The purpose of this study is to determine to which extent CD8+ T-cell distribution evaluated noninvasively by PET imaging with the tracer [89Zr]Zr-Df-IAB22M2C provides a diagnostic gain in the early detection of adverse immune-mediated side effects induced by ICT

Phase 1

• Conditions: Adult male or female patients scheduled for ICT with metastasized or irresectable melanoma; MedDRA version: 21.1Level: PTClassification code 10025650Term: Malignant melanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10025670Term: Malignant melanoma stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10027480Term: Metastatic malignant melanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-004328-13-DE
• Lead Sponsor: niversity Hospital Tübingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-27
• Last Update Posted: 18 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

All patients must meet all the following criteria:
•Male or female patients =18 years of age at the time of signing
the informed consent
? Patients with metastasized or irresectable melanoma stage
III/IV
? Eastern Cooperative Oncology Group Performance (ECOG)
Status = 2
? Patients scheduled for ICT by tumor board decision
? Understand and voluntarily sign an informed consent
document prior to any study related assessments/
procedures.
? Able to adhere to the study visit schedule and other protocol
requirements
? 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 is 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.must agree
Recommendations (CTFG Recommendations related to
contraception and pregnancy testing in clinical trials. Version
1.1, 2020) 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)
1A 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

Patients will be excluded if one or more of the following criteria are
met:
? Known hypersensitivity to [89Zr]Zr-Df-IAB22M2C or its
components or to any drug with similar chemical structure or
to any excipient present in the pharmaceutical form of the
investigational medicinal product.
? Clinical signs of active infection (>Grade 2 according to
CTCAE version 5.0).
? Major surgery within 4 weeks of starting study treatment.
Patients must have recovered from any effects of major
surgery.
? Heart failure NYHA III/IV.
? Patients not able to declare meaningful informed consent on
their own.
? Women during pregnancy and lactation; female patients of
childbearing potential or male patients with female partners of
childbearing potential not willing to practice effective
contraception by using a double-barrier method from Day 0
until 28 days post-dose.
? Male patients planning to donate sperm while participating in
the study and for at least 28 days after end of study treatment.
? Participation in other clinical trials or observation period of
competing trials.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified