RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Pumitamig for Recurrent Glioblastoma

This multi-site Phase II study will enroll adults with histologically confirmed diagnosis of World Health Organization (WHO) Grade IV glioblastoma (GBM), isocitrate dehydrogenase (IDH)-wildtype consistent with WHO central nervous system (CNS) 2021 criteria who have received prior first-line treatment including with at least radiotherapy and temozolomide, with a Karnofsky performance status (KPS) ≥60, adequate organ function, and at least one measurable lesion according to the response assessment in neuro-oncology (RANO) 2.0 criteria.

Official registry: https://clinicaltrials.gov/study/NCT07297212 · BioNTech SE · enrollment listed as 75

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Pumitamig, Bevacizumab, or Temozolomide. The registry lists allocation as randomized. This multi-site Phase II study will enroll adults with histologically confirmed diagnosis of World Health Organization (WHO) Grade IV glioblastoma (GBM), isocitrate dehydrogenase (IDH)-wildtype consistent with WHO central nervous system (CNS) 2021 criteria who have received prior first-line treatment including with at least radiotherapy and temozolomide, with a Karnofsky performance status (KPS) ≥60, adequate organ function, and at least one measurable lesion according to the response assessment in neuro-oncology (RANO) 2.0 criteria.

They plan to enroll about 75 people at 6 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase II, Multi-site, Open-label Trial Evaluating the Safety and Efficacy of Pumitamig and Bevacizumab as Monotherapy and Pumitamig in Combination With Temozolomide in Patients With Recurrent Glioblastoma

Interventions: Pumitamig, Bevacizumab, Temozolomide

Primary outcome (registry wording): Confirmed overall response rate (ORR)

Who it is for (from inclusion criteria)

Ages 18 Years to 75 Years
Have a histologically confirmed diagnosis of WHO Grade IV GBM, IDH-wildtype consistent with WHO CNS 2021 criteria
Have been clinically evaluated as having relapsed or progressed disease with at least one measurable lesion as the targeted lesion based on RANO 2.0 criteria
Can swallow the medication and maintain oral administration
Have a baseline brain MRI, not more than 14 days before starting the study treatment
Have a stable dose of steroids ≥7 days before the contrast-enhanced scan
Have adequate organ function, as defined in the protocol

Who the registry excludes

Have received any of the following therapies or drugs before study enrollment:
Programmed death-1 / programmed death-ligand 1/vascular endothelial growth factor bispecific antibodies, cluster of differentiation 137 agonists or other immune checkpoint blockade therapies including this drug alone with either category or combinations thereof
Systemic corticosteroids (at a dosage greater than 2 mg/day of dexamethasone or an equivalent dose of other corticosteroids) within 7 days before starting the study treatment
Vaccinations with live attenuated vaccine(s) within 4 weeks before starting the study treatment
Broad-spectrum intravenous antibiotics therapy within 2 weeks before starting the study treatment
Any non-study investigational medicinal product within five half-lives of the first dose or within 4 weeks, whichever is longer, before starting the study treatment in this study or ongoing participation in the active treatment phase of another treatment clinical study
Antiplatelet drugs, such as aspirin (\>325 mg/day), clopidogrel (\>75 mg/day), dipyridamole, ticlopidine or cilostazol, etc., within 10 days before starting the study treatment to avoid inclusion of participants who have used platelet aggregation inhibitors before the study

Public study contact (from the registry)

BioNTech clinical trials patient information

+49 6131 9084

patients@biontech.de

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

6 listed

Beijing Tiantan Hospital, Capital Medical University — Beijing, China (recruiting)
Affiliated Tumor Hospital of Chongqing Medical University — Chongqing, China (recruiting)
Affiliated Cancer Hospital of Shandong First Medical University — Jinan, China (recruiting)
Huashan Hospital, Fudan University — Shanghai, China (recruiting)
Shenzhen Second People's Hospital — Shenzhen, China (recruiting)
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, China (recruiting)

Related recruiting trials in this snapshot

RecruitingNot a traditional drug phaseBethesda, Maryland

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

This study will collect blood and urine samples from patients undergoing radiation therapy for glioblastoma multiforme (a type of brain tumor) to investigate the effects of this treatment on blood cells and certain proteins. The information from this study may help scientists develop new tests to measure radiation exposure and find new ways to treat cancer with radiation, and help determine which kinds of patients or tumors respond better to radiation therapy.

NCT00083512 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

RecruitingPhase 2Bethesda, Maryland

Phase 2: testing Pembrolizumab (Keytruda) for Metastatic Colorectal Cancer

Background: The NCI Surgery Branch has developed an experimental therapy that involves taking white blood cells from patients' tumors, growing them in the laboratory in large numbers, and then giving the cells back to the patient. These cells are called Tumor Infiltrating Lymphocytes, or TIL and we have given this type of treatment to over 200 patients with melanoma.

NCT01174121 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

RecruitingPhase 2 / Phase 3Birmingham, Alabama

Phase 2 / Phase 3: testing Temozolomide for Glioblastoma

Glioblastoma (GBM) adaptive, global, innovative learning environment (GBM AGILE) is an international, seamless Phase II/III response adaptive randomization platform trial designed to evaluate multiple therapies in newly diagnosed (ND) and recurrent GBM. All institutions are enrolling Newly Diagnosed participants.

NCT03970447 · Official ClinicalTrials.gov record · Global Coalition for Adaptive Research

FAQ about this NCT record

Is NCT07297212 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07297212?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07297212?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary