Central Nervous System TumorsPhase 1NCT05081180
Study of Avelumab in Combination With Lenvatinib for Children With Primary CNS Tumors
A Phase 1 study testing Avelumab and Lenvatinib in people with Central Nervous System Tumors, run by EMD Serono Research & Development Institute, Inc. at 9 sites in 4 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Central Nervous System Tumors
- What is being tested?
- Avelumab and Lenvatinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 9 sitesin 4 countries
- Study dates
- 3 Dec 2021to 9 Jun 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
France3 sites
CHU Angers - Hôpital Hôtel Dieu - Service de Cancérologie Pédiatrique
Angers
Hôpital de la Timone
Marseille
Institut Curie - Centre de Lutte Contre le Cancer (CLCC) de Paris
Paris
Canada2 sites
CHU Sainte-Justine
Montreal
The Hospital for Sick Children
Toronto
Germany2 sites
Universitaetsklinikum Hamburg Eppendorf
Hamburg
Universitaetsklinikum Muenster
Münster
South Korea2 sites
Seoul National University Hospital
Seoul
Severance Hospital, Yonsei University Health System
Seoul
About this study
Official title: Single-arm, Multicenter Phase I/Ib Study of Avelumab + Lenvatinib in Children With Primary CNS Tumors
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.
- Conditions
- Central Nervous System Tumors
- Being tested
- Avelumab, Lenvatinib
- Keywords
- Avelumab, Lenvatinib, Tumors, Pediatric CNS tumors
- Medical subject headings
- Central Nervous System Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvelumabDrug
Participants with primary CNS malignancies who have received at least 1 prior therapy will be enrolled into Dose Escalation Part 1 and will receive intravenous infusion at a flat dose or weight based dose of Avelumab, every 2 weeks (Q2W) until progression, unacceptable toxicity, or withdrawal of consent. Enrollment into part 1 of the study will end when Maximum tolerated dose (MTD) and/or a safe Recommended Dose for Expansion (RDE) for the expansion cohort is determined. Participants with defined CNS tumors will be enrolled into Dose Expansion Part 2 and will receive RDE in Part 2 until progression, unacceptable toxicity, or withdrawal of consent.
LenvatinibDrug
Participants with primary CNS malignancies who have received at least 1 prior therapy will be enrolled into Dose Escalation Part 1 and will receive daily oral escalated dose level of Lenvatinib until progression, unacceptable toxicity, or withdrawal of consent. Enrollment into part 1 of the study will end when MTD and/or a safe Recommended Dose for Expansion (RDE) for the expansion cohort is determined. Participants with defined CNS tumors will be enrolled into Dose Expansion Part 2 and will receive RDE of Lenvatinib in Part 2 until progression, unacceptable toxicity, or withdrawal of consent.
| Study group | Role | What they receive |
|---|---|---|
| Avelumab + Lenvatinib | Experimental | Not described Receives: Drug: Avelumab; Drug: Lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Escalation Part 1: Number of Participants with Common Terminology Criteria for Adverse Events (CTCAE) Grade Greater Than or Equal to (>=) 3 Treatment-emergent Adverse Event (TEAEs) According to National Cancer Institute-CTCAE Version 5.0
Measured: up to 857 days
Dose Escalation Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)
Measured: Baseline (Day 1) up to Day 28
Dose Expansion Part 2: Progression-free Survival (PFS) According to Response Assessment in Neuro-Oncology (RANO) Criteria as Assessed by Investigators
Measured: until progressive disease or death, assessed up to Day 1534
Secondary outcomes (25)
Dose Escalation Part 1: Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Treatment-related Adverse Events (AEs), Adverse Event of Special Interest (AESIs), AEs Leading to Deaths
Measured: up to 876 days
Dose Escalation Part 1: Number of Participants with Treatment-Emergent Adverse Events (AEs) Based on Severity According to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
Measured: up to 876 days
Dose Escalation Part 1: Number of Participants with Clinically Significant Changes from Baseline in Laboratory Parameters
Measured: up to 876 days
Dose Escalation Part 1: Objective Response Rate (ORR) According to Response Assessment in Neuro-Oncology (RANO) Criteria as Assessed by Investigators
