Response to Pembrolizumab in Metastatic Melanoma: Computed Tomography Texture Analysis as a Predictive Biomarker
Primary Purpose
Metastatic Melanoma
Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Pembrolizumab
CT Scan
Sponsored by

About this trial
This is an interventional treatment trial for Metastatic Melanoma
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed melanoma that is recurrent/metastatic and not amenable to potentially curative surgery.
- Presence of clinically and/or radiologically documented disease based on RECIST 1.1. At least one site of disease must be unidimensionally measurable by contrast-enhanced CT scan as follows:
CT scan (with slice thickness of ≤ 5 mm) ≥ 10 mm --> longest diameter Lymph nodes by CT scan ≥ 15 mm --> measured in short axis
- Age ≥ 18 years.
- ECOG Performance Status of 0 to 1.
- Previous Therapy
Surgery:
Previous surgery is permitted provided that it has been at least 21 days prior to patient registration and that wound healing has occurred.
Systemic Therapy:
Patients may not have received any prior systemic therapy for metastatic melanoma.
Radiation:
Palliative radiation is permitted provided > 7 days has elapsed between last dose and enrollment on the trial.
- Laboratory Requirements Absolute neutrophils ≥ 1.5 x 10^9/L Platelets ≥ 100 x 10^9/L Hemoglobin ≥ 90 g/L or ≥ 5.6 mmol/L (without transfusion or EPO dependency) Serum creatinine or measured or calculated creatinine: ≤1.5 x ULN or ≥ 60 mL/min for subject with creatinine clearance levels > 1.5 x ULN Serum Total Bilirubin ≤ 1.5 x ULN or Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 x ULN AST and ALT ≤ 2.5 x ULN (≤ 5 x ULN for subjects with liver mets) Albumin ≥ 25 g/L
- Women/men of childbearing potential must have agreed to use a highly effective contraceptive method.
- Women of childbearing potential will have a serum or urine pregnancy test within 7 days prior to registration to determine eligibility.
- Patient consent must be obtained according to local Institutional and/or University Human Experimental Committee requirements.
- Patients must be accessible for treatment and follow up. Patients registered on this trial must be treated and followed at the participating centre.
Exclusion Criteria:
- Patients who have received prior systemic treatment for metastatic melanoma.
- Patients with known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
- Patients with a known history of or known positive for Hepatitis B (HBsAg reactive) or Hepatitis C (HCV RNA [qualitative] is detected). Patients with unknown history of Hepatitis B virus (HBV) or Hepatitis C virus (HCV) will require screening.
- Patients with previously treated brain metastases may participate provided they are stable with no evidence of enlargement following radiation treatment and no acute radiation toxicity OR no evidence of enlargement at least 4 weeks prior to the first dose of study drug if untreated and are off systemic steroids for at least two weeks.
- Patients who are pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the pre-screening or screening visit through 4 months after the last dose of trial treatment.
- Patients who previously had a severe hypersensitivity reaction to treatment with another mAb.
- Patients with an active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents. (Only patients on active treatment are ineligible).
- Patients with a history of a malignancy (other than the disease under treatment in the study) within 5 years prior to first study drug administration.
- Patients on any systemic corticosteroid therapy within one week before the planned date for first dose of treatment or on any other form of immunosuppressive medication.
- Patients with an allergy to iodinated contrast media used for CT.
- Patients with a known history of active TB (Bacillus Tuberculosis).
- Patients with evidence of interstitial lung disease;
- Patients with known history of, or any evidence of active, non-infectious pneumonitis
Sites / Locations
- Kingston Health Sciences Centre
- London Regional Cancer Program
- Ottawa Hospital Research Institute
- Odette Cancer Centre
- Allan Blair Cancer Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pembrolizumab
Arm Description
200mg IV Day 1 every 3 weeks.
Outcomes
Primary Outcome Measures
Measurement of Tumor Texture by CT Scan
To assess whether tumour texture parameters from a CT scan can differentiate patients who do and who do not respond to treatment with pembrolizumab. Trial closed due to slow accrual, analysis was no done for the primary outcome because data were not collected.
Secondary Outcome Measures
Overall Response Rate Assessed by CT Scan
To determine the overall response rate (complete + partial response)/total number of patients.
Response and progression will be evaluated in this study using the revised international criteria (1.1) proposed by the RECIST (Response Evaluation Criteria in Solid Tumours) committee as well as the modified iRECIST guidelines. Response were assessed by CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Full Information
NCT ID
NCT02740920
First Posted
April 6, 2016
Last Updated
August 3, 2023
Sponsor
Canadian Cancer Trials Group
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT02740920
Brief Title
Response to Pembrolizumab in Metastatic Melanoma: Computed Tomography Texture Analysis as a Predictive Biomarker
Official Title
A Phase II Study of the Assessment of Response to Pembrolizumab in Metastatic Melanoma: CT Texture Analysis as a Predictive Biomarker
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Terminated
Study Start Date
January 10, 2017 (Actual)
Primary Completion Date
March 22, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Canadian Cancer Trials Group
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Studies have shown that the study drug, pembrolizumab, works by helping the immune system. In this way, pembrolizumab may help to slow the growth of melanoma or may cause cancer cells to die. Compared to standard treatments, pembrolizumab seems to lengthen the time patients lived overall and the time without their cancer getting worse.
Detailed Description
The main purpose of this study is to find out if a type of CT (computed topography) scan can help to know if pembrolizumab is working. This CT scan (called Texture Analysis) looks at the tumour in fine detail. The use of this type of CT scan has not been studied in patients with metastatic melanoma. Investigators want to see if this CT scan will show if some patients being treated with pembrolizumab respond better than others.
One of the other purposes is to compare the costs within this trial to costs of the standard of care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pembrolizumab
Arm Type
Experimental
Arm Description
200mg IV Day 1 every 3 weeks.
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Intervention Type
Procedure
Intervention Name(s)
CT Scan
Primary Outcome Measure Information:
Title
Measurement of Tumor Texture by CT Scan
Description
To assess whether tumour texture parameters from a CT scan can differentiate patients who do and who do not respond to treatment with pembrolizumab. Trial closed due to slow accrual, analysis was no done for the primary outcome because data were not collected.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Overall Response Rate Assessed by CT Scan
Description
To determine the overall response rate (complete + partial response)/total number of patients.
Response and progression will be evaluated in this study using the revised international criteria (1.1) proposed by the RECIST (Response Evaluation Criteria in Solid Tumours) committee as well as the modified iRECIST guidelines. Response were assessed by CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed melanoma that is recurrent/metastatic and not amenable to potentially curative surgery.
Presence of clinically and/or radiologically documented disease based on RECIST 1.1. At least one site of disease must be unidimensionally measurable by contrast-enhanced CT scan as follows:
CT scan (with slice thickness of ≤ 5 mm) ≥ 10 mm --> longest diameter Lymph nodes by CT scan ≥ 15 mm --> measured in short axis
Age ≥ 18 years.
ECOG Performance Status of 0 to 1.
Previous Therapy
Surgery:
Previous surgery is permitted provided that it has been at least 21 days prior to patient registration and that wound healing has occurred.
Systemic Therapy:
Patients may not have received any prior systemic therapy for metastatic melanoma.
Radiation:
Palliative radiation is permitted provided > 7 days has elapsed between last dose and enrollment on the trial.
Laboratory Requirements Absolute neutrophils ≥ 1.5 x 10^9/L Platelets ≥ 100 x 10^9/L Hemoglobin ≥ 90 g/L or ≥ 5.6 mmol/L (without transfusion or EPO dependency) Serum creatinine or measured or calculated creatinine: ≤1.5 x ULN or ≥ 60 mL/min for subject with creatinine clearance levels > 1.5 x ULN Serum Total Bilirubin ≤ 1.5 x ULN or Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 x ULN AST and ALT ≤ 2.5 x ULN (≤ 5 x ULN for subjects with liver mets) Albumin ≥ 25 g/L
Women/men of childbearing potential must have agreed to use a highly effective contraceptive method.
Women of childbearing potential will have a serum or urine pregnancy test within 7 days prior to registration to determine eligibility.
Patient consent must be obtained according to local Institutional and/or University Human Experimental Committee requirements.
Patients must be accessible for treatment and follow up. Patients registered on this trial must be treated and followed at the participating centre.
Exclusion Criteria:
Patients who have received prior systemic treatment for metastatic melanoma.
Patients with known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
Patients with a known history of or known positive for Hepatitis B (HBsAg reactive) or Hepatitis C (HCV RNA [qualitative] is detected). Patients with unknown history of Hepatitis B virus (HBV) or Hepatitis C virus (HCV) will require screening.
Patients with previously treated brain metastases may participate provided they are stable with no evidence of enlargement following radiation treatment and no acute radiation toxicity OR no evidence of enlargement at least 4 weeks prior to the first dose of study drug if untreated and are off systemic steroids for at least two weeks.
Patients who are pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the pre-screening or screening visit through 4 months after the last dose of trial treatment.
Patients who previously had a severe hypersensitivity reaction to treatment with another mAb.
Patients with an active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents. (Only patients on active treatment are ineligible).
Patients with a history of a malignancy (other than the disease under treatment in the study) within 5 years prior to first study drug administration.
Patients on any systemic corticosteroid therapy within one week before the planned date for first dose of treatment or on any other form of immunosuppressive medication.
Patients with an allergy to iodinated contrast media used for CT.
Patients with a known history of active TB (Bacillus Tuberculosis).
Patients with evidence of interstitial lung disease;
Patients with known history of, or any evidence of active, non-infectious pneumonitis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teresa Petrella
Organizational Affiliation
Sunnybrook Health Sciences Centre, Toronto ON
Official's Role
Study Chair
Facility Information:
Facility Name
Kingston Health Sciences Centre
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
London Regional Cancer Program
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Ottawa Hospital Research Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Odette Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Allan Blair Cancer Centre
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 7T1
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Response to Pembrolizumab in Metastatic Melanoma: Computed Tomography Texture Analysis as a Predictive Biomarker
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