A Phase 1 interventional study of Avelumab and Lenvatinib in Central Nervous System Tumors, sponsored by EMD Serono Research & Development Institute, Inc.. Terminated at 9 sites in 4 countries. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by EMD Serono Research & Development Institute, Inc. · Phase 1, Interventional, and Treatment
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.
673 studies on the registry are indexed under Central Nervous System Neoplasms; 68 are open to participants now.
This study's enrollment of 17 is below the median of 35 across 464 interventional studies indexed under Central Nervous System Neoplasms.
Browse Central Nervous System Neoplasms studies →EMD Serono Research & Development Institute, Inc. is the lead sponsor of 85 studies on the registry; 8 are open to participants now.
Of its 46 completed or terminated interventional studies of FDA-regulated products, 38 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Avelumab · Drug: Lenvatinib
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.
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.
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
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
Plan to share: 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.
This study is terminated, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Central Nervous System Neoplasms→
EMD Serono Research & Development Institute, Inc.