Measured: up to 876 days
Dose Escalation Part 1: Duration of Response (DOR) According to Response Assessment in Neuro-Oncology (RANO) Criteria as Assessed by Investigators
Measured: up to 876 days
Dose Escalation Part 1: Progression-Free Survival (PFS) According to Response Assessment in Neuro-Oncology (RANO) Criteria
Measured: until progressive disease or death, assessed up to 876 days
Dose Escalation Part 1: Overall Survival (OS)
Measured: up to 876 days
Dose Escalation Part 1: Serum Observed Concentration at End of Infusion (CEOI) of Avelumab
Measured: Pre-dose up to 30 days after last dose, assessed up to approximately 876 days
Dose Escalation Part 1: Area Under the Serum Concentration-Time Curve From the Time of Dosing 336 Hours (AUC0-336 [hr]) of Avelumab
Measured: Pre-dose up to 336 hours post-dose, assessed up to approximately 876 days
Dose Escalation Part 1: Serum Concentration Observed Immediately Before Next Dosing (Ctrough) of Avelumab
Measured: Pre-dose up to 30 days after last dose, assessed up to approximately 876 days
Dose Escalation Part 1: Maximum Observed Plasma Concentration (Cmax) of Lenvatinib
Measured: Pre-dose up to 30 days after last dose, assessed up to approximately 876 days
Dose Escalation Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Lenvatinib
Measured: Pre-dose up to 30 days after last dose, assessed up to approximately 876 days
Dose Escalation (Part 1): Area Under the Plasma Concentration-Time Curve From the Time of Dosing to 24 Hours (AUC0-24 [hr]) of Lenvatinib:
Measured: Pre-dose up to 24 hours post-dose, assessed up to approximately 876 days
Dose Escalation Part 1: Immunogenicity of Avelumab as Measured by Antidrug Antibody (ADA) Assay
Measured: up to 876 days
Dose Expansion Part 2: Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Treatment-related Adverse Events (AEs), Adverse Event of Special Interest (AESIs), AEs Leading to Deaths
Measured: up to Day 1534
Dose Expansion Part 2: Number of Participants with Treatment-Emergent Adverse Events (AEs) Based on Severity According to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
Measured: up to Day 1534
Dose Expansion Part 2: Number of Participants with Clinically Significant Changes in Laboratory Parameters
Measured: up to Day 1534
Dose Expansion Part 2: Objective Response Rate (ORR) Rate According to Response Assessment in Neuro-Oncology (RANO) Criteria as Assessed by Investigators
Measured: up to Day 1534
Dose Expansion Part 2: Duration of Response (DOR) According to Response Assessment in Neuro-Oncology (RANO) Criteria as Assessed by Investigators
Measured: up to Day 1534
Dose Expansion Part 2: Overall Survival (OS)
Measured: up to Day 1534
Dose Expansion Part 2: Serum Observed Concentration at End of Infusion (CEOI) of Avelumab
Measured: Pre-dose up to 30 days after last dose, assessed up to approximately Day 1534
Dose Expansion Part 2:Serum Concentration Observed Immediately Before Next Dosing (Ctrough) of Avelumab
Measured: Pre-dose up to 30 days after last dose, assessed up to approximately Day 1534
Dose Expansion Part 2: Maximum Observed Plasma Concentration (Cmax) of Lenvatinib
Measured: Pre-dose up to 30 days after last dose, assessed up to approximately Day 1534
Dose Expansion Part 2: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Lenvatinib
Measured: Pre-dose up to 30 days after last dose, assessed up to approximately Day 1534
Dose Expansion Part 2: Immunogenicity of avelumab as measured by ADA assay
Measured: up to Day 1534
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start3 Dec 2021
- Primary completion11 Feb 2026
- Study completion9 Jun 2026
Why it stopped: The study was stopped due to a lack of clear evidence of anti-tumor activity with the combination treatment in the participants treated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by EMD Serono Research & Development Institute, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05081180
- Sponsor's protocol ID
- MS100070_0087
- Other IDs
- 2020-004397-22, 2024-512940-51-00
- Status last verified
- Jul 2026
- First submitted
- 4 Oct 2021
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared for Phase I interventional or observational studies. Further information on how to request data can be found on our website bit.ly/IPD21.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-arm, Multicenter Phase I/Ib Study of Avelumab + Lenvatinib in Children With Primary CNS Tumors
- ClinicalTrials.gov ID
- NCT05081180
- Acronym / sponsor ID
- MS100070_0087
- Conditions
- Central Nervous System Tumors
- Keywords
- Avelumab, Lenvatinib, Tumors, Pediatric CNS tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped due to a lack of clear evidence of anti-tumor activity with the combination treatment in the participants treated.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- EMD Serono Research & Development Institute, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Study start
- 3 Dec 2021 (actual)
- Primary completion
- 11 Feb 2026 (actual)
- Study completion
- 9 Jun 2026 (actual)
- First posted
- 18 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Avelumab + Lenvatinib | Experimental | Drug: Avelumab, Drug: Lenvatinib |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AvelumabParticipants with primary CNS malignancies who have received at least 1 prior therapy will be enrolled into Dose Escalation Part 1 and will receive intravenous infusion at a flat dose or weight based dose of Avelumab, every 2 weeks (Q2W) until progression, unacceptable toxicity, or withdrawal of consent. Enrollment into part 1 of the study will end when Maximum tolerated dose (MTD) and/or a safe Recommended Dose for Expansion (RDE) for the expansion cohort is determined. Participants with defined CNS tumors will be enrolled into Dose Expansion Part 2 and will receive RDE in Part 2 until progression, unacceptable toxicity, or withdrawal of consent. | Drug | Avelumab + Lenvatinib |
| LenvatinibParticipants with primary CNS malignancies who have received at least 1 prior therapy will be enrolled into Dose Escalation Part 1 and will receive daily oral escalated dose level of Lenvatinib until progression, unacceptable toxicity, or withdrawal of consent. Enrollment into part 1 of the study will end when MTD and/or a safe Recommended Dose for Expansion (RDE) for the expansion cohort is determined. Participants with defined CNS tumors will be enrolled into Dose Expansion Part 2 and will receive RDE of Lenvatinib in Part 2 until progression, unacceptable toxicity, or withdrawal of consent. | Drug | Avelumab + Lenvatinib |
Primary outcome
Dose Escalation Part 1: Number of Participants with Common Terminology Criteria for Adverse Events (CTCAE) Grade Greater Than or Equal to (>=) 3 Treatment-emergent Adverse Event (TEAEs) According to National Cancer Institute-CTCAE Version 5.0
Time frame: up to 857 days
Dose Escalation Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)
Time frame: Baseline (Day 1) up to Day 28
Dose Expansion Part 2: Progression-free Survival (PFS) According to Response Assessment in Neuro-Oncology (RANO) Criteria as Assessed by Investigators
Time frame: until progressive disease or death, assessed up to Day 1534
25 secondary outcomes
Dose Escalation Part 1: Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Treatment-related Adverse Events (AEs), Adverse Event of Special Interest (AESIs), AEs Leading to Deaths
Time frame: up to 876 days
Dose Escalation Part 1: Number of Participants with Treatment-Emergent Adverse Events (AEs) Based on Severity According to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
Time frame: up to 876 days
Dose Escalation Part 1: Number of Participants with Clinically Significant Changes from Baseline in Laboratory Parameters
Time frame: up to 876 days
Dose Escalation Part 1: Objective Response Rate (ORR) According to Response Assessment in Neuro-Oncology (RANO) Criteria as Assessed by Investigators
Time frame: up to 876 days
Dose Escalation Part 1: Duration of Response (DOR) According to Response Assessment in Neuro-Oncology (RANO) Criteria as Assessed by Investigators
Time frame: up to 876 days
Dose Escalation Part 1: Progression-Free Survival (PFS) According to Response Assessment in Neuro-Oncology (RANO) Criteria
Time frame: until progressive disease or death, assessed up to 876 days
Dose Escalation Part 1: Overall Survival (OS)
Time frame: up to 876 days
Dose Escalation Part 1: Serum Observed Concentration at End of Infusion (CEOI) of Avelumab
Time frame: Pre-dose up to 30 days after last dose, assessed up to approximately 876 days
Dose Escalation Part 1: Area Under the Serum Concentration-Time Curve From the Time of Dosing 336 Hours (AUC0-336 [hr]) of Avelumab
Time frame: Pre-dose up to 336 hours post-dose, assessed up to approximately 876 days
Dose Escalation Part 1: Serum Concentration Observed Immediately Before Next Dosing (Ctrough) of Avelumab
Time frame: Pre-dose up to 30 days after last dose, assessed up to approximately 876 days
Dose Escalation Part 1: Maximum Observed Plasma Concentration (Cmax) of Lenvatinib
Time frame: Pre-dose up to 30 days after last dose, assessed up to approximately 876 days
Dose Escalation Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Lenvatinib
Time frame: Pre-dose up to 30 days after last dose, assessed up to approximately 876 days
Dose Escalation (Part 1): Area Under the Plasma Concentration-Time Curve From the Time of Dosing to 24 Hours (AUC0-24 [hr]) of Lenvatinib:
Time frame: Pre-dose up to 24 hours post-dose, assessed up to approximately 876 days
Dose Escalation Part 1: Immunogenicity of Avelumab as Measured by Antidrug Antibody (ADA) Assay
Time frame: up to 876 days
Dose Expansion Part 2: Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Treatment-related Adverse Events (AEs), Adverse Event of Special Interest (AESIs), AEs Leading to Deaths
Time frame: up to Day 1534
Dose Expansion Part 2: Number of Participants with Treatment-Emergent Adverse Events (AEs) Based on Severity According to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
Time frame: up to Day 1534
Dose Expansion Part 2: Number of Participants with Clinically Significant Changes in Laboratory Parameters
Time frame: up to Day 1534
Dose Expansion Part 2: Objective Response Rate (ORR) Rate According to Response Assessment in Neuro-Oncology (RANO) Criteria as Assessed by Investigators
Time frame: up to Day 1534
Dose Expansion Part 2: Duration of Response (DOR) According to Response Assessment in Neuro-Oncology (RANO) Criteria as Assessed by Investigators
Time frame: up to Day 1534
Dose Expansion Part 2: Overall Survival (OS)
Time frame: up to Day 1534
Dose Expansion Part 2: Serum Observed Concentration at End of Infusion (CEOI) of Avelumab
Time frame: Pre-dose up to 30 days after last dose, assessed up to approximately Day 1534
Dose Expansion Part 2:Serum Concentration Observed Immediately Before Next Dosing (Ctrough) of Avelumab
Time frame: Pre-dose up to 30 days after last dose, assessed up to approximately Day 1534
Dose Expansion Part 2: Maximum Observed Plasma Concentration (Cmax) of Lenvatinib
Time frame: Pre-dose up to 30 days after last dose, assessed up to approximately Day 1534
Dose Expansion Part 2: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Lenvatinib
Time frame: Pre-dose up to 30 days after last dose, assessed up to approximately Day 1534
Dose Expansion Part 2: Immunogenicity of avelumab as measured by ADA assay
Time frame: up to Day 1534
Results and safety
The study was stopped early (reason given: The study was stopped due to a lack of clear evidence of anti-tumor activity with the combination treatment in the participants treated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Trial Awareness and Transparency websiteLink provided by the sponsor.
- US Medical Information website, Medical ResourcesLink provided by the sponsor.
- Individual participant dataSharing planned: No. IPD will not be shared for Phase I interventional or observational studies. Further information on how to request data can be found on our website bit.ly/IPD21.
Related trials for Central Nervous System Tumors
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Responsible study director
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Avelumab and Lenvatinib in people with Central Nervous System Tumors, run by EMD Serono Research & Development Institute, Inc. at 9 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France, Canada, Germany, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was stopped due to a lack of clear evidence of anti-tumor activity with the combination treatment in the participants treated.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Escalation Part 1: Number of Participants with Common Terminology Criteria for Adverse Events (CTCAE) Grade Greater Than or Equal to (>=) 3 Treatment-emergent Adverse Event (TEAEs) According to National Cancer Institute-CTCAE Version 5.0 (time frame: up to 857 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.