Clinical trial • Phase III • Oncology

Avelumab for Solid Tumors

Phase III trial of Avelumab for Solid Tumors. open-label. 205 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Solid Tumors
Trial Stage
Phase III
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
08-07-2024
First CTIS Authorization Date
21-10-2024

Trial design

open-label Phase III trial across 13 sites in Spain, Romania, Hungary and others.

Open Label
Yes
Target Sample Size
205

Eligibility

Recruits 205 No vulnerable populations selected. Participants must be ≥ 18 years and able to give signed informed consent (see Appendix 2). There are no provisions for assent of minors because minors are excluded..

Pregnancy Exclusion
Participants are pregnant or breastfeeding.
Vulnerable Population
No vulnerable populations selected. Participants must be ≥ 18 years and able to give signed informed consent (see Appendix 2). There are no provisions for assent of minors because minors are excluded.

Inclusion criteria

  • {"criterion_text":"- Participants are ≥ 18 years of age at the time of signing the informed consent.\n- Participants are under enrollment in an avelumab clinical study under the sponsorship of EMD Serono Research & Development Institute, Inc. / Merck KGaA / Merck Serono Co., Ltd (Japan).\n- Participants currently enrolled in an avelumab parent study where the primary/main analysis has been completed and who are: •\tCurrently on active avelumab treatment in any parent study, regardless of indication, OR •\tIn long-term survival follow-up after treatment (participants in Non-Small Cell Lung Cancer [NSCLC], Renal Cell Carcinoma [RCC], Urothelial Carcinoma [UC], and ovarian cancer indications only), OR •\tWho experienced CR in the parent study and discontinued avelumab treatment according to the parent study protocol.\n- Participants are male or female. Participants on active treatment must agree to continue to use highly effective contraception (ie, methods with a failure rate of less than 1% per year) for both male and female participants if the risk of conception exists (Note: The effects of the study intervention on the developing human fetus are unknown; thus, women of childbearing potential and men must agree to use highly effective contraception, defined in Appendix 3 (Contraception) or as stipulated in national or local guidelines. Highly effective contraception must be used 28 days prior to the first study intervention administration, for the duration of study intervention, and at least for 60 days after stopping study intervention. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, the treating physician should be informed immediately).\n- Participants can give signed informed consent, as indicated in Appendix 2 (Study Governance), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol."}

Exclusion criteria

  • {"criterion_text":"- Participants are pregnant or breastfeeding.\n- For participants still on active treatment: Known hypersensitivity to any of the study intervention ingredients.\n- Participant has been enrolled in the comparator arm of avelumab parent study.\n- Participant has been withdrawn from avelumab parent study for any reason (Note: Participants in the Follow-up Period are eligible).\n- Any other reason that, in the opinion of the Investigator, precludes the participant from participating in the study."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Occurrence of treatment-related non-serious treatment-emergent adverse events (TEAEs), all serious adverse events (SAEs), immune-related adverse events (irAEs), and infusion-related reactions according to the version of National Cancer Institute Common Technology Criteria for Adverse Events (NCI-CTCAE) used in the respective parent study.","definition_or_measurement_approach":"Events (treatment-related non-serious TEAEs, all SAEs, irAEs, and infusion-related reactions) will be recorded and graded according to the version of the NCI-CTCAE used in the respective parent study."}

Secondary endpoints

  • {"endpoint_text":"- Overall Survival, from baseline in parent study to date of death due to any cause.","definition_or_measurement_approach":"Overall Survival (OS) measured from baseline in the parent study to date of death from any cause."}
  • {"endpoint_text":"- Progression Free Survival according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by Investigator, from baseline in parent study until progressive disease (PD) or death due to any cause.","definition_or_measurement_approach":"Progression-Free Survival (PFS) assessed by Investigator per RECIST v1.1 from baseline in the parent study until PD or death from any cause."}
  • {"endpoint_text":"- Duration Response assessed from complete response (CR) or partial response (PR) until PD or death due to any cause.","definition_or_measurement_approach":"Duration of Response (DR) measured from the time of CR or PR until PD or death from any cause."}

Recruitment

Planned Sample Size
205
Recruitment Window Months
104
Consent Approach
Participants (≥18 years) must provide signed informed consent as specified in Appendix 2. Country-specific ICFs and subject information materials are provided; available languages and country-specific ICF versions include English, Spanish, Hungarian, Bulgarian, French, Italian, Romanian, and Polish. No assent procedures for minors (minors excluded).

