are not allowed)
Show all 36Show fewer
- Prior biopsy and/or resection of glioblastoma must be completed at least 14 days prior to registration with adequate wound healing
- Age ≥ 18 years
- Karnofsky performance status (KPS) ≥ 60
- Absolute neutrophil count (ANC) ≥ 1,500/mm^3
- Platelet count ≥ 100,000 cells/mm^3
- Hemoglobin (Hg) ≥ 9.0 g/dL
- Calculated (Calc.) creatinine clearance (CrCl) ≥ 25 mL/min
- Calculated using the Cockcroft-Gault equation
- Bilirubin ≤ 1.5 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3.0 x ULN
- Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects.
- Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 14 days prior to registration is required.
- Women and men of reproductive potential must agree to use a highly effective method of birth control throughout their participation in this study and for at least 6 weeks (women) or 90 days (men) after last dose of treatment. Reproductive status and discussions about birth control measures should be documented in the patient's record. Appropriate methods of birth control include, but are not limited to: abstinence, oral contraceptives, implantable hormonal contraceptives or double barrier method (diaphragm plus condom)
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
- HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
- No known history of allergic reaction or hypersensitivity to mycophenolate mofetil (MMF), mycophenolic acid (MPA), or any component of the drug product
- No known history of hypersensitivity reactions to temozolomide (TMZ) or other ingredients in TMZ
- No known medical condition causing an inability to swallow oral formulations of agents
- No active systemic or central nervous system (CNS) infection
- No grade 4 lymphopenia (if absolute lymphocyte count [ALC] < 0.5, then patient must be on prophylaxis for Pneumocystis jirovecii)
- No known history of organ transplantation
- No known hypoxanthine-guanine phosphoribosyl-transferase deficiency
- No known serious intercurrent illness that limits participation in the trial
- No known immunosuppressive condition from autoimmune disease, immune deficiency syndrome, or chronic immunosuppressive therapy
- Patient must be able to undergo MRI brain with and without contrast
- No known phenylketonuria
- No known medical contraindication for mycophenolate mofetil (MMF) per treating physician(s)
- Patients on steroids must be on stable or decreasing dose within 7 days of registration (no more than 8 mg dexamethasone/day or equivalent)
Who cannot join
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Mycophenolate Mofetil to Overcome Glioblastoma Resistance to Radiotherapy and Temozolomide
This phase II/III trial tests how well adding mycophenolate mofetil, to the usual treatment with intensity-modulated radiation therapy and temozolomide works for the treatment of glioblastoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Mycophenolate mofetil blocks enzyme activity which can disrupt tumor activity and may make the tumor more sensitive to radiation and/or temozolomide. Intensity modulated radiation therapy is a type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Temozolomide is a chemotherapy drug and in a class of medications called alkylating agents. It damages the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. Giving mycophenolate mofetil with intensity-modulated radiation therapy and temozolomide may be more effective than intensity-modulated radiation therapy and temozolomide alone for the treatment of advanced glioblastoma.
Read the detailed description
The primary and secondary objectives of the study:
PRIMARY OBJECTIVE:
- To compare the overall survival (OS) (phase III) and progression-free survival (PFS) (phase II) between the experimental arm (mycophenolate mofetil [MMF] + standard of care [SOC]) and the control arm (SOC).
SECONDARY OBJECTIVES:
- To compare the proportion of patients with an objective tumor response (ORR), measured with Response Assessment in Neuro-Oncology (RANO) 2.0 criteria, between the two treatment arms.
II. To determine the adverse event profiles for each arm (using the current latest version of Common Terminology Criteria for Adverse Events [CTCAE]).
III. To determine if there is an association between OS and PFS between treatment arms.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients under 70 years undergo intensity modulated radiation therapy (IMRT), Monday-Friday for 30 treatments and patients greater than or equal to 70 years undergo hypofractionated radiation therapy, Monday-Friday for 15 treatments in the absence of disease progression or unacceptable toxicity. Starting 24 hours prior to radiation, patients also receive temozolomide orally (PO) once daily (QD) until the day of the last radiation treatment, in the absence of disease progression or unacceptable toxicity. Patients then undergo a 4-week rest period. Patients then receive temozolomide PO QD on days 1-5 of each cycle. Cycles repeat every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo magnetic resonance imaging (MRI) and blood sample collection throughout the study.
ARM II: Patients under 70 years undergo IMRT, Monday-Friday for 30 treatments and patients greater than or equal to 70 years undergo hypofractionated radiation therapy, Monday-Friday for 15 treatments in the absence of disease progression or unacceptable toxicity. Starting 24 hours prior to radiation, patients also receive temozolomide PO QD until the day of the last radiation treatment, and, starting on the first day of radiation, patients also receive mycophenolate mofetil PO twice daily (BID) in the absence of disease progression or unacceptable toxicity. Patients then undergo a 4-week rest period. Patients then receive temozolomide PO QD on days 1-5 and mycophenolate mofetil PO BID on days 1-28 of each cycle. Cycles repeat every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo MRI and blood sample collection throughout the study.
After completion of study treatment, patients are followed up every 10 weeks until 2 years then every 6 months until 5 years.
- Conditions
- Advanced Glioblastoma
- Being tested
- Intensity-Modulated Radiation Therapy, Hypofractionated Radiation Therapy, Temozolomide (TMZ), Magnetic Resonance Imaging, Biospecimen Collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensity-Modulated Radiation TherapyRadiation
Also called IMRT
Undergo IMRT
Hypofractionated Radiation TherapyRadiation
Undergo hypofractionated radiation therapy
Temozolomide (TMZ)Drug
Given PO
Magnetic Resonance ImagingProcedure or surgery
Undergo MRI
Biospecimen CollectionProcedure or surgery
undergo Biospecimen Collection
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Arm I (radiation, temozolomide) | Experimental | Patients under 70 years undergo IMRT, Monday-Friday for 30 treatments and patients greater than or equal to 70 years undergo hypofractionated radiation therapy, Monday-Friday for 15 treatments in the absence of disease progression or unacceptable toxicity. Starting 24 hours prior to radiation, patients also receive temozolomide PO QD until the day of the last radiation treatment, in the absence of disease progression or unacceptable toxicity. Patients then undergo a 4-week rest period. Patients then receive temozolomide PO QD on days 1-5 of each cycle. Cycles repeat every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo MRI and blood sample collection throughout the study. Receives: Radiation: Intensity-Modulated Radiation Therapy; Radiation: Hypofractionated Radiation Therapy; Drug: Temozolomide (TMZ); Procedure: Magnetic Resonance Imaging; Procedure: Biospecimen Collection |
| Arm II (radiation, temozolomide, mycophenolate mofetil) | Experimental | Patients under 70 years undergo IMRT, Monday-Friday for 30 treatments and patients greater than or equal to 70 years undergo hypofractionated radiation therapy, Monday-Friday for 15 treatments in the absence of disease progression or unacceptable toxicity. Starting 24 hours prior to radiation, patients also receive temozolomide PO QD until the day of the last radiation treatment, and, starting on the first day of radiation, patients also receive mycophenolate mofetil PO twice daily (BID) in the absence of disease progression or unacceptable toxicity. Patients then undergo a 4-week rest period. Patients then receive temozolomide PO QD on days 1-5 and mycophenolate mofetil PO BID on days 1-28 of each cycle. Cycles repeat every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo MRI and blood sample collection throughout the study. Receives: Radiation: Intensity-Modulated Radiation Therapy; Drug: Temozolomide (TMZ); Procedure: Magnetic Resonance Imaging; Procedure: Biospecimen Collection; Drug: Mycophenolate Mofetil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS) (phase II)
PFS will be calculated from randomization until disease progression according to RANO 2.0 criteria or death due to any cause, censoring patients at their last disease evaluation. The Kaplan-Meier method will be used to estimate PFS for each arm and a stratified log-rank test will be used to compare distributions
Measured: From randomization to the disease progression according to Response Assessment in Neuro-Oncology (RANO) 2.0 criteria or death due to any cause, up to 5 years
Overall survival (OS) (phase III)
OS will be calculated from randomization until death due to any cause, censoring patients at their last disease evaluation. The Kaplan-Meier method will be used to estimate OS for each arm and a stratified log-rank test will be used to compare distributions.
Measured: From randomization until death due to any cause, up to 5 years
Secondary outcomes (4)
Tumor response
Defined as a complete response or partial response as determined using RANO 2.0.
Measured: Up to 5 years
Incidence of adverse events
Determined by the most recent version of Common terminology Criteria for Adverse Events.
Measured: Up to 5 years
Overall survival (OS)
Kaplan Meier methods will be used to estimate key aspects of the OS distributions for each of the treatment arms, and log rank tests will be used to compare these distributions between arms.
Measured: From randomization until death due to any cause, up to 5 years
Progression free survival (PFS)
Kaplan-Meier methods will be used to estimate key aspects of the PFS distributions for each of the treatment arms, and log-rank tests will be used to compare these distributions between arms.
