Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
1,261
Countries
1
Sites
6
Inflammatory bowel disease
To determine the incidence and grading of infusion related/hypersensitivity reactions reported per drug using the definition of Common Terminology Criteria for Adverse Events (CTCAE) criteria for infusion related reaction during accelerated infusion of mAbs, compared to historical matching cohorts.
Key facts
- Sponsor
- Isala Klinieken Stichting
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 25 Nov 2024 → ongoing
- Decision date (initial)
- 2024-11-25
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-518878-14-01
- EudraCT number
- 2022-003588-55
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety
To determine the incidence and grading of infusion related/hypersensitivity reactions reported per drug using the definition of Common Terminology Criteria for Adverse Events (CTCAE) criteria for infusion related reaction during accelerated infusion of mAbs, compared to historical matching cohorts.
Secondary objectives 3
- to evaluate the intra- and inter-individual variation in plasma levels of the studied mAbs.
- Patient reported experience measures on the shortened infusion times.
- Health economic evaluation of the intervention
Conditions and MedDRA coding
Inflammatory bowel disease
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-518878-14-00 | Evaluating the safety of shortened infusion tiMes for dIfferent oNcological immUnoThErapies; An observational prospective study (MINUTE) | Isala Klinieken Stichting |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Starting, or on treatment with monoclonal antibodies: nivolumab, pembrolizumab ipilimumab, bevacizumab, trastuzumab, durvalumab, atezolizumab, or rituximab.
- 18 years and older.
- No known history of increased susceptibility to immunological reactions.
- Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
Exclusion criteria 3
- Other research medication within 4 weeks of the start of the study.
- Inclusion in medical research in which the administration of medication should follow its stated times and dosages of infusions
- Dosage deviates from standard protocol
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Numer of infusion related reactions
- Grade of IRR
Secondary endpoints 6
- Efficacy treatment parameters (progression, remission)
- plasma levels of the administered drug
- Patient reported expierence measurements
- number of treatments needed
- death
- switchting of treatmet
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 13
OPDIVO 10 mg/mL concentrate for solution for infusion.
PRD2941372 · Product
- Active substance
- Nivolumab
- Substance synonyms
- BMS936558, ABP 206
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 6 mg/kg milligram(s)/kilogram
- Max total dose
- 6 mg/kg milligram(s)/kilogram
- Max treatment duration
- 20 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01FF01 — -
- Marketing authorisation
- EU/1/15/1014/001
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
YERVOY 5 mg/ml concentrate for solution for infusion
PRD2341715 · Product
- Active substance
- Ipilimumab
- Substance synonyms
- BMS734016, HLX13, IBI310
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 3 mg/kg milligram(s)/kilogram
- Max total dose
- 3 mg/l milligram(s)/litre
- Max treatment duration
- 20 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01FX04 — -
- Marketing authorisation
- EU/1/11/698/001
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
IMFINZI 50 mg/mL concentrate for solution for infusion.
PRD6651398 · Product
- Active substance
- Durvalumab
- Substance synonyms
- MEDI4736
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 1500 mg milligram(s)
- Max total dose
- 1500 mg milligram(s)
- Max treatment duration
- 20 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01FF03 — -
- Marketing authorisation
- EU/1/18/1322/001
- MA holder
- ASTRAZENECA AB
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Truxima 500 mg concentrate for solution for infusion
PRD4797328 · Product
- Active substance
- Rituximab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 375 mg/m2 milligram(s)/sq. meter
- Max total dose
- 375 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 20 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01FA01 — -
- Marketing authorisation
- EU/1/16/1167/001
- MA holder
- CELLTRION HEALTHCARE HUNGARY KFT
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Remicade 100 mg powder for concentrate for solution for infusion.
PRD3349048 · Product
- Active substance
- Infliximab
- Substance synonyms
- ABP 710, CT-P13, NI-071, PF-06438179, R-TPR-015
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 10 mg/kg milligram(s)/kilogram
- Max total dose
- 10 mg/kg milligram(s)/kilogram
- Max treatment duration
- 40 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AB02 — -
- Marketing authorisation
- EU/1/99/116/003
- MA holder
- JANSSEN BIOLOGICS B.V.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
RoActemra 20 mg/mL concentrate for solution for infusion
PRD2154620 · Product
- Active substance
- Tocilizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 8 mg/kg milligram(s)/kilogram
- Max total dose
- 8 mg/kg milligram(s)/kilogram
- Max treatment duration
- 20 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AC07 — -
- Marketing authorisation
- EU/1/08/492/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Herceptin 150 mg powder for concentrate for solution for infusion
PRD2154035 · Product
- Active substance
- Trastuzumab
- Substance synonyms
- PF-05280014, TX05, BP02, ABP-980, SYD-977
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 8 mg/kg milligram(s)/kilogram
- Max total dose
- 8 mg/kg milligram(s)/kilogram
- Max treatment duration
- 15 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01FD01 — -
- Marketing authorisation
- EU/1/00/145/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
KEYTRUDA 25 mg/mL concentrate for solution for infusion
PRD4323105 · Product
- Active substance
- Pembrolizumab
- Substance synonyms
- Lambrolizumab, MK-3475, SCH-900475, BAT3306, Pabolizumab, FYB206, ABP 234
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 30 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01FF02 — -
- Marketing authorisation
- EU/1/15/1024/002
- MA holder
- MERCK SHARP & DOHME B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Tecentriq 1 875 mg solution for injection
PRD11048644 · Product
- Active substance
- Atezolizumab
- Substance synonyms
- RO5541267
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 1680 mg/kg milligram(s)/kilogram
- Max total dose
- 1680 mg/kg milligram(s)/kilogram
- Max treatment duration
- 20 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01FF05 — -
- Marketing authorisation
- EU/1/17/1220/003
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Perjeta 420 mg concentrate for solution for infusion
PRD2154581 · Product
- Active substance
- Pertuzumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 100 mg/m2 milligram(s)/sq. meter
- Max total dose
- 100 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 15 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01FD02 — -
- Marketing authorisation
- EU/1/13/813/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Entyvio 300 mg powder for concentrate for solution for infusion
PRD1598541 · Product
- Active substance
- Vedolizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 40 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AG05 — -
- Marketing authorisation
- EU/1/14/923/001
- MA holder
- TAKEDA PHARMA A/S
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Avastin 25 mg/ml concentrate for solution for infusion.
