Clinical trial • Phase II • Oncology

DOSTARLIMAB for Rectal adenocarcinoma | Locally advanced rectal cancer (dMMR/MSI-H)

Phase II trial of DOSTARLIMAB for Rectal adenocarcinoma | Locally advanced rectal cancer (dMMR/MSI-H). open-label. 99 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Rectal adenocarcinoma | Locally advanced rectal cancer (dMMR/MSI-H)
Trial Stage
Phase II
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
23-02-2024
First CTIS Authorization Date
15-03-2024

Trial design

open-label Phase II trial in Italy, Germany, Spain and others.

Open Label
Yes
Target Sample Size
99
Trial Duration For Participant
1095

Eligibility

Recruits 99 Vulnerable population selected (isVulnerablePopulationSelected = true). Participants must be at least 18 years of age (or local legal age of consent) at time of ICF signature. Legal representative consent documents are present in the dossier (e.g. 'ICF_main_legal representative_redacted', 'ICF_genetic_legal representative'), indicating provision for consent by a legal representative where applicable. Specific assent procedures are not detailed in the available records..

Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true). Participants must be at least 18 years of age (or local legal age of consent) at time of ICF signature. Legal representative consent documents are present in the dossier (e.g. 'ICF_main_legal representative_redacted', 'ICF_genetic_legal representative'), indicating provision for consent by a legal representative where applicable. Specific assent procedures are not detailed in the available records.

Inclusion criteria

  • {"criterion_text":"- Is at least 18 years of age (or the local legal age of consent) at the time of signing the ICF"}
  • {"criterion_text":"- Has histologically confirmed Stage II to III (T3-T4, N0, or T any, N+) locally advanced rectal adenocarcinoma"}
  • {"criterion_text":"- Has radiologically and endoscopically evaluable disease"}
  • {"criterion_text":"- Has an archival FFPE tissue sample that must be available and submitted to the central reference laboratory for testing at Screening"}
  • {"criterion_text":"- Has an ECOG performance status of 0 or 1"}
  • {"criterion_text":"- Has adequate organ function"}
  • {"criterion_text":"- Has a tumor demonstrating the presence of either dMMR status or MSI-H phenotype"}

Exclusion criteria

  • {"criterion_text":"- Has distant metastatic disease"}
  • {"criterion_text":"- Has received prior radiation therapy, systemic therapy, or surgery for management of rectal cancer"}
  • {"criterion_text":"- Has a tumor that, in the investigator's judgment, is causing symptomatic bowel obstruction or otherwise requires urgent/emergent local intervention"}
  • {"criterion_text":"- Has a known additional malignancy that progressed or required active treatment within the past 2 years (Exceptions include adequately treated superficial skin cancers, superficial bladder cancers, and other in situ cancers)"}
  • {"criterion_text":"- Is immunocompromised in the opinion of the investigator"}
  • {"criterion_text":"- Has an active autoimmune disease that has required systemic treatment in the past 2 years"}
  • {"criterion_text":"- Is receiving immunosuppressive medication ; Has received systemic corticosteroids"}
  • {"criterion_text":"- Has received or plans to receive an organ or stem cell transplant that uses donor stem cells (allogeneic stem cell transplant)."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- cCR12 as assessed by ICR, defined as maintenance of cCR for 12 months. The 12-month period starts from the first disease assessment after last dose of study intervention that demonstrates cCR by ICR.","definition_or_measurement_approach":"Assessed by Independent Central Review (ICR); defined as maintenance of clinical complete response (cCR) for 12 months starting from the first disease assessment after the last dose of study intervention that demonstrates cCR by ICR."}

