Phase I/II study of avelumab in pediatric cancer subjects

Open-label, Phase I/II study to evaluate pharmacokinetics, pharmacodynamics, safety, and anticancer activity of avelumab in pediatric subjects from birth to less than 18 years of age with refractory or relapsed solid tumors and lymphoma - N/A

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002985-28-BE

Enrollment

148

Registered

2017-12-15

Start date

2018-03-02

Completion date

Unknown

Last updated

2021-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid tumors (including central nervous system tumors) and lymphoma MedDRA version: 20.1 Level: LLT Classification code 10065143 Term: Malignant solid tumour System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10025632 Term: Malignant lymphoma System Organ Class: 100000004864

Interventions

Trade Name: BAVENCIO Product Name: BAVENCIO Product Code: MSB0010718C Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: AVELUMAB CAS Number: N/A Current Sponsor code: MSB

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Male or female subjects 0 to =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Prior therapy with any antibody or drug targeting T-cell coregulatory proteins; concurrent anticancer treatment or immunosuppressive agents; prior organ transplantation; significant acute or chronic infections; other significant diseases or conditions that might impair the subject’s tolerance of trial treatment.

Design outcomes

Primary

Measure	Time frame
Main Objective: Phase I - To evaluate the safety and tolerability of avelumab - To determine the RP2D of avelumab in pediatric subjects 0 to < 18 years of age with solid tumors and lymphoma Phase II - To assess antitumor activity of avelumab by determining the ORR according to RECIST 1.1 and as adjudicated by the Investigator in 2 expansion cohorts in specified tumor types in pediatric subjects treated with avelumab;Secondary Objective: Phase I -To assess antitumor activity of avelumab by determining the ORR according to RECIST 1.1 and as adjudicated by the Investigator in pediatric subjects with solid tumors and lymphoma treated with avelumab Phase II -To evaluate the safety and tolerability of avelumab Phase I and Phase II -To assess PFS based on Investigator assessments, DOR, TTR, and OS -To characterize the PK of avelumab -To assess the immunogenicity of avelumab -To evaluate PD-L1 expression; tumor-infiltrating T-cell activity; T-cell population; and T-cell, B-cell, and NK-cell numbers in tumor tissue at Baseline and at confirmed progression (if tumor tissue is obtained) -To measure changes in vaccination-related antibody concentrations (diphtheria, tetanus, and pneumococcal conjugate);Primary end point(s): Phase I 1.Occurrence and severity of TEAEs = Grade 3 according to NCI-CTCAE v4.03 2.DLTs to determine the RP2D Phase II 3.Confirmed BOR according to RECIST 1.1 and as adjudicated by the Investigator;Timepoint(s) of evaluation of this end point: Phase I 1.Time from the first trial drug administration to the last drug administration date + 30 days or the earliest date of subsequent anticancer drug therapy minus 1 day, whichever occurs first, unless otherwise stated. 2.Time from the first trial drug administration to completion of the first 2 cycles of treatment. Phase II 3.Time from rom the first trial administration date until confirmed disease progression.	—

Measure

Time frame

Main Objective: Phase I - To evaluate the safety and tolerability of avelumab - To determine the RP2D of avelumab in pediatric subjects 0 to < 18 years of age with solid tumors and lymphoma Phase II - To assess antitumor activity of avelumab by determining the ORR according to RECIST 1.1 and as adjudicated by the Investigator in 2 expansion cohorts in specified tumor types in pediatric subjects treated with avelumab;Secondary Objective: Phase I -To assess antitumor activity of avelumab by determining the ORR according to RECIST 1.1 and as adjudicated by the Investigator in pediatric subjects with solid tumors and lymphoma treated with avelumab Phase II -To evaluate the safety and tolerability of avelumab Phase I and Phase II -To assess PFS based on Investigator assessments, DOR, TTR, and OS -To characterize the PK of avelumab -To assess the immunogenicity of avelumab -To evaluate PD-L1 expression; tumor-infiltrating T-cell activity; T-cell population; and T-cell, B-cell, and NK-cell numbers in tumor tissue at Baseline and at confirmed progression (if tumor tissue is obtained) -To measure changes in vaccination-related antibody concentrations (diphtheria, tetanus, and pneumococcal conjugate);Primary end point(s): Phase I 1.Occurrence and severity of TEAEs = Grade 3 according to NCI-CTCAE v4.03 2.DLTs to determine the RP2D Phase II 3.Confirmed BOR according to RECIST 1.1 and as adjudicated by the Investigator;Timepoint(s) of evaluation of this end point: Phase I 1.Time from the first trial drug administration to the last drug administration date + 30 days or the earliest date of subsequent anticancer drug therapy minus 1 day, whichever occurs first, unless otherwise stated. 2.Time from the first trial drug administration to completion of the first 2 cycles of treatment. Phase II 3.Time from rom the first trial administration date until confirmed disease progression.

