Clinical trial • Phase II • Oncology

PEMBROLIZUMAB for Metastatic colorectal cancer | MSI-H/dMMR colorectal cancer | BRAF V600E-mutant colorectal cancer

Phase II trial of PEMBROLIZUMAB for Metastatic colorectal cancer | MSI-H/dMMR colorectal cancer | BRAF V600E-mutant colorectal cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Metastatic colorectal cancer | MSI-H/dMMR colorectal cancer | BRAF V600E-mutant colorectal cancer
Trial Stage
Phase II
Drug Modality
Monoclonal antibody|Small molecule
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
17-05-2024
First CTIS Authorization Date
18-07-2024

Trial design

Randomised, open-label, control arm (arm b): pembrolizumab alone (drug name stated; dose/schedule not specified in the public record). experimental/triplet arm (arm a): encorafenib + cetuximab + pembrolizumab (combination experimental arm; per protocol title). Phase II trial in Sweden, Norway, Netherlands and others.

Randomised
Yes
Open Label
Yes
Comparator
Control Arm (Arm B): Pembrolizumab alone (drug name stated; dose/schedule not specified in the public record). Experimental/Triplet Arm (Arm A): Encorafenib + Cetuximab + Pembrolizumab (combination experimental arm; per protocol title).
Target Sample Size
29

Eligibility

Recruits 29 paediatric patients.

Vulnerable Population
Adolescents included: participants age ≥16 years are eligible; where local regulations do not permit adolescent enrollment, minimum age is ≥18. Participants ≥16 years under guardianship may participate with consent of their legally authorised guardian. The investigator (or designee) will obtain written/electronically signed informed consent from each participant's legal guardian (and the participant’s assent, when applicable) before any study-specific activity; legal guardians should be fully informed and participants informed to the fullest extent possible. Age-specific consent/assent and parent information documents are provided (assent/parent ICDs present in the public documents for multiple countries).