PRD2153901 · Product
- Active substance
- Bevacizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 15 mg/Kg milligram(s)/kilogram
- Max total dose
- 15 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 15 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01FG01 — -
- Marketing authorisation
- EU/1/04/300/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Vectibix 20 mg/ml concentrate for solution for infusion
PRD3606040 · Product
- Active substance
- Panitumumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 6 mg/kg milligram(s)/kilogram
- Max total dose
- 6 mg/kg milligram(s)/kilogram
- Max treatment duration
- 10 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01FE02 — -
- Marketing authorisation
- EU/1/07/423/001
- MA holder
- AMGEN EUROPE B.V.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Isala Klinieken Stichting
- Sponsor organisation
- Isala Klinieken Stichting
- Address
- Dokter Van Heesweg 2
- City
- Zwolle
- Postcode
- 8025 AB
- Country
- Netherlands
Scientific contact point
- Organisation
- Isala Klinieken Stichting
- Contact name
- Elise Smolders
Public contact point
- Organisation
- Isala Klinieken Stichting
- Contact name
- Onderzoeksafdeling Isala
Locations
1 EU/EEA country · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 1,261 | 6 |
| Rest of world | — | 0 | — |
Investigational sites
Rijnstate Ziekenhuis Stichting
Medical oncology, Wagnerlaan 55, 6815 AD, Arnhem
Jeroen Bosch Ziekenhuis Stichting
Medical oncology, Henri Dunantstraat 1, 5223 GZ, 'S-Hertogenbosch
Universitair Medisch Centrum Groningen
Medical oncology, Hanzeplein 1, 9713 GZ, Groningen
Isala Klinieken Stichting
Clinical Pharmacy, Dokter Van Heesweg 2, 8025 AB, Zwolle
Medisch Spectrum Twente
pharmacy, Koningsplein 1, 7512 KZ, Enschede
Noordwest Ziekenhuisgroep Stichting
Medical oncology, Wilhelminalaan 12, 1815 JD, Alkmaar
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2024-11-25 | 2024-11-25 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 25 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1 protocol 2024 518878 14 01 clean | 1 |
| Protocol (for publication) | D1 protocol 2024 518878 14 01 TC | 1 |
| Recruitment arrangements (for publication) | K1 Recruitment arrangements V1 01032025_TC | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_MINUTE_2024 518878 14 01_addendum PUSH protocol_clean | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_MINUTE_2024 518878 14 01_addendum PUSH protocol_TC | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_MINUTE_2024 518878 14 01_clean | 8 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_MINUTE_2024 518878 14 01_zonder bloedafname_clean | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_MINUTE_2024 518878 14 01_zonder bloedafname_TC | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_MINUTE_2024-518878-14-01_track changes | 8 |
| Summary of Product Characteristics (SmPC) (for publication) | D2 SMPC Opdivo nivolumab_2024-518878-14-01 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | D2_SMPC Avastin bevacizumab_2024-518878-14-01 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | D2_SMPC Herceptin trastuzumab_2024-518878-14-01 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | D2_SMPC Imfinzi durvalumab_2024-518878-14-01 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | D2_SMPC Keydruda pembrolizumab_2024-518878-14-01 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | D2_SMPC Tecentriq atezolizumab | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | D2_SMPC Truxima rituximab_2024-518878-14-01 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | D2_SMPC Yervoy ipilimumab_2024-518878-14-01 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC infliximab | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC panitumimab | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC pertuzumab | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC tocilizumab | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC vedolizumab | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis MS ENG 2024 518878 1 01 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis MS NED 20245188781401 | 1 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-14 | Netherlands | Acceptable 2024-11-25
|
2024-11-25 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-07-17 | Netherlands | Acceptable 2025-10-09
|
2025-10-23 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-10-30 | Netherlands | Acceptable 2025-10-09
|
2025-10-30 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-12-15 | Netherlands | Acceptable 2025-10-09
|
2025-12-15 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-12-18 | Netherlands | Acceptable 2025-10-09
|
2025-12-18 |