Clinical trial • Phase I/II • Oncology
PEMBROLIZUMAB for Metastatic colorectal cancer | Malignant solid tumor
Phase I/II trial of PEMBROLIZUMAB for Metastatic colorectal cancer | Malignant solid tumor. Randomised, adaptive. 182 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Metastatic colorectal cancer | Malignant solid tumor
- Trial Stage
- Phase I/II
- Drug Modality
- Bispecific antibody | Monoclonal antibody | Small molecule
Key dates
- Initial CTIS Submission Date
- 03-10-2024
- First CTIS Authorization Date
- 22-10-2024
Trial design
Randomised, adaptive Phase I/II trial across 21 sites in Spain, Belgium, France and others.
- Randomised
- Yes
- Adaptive
- Yes
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 182
Eligibility
Recruits 182 Vulnerable population flag is set for the trial. All participants must provide a signed informed consent form prior to any study procedures (age ≥18). No assent process or enrolment of minors is described in the provided data..
- Pregnancy Exclusion
- Pregnant or breastfeeding patients; patients of childbearing potential must use highly effective contraception methods prior to study entry, for the duration of study participation, and for 6 months after the last dose of petosemtamab.
- Vulnerable Population
- Vulnerable population flag is set for the trial. All participants must provide a signed informed consent form prior to any study procedures (age ≥18). No assent process or enrolment of minors is described in the provided data.
Inclusion criteria
- {"criterion_text":"- Signed informed consent form (ICF) before initiation of any study procedures"}
- {"criterion_text":"- Age ≥18 years at signing of ICF"}
- {"criterion_text":"- FIRST-LINE HNSCC: patients eligible to receive pembrolizumab as first-line monotherapy with tumors expressing PD-L1, CPS ≥1"}
- {"criterion_text":"- SECOND-/THIRD-LINE HNSCC PATIENTS: patients who have progressed on or after, or are intolerant to, anti-PD-(L)1 therapy as monotherapy or in combination with other agents, and have progressed to a platinum-based chemotherapy"}
- {"criterion_text":"- 1L/2L mCRC: Patients should have been previously diagnosed with histologically or cytologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum. Patients must be RAS/RAF wild type and naive to prior anti-EGFR therapy"}
- {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1"}
- {"criterion_text":"- Adequate cardiac and organ function"}
Exclusion criteria
- {"criterion_text":"- Central nervous system metastases that are untreated or symptomatic, or require radiation, surgery, or continued steroid therapy to control symptoms within 14 days of study entry"}
- {"criterion_text":"- History of hypersensitivity reaction or any toxicity attributed to human proteins or any of the excipients that warranted permanent cessation of these agents"}
- {"criterion_text":"- Uncontrolled hypertension with appropriate treatment, or unstable angina"}
- {"criterion_text":"- History of congestive heart failure or serious cardiac arrhythmia requiring treatment (except atrial fibrillation, paroxysmal supraventricular tachycardia)"}
- {"criterion_text":"- History of prior malignancies with the exception of excised cervical intraepithelial neoplasia or nonmelanoma skin cancer, or curatively treated cancer deemed at low risk for recurrence with no evidence of disease for at least 3 years"}
- {"criterion_text":"- Patients with a history of interstitial lung disease (ILD) (eg, pneumonitis or pulmonary fibrosis), or evidence of ILD on baseline chest computerized tomography (CT) scan"}
- {"criterion_text":"- Pregnant or breastfeeding patients; patients of childbearing potential must use highly effective contraception methods prior to study entry, for the duration of study participation, and for 6 months after the last dose of petosemtamab."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Objective Response Rate (ORR)","definition_or_measurement_approach":"Not specified in the provided data"}
- {"endpoint_text":"- Frequency and severity of adverse events, serious adverse events, treatment discontinuations and modifications","definition_or_measurement_approach":"Not specified in the provided data"}
Secondary endpoints
- {"endpoint_text":"- Pharmacokinetic parameters (CEOI, Cmax, C0h, AUC, CL, Vss, tmax and t1/2,) and population pharmacokinetics","definition_or_measurement_approach":"Measurement of PK parameters: CEOI, Cmax, C0h, AUC, CL, Vss, tmax, t1/2 and population PK analyses as listed"}
- {"endpoint_text":"- Progression-Free Survival (PFS) and Duration of Response (DOR)","definition_or_measurement_approach":"Not specified in the provided data"}
- {"endpoint_text":"- Overall Survival (OS)","definition_or_measurement_approach":"Not specified in the provided data"}
Recruitment
- Planned Sample Size
- 395
- Recruitment Window Months
- 116
- Consent Approach
- Participants (age ≥18) must sign a written informed consent form (ICF) prior to any study procedures (inclusion criterion). Country-specific ICF/SIS documents are provided; available language-specific ICFs in the document list include Spanish, French, Dutch and Italian versions (country-specific versions noted). No assent process for minors is described (minors excluded).
