Response to Pembrolizumab in Metastatic Melanoma: Computed Tomography Texture Analysis as a Predictive Biomarker

NCT02740920 | Terminated Phase 2 Results DMC

• 1 other identifier: I225
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 5

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.

Conditions

Metastatic Melanoma

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (1)

• Overall Response Rate Assessed by CT Scan

  24 months

Study Arms (1)

Pembrolizumab

EXPERIMENTAL

200mg IV Day 1 every 3 weeks.

Drug: Pembrolizumab; Procedure: CT Scan

Interventions

Pembrolizumab DRUG

Pembrolizumab

CT Scan PROCEDURE

Pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Canadian Cancer Trials Group: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (5)

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

Location

London Regional Cancer Program

London, Ontario, N6A 5W9, Canada

Location

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 8L6, Canada

Location

Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

MeSH Terms

Conditions

Melanoma

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Janet Dancey
• Organization: Canadian Cancer Trials Group

jdancey@ctg.queensu.ca

613-533-2430

Study Officials

• Teresa Petrella

  Sunnybrook Health Sciences Centre, Toronto ON

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2016
• First Posted: April 15, 2016
• Study Start: January 10, 2017
• Primary Completion: March 22, 2019
• Study Completion: September 30, 2019
• Last Updated: August 25, 2023
• Results First Posted: September 20, 2019

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5)