Imaging FDG Flare in Melanoma

Metastatic Melanoma Clinical Trial

Official title:

Imaging the Flare Response With FDG PET/CT in Patients With Advanced Metastatic Melanoma on Pembrolizumab.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02791594
• Other study ID #: UPCC 02616
• Status: Completed
• Start date: June 2016
• Est. completion date: July 1, 2020

Study information

• Verified date: July 2020
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Up to 35 adult patients with metastatic melanoma will be enrolled in this study with a target enrollment of 30 evaluable subjects who complete the baseline and an approximately 3 week FDG PET/CT scans, they may also complete an FDG PET/CT after 10 weeks of pembrolizumab therapy. Subjects may also be a part of the Penn Melanoma Tissue Collection Program and then will be asked to have one additional tumor biopsy and one additional blood draw for the purposes of this imaging study. Subjects who are eligible for this imaging protocol will undergo a baseline FDG PET/CT scan as part of their clinical restaging prior to starting new therapy. A research FDG PET/CT will take place approximately 3 weeks post-therapy and a 3rd FDG PET/CT scan will be done at more than 10 weeks after starting pembrolizumab, this scan may be done as a clinical scan for evaluation of response or restaging after therapy, however, if it is not ordered as a clinical scan it will be done as a research scan. Changes in FDG uptake will be correlated with blood and tissue results from the patient's medical records and from the data collected as part of the Penn Melanoma Tissue Collection Program and with long term outcomes including progression free and overall survival.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The subject must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.

• The subject must be = 18 years of age on day of signing informed consent.

• The subject must have biopsy proven or clinically documented advanced stage metastatic melanoma.

• The subject must have measurable disease (per RECIST 1.1) that is seen on CT, MRI, or FDG PET/CT.

• The subject must be recommended to start pembrolizumab.

Exclusion Criteria:

• Females who are pregnant or breast-feeding at the time of screening will not be eligible for this study. Female participants of child-bearing potential will have a urine pregnancy test at the time of the screening visit.

• Subject is not able to tolerate imaging procedures in the opinion of the investigator or treating physician.

• Subject has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.

• Subject has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent as assessed by medical record review and/or self-reported.

• Subject has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies) as determined by medical record review.

• Subject has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.

• Subject has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected) as determined by medical record review.

• Subject has known active central nervous system metastases and/or carcinomatous meningitis.

Note: Subjects with previously treated brain metastases will be eligible to participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to receiving pembrolizumab and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment.

Related Conditions & MeSH terms

• Melanoma
• Metastatic Melanoma

Intervention

Drug:
• Pembrolizumab

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of complete response or partial response or nonresponders (stable disease or progressive disease) to CT.	Response will be determined by RECIST version 1.1.	6 months