Inclusion criteria

  • {"criterion_text":"- Molecular Prescreening Inclusion Criteria: 1. Locally confirmed dMMR or MSI-H disease in tumor tissue or blood (eg. ctDNA genetic testing) as determined by a local laboratory assay in a CLIA- or similarly certified laboratory\n- Molecular Prescreening Inclusion Criteria 2. Locally confirmed BRAF V600E mutation in tumor tissue or blood (eg, ctDNA genetic testing) as determined by either PCR or NGS-based local laboratory assay in a CLIA- or similarly certified laboratory.\n- Screening Inclusion Criteria - 3. Male or female participants age ≥16 years at the time of informed consent/assent (or the minimum country specific age of consent if >16). In countries or sites where enrollment of adolescents is not permitted (eg, Germany), male or female participants age ≥18 years at the time of informed consent.\n- Screening Inclusion Criteria - 4. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.\n- Screening Inclusion Criteria: 5. Histologically or cytologically confirmed metastatic Stage IV colorectal adenocarcinoma. Note: Patients with oligometastatic disease previously treated with curative intent are eligible to participate in the study as long as they have baseline measurable disease per RECIST 1.1.\n- Screening Inclusion Criteria: 6. Presence of measurable disease per RECIST v1.1, as assessed by investigator and evidenced by available baseline tumor scan. Note: Baseline scan is defined as the last scan prior to the date of randomization (Section 10.10). Note: Baseline scans will be required to be available for subsequent submission to a central radiology vendor to be assessed by the BICR.\n- Screening Inclusion Criteria: 7. Availability of adequate tumor tissue (primary or metastatic; archival or newly obtained; block or slides; see Section 8.6.1). Whenever possible, the archival sample should be from the same tumor block that was used for local BRAF V600E mutation and MSI-H/dMMR testing. It is recommended that the tissue block be obtained from a biopsy or surgery that was performed within 2 years prior to study enrollment. Please consult the study clinician if samples are older. A newly obtained tumor tissue biopsy must be provided prior to randomization for participants unable to provide adequate archival tumor tissue. If a newly obtained biopsy is taken, the biopsy should be taken from a nontarget lesion when possible. Note: Participants with early stage disease (eg, Stages I-III) treated with surgery followed by chemotherapy (eg, treatment in the adjuvant setting) or have received prior systemic neoadjuvant therapy with or without radiation who present with new lesions or evidence of disease recurrence during or within 6 months of the last dose of chemotherapy would be considered as having received 1 prior systemic therapy in the metastatic setting.\n- Screening Inclusion Criteria: 8. Have not received prior systemic regimens for metastatic disease. Note: Participants with early stage disease (eg, Stages I-III) treated with surgery followed by chemotherapy (eg, treatment in the adjuvant setting) or have received prior systemic neoadjuvant therapy with or without radiation who present with new lesions or evidence of disease recurrence during or within 6 months of the last dose of chemotherapy would be considered as having received 1 prior systemic therapy in the metastatic setting.\n- Screening Inclusion Criteria: 9. ECOG performance status of ≤1.\n- Screening Inclusion Criteria: 10. Adequate bone marrow function characterized by the following at screening: a. ANC ≥1.5 × 109/L b. Platelets ≥100 × 109/L c. Hemoglobin ≥9.0 g/dL (without blood transfusions 2 weeks prior to randomization)\n- Screening Inclusion Criteria: 11. Adequate hepatic and renal function characterized by the following at screening: a. Serum Tbili ≤1.5 × ULN and < 2 mg/dL. Note: Tbili >1.5 × ULN is allowed if direct (conjugated) ≤ 1.5 × ULN and indirect (unconjugated) bilirubin is ≤ 4.25 × ULN. Note: Participants with documented Gilbert syndrome or hyperbilirubinemia due to non-hepatic cause (eg, hemolysis, hematoma) may be enrolled following discussion and agreement with the sponsor or designee. b. ALT and AST ≤ 2.5 × ULN, or ≤ 5 × ULN in the presence of liver metastases.\n- Screening Inclusion Criteria: 12.\tCapable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol. Note: Participants ≥ 16 years old that are under guardianship may participate with the consent of their legally authorized guardian if permitted by local regulations. When appropriate, adolescent participants will be included in all discussions (see Sectiopn 10.1.3). Note: The investigator, or a person designated by the investigator, will obtain [written/electronically signed] informed consent/assent from each study participant’s legal guardian (as defined in Appendix 1 [and the participant’s assent, when applicable,] before any study-specific activity is performed [unless a waiver of informed consent has been granted by an IRB/ EC]). All legal guardians should be fully informed, and participants should be informed to the fullest extent possible, about the study in language and terms they are able to understand. The investigator will retain the original copy of each participant's signed consent[/assent document."}

