Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Infections

Symptoms and General Pathology

Rare Diseases

Carcinoma, Non-Small-Cell Lung

Carcinoma

Lung Neoplasms

Melanoma

Carcinoma, Renal Cell

Carcinoma, Merkel Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Communicable Diseases

Polyomavirus Infections

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Carcinoma, Neuroendocrine

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Merkel Cell Carcinoma

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Immunomodulating Agents

Eligible subjects will receive up to three zirconium Zr 89 crefmirlimab berdoxam PET scans (up to 1.0 mCi ± 20% at 1.5 mg API per scan, for a total of up to 3.0 mCi ± 20% and 4.5 mg API) as an IV infusion or slow bolus injection as follows: First scan within 14 days prior to the onset of IOT, and a second scan 4 to 6 weeks after start of immunotherapy. The second zirconium Zr 89 crefmirlimab berdoxam administration and scan should be completed prior to the start of the third cycle of IOT. Subjects who are determined by the treating physician to have PD on immunotherapy can receive the optional third zirconium Zr 89 crefmirlimab berdoxam PET scan at the principal investigator's (PI's) discretion.

Up to three zirconium Zr 89 crefmirlimab berdoxam PET scans (up to 1.0 mCi ± 20% at 1.5 mg API per scan, for a total of up to 3.0 mCi ± 20% and 4.5 mg API) as an IV infusion or slow bolus injection as follows: First (PETbaseline) within 14 days prior to the onset of IOT, and a second (PETEOC1) 4 to 6 weeks after start of immunotherapy. The second zirconium Zr 89 crefmirlimab berdoxam administration and scan (PETEOC1) should be completed prior to the start of the third cycle of IOT. Subjects who are determined by the treating physician to have PD on immunotherapy can receive the optional third zirconium Zr 89 crefmirlimab berdoxam PET scan at the principal investigator's (PI's) discretion.

zirconium Zr 89 crefmirlimab berdoxam

Kristin Schmiedehausen, MD

Michael Ferris, PhD

Kelsey Williams

David Hays, MD

Jennifer Simpson

Jeffrey Wong, MD

Kelly Garver

Kim Margolin, MD

Sonya Brisbane

Neeta Pandit-Taskar, MD

Vida Rhodes

James Brugarolas, MD

Elsa Roberts, MD

Delphine Chen, MD

Harrison O'Brien

Alison Zhang, MD

Maria Vatca

Wen Xu, MD

Jesikah Logan

Michael Brown, MD

Tina Chen

Andrew Scott, MD

Leeanne Pasanen

Ramin Alipour

Christophe Deroose, MD

Michel de Groot

Erik Aarntzen, MD

Ellen Kapiteijn, MD

Niklaus Schaefer

Rachel Pearson, MD

The purpose of this study is to evaluate whether zirconium Zr 89 crefmirlimab berdoxam (other names 89Zr-crefmirlimab berdoxam, 89Zr-Df-crefmirlimab, 89Zr-Df-IAB22M2C) PET/CT can predict the response of advanced or metastatic melanoma, Merkel cell carcinoma, renal cell carcinoma, or non-small cell lung cancer tumors to immuno-oncology therapy.

Study of Zirconium Zr 89 Crefmirlimab Berdoxam PET/CT in Subjects With Advanced or Metastatic Malignancies

A Phase IIB, Open Label, Study of Zirconium Zr 89 Crefmirlimab Berdoxam PET/CT in Subjects With Advanced or Metastatic Malignancies, Scheduled to Receive Immunotherapy (IOT) as a Single Agent or Combination, to Predict Response to Therapy

Incidence of iRECIST defined pseudo-progression events.

Incidence of Immuno-oncology related TEAEs in non-diseased tissues and organs.

CD8 expressing cells and PD-1/PD-L1 expressing cells.

Best overall response (BOR) assessed by conventional imaging CT and/or MRI using RECIST 1.1 from 3 (or up to 3) consecutive imaging assessments (CT and/or MRI) following onset of immuno-oncology treatment.

Largest measured difference from baseline in the lesion major axis from three (or up to three) consecutive standard of care imaging assessments (CT and/or MRI) following onset of immuno-oncology treatment.

Incidence and severity of infusion or injection reactions reported during or shortly after administration of the investigational product.

Incidence of withdrawal from scanning protocol due to zirconium Zr 89 crefmirlimab berdoxam related AEs

Ventricular rate (bpm) will be recorded from the 12-lead ECG

PR interval (msec) will be recorded from the 12-lead ECG

QRS interval (msec) will be recorded from the 12-lead ECG

QT interval (msec) will be recorded from the 12-lead ECG

QTc interval (msec) will be recorded from the 12-lead ECG

Investigator's overall assessment of the ECG reading will be recorded as normal or abnormal. If abnormal, as either "not clinically significant" or "clinically significant"

Blood AST levels (U/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.

Blood ALT levels (U/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.

Blood ALP levels (U/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.

Blood bilirubin levels (mg/dL) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.

Blood LDH levels (U/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.

