ZIRCONIUM (89ZR) CREFMIRLIMAB BERDOXAM for Metastatic melanoma|Unresectable melanoma|Malignant melanoma

Inclusion criteria

• {"criterion_text":"- Male or female patients ≥18 years of age at the time of signing the informed consent."}
• {"criterion_text":"- Patients with metastasized or irresectable melanoma."}
• {"criterion_text":"- Eastern Cooperative Oncology Group Performance (ECOG) Status ≤2."}
• {"criterion_text":"- Patients scheduled for ICT as recommended by the interdisciplinary tumor board."}
• {"criterion_text":"- Understand and voluntarily sign an informed consent document prior to any study related assessments/ procedures."}
• {"criterion_text":"- Able to adhere to the study visit schedule and other protocol requirements"}
• {"criterion_text":"- 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."}

Exclusion criteria

• {"criterion_text":"- 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."}
• {"criterion_text":"- Participation in other therapeutic clinical trials or observation period of competing trials."}
• {"criterion_text":"- Persistent toxicity (>Grade 2) according to Common Terminology Criteria for Adverse Events [CTCAE] version 5.0, caused by previous cancer therapy, excluding alopecia."}
• {"criterion_text":"- Clinical signs of active infection (>Grade 2 according to CTCAE version 5.0)."}
• {"criterion_text":"- Major surgery within 4 weeks of starting study treatment. Patients must have recovered from any effects of major surgery."}
• {"criterion_text":"- Patients receiving any systemic chemotherapy or radiotherapy within 2 weeks prior to study treatment or a longer period depending on the defined characteristics of the agents used."}
• {"criterion_text":"- Heart failure NYHA III/IV."}
• {"criterion_text":"- Patients not able to declare meaningful informed consent on their own."}
• {"criterion_text":"- 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 1 until 28 days postdose."}
• {"criterion_text":"- Male patients planning to donate sperm while participating in the study and for at least 28 days after end of study treatment."}

Primary endpoints

• {"endpoint_text":"- Number of patients for whom [89Zr]Zr-Df-IAB22M2C PET-imaging was feasible.","definition_or_measurement_approach":"Count of patients in whom PET imaging using [89Zr]Zr-Df-IAB22M2C could be performed successfully (feasibility of PET-imaging with the tracer)."}

Secondary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Number of patients with CTCAE grade 3/4 immune checkpoint therapy (ICT) related side effects who show detectable differences in tracer uptake on PET imaging before vs after first ICT cycle."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Measurement of absolute tracer uptake by PET imaging in target organs and lymphatic tissue prior to first ICT cycle, comparing patients with CTCAE grade 3/4 autoimmune side effects to those without."}
• {"endpoint_text":"- % 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.","definition_or_measurement_approach":"Percentage change in tracer uptake measured by PET before vs after first ICT cycle in organs/lymphatic tissue, comparing patients with CTCAE grade 3/4 autoimmune side effects to those without."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Number of patients who show detectable PET uptake changes before vs after first ICT cycle in tumor/metastasis/lymphatic tissue and who also demonstrate clinical response to ICT."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Absolute PET tracer uptake prior to first ICT cycle in tumor/metastasis/lymphatic tissue comparing responders versus non-responders."}
• {"endpoint_text":"- % 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.","definition_or_measurement_approach":"Percentage change in PET tracer uptake before vs after first ICT cycle in tumors/metastases/lymphatic organs in patients who demonstrate clinical response to ICT."}

Germany

Earliest CTIS Part Ii Submission Date

26-02-2024

Latest Decision Or Authorization Date

13-03-2024

Processing Time Days

16

Number Of Sites

1

Number Of Participants

35

Primary sponsor

Full Name

Universitaetsklinikum Tuebingen AöR

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Germany