Exclusion criteria

  • {"criterion_text":"- 1. Colorectal adenocarcinoma that is RAS mutant or for which RAS mutation status is unknown.\n- 2. Documented clinical disease progression (eg, worsening of performance status, clinical symptoms, or clinically significant laboratory parameters demonstrating worsening of disease) or radiographic disease progression during the screening period.\n- 3. Has active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, ie, without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.\n- 4. Leptomeningeal disease.\n- 5. Diagnosis of immunodeficiency or an active autoimmune disease that required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Note: Participants with diabetes type I, vitiligo, psoriasis, controlled asthma, Graves' disease, Hashimoto's disease or hypo- or hyperthyroid disease are exceptions and may participate. Note: Replacement and symptomatic therapies (eg, levothyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) are not considered a form of immunosuppressive agents and are permitted.\n- 6. Presence of acute or chronic pancreatitis.\n- 7. History of chronic inflammatory bowel disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) ≤ 12 months prior to randomization.\n- 8. Unable to swallow, retain, and absorb oral medications.\n- 9. Impaired gastrointestinal function (eg, uncontrolled nausea, vomiting or diarrhea, malabsorption syndrome, small bowel resection) or disease which may significantly alter the absorption of oral study intervention or recent changes in bowel function suggesting current or impending bowel obstruction.\n- 10. Clinically significant cardiovascular diseases, including any of the following: a. History of acute myocardial infarction, acute coronary syndromes (including unstable angina, coronary artery bypass graft, coronary angioplasty or stenting) ≤ 6 months prior to randomization. b. Congestive heart failure requiring treatment (New York Heart Association Grade ≥ 2). c. Recent history (one year) or presence of clinically significant cardiac arrhythmias (including uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia). d. History of thromboembolic or cerebrovascular events ≤ 12 weeks prior to randomization. Examples include transient ischemic attacks, cerebrovascular accidents, hemodynamically significant (ie, massive or sub-massive) deep vein thrombosis or pulmonary emboli. Note: Participants with either deep vein thrombosis or pulmonary emboli that do not result in hemodynamic instability are allowed to enroll as long as they are on a stable dose of anticoagulants for at least 4 weeks. Note: Participants with thromboembolic events related to indwelling catheters (including PICC lines) or other procedures may be enrolled e. Triplicate average QTcF interval ≥480 ms or a history of prolonged QT syndrome. Note: Participants with BBB or with an implanted cardiac pacemaker may enroll into the study upon agreement between the investigator and sponsor or designee. f. Congenital LQTS.\n- 11. Has a history of (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease.\n- 12. Evidence of active and uncontrolled bacterial or viral infection, with certain exceptions, as noted below, for chronic infection with hepatitis B or hepatitis C, within 2 weeks prior to start of study intervention. Note: For COVID-19/SARS-CoV-2, SARS-CoV-2 testing is not mandated for study entry, and testing should follow local clinical practice standards. Any participant with a positive test result for SARS-CoV-2 infection, is known to have asymptomatic infection or is suspected of having SARS-CoV-2, is excluded. Once the infection resolves, the participant may be considered for re-screening.\n- 13. Participants positive for HIV are ineligible unless they meet all of the following: a. A stable regimen of highly active anti-retroviral therapy that is not contraindicated. b. No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections c. A CD4 count >250 cells/mcL, and an undetectable HIV viral load on standard PCR-based tests. Note: Participants with a history of Kaposi sarcoma and/or Multicentric Castleman Disease are not eligible.\n- 14. Active hepatitis B or hepatitis C infection"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- PFS per investigator, defined as the time from randomization until PD based on investigator assessment per RECIST v1.1 or death due to any cause, whichever occurs first","definition_or_measurement_approach":"Time from randomization until disease progression (PD) as assessed by the investigator per RECIST v1.1, or death from any cause (whichever occurs first)."}

Secondary endpoints

  • {"endpoint_text":"- Incidence and severity of AEs graded according to the NCI CTCAE v4.03 and changes in clinical laboratory test parameters, vital signs and ECGs","definition_or_measurement_approach":"Adverse events graded per NCI CTCAE v4.03; monitoring of clinical laboratory parameters, vital signs and ECG changes."}
  • {"endpoint_text":"- Incidence of dosing interruptions, dose modifications and permanent discontinuations associated with AEs","definition_or_measurement_approach":"Recording incidence of dose interruptions, modifications and permanent discontinuations attributed to adverse events."}
  • {"endpoint_text":"- OS, defined as the time from the date of randomization to the date of death due to any cause","definition_or_measurement_approach":"Overall survival measured from randomization date to date of death from any cause."}
  • {"endpoint_text":"- Objective response, defined as confirmed CR or confirmed PR based on investigator assessment per RECIST v1.1, from the date of randomization until the date of the first documentation of PD, death or start of new anticancer therapy","definition_or_measurement_approach":"Confirmed complete response (CR) or partial response (PR) per RECIST v1.1 as assessed by investigator; measured from randomization until PD, death, or start of new anticancer therapy."}
  • {"endpoint_text":"- DOR, defined as the time from the first response, until PD based on investigator assessment per RECIST v1.1 or death due to any cause, whichever occurs first","definition_or_measurement_approach":"Duration of response measured from date of first documented response until PD per investigator RECIST v1.1 assessment or death."}
  • {"endpoint_text":"- BRAF and MSI-status as determined by retrospective central testing of baseline tumor tissue;","definition_or_measurement_approach":"Retrospective central laboratory testing of baseline tumor tissue to confirm BRAF and MSI status."}
  • {"endpoint_text":"- EORTC QLQ-C30: change from baseline in the global health status/QoL, functional and symptom scales, and single items","definition_or_measurement_approach":"Patient-reported outcomes using EORTC QLQ-C30; change from baseline in global health/QoL, functional and symptom scales, and individual items."}
  • {"endpoint_text":"- EQ-5D-5L: change from baseline in the index score and VAS","definition_or_measurement_approach":"EQ-5D-5L index score and visual analogue scale (VAS) change from baseline."}
  • {"endpoint_text":"- PGIS score: change from baseline in the score","definition_or_measurement_approach":"Patient Global Impression of Severity (PGIS) score change from baseline."}
  • {"endpoint_text":"- PGIC score","definition_or_measurement_approach":"Patient Global Impression of Change (PGIC) assessment."}