Blood BUN levels (mg/dL) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.

Blood GGT levels (U/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.

Serum creatinine levels (mg/dL) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.

Blood uric acid levels (mg/dL) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.

Blood sodium (mmol/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.

Blood potassium (mmol/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.

Blood chloride (mmol/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.

Blood glucose (mg/dL) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.

ImaginAb, Inc.

Eye Diseases

Carcinoma, Basal Cell

Eyelid Neoplasms

Adenocarcinoma, Sebaceous

Eccrine Porocarcinoma

Neoplasms, Basal Cell

Neoplasms, Adnexal and Skin Appendage

Conjunctival Melanoma

patients with sebaceous carcinoma both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS

patients with Merkel's carcinoma both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS

patients with Porocarcinoma both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS

patients with Conjunctival Melanoma both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS

patients with squamous cell Carcinoma of the ocular surface and adnexa both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS

* Injection of 99mTc-labeled nanocolloids
* Preoperative lymphoscintigraphy
* Intraoperative gamma probe search of the sentinel lymph node
* Sentinel lymph node biopsy
* Excisional biopsy of the neoformation in cases not undergoing excision before SLN biopsy.
* If the SLN is histologically positive, the multidisciplinary team will consider whether to refer the patient for parotidectomy and excision of the lymph node chain and/or adjuvant radio/chemotherapy.

Sentinel Lymph Node Biopsy

Gustavo Savino, MD

The study involves enrollment of patients with sebaceous carcinoma, Merkel's carcinoma, Porocarcinoma, Melanoma, and squamous cell Ca of the ocular surface and adnexa both primary and relapsed after surgical and/or radiation-chemotherapy treatment at the Fondazione Policlinico Universitario A. Gemelli, IRCCS. The study will last 9 years: 1 year will be devoted to the first phase of the study. Patient enrollment will continue for an additional 3 years, and 5 years will be devoted overall to patient follow-up so that survival outcomes at 1-3 and 5 years can be assessed in a congruent number of patients. A preliminary analysis of the data at 1 year (pilot phase), an analysis at 4 years to confirm the preliminary study data on a larger sample, and a final analysis to evaluate OS and PFS at the 3 time-points indicated are planned.

Patients will undergo:

* Evaluation in the ocular oncology outpatient clinic with examination and anterior segment photography
* Staging according to TNM AJCC 8th edition by incisional biopsy (if necessary after clinical evaluation) and/or excisional biopsy and imaging to be performed in current clinical practice (MRI with mdc orbits, massif and neck + Tc/Pet total body)
* Injection of 99mTc-labeled nanocolloids
* Preoperative lymphoscintigraphy
* Intraoperative search by gamma probe of the sentinel lymph node
* Sentinel lymph node biopsy
* Excisional biopsy of the neoformation in cases not undergoing excision before SLN biopsy.
* In case of SLN histologic positivity, the multidisciplinary team will consider whether to refer the patient for parotidectomy and excision of the lymph node chain and/or adjuvant radio/chemotherapy.
* Clinical-instrumental follow-up to be performed in current clinical practice (Clinical examination, cranial orbit and neck MRI, total body CT scan) at 3, 6, 12, 18, 24, 36, 48, 60 months or according to periodicity assessed on a case-by-case basis by the Tumor Board.

Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers

Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers: Prospective Observational Study

Positive predictive value (PPV) and negative predictive value (NPV), in percentage, in order to determine the likelihood of lymphoscintigraphic examination and SLN biopsy in diagnosing Ocular Surface and Adnexal Cancers.

Sensitivity and sensibility, in percentage, in order to determine the likelihood of lymphoscintigraphic examination and SLN biopsy in diagnosing Ocular Surface and Adnexal Cancers.

Changes in clinical parameter (tumor diameters) of patients at follow-up (3, 6, 12, 24, 36, 48, 60 months)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Zirconium Zr 89 Crefmirlimab Berdoxam PET/CT in Subjects With Advanced or Metastatic Malignancies	NCT05013099	Melanoma Merkel Cell Car... Renal Cell Carc... Non Small Cell ...	zirconium Zr 89...	18 Years -	ImaginAb, Inc.
Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers	NCT05797415	Ocular Sebaceou... Ocular Basal Ce... Ocular Surface ... Merkel Cell Car... Porocarcinoma Conjunctival Me...	Sentinel Lymph ...	18 Years - 95 Years	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers	NCT05797415	Ocular Sebaceou... Ocular Basal Ce... Ocular Surface ... Merkel Cell Car... Porocarcinoma Conjunctival Me...	Sentinel Lymph ...	18 Years - 95 Years	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study of Zirconium Zr 89 Crefmirlimab Berdoxam PET/CT in Subjects With Advanced or Metastatic Malignancies	NCT05013099	Melanoma Merkel Cell Car... Renal Cell Carc... Non Small Cell ...	zirconium Zr 89...	18 Years -	ImaginAb, Inc.

Spots Global Cancer Trial Database for merkel cell carcinoma, unspecified