Clinical trial • Not applicable • Oncology|Gastroenterology|Immunology|Musculoskeletal
NIVOLUMAB for Inflammatory bowel disease|Rheumatic disease|Cancer
Not applicable trial of NIVOLUMAB for Inflammatory bowel disease|Rheumatic disease|Cancer. open-label. 1261 participants.
Overview
- Trial Therapeutic Area
- Oncology|Gastroenterology|Immunology|Musculoskeletal
- Trial Disease
- Inflammatory bowel disease|Rheumatic disease|Cancer
- Trial Stage
- Not applicable
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 14-11-2024
- First CTIS Authorization Date
- 25-11-2024
Trial design
open-label Not applicable trial across 6 sites in Netherlands.
- Open Label
- Yes
- Real World Control
- Yes
- Target Sample Size
- 1261
Eligibility
Recruits 1261 Vulnerable populations not selected; participants must be able and willing to sign the Informed Consent Form prior to screening; no assent or special consent provisions for minors described (study enrols 18 years and older)..
- Vulnerable Population
- Vulnerable populations not selected; participants must be able and willing to sign the Informed Consent Form prior to screening; no assent or special consent provisions for minors described (study enrols 18 years and older).
Inclusion criteria
- {"criterion_text":"- Starting, or on treatment with monoclonal antibodies: nivolumab, pembrolizumab ipilimumab, bevacizumab, trastuzumab, durvalumab, atezolizumab, or rituximab."}
- {"criterion_text":"- 18 years and older."}
- {"criterion_text":"- No known history of increased susceptibility to immunological reactions."}
- {"criterion_text":"- Subject is able and willing to sign the Informed Consent Form prior to screening evaluations."}
Exclusion criteria
- {"criterion_text":"- Other research medication within 4 weeks of the start of the study."}
- {"criterion_text":"- Inclusion in medical research in which the administration of medication should follow its stated times and dosages of infusions"}
- {"criterion_text":"- Dosage deviates from standard protocol"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Numer of infusion related reactions","definition_or_measurement_approach":"Incidence of infusion-related reactions reported per drug using the definition of Common Terminology Criteria for Adverse Events (CTCAE) for infusion related reaction during accelerated infusion of mAbs (comparison to historical matching cohorts)."}
- {"endpoint_text":"- Grade of IRR","definition_or_measurement_approach":"Grading of infusion-related reactions using CTCAE criteria."}
Secondary endpoints
- {"endpoint_text":"- Efficacy treatment parameters (progression, remission)","definition_or_measurement_approach":"Assessment of treatment efficacy parameters such as disease progression and remission as recorded in patient records."}
- {"endpoint_text":"- plasma levels of the administered drug","definition_or_measurement_approach":"Measurement of intra- and inter-individual plasma concentrations of the studied monoclonal antibodies."}
- {"endpoint_text":"- Patient reported expierence measurements","definition_or_measurement_approach":"Patient-reported experience measures assessing shortened infusion times."}
- {"endpoint_text":"- number of treatments needed","definition_or_measurement_approach":"Count of treatments administered per participant as recorded in clinical records."}
- {"endpoint_text":"- death","definition_or_measurement_approach":"All-cause mortality captured during study period."}
- {"endpoint_text":"- switchting of treatmet","definition_or_measurement_approach":"Recording of treatment switches (change of therapy) during follow-up."}
Recruitment
- Planned Sample Size
- 1261
- Recruitment Window Months
- 36
- Consent Approach
- Participants must sign the Informed Consent Form prior to screening evaluations. Subject information and ICF documents are provided (multiple versions present in the dossier). Study enrols adults (18+); no assent/parental consent arrangements described.
