Adult male or female patients scheduled for ICT with metastasized or irresectable melanoma MedDRA version: 21.1 Level: PT Classification code 10025650 Term: Malignant melanoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: PT Classification code 10025670 Term: Malignant melanoma stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level:
Conditions
Interventions
Product Name: [89Zr]Zr-Df-IAB22M2C-PET
Product Code: [89Zr]Zr
Pharmaceutical Form: Injection/infusion
INN or Proposed INN: INN-[89Zr]Zr-Df-IAB22M2C
Other descriptive name: [89Zr]Zr-Df-IAB22M2C
Conc
Sponsors
University Hospital Tübingen
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: •To assess the prediction of immune-mediated ICT side effects by using noninvasive [89Zr]Zr-Df-IAB22M2C PET imaging for semiquantitative assessment of CD8+ lymphocyte infiltration. •To assess the correlation of the CD8+ lymphocyte infiltration in the tumors, metastasis and lymphoid organs by [89Zr]Zr-Df-IAB22M2C PET with treatment response to ICT according to clinical standard of care [18F]-FDG PET/CT until 6 months after start of ICT •Assessment of potential side effects of [89Zr]-Df-IAB22M2C up to 24h p.i. ;Main Objective: •Feasibility of the early detection of immune-mediated ICT side effects by semiquantitative assessment of CD8+ lymphocyte infiltration using noninvasive [89Zr]Zr-Df-IAB22M2C PET imaging ;Primary end point(s): Number of patients who are affected by grade 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 ;Timepoint(s) of evaluation of this end point: Number of patients who are affected by grade 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 (3 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • 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. • % uptake difference of [89Zr]Zr-Df-IAB22M2C uptake before and after the first cycle of ICT in the tumors and metastasis as well as in the lymphatic organs in patients who are showing a clinical response to ICT ;Timepoint(s) of evaluation of this end point: before and after the first cycle of ICT (3 weeks) | — |
Countries
Germany
Contacts
Public ContactZentrum für klinische Studien
University Hospital Tübingen
Outcome results
None listed