Informations générales (source: ClinicalTrials.gov)
Single-arm, Multicenter Phase I/Ib Study of Avelumab + Lenvatinib in Children With Primary CNS Tumors
Interventional
Phase 1
EMD Serono Research & Development Institute, Inc. (Voir sur ClinicalTrials)
décembre 2021
décembre 2025
02 octobre 2024
This study consists of 2 parts: Dose Escalation Part 1 and Dose Expansion Part 2. The
Dose Escalation Part 1 will evaluate the safety and tolerability of Avelumab in
combination with Lenvatinib and determine the recommended Avelumab and Lenvatinib dose
for expansion. Dose Expansion Part 2 will assess the efficacy of Avelumab in combination
with Lenvatinib by Progression-free Survival in participants with pre-defined primary
central nervous system (CNS) tumors.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/09/2024 13:49:43 | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU Angers - Hôpital Hôtel Dieu - Service de Cancérologie Pédiatrique - Angers Cedex 9 - France | Contact (sur clinicalTrials) | ||||
| Hôpital de la Timone - Marseille Cedex 05 - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Participants with histologically confirmed diagnosis of primary CNS malignancy as
follows: a) Primary CNS tumors: the tumor should be considered high-grade
histologically; prior radiotherapy is allowed; participants must have progressed
after at least 1 prior systemic therapy, except for those with diffuse midline
glioma with or without the H3 K27M mutation. b) Specific for participants with
diffuse midline glioma with or without the H3 K27M mutation: prior radiotherapy is
allowed; no more than 1 prior systemic therapy is allowed; participants with diffuse
midline glioma with or without the H3 K27M mutation who have not received prior
systemic therapy but have prior radiotherapy only are allowed to enroll
- On screening scans, measurable disease by RANO criteria
- Participants must have a Lansky performance status >= 50 for age <= 16 years or
Karnofsky performance status >= 50 for age > 16 years at Screening
- Other protocol defined inclusion criteria could apply
- Participants with histologically confirmed diagnosis of primary CNS malignancy as
follows: a) Primary CNS tumors: the tumor should be considered high-grade
histologically; prior radiotherapy is allowed; participants must have progressed
after at least 1 prior systemic therapy, except for those with diffuse midline
glioma with or without the H3 K27M mutation. b) Specific for participants with
diffuse midline glioma with or without the H3 K27M mutation: prior radiotherapy is
allowed; no more than 1 prior systemic therapy is allowed; participants with diffuse
midline glioma with or without the H3 K27M mutation who have not received prior
systemic therapy but have prior radiotherapy only are allowed to enroll
- On screening scans, measurable disease by RANO criteria
- Participants must have a Lansky performance status >= 50 for age <= 16 years or
Karnofsky performance status >= 50 for age > 16 years at Screening
- Other protocol defined inclusion criteria could apply
- Participants with low-grade gliomas, for example but not limited to, subependymal
giant cell astrocytoma, pilocytic astrocytoma and World Health organization (WHO)
Grade 1 tumors
- Participants demonstrating evidence of worsening of neurologic deficit within 1 week
prior to initiation of study interventions
- Participants with bulky tumor, defined as: a) Tumor with any evidence of uncal
herniation or midline shift; b) Tumor with a diameter of > 4 centimeters (cm) in 1
dimension on T2/ fluid-attenuated inversion recovery (FLAIR) images; c) Tumor that
in the opinion of the Investigator shows significant mass effect
- Participants are not eligible if they experience uncontrolled seizures, defined as:
a) Seizures requiring regular use of rescue medications. b) Seizures requiring
increasing doses of antiepileptic medications. c) Seizures that in the opinion of
the Investigator compromise the ability of the participant to tolerate study
intervention or interfere with study procedures
- Participants who have received major surgery (including but not limited to
neurosurgical resection, brain biopsy, or radiation to the primary brain tumor)
within 28 days prior to the first dose of study interventions
- Participants with history of intracranial hemorrhage/spinal cord hemorrhage within
28 days prior to the first dose of study interventions
- Other protocol defined exclusion criteria could apply