Research with human participants

Overview of medical research in the Netherlands

Dose tapering and early discontinuation to increase cost-effectiveness of immunotherapy trial number 1

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To investigate the non-inferiority of a reduced dose and to develop biomarkers for early treatment response.

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Ethical review
Approved WMO
Status
Recruiting
Health condition type
Respiratory and mediastinal neoplasms malignant and unspecified
Study type
Interventional

ID

NL-OMON54321

Source

ToetsingOnline

Brief title

Dedication-1 NVALT30

Condition

  • Respiratory and mediastinal neoplasms malignant and unspecified

Synonym

Lung cancer

Research involving

Human

Sponsors and support

Primary sponsor :
Radboud Universitair Medisch Centrum
Source(s) of monetary or material Support :
Zorgverzekeraars

Intervention

Keyword :
biomarkers, dose tapering, Immune therapy, pembrolizumab

Outcome measures

Primary outcome

1-year survival

Secondary outcome

Biomarker performance to predict treatment response

Background summary

Pembrolizumab is overdosed, only 50% of lung cancer patients responds to
therapy and pembrolizumab is expensive.

Study objective

To investigate the non-inferiority of a reduced dose and to develop biomarkers
for early treatment response.

Study design

An open label randomized trial

Intervention

Reduced dose versus standard dose

Study burden and risks

Negligible

Public
Radboud Universitair Medisch Centrum

Geert Grooteplein Zuid 10
Nijmegen 6525GA
NL
Scientific
Radboud Universitair Medisch Centrum

Geert Grooteplein Zuid 10
Nijmegen 6525GA
NL

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

Eligible for treatment of non-small cell lung cancer with pembrolizumab in line
with the current ESMO treatment guidelines

Exclusion criteria

Not willing to give informed consent

Design

Study phase :
3
Study type :
Interventional
Intervention model
:
Parallel
Allocation :
Randomized controlled trial
Masking :
Open (masking not used)
Control :
Active
Primary purpose :
Treatment

Recruitment

NL
Recruitment status
:
Recruiting
Start date (anticipated) :
Enrollment :
750
Type :
Actual

Medical products/devices used

Registration
:
No
Product type :
Medicine
Brand name :
Keytruda
Generic name :
Pembrolizumab
Registration
:
Yes - NL intended use

Approved WMO
Date :
Application type :
First submission
Review commission :
CMO regio Arnhem-Nijmegen (Nijmegen)
Approved WMO
Date :
Application type :
First submission
Review commission :
CMO regio Arnhem-Nijmegen (Nijmegen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
CMO regio Arnhem-Nijmegen (Nijmegen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
CMO regio Arnhem-Nijmegen (Nijmegen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
CMO regio Arnhem-Nijmegen (Nijmegen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
CMO regio Arnhem-Nijmegen (Nijmegen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
CMO regio Arnhem-Nijmegen (Nijmegen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
CMO regio Arnhem-Nijmegen (Nijmegen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
CMO regio Arnhem-Nijmegen (Nijmegen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
CMO regio Arnhem-Nijmegen (Nijmegen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
CMO regio Arnhem-Nijmegen (Nijmegen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
CMO regio Arnhem-Nijmegen (Nijmegen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
CMO regio Arnhem-Nijmegen (Nijmegen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
CMO regio Arnhem-Nijmegen (Nijmegen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
CMO regio Arnhem-Nijmegen (Nijmegen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
CMO regio Arnhem-Nijmegen (Nijmegen)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
EudraCT EUCTR2020-000493-15-NL
CCMO NL72883.091.20