Geography
- Total Number Of Sites
- 21
- Total Number Of Participants
- 395
Spain
- Earliest CTIS Part Ii Submission Date
- 17-10-2024
- Latest Decision Or Authorization Date
- 25-10-2024
- Processing Time Days
- 8
- Number Of Sites
- 5
- Number Of Participants
- 111
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Principal Investigator Name
- Josep Tabernero
- Principal Investigator Email
- jtabernero@vhio.net
- Contact Person Name
- Josep Tabernero
- Contact Person Email
- jtabernero@vhio.net
- Site Name
- Hospital Universitario De Navarra
- Department Name
- Oncology
- Principal Investigator Name
- Virginia Arrazubi
- Principal Investigator Email
- virginia.arrazubi.arrula@navarra.es
- Contact Person Name
- Virginia Arrazubi
- Contact Person Email
- virginia.arrazubi.arrula@navarra.es
- Site Name
- Fundacion Instituto Valenciano De Oncologia
- Department Name
- Oncology
- Principal Investigator Name
- Hector Aguilar
- Principal Investigator Email
- haguilar@fivo.org
- Contact Person Name
- Hector Aguilar
- Contact Person Email
- haguilar@fivo.org
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Oncology
- Principal Investigator Name
- José Maria Lopez-Picazo
- Principal Investigator Email
- jlpicazo@unav.es
- Contact Person Name
- José Maria Lopez-Picazo
- Contact Person Email
- jlpicazo@unav.es
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncology
- Principal Investigator Name
- Rocio Carbonero
- Principal Investigator Email
- rgcarbonero@gmail.com
- Contact Person Name
- Rocio Carbonero
- Contact Person Email
- rgcarbonero@gmail.com
Belgium
- Earliest CTIS Part Ii Submission Date
- 17-10-2024
- Latest Decision Or Authorization Date
- 24-10-2024
- Processing Time Days
- 7
- Number Of Sites
- 4
- Number Of Participants
- 34
Sites
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Oncology
- Principal Investigator Name
- Michael Saerens
- Principal Investigator Email
- michael.saerens@uzgent.be
- Contact Person Name
- Michael Saerens
- Contact Person Email
- michael.saerens@uzgent.be
- Site Name
- Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
- Department Name
- Oncology
- Principal Investigator Name
- Stéphanie Henry
- Principal Investigator Email
- stephanie.henry@uclouvain.be
- Contact Person Name
- Stéphanie Henry
- Contact Person Email
- stephanie.henry@uclouvain.be
- Site Name
- Institut Jules Bordet
- Department Name
- Oncology
- Principal Investigator Name
- Christiane Jungels
- Principal Investigator Email
- christiane.jungels@hubruxelles.be
- Contact Person Name
- Christiane Jungels
- Contact Person Email
- christiane.jungels@hubruxelles.be
- Site Name
- Cliniques Universitaires Saint-Luc
- Department Name
- Oncology
- Principal Investigator Name
- Marc Van den Eynde
- Principal Investigator Email
- marc.vandeneynde@saintluc.uclouvain.be
- Contact Person Name
- Marc Van den Eynde
- Contact Person Email
- marc.vandeneynde@saintluc.uclouvain.be
France
- Earliest CTIS Part Ii Submission Date
- 17-10-2024
- Latest Decision Or Authorization Date
- 24-10-2024
- Processing Time Days
- 7
- Number Of Sites
- 8
- Number Of Participants
- 206
Sites
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Oncologie Médicale
- Principal Investigator Name
- Amaury Daste
- Principal Investigator Email
- amaury.daste@chu-bordeaux.fr
- Contact Person Name
- Amaury Daste
- Contact Person Email
- amaury.daste@chu-bordeaux.fr
- Site Name
- Centre Leon Berard
- Department Name
- Oncologie
