Single-arm, multicenter Phase I/Ib study of avelumab + lenvatinib in children with primary CNS tumors

Conditions

Central Nervous System Tumors

Brief summary

Dose Escalation Part 1 Occurrence and severity of CTCAE Grade ≥ 3 TEAEs according to NCICTCAE Version 5.0., Dose Escalation Part 1 Occurrence of DLTs, Dose Expansion Part 2 PFS as assessed by Investigators according to RANO criteria

Detailed description

Dose Escalation Part 1 and Dose Expansion Part 2 Occurrence and severity of any grade TEAEs, treatment-related AEs, AESIs, deaths, and clinically significant changes in laboratory parameters., Dose Escalation Part 1 and Dose Expansion Part 2 Confirmed objective response as assessed by Investigators according to RANO criteria, Dose Escalation Part 1 PFS per RANO criteria and Overall Survival, Dose Expansion Part 2 Overall Survival, Dose Escalation Part 1 and Dose Expansion Part 2 PK parameters including CEOI, AUC, Ctrough of avelumab; Cmax, tmax, and AUC of lenvatinib of at least a single dose as data permit., Dose Escalation Part 1 and Dose Expansion Part 2 Immunogenicity of avelumab as measured by ADA assay

Related papers

No related papers found yet.

Interventions

DRUGLENVIMA 10 mg hard capsules

DRUGLENVIMA 4 mg hard capsules

DRUGBavencio 20 mg/mL concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Dose Escalation Part 1 Occurrence and severity of CTCAE Grade ≥ 3 TEAEs according to NCICTCAE Version 5.0., Dose Escalation Part 1 Occurrence of DLTs, Dose Expansion Part 2 PFS as assessed by Investigators according to RANO criteria	—

Secondary

Measure	Time frame
Dose Escalation Part 1 and Dose Expansion Part 2 Occurrence and severity of any grade TEAEs, treatment-related AEs, AESIs, deaths, and clinically significant changes in laboratory parameters., Dose Escalation Part 1 and Dose Expansion Part 2 Confirmed objective response as assessed by Investigators according to RANO criteria, Dose Escalation Part 1 PFS per RANO criteria and Overall Survival, Dose Expansion Part 2 Overall Survival, Dose Escalation Part 1 and Dose Expansion Part 2 PK parameters including CEOI, AUC, Ctrough of avelumab; Cmax, tmax, and AUC of lenvatinib of at least a single dose as data permit., Dose Escalation Part 1 and Dose Expansion Part 2 Immunogenicity of avelumab as measured by ADA assay	—

Measure

Time frame

Dose Escalation Part 1 and Dose Expansion Part 2 Occurrence and severity of any grade TEAEs, treatment-related AEs, AESIs, deaths, and clinically significant changes in laboratory parameters., Dose Escalation Part 1 and Dose Expansion Part 2 Confirmed objective response as assessed by Investigators according to RANO criteria, Dose Escalation Part 1 PFS per RANO criteria and Overall Survival, Dose Expansion Part 2 Overall Survival, Dose Escalation Part 1 and Dose Expansion Part 2 PK parameters including CEOI, AUC, Ctrough of avelumab; Cmax, tmax, and AUC of lenvatinib of at least a single dose as data permit., Dose Escalation Part 1 and Dose Expansion Part 2 Immunogenicity of avelumab as measured by ADA assay

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Countries

France, Germany

Outcome results

None listed