Geography
- Total Number Of Sites
- 6
- Total Number Of Participants
- 1261
Netherlands
- Earliest CTIS Part Ii Submission Date
- 19-11-2024
- Latest Decision Or Authorization Date
- 18-12-2025
- Processing Time Days
- 394
- Number Of Sites
- 6
- Number Of Participants
- 1261
Sites
- Site Name
- Rijnstate Ziekenhuis Stichting
- Department Name
- Medical oncology
- Contact Person Name
- N Claessens
- Contact Person Email
- nclaessens@rijnstate.nl
- Site Name
- Jeroen Bosch Ziekenhuis Stichting
- Department Name
- Medical oncology
- Contact Person Name
- J Tol
- Contact Person Email
- j.tol@jbz.nl
- Site Name
- Medisch Spectrum Twente
- Department Name
- pharmacy
- Contact Person Name
- N Lankheet
- Contact Person Email
- a.lankheet@mst.nl
- Site Name
- Isala Klinieken Stichting
- Department Name
- Clinical Pharmacy
- Contact Person Name
- Elise Smolders
- Contact Person Email
- e.j.smolders@isala.nl
- Site Name
- Universitair Medisch Centrum Groningen
- Department Name
- Medical oncology
- Contact Person Name
- DG Knapen
- Contact Person Email
- d.g.knapen@umcg.nl
- Site Name
- Noordwest Ziekenhuisgroep Stichting
- Department Name
- Medical oncology
- Contact Person Name
- M Hendriks
- Contact Person Email
- m.p.hendriks@nwz.nl
Sponsor
Primary sponsor
- Full Name
- Isala Klinieken Stichting
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Netherlands
Investigational products
- Investigational Product Name
- OPDIVO 10 mg/mL concentrate for solution for infusion.
- Active Substance
- NIVOLUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENIOUS INFUSION
- Route
- INTRAVENIOUS INFUSION
- Authorisation Status
- Authorised
- Maximum Dose
- 6 mg/kg
- Investigational Product Name
- Remicade 100 mg powder for concentrate for solution for infusion.
- Active Substance
- INFLIXIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Authorised
- Maximum Dose
- 10 mg/kg
- Investigational Product Name
- Herceptin 150 mg powder for concentrate for solution for infusion
- Active Substance
- TRASTUZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENIOUS INFUSION
- Route
- INTRAVENIOUS INFUSION
- Authorisation Status
- Authorised
- Maximum Dose
- 8 mg/kg
- Investigational Product Name
- KEYTRUDA 25 mg/mL concentrate for solution for infusion
- Active Substance
- PEMBROLIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENIOUS INFUSION
- Route
- INTRAVENIOUS INFUSION
- Authorisation Status
- Authorised
- Maximum Dose
- 400 mg
- Investigational Product Name
- IMFINZI 50 mg/mL concentrate for solution for infusion.
- Active Substance
- DURVALUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENIOUS INFUSION
- Route
- INTRAVENIOUS INFUSION
- Authorisation Status
- Authorised
- Maximum Dose
- 1500 mg
- Investigational Product Name
- Vectibix 20 mg/ml concentrate for solution for infusion
- Active Substance
- PANITUMUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Authorised
- Maximum Dose
- 6 mg/kg
- Investigational Product Name
- Entyvio 300 mg powder for concentrate for solution for infusion
- Active Substance
- VEDOLIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Authorised
- Maximum Dose
- 300 mg
- Investigational Product Name
- Truxima 500 mg concentrate for solution for infusion
- Active Substance
- RITUXIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENIOUS INFUSION
- Route
- INTRAVENIOUS INFUSION
- Authorisation Status
- Authorised
- Maximum Dose
- 375 mg/m2
- Investigational Product Name
- Tecentriq 1 875 mg solution for injection
- Active Substance
- ATEZOLIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENIOUS INFUSION
- Route
- INTRAVENIOUS INFUSION
- Authorisation Status
- Authorised
- Maximum Dose
- 1680 mg/kg
- Investigational Product Name
- YERVOY 5 mg/ml concentrate for solution for infusion
- Active Substance
- IPILIMUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENIOUS INFUSION
- Route
- INTRAVENIOUS INFUSION
- Authorisation Status
- Authorised
- Maximum Dose
- 3 mg/kg
- Investigational Product Name
- RoActemra 20 mg/mL concentrate for solution for infusion
- Active Substance
- TOCILIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Authorised
- Maximum Dose
- 8 mg/kg
- Investigational Product Name
- Perjeta 420 mg concentrate for solution for infusion
- Active Substance
- PERTUZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Authorised
- Maximum Dose
- 100 mg/m2
- Investigational Product Name
- Avastin 25 mg/ml concentrate for solution for infusion.
- Active Substance
- BEVACIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENIOUS INFUSION
- Route
- INTRAVENIOUS INFUSION
- Authorisation Status
- Authorised
- Maximum Dose
- 15 mg/kg