Actively Recruiting
Combination of Tarlatamab and Temozolomide in Patients With Central Nervous System Tumors
Led by Centre Leon Berard · Updated on 2026-04-22
70
Participants Needed
11
Research Sites
256 weeks
Total Duration
On this page
Sponsors
C
Centre Leon Berard
Lead Sponsor
A
Amgen
Collaborating Sponsor
AI-Summary
What this Trial Is About
This clinical trial is a 2-phase trial designed to evaluate the safety of tarlatamab in combination with a fixed dose of metronomic temozolomide in adolescents and adults with CNS tumors (stratified into two age-based cohorts), and to assess the clinical activity of this therapeutic strategy in three parallel, histology-defined cohorts (IDH-mutant glioma, other gliomas, and other CNS tumors). A pre-screening to detect DLL3 expression by IHC on archival tumor sample must be performed before the therapeutic part. Only patients with DLL3 positive tumor on IHC can be enrolled in the therapeutic part. This pre-screening must be optimally performed during the ongoing treatment line i.e. before documented progression to not delay treatment starts at time of progression. Tumor samples (surgery or biopsy specimen) will be sent to a central lab for IHC testing.
CONDITIONS
Official Title
Combination of Tarlatamab and Temozolomide in Patients With Central Nervous System Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 12 years or older at the time of informed consent.
- Histologically confirmed diagnosis of CNS malignant tumor: IDH-mutant high-grade glioma, other high-grade glioma, or other high-grade CNS tumors.
- Tumor expresses DLL3 with at least 1+ intensity on immunohistochemistry.
- Disease is progressive or refractory after at least one standard therapy including radiotherapy with no effective standard options remaining.
- Presence of evaluable or measurable disease according to iRANO criteria.
- Performance status: Karnofsky score 716 years 9670%; Lansky score 12-15 years 9670%; ECOG 0 or 1 for adults.
- Life expectancy of at least 3 months.
- Adequate blood counts and organ function as specified by laboratory criteria.
- Left ventricular ejection fraction (LVEF) of 50% or higher.
- Adequate pulmonary function and absence of significant pleural effusion.
- Availability of suitable archival tumor tissue sample with at least 30% tumor cells.
- Discontinuation of all prior anti-cancer treatments with appropriate washout periods.
- Negative pregnancy test for women of childbearing potential and agreement to use effective contraception.
- Agreement by sexually active males to use contraception during and for 6 months after treatment.
- Ability to understand and sign informed consent, with assent for minors.
- Coverage by medical insurance.
You will not qualify if you...
- Diagnosis of non-CNS tumor.
- Diagnosis of diffuse intrinsic pontine glioma.
- Current treatment with bevacizumab.
- Prior treatment with DLL3-directed therapy.
- Neurologic instability or need for increasing corticosteroids above specified low dose.
- Recent CNS hemorrhage greater than Grade 1.
- Bulky tumors with uncial herniation, severe midline shift, diameter over 6 cm, or significant mass effect.
- Gastrointestinal conditions that affect drug absorption.
- Recent history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess.
- Clinically significant uncontrolled heart disease within 6 months.
- Other malignancies that may interfere with study evaluation unless inactive for 2 years.
- History of hypophysitis or pituitary dysfunction.
- Severe allergic reactions to study drugs or their components.
- Ongoing toxicities from prior therapies not resolved to Grade 1 except certain exceptions.
- Arterial thrombosis or pulmonary embolism requiring anticoagulants.
- Evidence of interstitial lung disease or active pneumonitis.
- Recurrent severe immune-related adverse events.
- Live vaccine within 4 weeks prior to starting treatment.
- Active or recent autoimmune disease requiring systemic treatment.
- Active hepatitis B or C infection or HIV infection.
- Prior organ or bone marrow transplant.
- Any other condition or lab abnormality that would interfere with participation or study results.
- Pregnant or breastfeeding women.
AI-Screening
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Trial Site Locations
Total: 11 locations
1
Institut de Cancérologie de l'Ouest
Angers, France, 49055
Actively Recruiting
2
Hôpital Universitaire d'Angers
Angers, France, 49933
Not Yet Recruiting
3
CHU de Bordeaux
Bordeaux, France, 33000
Not Yet Recruiting
4
Hôpital Saint-André
Bordeaux, France, 33075
Not Yet Recruiting
5
Hôpital Neurologique Pierre Wertheimer
Bron, France, 69677
Actively Recruiting
6
Centre Oscar Lambret
Lille, France, 59000
Not Yet Recruiting
7
Centre Léon Bérard
Lyon, France, 69373
Actively Recruiting
8
Hôpital de la Timone
Marseille, France, 13005
Not Yet Recruiting
9
Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix
Paris, France, 75013
Not Yet Recruiting
10
IUCT - Claudius Regaud
Toulouse, France, 31100
Not Yet Recruiting
11
Institut Gustave Roussy
Villejuif, France, 94085
Not Yet Recruiting
Research Team
P
Pierre LEBLOND, MD, PhD
CONTACT
A
Aurélien MAUREILLE, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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