Trials Sponsors Conditions Drugs Pricing

Conditions

melanoma

Outcome Measures

Primary Outcomes (1)

Number of patients for whom [89Zr]Zr-Df-IAB22M2C PET-imaging was feasible.

Secondary Outcomes (6)

Number of patients who are affected by 3/4 (CTCAE) ICT related side effects with detectable differences in [89Zr]Zr-Df-IAB22M2C PET-imaging before and after the first cycle of ICT.
Absolute uptake of [89Zr]Zr-Df-IAB22M2C as assessed by PET imaging before the first cycle of ICT in the organs predisposed for immune related side effects and lymphatic tissue in the patients with autoimmune side effects grade 3/4 (CTCAE) induced by ICT compared to patients without grade 3/4 (CTCAE) autoimmune side effects of ICT.
% uptake difference of [89Zr]Zr-Df-IAB22M2C before and after the first cycle of ICT in the organs predisposed for immune related side effects and the lymphatic tissue in the patients with autoimmune grade 3/4 (CTCAE) side effects induced by ICT compared to patients without autoimmune side effects of ICT.
Number of patients with detectable differences in [89Zr]Zr-Df-IAB22M2C uptake before and after the first cycle of ICT in the tumors, metastasis or the lymphatic tissue, who are showing a clinical response to ICT.
Absolute uptake of [89Zr]Zr-Df-IAB22M2C before the first cycle of ICT in the tumors, metastasis and lymphatic tissue in the patients who are showing a clinical response to ICT compared to non-responders.
+1 more secondary outcomes

Interventions

[89Zr]Zr-Df-IAB22M2C-UKTType not reported

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or female patients ≥18 years of age at the time of signing the informed consent.
Patients with metastasized or irresectable melanoma.
Eastern Cooperative Oncology Group Performance (ECOG) Status ≤2.

Sponsors & Collaborators

Universitaetsklinikum Tuebingen AöR
Type not reportedlead

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Study Sites (1)

Universitaetsklinikum Tuebingen AöR

Tuebingen, 72076, Germany

Christian la Fougère+4970712986553 christian.lafougere@med.uni-tuebingen

Central Study Contacts

Prof. Dr. med. Christian la Fougère

004970712986553 christian.lafougere@med.uni-tuebingen.de

Study Design

Study Type: interventional
Phase: phase 2

Study Record Dates

First Submitted

February 29, 2024

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2024-512219-37-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-29 06:54:06 UTC

Documents

D1_Protocol_2024-512219-37-00_CD8-Pet _public

Consent to practice double-barrier contraception until end of the study (28 days after last [89Zr]Zr-Df-IAB22M2C injection): Females of childbearing potential (FCBP1) and male patients with female partner of childbearing potential1 are willing to use highly effective contraceptive methods at least 28 days before starting study drug, while participating in the study (including dose interruptions), and for at least 28 days after end of study treatment after the last dose. Recommendations (CTFG Recommendations related to contraception and pregnancy testing in clinical trials. Version 1.1, 2020) for highly effective contraceptive methods are: a) combined hormonal contraception associated with inhibition of ovulation • oral • intravaginal • transdermal b) progestogen-only hormonal contraception associated with inhibition of ovulation • oral • injectable • implantable c) intrauterine device (IUD) d) intrauterine hormone - releasing system (IUS) e) bilateral tubal occlusion f) vasectomized partner (2) g) sexual abstinence (3) 1For the purpose of this document, a female is considered of childbearing potential (FCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. For the purpose of this document, a man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy. 2Vasectomised partner is a highly effective birth control method provided that partner is the sole sexual partner of the WOCBP trial participant and that the vasectomised partner has received medical assessment of the surgical success. 3In the context of the CTFG guidance sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.

Early detection of side effects in patients with metastatic melanoma receiving immune checkpoint inhibitor therapy by investigation of the CD8+ immune infiltrate using [89Zr]Zr-Df-IAB22M2C-PET

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations