Authorised Therapeutic use (Phase IV) Inflammatory bowel disease

Evaluating the safety of shortened infusion tiMes for dIfferent oNcological immUnoThErapies; An observational prospective study

EU CTIS ID: 2024-518878-14-01

What this study is testing

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.

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 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.

You likely can't join if

  • 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

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.