- Principal Investigator Name
- Jérôme Fayette
- Principal Investigator Email
- jerome.fayette@lyon.unicancer.fr
- Contact Person Name
- Jérôme Fayette
- Contact Person Email
- jerome.fayette@lyon.unicancer.fr
- Site Name
- Institut Curie
- Department Name
- Oncologie
- Principal Investigator Name
- Edith Borcoman
- Principal Investigator Email
- edith.borcoman@curie.fr
- Contact Person Name
- Edith Borcoman
- Contact Person Email
- edith.borcoman@curie.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Drug development (DITEP)
- Principal Investigator Name
- Antoine Hollebecque
- Principal Investigator Email
- antoine.hollebecque@gustaveroussy.fr
- Contact Person Name
- Antoine Hollebecque
- Contact Person Email
- antoine.hollebecque@gustaveroussy.fr
- Site Name
- Hoptial La Timone
- Department Name
- Oncologie médicale
- Principal Investigator Name
- Sébastien Salas
- Principal Investigator Email
- sebastien.salas@ap-hm.fr
- Contact Person Name
- Sébastien Salas
- Contact Person Email
- sebastien.salas@ap-hm.fr
- Site Name
- Centre Antoine Lacassagne
- Department Name
- Unité de phase précoce
- Principal Investigator Name
- Esma Saada-Bouzid
- Principal Investigator Email
- esma.saada-bouzid@nice.unicancer.fr
- Contact Person Name
- Esma Saada-Bouzid
- Contact Person Email
- esma.saada-bouzid@nice.unicancer.fr
- Site Name
- Institut Regional Du Cancer De Montpellier
- Department Name
- Oncologie médicale
- Principal Investigator Name
- Thibault Mazard
- Principal Investigator Email
- Thibault.Mazard@icm.unicancer.fr
- Contact Person Name
- Thibault Mazard
- Contact Person Email
- Thibault.Mazard@icm.unicancer.fr
- Site Name
- Centre Henri Becquerel
- Department Name
- Oncologie médiacale
- Principal Investigator Name
- Florian Clatot
- Principal Investigator Email
- florian.clatot@chb.unicancer.fr
- Contact Person Name
- Florian Clatot
- Contact Person Email
- florian.clatot@chb.unicancer.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 22-09-2025
- Latest Decision Or Authorization Date
- 21-10-2025
- Processing Time Days
- 29
- Number Of Sites
- 1
- Number Of Participants
- 10
Sites
- Site Name
- ASST Grande Ospedale Metropolitano Niguarda
- Department Name
- Oncology
- Principal Investigator Name
- Andrea Sartore Bianchi
- Principal Investigator Email
- andrea.sartorebianchi@ospedaleniguarda.it
- Contact Person Name
- Andrea Sartore Bianchi
- Contact Person Email
- andrea.sartorebianchi@ospedaleniguarda.it
Netherlands
- Earliest CTIS Part Ii Submission Date
- 17-10-2024
- Latest Decision Or Authorization Date
- 22-10-2024
- Processing Time Days
- 5
- Number Of Sites
- 3
- Number Of Participants
- 34
Sites
- Site Name
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Department Name
- Oncology
- Principal Investigator Name
- Marieke Vollebergh
- Principal Investigator Email
- m.vollebergh@nki.nl
- Contact Person Name
- Marieke Vollebergh
- Contact Person Email
- m.vollebergh@nki.nl
- Site Name
- Radboud universitair medisch centrum / RADBOUDUMC
- Department Name
- Oncology
- Principal Investigator Name
- Carla van Herpen
- Principal Investigator Email
- Carla.vanHerpen@radboudumc.nl
- Contact Person Name
- Carla van Herpen
- Contact Person Email
- Carla.vanHerpen@radboudumc.nl
- Site Name
- Universitair Medisch Centrum Utrecht
- Department Name
- Oncology
- Principal Investigator Name
- Lot Devriese
- Principal Investigator Email
- l.a.devriese@umcutrecht.nl
- Contact Person Name
- Lot Devriese
- Contact Person Email
- l.a.devriese@umcutrecht.nl
Sponsor
Primary sponsor
- Full Name
- Merus B.V.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Netherlands
Contract research organisations
- Name
- Oncology Therapeutic Development
- Responsibilities
- sponsor duties codes: [1,11,12,2,5,9] (listed as third party duties; also referenced as CRO in serious breach documentation)
- Name
- Almac Clinical Services Limited
- Responsibilities
- sponsor duties codes: [3]
- Name
- Medpace UK Limited
- Responsibilities
- sponsor duties codes: [15 (SAE management and data entry), 8]
- Name
- Syneos Health Inc.
- Responsibilities
- sponsor duties codes: [7]
- Name
- P95
- Responsibilities
- sponsor duties codes: [10,6,7]
Third parties
- {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"codes: [4]","organisation_type":"Non-Pharmaceutical company"}
- {"country":"France","full_name":"Oncology Therapeutic Development","duties_or_roles":"codes: [1,11,12,2,5,9]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"France","full_name":"Median Technologies","duties_or_roles":"codes: [15] (Medical image analysis/ review - X-ray, MRI, ultrasound, etc.)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"codes: [7]","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"codes: [3]","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Medpace UK Limited","duties_or_roles":"codes: [15 (SAE management and data entry), 8]","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"P95","duties_or_roles":"codes: [10,6,7]","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- KEYTRUDA 25 mg/mL concentrate for solution for infusion
- Active Substance
- PEMBROLIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- Intravenous administration
- Route
- Intravenous
- Authorisation Status
- Authorised
- Investigational Product Name
- PETOSEMTAMAB (MCLA-158)
- Active Substance
- PETOSEMTAMAB
- Modality
- Bispecific antibody
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Authorisation Status
- Investigational (no MA)
- Investigational Product Name
- OXALIPLATIN
- Active Substance
- OXALIPLATIN
- Modality
- Small molecule
- Routes Of Administration
- Intravenous administration
- Route
- Intravenous
- Authorisation Status
- Authorised
- Investigational Product Name
- FLUOROURACIL
- Active Substance
- FLUOROURACIL
- Modality
- Small molecule
- Routes Of Administration
- Intravenous bolus injection / IV infusion
- Route
- Intravenous
- Authorisation Status
- Authorised
- Investigational Product Name
- CALCIUM FOLINATE
- Active Substance
- CALCIUM FOLINATE
- Modality
- Small molecule
- Routes Of Administration
- Intravenous administration
- Route
- Intravenous
- Authorisation Status
- Authorised
- Investigational Product Name
- IRINOTECAN
- Active Substance
- IRINOTECAN
- Modality
- Small molecule
- Routes Of Administration
- Intravenous administration
- Route
- Intravenous
- Authorisation Status
- Authorised
- Combination Treatment
- Yes
Related trials
Other published trials that may interest you.
- GDC-9545 for Locally advanced or metastatic estrogen receptor-positive breast cancer
- Abemaciclib for Stage IV lung cancer | Breast cancer
- BGB-43395 for Advanced or metastatic solid tumors | Hormone receptor positive HER2 negative breast cancer
- AZD9833 for Estrogen receptor-positive HER2-negative advanced breast cancer
- Pembrolizumab for Classical Hodgkin lymphoma | Melanoma | Solid tumours (MSI-H/dMMR) | Solid tumours (TMB-H)