Actively Recruiting
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
Led by BioNTech SE · Updated on 2026-04-29
75
Participants Needed
6
Research Sites
78 weeks
Total Duration
On this page
Sponsors
B
BioNTech SE
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the investigational drug pumitamig alone and in combination with temozolomide, compared to bevacizumab alone, in adults with recurrent glioblastoma (GBM), a type of brain cancer. This Phase II study includes participants with a confirmed diagnosis of WHO Grade IV GBM, IDH-wildtype, who have already received standard first-line treatment including radiotherapy and temozolomide. The study aims to understand treatment responses and side effects in this patient group. Participants will be randomly assigned to one of two treatment groups initially: pumitamig alone or bevacizumab alone. After reviewing initial safety and effectiveness data from the pumitamig group, a third group receiving pumitamig combined with temozolomide may be added. Treatments are delivered via intravenous infusion for pumitamig and bevacizumab, while temozolomide is taken orally. The treatment phase can last up to two years. Before treatment, there is a screening period of up to 28 days to confirm eligibility. Participants will be monitored for safety for up to 90 days after their last treatment dose or until they start new cancer therapy. After the treatment and safety follow-up, survival status will be tracked until the participant dies, withdraws consent, is lost to follow-up, or the study ends. Researchers will measure tumor response rates, progression-free survival, overall survival, adverse events, and drug levels in the body during the study.
CONDITIONS
Brief Title
A Clinical Trial Testing the Safety of the Investigational Drug Pumitamig (BNT327) and How Well it Works in Patients With Recurrent Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years inclusive at consent
- Histologically confirmed diagnosis of WHO Grade IV glioblastoma, IDH-wildtype
- Recurrent supratentorial glioblastoma with prior radiotherapy and temozolomide treatment
- First recurrence documented by MRI at least 12 weeks after prior radiotherapy unless confirmed otherwise
- Relapsed or progressed disease with at least one measurable lesion based on RANO 2.0 criteria
- Karnofsky performance status of 60 or higher
- Able to swallow medication and maintain oral administration
- Baseline brain MRI within 14 days before starting study treatment
- Stable dose of steroids for at least 7 days before contrast-enhanced scan
- Adequate organ function as defined in the protocol
You will not qualify if you...
- Recent anticancer therapies within 4 weeks or five half-lives before study treatment
- Prior immune checkpoint blockade therapies or PD(L)-1/VEGF bispecific antibodies
- Systemic corticosteroids over 2 mg/day dexamethasone or equivalent within 7 days before treatment
- Live attenuated vaccines within 4 weeks before treatment
- Broad-spectrum intravenous antibiotics within 2 weeks before treatment
- Participation in other investigational drug studies recently or ongoing
- Use of high-dose antiplatelet drugs within 10 days before treatment
- More than one recurrence of glioblastoma
- Allergy to dacarbazine or temozolomide
- Known leptomeningeal, extracranial, or multicentric disease
- Secondary glioblastoma diagnosis
- Prior non-standard radiotherapy or local therapies like brachytherapy or Gliadel wafers
- Uncontrolled hypertension or poorly controlled diabetes
- Inability or unwillingness to have contrast-enhanced MRI
- Recent major surgery or injury within 28 days before treatment
- Prior organ or stem cell transplantation
- Other malignancies within 5 years except certain cured cancers
- Serious heart conditions within 6 months before treatment
- Serious or non-healing wounds, ulcers, or bone fractures
- Significant risk of hemorrhage or major coagulation disorders
- Uncontrolled pleural, pericardial effusion, or ascites requiring frequent drainage
- Ongoing adverse events from prior antitumor therapies above Grade 1 except certain conditions
- Active colitis within 4 weeks before treatment
- History of serious allergic or drug allergy reactions
- Uncontrolled seizures or other neurological conditions increasing risk
- Superior vena cava syndrome or spinal cord compression symptoms
- Active or history of pneumonitis or interstitial lung disease
- Untreated or unsuccessfully treated tuberculosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 2 years
Participants receive one of the study treatments by intravenous infusion or oral medication as assigned to their treatment arm.
Visits occur as per treatment schedule during treatment period
Duration - Up to approximately 42 months including survival follow-up
Participants are monitored for safety for up to 90 days after the last dose of study treatment or until starting new anticancer treatment, followed by survival follow-up until death, withdrawal, loss of contact, or study termination.
Safety follow-up visits up to 90 days post-treatment, then periodic survival follow-up contacts
Trial Site Locations
Total: 6 locations
1
Beijing Tiantan Hospital, Capital Medical University
Beijing, China, 100070
Actively Recruiting
2
Affiliated Tumor Hospital of Chongqing Medical University
Chongqing, China, 350209
Actively Recruiting
3
Affiliated Cancer Hospital of Shandong First Medical University
Jinan, China, 250117
Actively Recruiting
4
Huashan Hospital, Fudan University
Shanghai, China, 201107
Actively Recruiting
5
Shenzhen Second People's Hospital
Shenzhen, China, 518000
Actively Recruiting
6
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China, 430030
Actively Recruiting
Research Team
B
BioNTech clinical trials patient information
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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