Active — Not RecruitingPhase 1/2

A Study to Evaluate Safety and Efficacy of ACT001 and Anti-PD-1 in Patients With Surgically Accessible Recurrent Glioblastoma Multiforme

United States48 participantsStarted 2021-09-22

Plain-language summary

The current design provides a window to analyze the impact of the ACT001+Pembrolizumab combination on the tumor microenvironment and disease outcomes.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patient has provided written informed consent.
. ≥ 18 years old at time of screening visit.
. Histologically confirmed GBM at the time of diagnosis.
. First or second relapse by the time of consenting.
. Tumor progression (magnetic resonance imaging \[MRI\], defined by RANO) post prior treatments.
. Feasibility for re-surgery.
. Karnofsky Performance Status ≥ 70% (requires occasional assistance, but able to care for most of their needs, equivalent to \< ECOG 2).
. Must be ≥ 4 weeks from administration of last dose of cancer therapy (including radiation therapy or chemotherapy). The patient must have recovered from all treatment-related toxicities to less than grade 2 per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Exclusion criteria

. The patient has uncontrolled infection.
. The patient has serious diseases such as unstable angina pectoris, myocardial infarction in the past 6 months, heart failure (New York Heart Association class \> II) or stroke within 6 months prior to the enrollment.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this trial is still in the Phase 1/Phase 2 stage and is actively measuring how safe ACT001 combined with anti-PD-1 is — including things like heart rate changes, blood pressure, and serious side effects — what do we know so far about the safety profile, and how does that compare to the risks I'd face with other options for recurrent GBM?
2The trial is no longer enrolling new patients — does that mean I've missed the window to participate, or are there other ways I might still access ACT001 or a similar combination treatment?
3One of the main things this trial is measuring is whether patients are still alive without their tumor progressing at 6 months — given what you know about my specific tumor and health status, how realistic is that kind of outcome for me, and how does it stack up against standard second-line treatments?
4The trial involves surgery to access the tumor, which is a significant physical demand — given my current condition and Karnofsky performance score, would my care team consider me a good candidate for a surgically intensive approach like this?
5Since this is still an early-phase trial combining two treatments that are being tested together, how much uncertainty is there about the right dose and the long-term effects, and should I consider whether a more established treatment path might be a safer starting point for me?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

1b-Incidence, type and severity of treatment-emergent AEs (TEAEs)

Timeframe: Approximately 7 months. Each cycle is 21 days; from start of first dose with investigational product until completion of the last study related procedure (including follow-up for safety assessments- 30days after last dose)

1b-Dose limiting toxicities (DLTs)

Timeframe: From first dose of study therapy until the end of the first post-surgery cycle (Cycle 1, Day 21).

1b-Mean changes in vital sign measurements-Heart Rate

Timeframe: Approximately 8months/ patient. Each cycle is 21 days. Start at screening, Pre-surgical Treatment Period, Cycle 1 and each subsequent Cycle and 30 days after last dose

1b-Mean changes in vital sign measurements- supine blood pressure

Timeframe: Approximately 8months/ patient.Each cycle is 21 days. Start at screening, Pre-surgical Treatment Period, Cycle 1 and each subsequent Cycle and 30 days after last dose

1b-Mean changes in vital sign measurements- body temperature

Timeframe: Approximately 8months/ patient. Each cycle is 21 days. Start at screening, Pre-surgical Treatment Period, Cycle 1 and each subsequent Cycle and 30 days after last dose

Trial details

NCT IDNCT05053880

SponsorAccendatech USA Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-25

View on ClinicalTrials.gov More Recurrent Glioblastoma Multiforme(GBM) trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patient has provided written informed consent.
. ≥ 18 years old at time of screening visit.
. Histologically confirmed GBM at the time of diagnosis.
. First or second relapse by the time of consenting.
. Tumor progression (magnetic resonance imaging \[MRI\], defined by RANO) post prior treatments.
. Feasibility for re-surgery.
. Karnofsky Performance Status ≥ 70% (requires occasional assistance, but able to care for most of their needs, equivalent to \< ECOG 2).
. Must be ≥ 4 weeks from administration of last dose of cancer therapy (including radiation therapy or chemotherapy). The patient must have recovered from all treatment-related toxicities to less than grade 2 per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Exclusion criteria

. The patient has uncontrolled infection.
. The patient has serious diseases such as unstable angina pectoris, myocardial infarction in the past 6 months, heart failure (New York Heart Association class \> II) or stroke within 6 months prior to the enrollment.

What they're measuring

1b-Incidence, type and severity of treatment-emergent AEs (TEAEs)

1b-Dose limiting toxicities (DLTs)

Timeframe: From first dose of study therapy until the end of the first post-surgery cycle (Cycle 1, Day 21).

1b-Mean changes in vital sign measurements-Heart Rate

Timeframe: Approximately 8months/ patient. Each cycle is 21 days. Start at screening, Pre-surgical Treatment Period, Cycle 1 and each subsequent Cycle and 30 days after last dose

1b-Mean changes in vital sign measurements- supine blood pressure

Timeframe: Approximately 8months/ patient.Each cycle is 21 days. Start at screening, Pre-surgical Treatment Period, Cycle 1 and each subsequent Cycle and 30 days after last dose

1b-Mean changes in vital sign measurements- body temperature

Timeframe: Approximately 8months/ patient. Each cycle is 21 days. Start at screening, Pre-surgical Treatment Period, Cycle 1 and each subsequent Cycle and 30 days after last dose