Geography

Total Number Of Sites
13
Total Number Of Participants
13

Spain

Earliest CTIS Part Ii Submission Date
30-07-2024
Latest Decision Or Authorization Date
17-11-2025
Processing Time Days
475
Number Of Sites
3
Number Of Participants
3

Sites

Site Name
Consorci Sanitari Del Maresme
Department Name
Oncology
Contact Person Name
Laura Puntí Brun
Contact Person Email
lpunti@csdm.cat
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Oncology
Contact Person Name
Pilar García Alfonso
Contact Person Email
pgalfonso@salud.madrid.org
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Contact Person Name
Enriqueta Felip Font
Contact Person Email
efelip@vhio.net

Romania

Earliest CTIS Part Ii Submission Date
30-07-2024
Latest Decision Or Authorization Date
19-12-2025
Processing Time Days
506
Number Of Sites
3
Number Of Participants
3

Sites

Site Name
Radiotherapy Center Cluj S.R.L.
Department Name
Specialitatea Oncologie Medicala
Contact Person Name
Andrei Ungureanu
Site Name
Oncomed S.R.L.
Department Name
Specialitatea Oncologie Medicala
Contact Person Name
Serban Mircea Negru
Contact Person Email
snegru@yahoo.com
Site Name
Institutul Regional De Oncologie Iasi
Department Name
Sectia Oncologie Medicala
Contact Person Name
Mihai Vasile Marinca
Contact Person Email
marincarct@gmail.com

Hungary

Earliest CTIS Part Ii Submission Date
30-07-2024
Latest Decision Or Authorization Date
18-12-2025
Processing Time Days
505
Number Of Sites
1
Number Of Participants
1

Sites

Site Name
Zala Varmegyei Szent Rafael Korhaz
Department Name
Pulmonologiai Osztaly
Contact Person Name
Sandor Tehenes
Contact Person Email
tehenes.pul@zmkorhaz.hu

Italy

Earliest CTIS Part Ii Submission Date
30-07-2024
Latest Decision Or Authorization Date
13-11-2025
Processing Time Days
470
Number Of Sites
3
Number Of Participants
3

Sites

Site Name
Humanitas Mirasole S.p.A.
Department Name
U.O. Oncologia Medica ed Ematologia
Contact Person Name
Armando Santoro
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOC Oncologia Medica
Contact Person Name
Ettore D'Argento
Site Name
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
UOC Medical Oncology - Department of Precision
Contact Person Name
Floriana Morgillo

Bulgaria

Earliest CTIS Part Ii Submission Date
30-07-2024
Latest Decision Or Authorization Date
14-11-2025
Processing Time Days
471
Number Of Sites
1
Number Of Participants
1

Sites

Site Name
Mbal Za Zhensko Zdrave Nadezhda OOD
Department Name
Clinic of Medical Oncology
Contact Person Name
Mila Petrova
Contact Person Email
milllapetrova@gmail.com

France

Earliest CTIS Part Ii Submission Date
30-07-2024
Latest Decision Or Authorization Date
14-11-2025
Processing Time Days
471
Number Of Sites
1
Number Of Participants
1

Sites

Site Name
CHU Besancon
Department Name
Service d'oncologie Medicale
Contact Person Name
Thierry Nguyen
Contact Person Email
doctnguyen@hotmail.com

Poland

Earliest CTIS Part Ii Submission Date
30-07-2024
Latest Decision Or Authorization Date
15-11-2025
Processing Time Days
472
Number Of Sites
1
Number Of Participants
1

Sites

Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Dept of Lungs and Chest Oncology
Contact Person Name
Adam Pluzanski
Contact Person Email
Adam.Pluzanski@nio.gov.pl

Sponsor

Primary sponsor

Full Name
Merck KGaA
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Contract research organisations

Name
IQVIA Limited
Responsibilities
onsite monitoring, interactive response technology, project management, data management, safety reporting, statistical analysis, medical writing, regulatory expertise, medicinal product management, management of patient travel expenses reimbursement

Third parties

  • {"country":"United States","full_name":"Catalent Pharma Solutions LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Hungary","full_name":"Opt-X-Pense Kft.","duties_or_roles":"Patient travel expenses reimbursement","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Poland","full_name":"Let Me Pay Sp. z o.o.","duties_or_roles":"Patient travel expenses reimbursement","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Oracle Corp.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Germany","full_name":"Catalent Germany Schorndorf GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"onsite monitoring, interactive response technology, project management, data management, safety reporting, statistical analysis, medical writing, regulatory expertise, medicinal product management, management of patient travel expenses reimbursement","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Bavencio 20 mg/mL concentrate for solution for infusion
Active Substance
Avelumab
Modality
Monoclonal antibody
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
Authorised (marketing authorisation EU/1/17/1214/001)
Starting Dose
10 mg/kg
Dose Levels
10 mg/kg
Frequency
Once every 2 weeks

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