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Secondary

Measure	Time frame
Secondary end point(s): Phase I 1.Confirmed BOR according to RECIST 1.1 and as adjudicated by the Investigator Phase I and Phase II 2.Occurrence and severity of TEAEs, AEs of special interest, and treatment-related AEs, and incidence of laboratory abnormalities, as graded by NCI-CTCAE v4.03 3.DORper RECIST 1.1 and as adjudicated by the Investigator 4.TTR,per RECIST 1.1 and as adjudicated by the Investigator 5.PFS per RECIST 1.1 and as adjudicated by the Investigator 6.OS 7.Vital signs (including blood pressure and heart rate) 8.Single- and multiple-dose PK profiles of avelumab (ie, Cmax, AUC, t1/2, and Ctrough, as data permit) 9.Immunogenicity as measured by avelumab ADA, including NAbs 10.Assessment of tumor PD-L1 expression; tumor-infiltrating T-cell activity; T-cell population; and T-cell, B-cell, and NK-cell numbers at Baseline and at confirmed progression (if tumor tissue is obtained) 11.Vaccination-related antibody concentrations.;Timepoint(s) of evaluation of this end point: 1.From 1st administration until progression 2.From 1st administration to the last administration date + 30d or date of subsequent anticancer drug therapy -1d 3.From 1st occurrence of CR or PR to either PD or death 4.From the date of 1st dose to the 1st documentation of CR or PR 5.From 1st administration to either 1st observation of PD or death within 12W of the last tumor assessment 6.From the 1st administration to death 7.At screening, every 2W during treatment period, EoT, Safety FU (30d after last tx) 8.At W1,W3,W5,W9,W13,W15,W25,W37,W49 and every 6 cycle thereafter, EoT,Safety FU (30d after last tx) 9.At W1, W3,W5,W9, W13, W25,W37,W49 and every 6 cycle thereafter, EoT and at Safety FU (30 d after last tx) 10.Baseline and at confirmed progression 11.At W1, W13 and EoT	—

Measure

Time frame

Secondary end point(s): Phase I 1.Confirmed BOR according to RECIST 1.1 and as adjudicated by the Investigator Phase I and Phase II 2.Occurrence and severity of TEAEs, AEs of special interest, and treatment-related AEs, and incidence of laboratory abnormalities, as graded by NCI-CTCAE v4.03 3.DORper RECIST 1.1 and as adjudicated by the Investigator 4.TTR,per RECIST 1.1 and as adjudicated by the Investigator 5.PFS per RECIST 1.1 and as adjudicated by the Investigator 6.OS 7.Vital signs (including blood pressure and heart rate) 8.Single- and multiple-dose PK profiles of avelumab (ie, Cmax, AUC, t1/2, and Ctrough, as data permit) 9.Immunogenicity as measured by avelumab ADA, including NAbs 10.Assessment of tumor PD-L1 expression; tumor-infiltrating T-cell activity; T-cell population; and T-cell, B-cell, and NK-cell numbers at Baseline and at confirmed progression (if tumor tissue is obtained) 11.Vaccination-related antibody concentrations.;Timepoint(s) of evaluation of this end point: 1.From 1st administration until progression 2.From 1st administration to the last administration date + 30d or date of subsequent anticancer drug therapy -1d 3.From 1st occurrence of CR or PR to either PD or death 4.From the date of 1st dose to the 1st documentation of CR or PR 5.From 1st administration to either 1st observation of PD or death within 12W of the last tumor assessment 6.From the 1st administration to death 7.At screening, every 2W during treatment period, EoT, Safety FU (30d after last tx) 8.At W1,W3,W5,W9,W13,W15,W25,W37,W49 and every 6 cycle thereafter, EoT,Safety FU (30d after last tx) 9.At W1, W3,W5,W9, W13, W25,W37,W49 and every 6 cycle thereafter, EoT and at Safety FU (30 d after last tx) 10.Baseline and at confirmed progression 11.At W1, W13 and EoT

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Countries

Belgium, Canada, Denmark, Korea, Republic of, United States

Contacts

Public ContactCommunication Center

Merck KGaA

service@merckgroup.com+496151725200

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026