Ensayos clínicos

​​​​​​Inclusion Criteria:

• Ability to understand and willingness to provide informed consent.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Male or female, aged ≥ 18 years.
• Diagnosed with Stage IV metastatic melanoma, or inoperable Stage III equivalent.
• FDG-PET/CT scan available to serve as baseline; the archived scan date must be within 30 days prior to date of enrollment (date initial ICF signed); images from external facilities are allowed. If no archived FDG-PET/CT scan in window, the baseline scan must be obtained at Screening.
• Complete blood count with differential, within 14 calendar days prior to enrollment, demonstrating the following:
  • White blood cells (WBC) > 2500/mm^3;
  • Hemoglobin (Hgb) > 9.0 g/dL;
  • Platelets > 60,000/mm^3;
  • Absolute Neutrophil Count (ANC) > 1,250/mm^3
    • If no differential is available in the SOC results for enrollment, a subject may be enrolled without the ANC level. Following enrollment, however, this criterion must be met to proceed in the study.
• Comprehensive metabolic panel, within 14 calendar days prior to enrollment, demonstrating values within the site’s upper limit of normal (ULN), with the following exceptions:
  • Alanine aminotransferase (ALT) ≤ 3 x ULN;
  • Aspartate aminotransferase (AST) ≤ 3 x ULN;
  • Alkaline phosphatase (ALP) ≤ 2.5 x ULN.
• Ability to lie flat and still for a minimum of two hours for the SPECT scan.
• For females of reproductive potential: use of highly effective contraception for at least one month prior to screening, and agreement to use such a method during study participation and for an additional four weeks after the end of last investigational imaging agent administration.
• For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner during study participation and for an additional four weeks after the end of last investigational imaging agent administration.
• Agreement to adhere to Lifestyle Considerations throughout study duration.
• Documented life expectancy of at least 3 months.
• Access to most recent biopsy is requested (if tissue is available) at screen or if it is obtained through SOC during an expanded window of acceptability; i.e., throughout entire conduct of study at this site. (An updated consent will be obtained.) If a biopsy is completed as part of routine clinical care prior to IRB closure, the study may request access to this sample for tissue MC1R staining and analysis.

Exclusion Criteria:

• Active secondary malignancy.
• Prior treatment (for any reason) with radioactive nuclides; imaging tracers are acceptable.
• Pregnancy.
• Lactation.
• Febrile illness within 48 hours of scheduled imaging procedure.
• Uncontrolled infection.
• Treatment with another investigational drug within 30 days prior to enrollment date.
• Subjects initiating BRAFi drugs between baseline FDG scan and enrollment. Subjects receiving consistent, stable therapy with BRAFi for ≥ 3 months prior to enrollment and who have persistent FDG positive malignant lesions on PET imaging are eligible.
• eGFR < 50 mL/min/1.73m^2.
• BMI > 50 kg/m^2.
• Previous medical history of a condition resulting in anaphylaxis or angioedema.
• Planned treatment while on study with concomitant investigative agents that do not have disclosed safety profiles in the melanoma population (peer-reviewed publications and investigator’s brochures for phase 2 or 3 trials will be accepted as disclosed safety profiles).

Eligibility last updated 11/10/21. Questions regarding updates should be directed to the study team contact.