NCT02740920

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

Terminated Phase 2 Results posted Last updated 25 August 2023

What this trial tests

Phase 2 trial testing Pembrolizumab in Metastatic Melanoma in 9 participants. Terminated before completion.

Timeline

10 January 2017

Primary endpoint
22 March 2019

30 September 2019

Quick facts

Lead sponsor	Canadian Cancer Trials Group
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	9
Start date	10 January 2017
Primary completion	22 March 2019
Estimated completion	30 September 2019
Sites	5 locations across Canada

Drugs / interventions tested

• Pembrolizumab (pembrolizumab) — full drug profile →
• CT Scan — full drug profile →

Conditions studied

• Metastatic Melanoma — all drugs for Metastatic Melanoma →

Sponsor

Canadian Cancer Trials Group — full company profile →

Who can join

18 and older, any sex, with Metastatic Melanoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Overall Response Rate Assessed by CT Scan Secondary · 24 months

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.

Group	Value	95% CI
Pembrolizumab	2
Pembrolizumab	7

Adverse events — posted to ClinicalTrials.gov

Time frame: 24 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Pembrolizumab

Serious: 2/9 (22%)

Deaths: 5/9

Serious adverse events (6 terms)

Reaction	System	Pembrolizumab
Fever	General disorders	—
Muscle weakness right-sided	Musculoskeletal and connective tissue disorders	—
Other neoplasms benign, malignant and unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Depressed level of consciousness	Nervous system disorders	—
Dysarthria	Nervous system disorders	—
Other nervous system disorders	Nervous system disorders	—

Other adverse events (28 terms — click to expand)

Reaction	System	Pembrolizumab
Fatigue	General disorders	—
Upper respiratory infection	Infections and infestations	—
Cough	Respiratory, thoracic and mediastinal disorders	—
Other skin and subcutaneous tissue disorders	Skin and subcutaneous tissue disorders	—
Rash maculo-papular	Skin and subcutaneous tissue disorders	—
Other gastrointestinal disorders	Gastrointestinal disorders	—
Non-cardiac chest pain	General disorders	—
Pain	General disorders	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—
Chest pain - cardiac	Cardiac disorders	—
Blurred vision	Eye disorders	—
Abdominal pain	Gastrointestinal disorders	—
Constipation	Gastrointestinal disorders	—
Diarrhea	Gastrointestinal disorders	—
Edema limbs	General disorders	—
Fever	General disorders	—
Other infections and infestations	Infections and infestations	—
Muscle weakness right-sided	Musculoskeletal and connective tissue disorders	—
Other neoplasms benign, malignant and unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Depressed level of consciousness	Nervous system disorders	—
Dysarthria	Nervous system disorders	—
Headache	Nervous system disorders	—
Other nervous system disorders	Nervous system disorders	—
Peripheral sensory neuropathy	Nervous system disorders	—
Hyperhidrosis	Skin and subcutaneous tissue disorders	—
Pruritus	Skin and subcutaneous tissue disorders	—
Rash acneiform	Skin and subcutaneous tissue disorders	—
Hypertension	Vascular disorders	—

Most-reported serious reactions: Fever, Muscle weakness right-sided, Other neoplasms benign, malignant and unspecified, Depressed level of consciousness, Dysarthria, Other nervous system disorders.

Data from ClinicalTrials.gov NCT02740920 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.