Recruitment

Planned Sample Size
29
Recruitment Window Months
56
Consent Approach
Written or electronically signed informed consent is obtained as described in Appendix 1. Participants must be capable of giving signed informed consent. Participants ≥16 years under guardianship may participate with the consent of their legally authorised guardian if permitted by local regulations. Investigators (or designees) obtain written/electronically signed informed consent/assent from each participant's legal guardian (and the participant's assent when applicable) before any study-specific activity; the investigator retains the original signed consent/assent document. Age-specific and parent/assent information/consent documents are provided (assent and parent ICDs are present for multiple countries). Public documents are available in multiple languages (examples in the record include English, French, Dutch, Spanish, Italian, German, Danish, Polish, Slovak, Czech, Norwegian).

Methods

  • Innovative Trials Limited (United Kingdom) - Patient Recruitment (third-party vendor listed with responsibility 'Patient Recruitment'; specific channels/approaches not described in the public record)

Geography

Total Number Of Sites
42
Total Number Of Participants
75

Sweden

Earliest CTIS Part Ii Submission Date
04-06-2024
Latest Decision Or Authorization Date
18-07-2024
Processing Time Days
44
Number Of Sites
3
Number Of Participants
4

Sites

Site Name
Soedersjukhuset AB
Department Name
Onkologmottagningen
Contact Person Name
Pehr A Lind
Contact Person Email
pehr.lind@regionstockholm.se
Site Name
Karolinska University Hospital
Contact Person Name
Sandra Andersson
Site Name
Skaraborg Hospital-Vastra Gotalandsregionen
Department Name
Onkologisk mottagning
Contact Person Name
Johan Haux
Contact Person Email
johan.haux@vgregion.se

Norway

Earliest CTIS Part Ii Submission Date
04-06-2024
Latest Decision Or Authorization Date
18-07-2024
Processing Time Days
44
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Oslo University Hospital HF
Contact Person Name
Tormod Kyrre Guren
Contact Person Email
uxtour@ous-hf.no

Netherlands

Earliest CTIS Part Ii Submission Date
04-06-2024
Latest Decision Or Authorization Date
18-07-2024
Processing Time Days
44
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Academisch Ziekenhuis Maastricht
Contact Person Name
Loes Maria Latten Jansen
Contact Person Email
loes.jansen@mumc.nl

Belgium

Earliest CTIS Part Ii Submission Date
04-06-2024
Latest Decision Or Authorization Date
18-07-2024
Processing Time Days
44
Number Of Sites
3
Number Of Participants
5

Sites

Site Name
Institut Jules Bordet
Department Name
Medical Oncology - GI department
Contact Person Name
Francesco Sclafani
Contact Person Email
francesco.sclafani@bordet.be
Site Name
Imelda
Department Name
Imelda GI Clinical Research Center
Contact Person Name
Pieter-Jan Cuyle
Contact Person Email
pieter-jan.cuyle@imelda.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Clinical research
Contact Person Name
Marc Van den Eynde

Poland

Earliest CTIS Part Ii Submission Date
04-06-2024
Latest Decision Or Authorization Date
18-07-2024
Processing Time Days
44
Number Of Sites
2
Number Of Participants
5

Sites

Site Name
Przychodnia Lekarska KOMED
Contact Person Name
Boguslawa Karaszewska
Contact Person Email
karasiowa@gmail.com
Site Name
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
Department Name
Oddział Dzienny Chemioterapii i Hematologii Onkologicznej/Oddział Onkologii Klinicznej
Contact Person Name
Dariusz Sawka
Contact Person Email
dyronk@szpital-brzozow.pl

