Evaluating the safety of shortened infusion times for different oncological immunotherapies; An observational prospective study

• Conditions: cancer; lungcancer; melanoma (among others); 10027655

• Registration Number: NL-OMON51857
• Lead Sponsor: Isala Klinieken

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

• Starting, or already on treatment with monoclonal antibodies: nivolumab,
pembrolizumab and ipilimumab, durvalumab, atezolizumab, trastuzumab and
bevacizumab.
• 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

• 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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Patient parameters:<br /><br>• Weight<br /><br>• Height<br /><br>• Body Surface Area (m2)<br /><br>• Sex<br /><br>• Age<br /><br>• Stage of disease<br /><br>• Cancer type<br /><br><br /><br>Treatment parameters:<br /><br>• Treatment with<br /><br>Nivolumab/ipilimumab/Durvalumab/Bevacizumab/Atezolizumab/Trastuzumab<br /><br>• Dose<br /><br>• Infusion rate<br /><br>• Number of infusions and treatment cycle<br /><br>• Development of IRR<br /><br>• Management of IRR<br /><br>• Cycle of infusion where IRR is developed<br /><br>• Grade of IRR</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Standard clinical chemistry data for each mAb according to each mAbs standard<br /><br>protocol<br /><br>• Efficacy of treatment parameters (measured until end of study):<br /><br>• Number of treatments needed<br /><br>• Death<br /><br>• Remission<br /><br>• Progression<br /><br>• Plasma levels of the administered mAb<br /><br>• Patient reported experience measurements (PREMs)</p><br>