Indikation (Clinical Trials):
Nervous System Neoplasms, Central Nervous System Neoplasms
Geschlecht:
Alle
Altersgruppe:
Alle
Phase:
Phase 1
Sponsor:
EMD Serono Research & Development Institute, Inc.
Collaborator:
Merck KGaA, Darmstadt, Germany
Studienleiter
Medical Responsible Study Director Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Kontakt
US Medical Information Kontakt: Phone: 888-275-7376 E-Mail: eMediUSA@emdserono.com» Kontaktdaten anzeigen Communication Center Kontakt: Phone: +49 6151 72 5200 E-Mail: service@emdgroup.com» Kontaktdaten anzeigen
E-Mail: nicolas.andre@mail.ap-hm.fr» Ansprechpartner anzeigenInstitut Curie - Centre de Lutte Contre le Cancer (CLCC) de Paris Paris cedex 05 FranceRekrutierend» Google-Maps Ansprechpartner:
E-Mail: francois.doz@curie.fr» Ansprechpartner anzeigenSeoul National University Hospital Seoul Korea, Republic ofRekrutierend» Google-Maps Ansprechpartner:
E-Mail: kanghj@snu.ac.kr» Ansprechpartner anzeigenSeverance Hospital, Yonsei University Health System Seoul Korea, Republic ofRekrutierend» Google-Maps Ansprechpartner:
1. 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)
2. Dose Escalation Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) (Time Frame - Baseline (Day 1) up to Day 28)
3. 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)
Secondary outcome:
1. 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)
2. 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)
3. Dose Escalation Part 1: Number of Participants with Clinically Significant Changes from Baseline in Laboratory Parameters (Time Frame - up to 876 days)
4. 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)
5. 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)
6. 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)
7. Dose Escalation Part 1: Overall Survival (OS) (Time Frame - up to 876 days)
8. 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)
9. 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)
10. 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)
11. 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)
12. 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)
13. 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)
14. Dose Escalation Part 1: Immunogenicity of Avelumab as Measured by Antidrug Antibody (ADA) Assay (Time Frame - up to 876 days)
15. 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)
16. 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)
17. Dose Expansion Part 2: Number of Participants with Clinically Significant Changes in Laboratory Parameters (Time Frame - up to Day 1534)
18. 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)
19. 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)
20. Dose Expansion Part 2: Overall Survival (OS) (Time Frame - up to Day 1534)
21. 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)
22. 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)
23. 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)
24. 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)
25. Dose Expansion Part 2: Immunogenicity of avelumab as measured by ADA assay (Time Frame - up to Day 1534)
Avelumab: 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.
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 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.
Quelle: ClinicalTrials.gov
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"Study of Avelumab in Combination With Lenvatinib for Children With Primary CNS Tumors"
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