Denmark

Earliest CTIS Part Ii Submission Date
04-06-2024
Latest Decision Or Authorization Date
21-07-2024
Processing Time Days
47
Number Of Sites
4
Number Of Participants
4

Sites

Site Name
Region Hovedstaden
Department Name
Department of Oncology
Contact Person Name
Jakob Vasehus Schou
Site Name
Rigshospitalet
Department Name
Depart. of Oncology
Contact Person Name
Camilla Qvortrup
Contact Person Email
Camilla.qvortrup@regionh.dk
Site Name
Sygehus Lillebælt
Department Name
Dept. of Oncology
Contact Person Name
Torben Frøstrup Hansen
Contact Person Email
Torben.Hansen@rsyd.dk
Site Name
Aalborg University Hospital
Contact Person Name
Laurids Østergaard Poulsen
Contact Person Email
laop@rn.dk

France

Earliest CTIS Part Ii Submission Date
04-06-2024
Latest Decision Or Authorization Date
18-07-2024
Processing Time Days
44
Number Of Sites
4
Number Of Participants
5

Sites

Site Name
Institut Regional Du Cancer De Montpellier
Contact Person Name
Thibault Mazard
Site Name
University Hospital Of Clermont-Ferrand
Contact Person Name
Denis Pezet
Contact Person Email
dpezet@chu-clermontferrand.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service d'hépatogastroentérologie et d'oncologie digestive
Contact Person Name
Aziz Zaanan
Contact Person Email
aziz.zaanan@aphp.fr
Site Name
Hopital Saint Antoine
Department Name
service d`Oncologie Médicale
Contact Person Name
Thierry André
Contact Person Email
thierry.andre@aphp.fr

Germany

Earliest CTIS Part Ii Submission Date
04-06-2024
Latest Decision Or Authorization Date
22-07-2024
Processing Time Days
48
Number Of Sites
1
Number Of Participants
9

Sites

Site Name
Facharztzentrum Eppendorf
Department Name
Facharztzentrum Eppendorf
Contact Person Name
Eray Goekkurt
Contact Person Email
goekkurt@hope-hamburg.de

Italy

Earliest CTIS Part Ii Submission Date
04-06-2024
Latest Decision Or Authorization Date
23-07-2024
Processing Time Days
49
Number Of Sites
11
Number Of Participants
15

Sites

Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Dipartimento di Ematologia e Oncologia
Contact Person Name
Andrea Sartore-Bianchi
Site Name
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
UOC Oncoematologia
Contact Person Name
Erika Martinelli
Site Name
Casa Sollievo Della Sofferenza
Department Name
U.O.C ONCOLOGIA
Contact Person Name
Tiziana Pia Latiano
Contact Person Email
latiano.tiziana@gmail.com
Site Name
Istituto Oncologico Veneto
Department Name
Oncologia Medica 1
Contact Person Name
Sara Lonardi
Contact Person Email
sara.lonardi@iov.veneto.it
Site Name
Azienda Ospedaliero-Universitaria Di Cagliari
Department Name
SC ONCOLOGIA MEDICA
Contact Person Name
MARIO SCARTOZZI
Contact Person Email
marioscartozzi@gmail.com
Site Name
Fondazione Poliambulanza
Department Name
U.O.ONCOLOGIA MEDICA
Contact Person Name
Alberto Zaniboni
Site Name
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS
Department Name
Oncologia Medica
Contact Person Name
Elisabetta Fenocchio
Contact Person Email
elisabetta.fenocchio@ircc.it
Site Name
Azienda USL IRCCS Di Reggio Emilia
Department Name
Medical Oncology
Contact Person Name
Francesco Iachetta
Contact Person Email
Francesco.iachetta@ausl.re.it
Site Name
Azienda Unita Sanitaria Locale 6 Livorno
Department Name
UOC Oncologi
Contact Person Name
Samanta Cupini
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
U.O. Oncologia Medica 2
Contact Person Name
Chiara Cremolini
Contact Person Email
chiaracremolini@gmail.com
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Divisione di Oncologia Medica Gastrointestinale e Tumori Neuroendocrini
Contact Person Name
Maria Giulia Zampino
Contact Person Email
maria.zampino@ieo.it