Measured: From randomization to the disease progression according to RANO 2.0 criteria or death due to any cause, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start10 Jun 2026 (estimated)
- Primary completion30 Sep 2029 (estimated)
- Study completion5 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced GlioblastomaStudies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 422 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Priya Kumthekar, MD, Study chair, Alliance for Clinical Trials in OncologyYoshie Umemura, MD, MS, Study chair, Alliance for Clinical Trials in Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07605364
- Sponsor's protocol ID
- A072402
- Status last verified
- May 2026
- First submitted
- 19 May 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mycophenolate Mofetil to Overcome Glioblastoma Resistance to Radiotherapy and Temozolomide
- ClinicalTrials.gov ID
- NCT07605364
- Acronym / sponsor ID
- A072402
- Conditions
- Advanced Glioblastoma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 422 participants (estimated)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 10 Jun 2026 (estimated)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 5 Jan 2031 (estimated)
- First posted
- 26 May 2026 (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 phase II/III trial tests how well adding mycophenolate mofetil, to the usual treatment with intensity-modulated radiation therapy and temozolomide works for the treatment of glioblastoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Mycophenolate mofetil blocks enzyme activity which can disrupt tumor activity and may make the tumor more sensitive to radiation and/or temozolomide. Intensity modulated radiation therapy is a type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Temozolomide is a chemotherapy drug and in a class of medications called alkylating agents. It damages the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. Giving mycophenolate mofetil with intensity-modulated radiation therapy and temozolomide may be more effective than intensity-modulated radiation therapy and temozolomide alone for the treatment of advanced glioblastoma.
Detailed description
The primary and secondary objectives of the study:
PRIMARY OBJECTIVE:
- To compare the overall survival (OS) (phase III) and progression-free survival (PFS) (phase II) between the experimental arm (mycophenolate mofetil [MMF] + standard of care [SOC]) and the control arm (SOC).
SECONDARY OBJECTIVES:
- To compare the proportion of patients with an objective tumor response (ORR), measured with Response Assessment in Neuro-Oncology (RANO) 2.0 criteria, between the two treatment arms.
II. To determine the adverse event profiles for each arm (using the current latest version of Common Terminology Criteria for Adverse Events [CTCAE]).
III. To determine if there is an association between OS and PFS between treatment arms.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients under 70 years undergo intensity modulated radiation therapy (IMRT), Monday-Friday for 30 treatments and patients greater than or equal to 70 years undergo hypofractionated radiation therapy, Monday-Friday for 15 treatments in the absence of disease progression or unacceptable toxicity. Starting 24 hours prior to radiation, patients also receive temozolomide orally (PO) once daily (QD) until the day of the last radiation treatment, in the absence of disease progression or unacceptable toxicity. Patients then undergo a 4-week rest period. Patients then receive temozolomide PO QD on days 1-5 of each cycle. Cycles repeat every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo magnetic resonance imaging (MRI) and blood sample collection throughout the study.
ARM II: Patients under 70 years undergo IMRT, Monday-Friday for 30 treatments and patients greater than or equal to 70 years undergo hypofractionated radiation therapy, Monday-Friday for 15 treatments in the absence of disease progression or unacceptable toxicity. Starting 24 hours prior to radiation, patients also receive temozolomide PO QD until the day of the last radiation treatment, and, starting on the first day of radiation, patients also receive mycophenolate mofetil PO twice daily (BID) in the absence of disease progression or unacceptable toxicity. Patients then undergo a 4-week rest period. Patients then receive temozolomide PO QD on days 1-5 and mycophenolate mofetil PO BID on days 1-28 of each cycle. Cycles repeat every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo MRI and blood sample collection throughout the study.
