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Metastatic MelanomaPhase 2NCT02740920

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

A Phase 2 study testing Pembrolizumab and CT Scan in people with Metastatic Melanoma, run by Canadian Cancer Trials Group at 5 sites in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Melanoma
What is being tested?
Pembrolizumab and CT Scan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
5 sitesCanada
Study dates
10 Jan 2017to 30 Sep 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Canada5 sites

  • Kingston Health Sciences Centre

    Kingston, Ontario, K7L 2V7

  • London Regional Cancer Program

    London, Ontario, N6A 5W9

  • Ottawa Hospital Research Institute

    Ottawa, Ontario, K1H 8L6

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Odette Cancer Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

About this study

Official title: A Phase II Study of the Assessment of Response to Pembrolizumab in Metastatic Melanoma: CT Texture Analysis as a Predictive Biomarker

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.

Read the 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.

Being tested
Pembrolizumab, CT Scan
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02740920
Study groupRoleWhat they receive
PembrolizumabExperimental200mg IV Day 1 every 3 weeks.
Receives: Drug: Pembrolizumab; Procedure: CT Scan

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (1)

  1. 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.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2016 (estimated)
  2. Study start10 Jan 2017
  3. Primary completion22 Mar 2019
  4. Study completion30 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02740920
Sponsor's protocol ID
I225
Status last verified
Apr 2020
First submitted
6 Apr 2016
Last updated
25 Aug 2023
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab and CT Scan in people with Metastatic Melanoma, run by Canadian Cancer Trials Group at 5 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measurement of Tumor Texture by CT Scan (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02740920.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023.

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