Spain

Earliest CTIS Part Ii Submission Date
04-06-2024
Latest Decision Or Authorization Date
22-07-2024
Processing Time Days
48
Number Of Sites
9
Number Of Participants
13

Sites

Site Name
University Hospital Virgen Del Rocio S.L.
Contact Person Name
Maria Luisa Limon Miron
Contact Person Email
mllimon02@hotmail.com
Site Name
Hospital Unviersitario Miguel Servet
Contact Person Name
Eduardo Polo Marques
Contact Person Email
eduardopolomarques@hotmail.com
Site Name
Hospital General Universitario Gregorio Maranon
Contact Person Name
Pilar Garcia Alfonso
Contact Person Email
pgarcaalfonso@gmail.com
Site Name
Hospital General Universitario De Valencia
Department Name
Servicio de Oncología
Contact Person Name
Maria Jose Safont Aguilera
Contact Person Email
mjsafont@yahoo.es
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncología Médica
Contact Person Name
Maria Reyes Ferreiro Monteagudo
Contact Person Email
reyes-ferreiro@hotmail.com
Site Name
Hospital Clinic De Barcelona
Contact Person Name
Joan Maurel Santasusana
Contact Person Email
jmaurel@clinic.cat
Site Name
Institut Catala D'oncologia
Department Name
Servicio Oncologia Medica
Contact Person Name
Jose Carlos Ruffinelli Rodriguez
Contact Person Email
jruffinelli@iconcologia.net
Site Name
Complexo Hospitalario Universitario De Santiago
Contact Person Name
Juan Ruiz Banobre
Contact Person Email
juan.ruiz.banobre@sergas.es
Site Name
Hospital Universitari Vall D Hebron
Contact Person Name
Elena Elez Fernandez
Contact Person Email
meelez@vhio.net

Slovakia

Earliest CTIS Part Ii Submission Date
04-06-2024
Latest Decision Or Authorization Date
18-07-2024
Processing Time Days
44
Number Of Sites
1
Number Of Participants
5

Sites

Site Name
Narodny Onkologicky Ustav
Contact Person Name
Stefan Porsok
Contact Person Email
stefan.porsok@nou.sk

Czechia

Earliest CTIS Part Ii Submission Date
04-06-2024
Latest Decision Or Authorization Date
23-07-2024
Processing Time Days
49
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Fakultni Thomayerova nemocnice
Department Name
Onkologická klinika 1. LF UK a FTN
Contact Person Name
Eugen Kubala
Contact Person Email
eugen.kubala@ftn.cz
Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
Klinika onkologie a radioterapie
Contact Person Name
John Stanislav
Contact Person Email
stanislav.john@fnhk.cz

Sponsor

Primary sponsor

Full Name
Pfizer Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
PPD Global Limited
Responsibilities
pCRO, contacts
Name
Icon Clinical Research Limited
Responsibilities
Training

Third parties

  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Site Payments","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Signant Health","duties_or_roles":"eCOA, Helpdesk, Hosting, Telecommunications, Translation","organisation_type":"Industry"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"CIRB","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Training","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Icon Laboratory Services Inc.","duties_or_roles":"Central Lab","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Imagining","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Transperfect Translations International Inc.","duties_or_roles":"Translation","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"PPD Global Limited","duties_or_roles":"pCRO, contacts","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Innovative Trials Limited","duties_or_roles":"Patient Recruitment","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
PEMBROLIZUMAB
Active Substance
PEMBROLIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
Intravenous
Route
Intravenous
Maximum Dose
400 mg
Investigational Product Name
CETUXIMAB
Active Substance
CETUXIMAB
Modality
Monoclonal antibody
Routes Of Administration
Intravenous
Route
Intravenous
Maximum Dose
500 mg/m2
Investigational Product Name
ENCORAFENIB
Active Substance
ENCORAFENIB
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Maximum Dose
300 mg
Combination Treatment
Yes

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