After completion of study treatment, patients are followed up every 10 weeks until 2 years then every 6 months until 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (radiation, temozolomide) | Experimental | Radiation: Intensity-Modulated Radiation Therapy, Radiation: Hypofractionated Radiation Therapy, Drug: Temozolomide (TMZ), Procedure: Magnetic Resonance Imaging, Procedure: Biospecimen CollectionPatients under 70 years undergo IMRT, Monday-Friday for 30 treatments and patients greater than or equal to 70 years undergo hypofractionated radiation therapy, Monday-Friday for 15 treatments in the absence of disease progression or unacceptable toxicity. Starting 24 hours prior to radiation, patients also receive temozolomide PO QD until the day of the last radiation treatment, in the absence of disease progression or unacceptable toxicity. Patients then undergo a 4-week rest period. Patients then receive temozolomide PO QD on days 1-5 of each cycle. Cycles repeat every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo MRI and blood sample collection throughout the study. |
| Arm II (radiation, temozolomide, mycophenolate mofetil) | Experimental | Radiation: Intensity-Modulated Radiation Therapy, Drug: Temozolomide (TMZ), Procedure: Magnetic Resonance Imaging, Procedure: Biospecimen Collection, Drug: Mycophenolate MofetilPatients under 70 years undergo IMRT, Monday-Friday for 30 treatments and patients greater than or equal to 70 years undergo hypofractionated radiation therapy, Monday-Friday for 15 treatments in the absence of disease progression or unacceptable toxicity. Starting 24 hours prior to radiation, patients also receive temozolomide PO QD until the day of the last radiation treatment, and, starting on the first day of radiation, patients also receive mycophenolate mofetil PO twice daily (BID) in the absence of disease progression or unacceptable toxicity. Patients then undergo a 4-week rest period. Patients then receive temozolomide PO QD on days 1-5 and mycophenolate mofetil PO BID on days 1-28 of each cycle. Cycles repeat every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo MRI and blood sample collection throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (36 listed)
- Newly diagnosed primary glioblastoma by World Health Organization (WHO) 2021 criteria
- No spinal cord glioblastoma
- No leptomeningeal disease
- No extracranial metastatic disease
- Patient is a candidate for first-line standard of care chemoradiation per treating physician(s)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Intensity-Modulated Radiation TherapyAlso: IMRTUndergo IMRT | Radiation | Arm I (radiation, temozolomide), Arm II (radiation, temozolomide, mycophenolate mofetil) |
| Hypofractionated Radiation TherapyUndergo hypofractionated radiation therapy | Radiation | Arm I (radiation, temozolomide) |
| Temozolomide (TMZ)Given PO | Drug | Arm I (radiation, temozolomide), Arm II (radiation, temozolomide, mycophenolate mofetil) |
| Magnetic Resonance ImagingUndergo MRI | Procedure or surgery | Arm I (radiation, temozolomide), Arm II (radiation, temozolomide, mycophenolate mofetil) |
| Biospecimen Collectionundergo Biospecimen Collection | Procedure or surgery | Arm I (radiation, temozolomide), Arm II (radiation, temozolomide, mycophenolate mofetil) |
| Mycophenolate MofetilGiven PO | Drug | Arm II (radiation, temozolomide, mycophenolate mofetil) |
Primary outcome
Progression free survival (PFS) (phase II)
Time frame: From randomization to the disease progression according to Response Assessment in Neuro-Oncology (RANO) 2.0 criteria or death due to any cause, up to 5 years
PFS will be calculated from randomization until disease progression according to RANO 2.0 criteria or death due to any cause, censoring patients at their last disease evaluation. The Kaplan-Meier method will be used to estimate PFS for each arm and a stratified log-rank test will be used to compare distributions
Overall survival (OS) (phase III)
Time frame: From randomization until death due to any cause, up to 5 years
OS will be calculated from randomization until death due to any cause, censoring patients at their last disease evaluation. The Kaplan-Meier method will be used to estimate OS for each arm and a stratified log-rank test will be used to compare distributions.
4 secondary outcomes
Tumor response
Time frame: Up to 5 years
Incidence of adverse events
Time frame: Up to 5 years
Overall survival (OS)
Time frame: From randomization until death due to any cause, up to 5 years
Progression free survival (PFS)
Time frame: From randomization to the disease progression according to RANO 2.0 criteria or death due to any cause, up to 5 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 26 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Advanced Glioblastoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
Anti-GD2 ADC M3554 in Advanced Solid Tumors
Advanced Solid Tumor
Active, not recruitingPhase 1
A Trial of Belzutifan (PT2977, MK-6482) Tablets In Patients With Advanced Solid Tumors (MK-6482-001)
Advanced Solid Tumors, Solid Tumor
RecruitingPhase 1
A Phase 1, Open-Label, Dose-Escalation Study to Evaluate Safety, Tolerability, and Clinical Activity of CBX-663 in Participants With Relapsed or Refractory Myeloid Malignancies, Advanced Solid Tumors, or Recurrent or Progressive Glioblastoma.
Advanced Solid Tumors, Recurrent or Progressive Glioblastoma
RecruitingPhase 1/2
A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations
Locally Advanced Solid Tumors, Metastatic Solid Tumors
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.
Priya Kumthekar, MD study chair
Alliance for Clinical Trials in Oncology
Yoshie Umemura, MD, MS study chair
Alliance for Clinical Trials in Oncology
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Intensity-Modulated Radiation Therapy, Hypofractionated Radiation Therapy and Temozolomide (TMZ) in people with Advanced Glioblastoma, run by Alliance for Clinical Trials in Oncology.
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 1 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: opening soon, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Amanda Clark ((773) 702-9171, neurooncologyprotocols@alliancenctn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (phase II) (time frame: From randomization to the disease progression according to Response Assessment in Neuro-Oncology (RANO) 2.0 criteria or death due to any cause, up to 5 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 26 May 2026.