Secondary endpoints

  • {"endpoint_text":"- cCR24 as assessed by ICR, defined as maintenance of cCR for 24 months. The 24-month period starts from the first disease assessment after last dose of study intervention that demonstrates cCR by ICR.","definition_or_measurement_approach":"Assessed by ICR; maintenance of cCR for 24 months starting from first disease assessment after last dose demonstrating cCR by ICR."}
  • {"endpoint_text":"- cCR36 as assessed by ICR, defined as maintenance of cCR for 36 months. The 36-month period starts from the first disease assessment after last dose of study intervention that demonstrates cCR by ICR","definition_or_measurement_approach":"Assessed by ICR; maintenance of cCR for 36 months starting from first disease assessment after last dose demonstrating cCR by ICR."}
  • {"endpoint_text":"- EFS3 as assessed by investigator assessment, defined as remaining alive and free of 1) disease progression precluding surgery, 2) local recurrence, and 3) distant recurrence, as assessed by investigator at 3 years from the first dose of study intervention.","definition_or_measurement_approach":"Assessed by investigator at 3 years from first dose; event-free survival at 3 years defined as alive and free of (1) disease progression precluding surgery, (2) local recurrence, (3) distant recurrence."}

Recruitment

Planned Sample Size
99
Recruitment Window Months
78
Consent Approach
Informed consent is provided by the participant (minimum age requirement: at least 18 years or local legal age of consent). Country-specific ICF documents are present (multiple L1_ICF Main versions and language-specific ICFs and subject cards). Legal representative consent forms are included where applicable (e.g. 'ICF_main_legal representative_redacted', 'ICF_genetic_legal representative'). ICF documents and study materials are available in multiple languages as per country (documents available for France, Germany, Italy, Spain, Netherlands and English-language versions of questionnaires). Specific assent procedures are not described in the available records.

Methods

  • Site-based recruitment via participating hospital/clinic oncology departments in the participating countries (France, Germany, Italy, Spain, Netherlands) as evidenced by listed trial sites.
  • Country-specific recruitment and informed consent procedure documents available (e.g. 'Recruitment and Informed Consent Procedure_Blank_No CCI PI', 'Recruitment and Informed Consent Procedure_redacted').
  • Recruitment advertising material (document: 'Recruitment Advertising Material Flyer' associated with Germany).
  • Public/sponsor contact via EU GSK Clinical Trials Call Center (functional contact: EU GSK Clinical Trials Call Center; email: GSKClinicalSupportHD@gsk.com)

Geography

Total Number Of Sites
20
Total Number Of Participants
51

Italy

Earliest CTIS Part Ii Submission Date
07-02-2024
Latest Decision Or Authorization Date
23-12-2025
Processing Time Days
685
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Oncologia Medica 1
Contact Person Name
Federica Morano
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
U.O.C. Oncologia Medica
Contact Person Name
Lisa Salvatore
Site Name
Istituto Oncologico Veneto
Department Name
Oncologia Medica I
Contact Person Name
Sara Lonardi
Contact Person Email
sara.lonardi@iov.veneto.it

Germany

Earliest CTIS Part Ii Submission Date
07-02-2024
Latest Decision Or Authorization Date
02-01-2026
Processing Time Days
695
Number Of Sites
5
Number Of Participants
10

Sites

Site Name
Krankenhaus Nordwest GmbH
Department Name
Institut fuer Klinisch-Onkologische Forschung (IKF)
Contact Person Name
Thorsten Götze
Contact Person Email
Goetze.Thorsten@KHNW.DE
Site Name
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name
Medizinische Klinik I
Contact Person Name
Gunnar Folprecht
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Campus Virchow Klinikum - Medizinische Klinik m. S. Haematologie/Onkologie und Tumorimmunologie
Contact Person Name
Dominik Modest
Contact Person Email
dominik.modest@charite.de
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Medizinische Klinik und Poliklinik III
Contact Person Name
Volker Heinemann
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Klinik fuer Gastroenterologie, Hepatologie und Infektiologie
Contact Person Name
Christoph Roderburg

Spain

Earliest CTIS Part Ii Submission Date
07-02-2024
Latest Decision Or Authorization Date
02-01-2026
Processing Time Days
695
Number Of Sites
6
Number Of Participants
12

Sites

Site Name
Hospital Universitario Virgen De Las Nieves
Department Name
Oncología Médica
Contact Person Name
Encarna González Flores
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Oncología Médica
Contact Person Name
Pilar García Alfonso
Contact Person Email
pgarcaalfonso@gmail.com
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Oncología Médica
Contact Person Name
Susana Roselló Keränen
Contact Person Email
srosello@incliva.es
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncología Médica
Contact Person Name
María del Carmen Riesco Martínez
Contact Person Email
criesco@salud.madrid.org
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncología Médica
Contact Person Name
Jaume Capdevilla Castillon
Contact Person Email
jcapdevila@vhio.net
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Oncología Médica
Contact Person Name
Carlos López López
Contact Person Email
carlos.lopez@scsalud.es

Netherlands

Earliest CTIS Part Ii Submission Date
07-02-2024
Latest Decision Or Authorization Date
15-03-2024
Processing Time Days
37
Number Of Sites
1
Number Of Participants
5

Sites

Site Name
Universitair Medisch Centrum Utrecht
Department Name
Dept of medical oncology
Contact Person Name
Jeanine Roodhart-Wolters
Contact Person Email
oncostudies@umcutrecht.nl

France

Earliest CTIS Part Ii Submission Date
07-02-2024
Latest Decision Or Authorization Date
24-12-2025
Processing Time Days
686
Number Of Sites
5
Number Of Participants
12

Sites

Site Name
Besancon University Hospital Center
Department Name
Service Oncologie 3
Contact Person Name
Christophe Borg
Contact Person Email
xtoph.borg@gmail.com
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Service Maladies de l'Appareil Digestif
Contact Person Name
Géraldine Perkins
Site Name
Institut Paoli Calmettes
Department Name
Service Oncologie Médical 1
Contact Person Name
Emmanuel Mitry
Contact Person Email
mitryje@ipc.unicancer.fr
Site Name
Hopital Saint Antoine
Department Name
Service Oncologie Médicale
Contact Person Name
Jean-Baptiste Bachet
Contact Person Email
jean-baptiste.bachet@aphp.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Service Hépato-Gastroentérologie et Oncologie Digestive
Contact Person Name
Denis Smith
Contact Person Email
denis.smith@chu-bordeaux.fr

Sponsor

Primary sponsor

Full Name
Glaxosmithkline Research & Development Limited
Organisation Type
Pharmaceutical company
Country Of Registered Address
United Kingdom

Contract research organisations

Name
Sermes CRO
Responsibilities
patient fees reimbursement
Name
Trial Form Support S.L.
Responsibilities
Site Coordination Services, including data management.
Name
Q Squared Solutions Limited
Responsibilities
Central Laboratory for kit distribution, sample storage and transfer of samples to analyzing lab.
Name
IL-CSM Clinical Supplies Management GmbH
Responsibilities
Patient reimbursement
Name
Medable Inc.
Responsibilities
Patient Reported Outcome (PRO)

Third parties

  • {"country":"France","full_name":"Fm Richard Et Associes","duties_or_roles":"patient fees reimbursement","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Spain","full_name":"Sermes CRO","duties_or_roles":"patient fees reimbursement","organisation_type":"Pharmaceutical company"}
  • {"country":"Spain","full_name":"Alcura Health Espana S.A.","duties_or_roles":"medicine product destruction","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"IL-CSM Clinical Supplies Management GmbH","duties_or_roles":"Patient reimbursement","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"ZALARIS Deutschland GmbH","duties_or_roles":"Patient reimbursement","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Charles River Laboratories Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Spain","full_name":"Trial Form Support S.L.","duties_or_roles":"Site Coordination Services, including data management.","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medable Inc.","duties_or_roles":"Patient Reported Outcome (PRO)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Neogenomics Laboratories Inc.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"Central Laboratory for kit distribution, sample storage and transfer of samples to analyzing lab.","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
JEMPERLI 500 mg concentrate for solution for infusion
Active Substance
DOSTARLIMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
Marketing authorisation EU/1/21/1538/001
Maximum Dose
500 mg

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