Trial Outcomes & Findings for Response to Pembrolizumab in Metastatic Melanoma: Computed Tomography Texture Analysis as a Predictive Biomarker (NCT NCT02740920)

Last Updated: 2023-08-25

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

9 participants

Primary outcome timeframe

12 months

Results posted on

2023-08-25

Participant Flow

Participant milestones

Participant milestones
Measure	Pembrolizumab 200mg IV Day 1 every 3 weeks. Pembrolizumab CT Scan
Overall Study STARTED	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pembrolizumab n=9 Participants 200mg IV Day 1 every 3 weeks. Pembrolizumab CT Scan
Age, Continuous	65 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Performance status Grade 0	6 Participants n=5 Participants
Performance status Grade 1	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Trial closed due to slow accrual, analysis was no done for the primary outcome because data were not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Population: All patients who received the protocol treatment.

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.

Outcome measures

Outcome measures
Measure	Pembrolizumab n=9 Participants 200mg IV Day 1 every 3 weeks. Pembrolizumab CT Scan
Overall Response Rate Assessed by CT Scan Number of Response	2 Participants
Overall Response Rate Assessed by CT Scan Nomuber of non-response	7 Participants

Adverse Events

Pembrolizumab

Serious events: 2 serious events

Other events: 8 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	Pembrolizumab n=9 participants at risk 200mg IV Day 1 every 3 weeks. Pembrolizumab CT Scan
General disorders Fever	11.1% 1/9 • 24 months
Musculoskeletal and connective tissue disorders Muscle weakness right-sided	11.1% 1/9 • 24 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Other neoplasms benign, malignant and unspecified	11.1% 1/9 • 24 months
Nervous system disorders Depressed level of consciousness	11.1% 1/9 • 24 months
Nervous system disorders Dysarthria	11.1% 1/9 • 24 months
Nervous system disorders Other nervous system disorders	11.1% 1/9 • 24 months

Other adverse events

Other adverse events
Measure	Pembrolizumab n=9 participants at risk 200mg IV Day 1 every 3 weeks. Pembrolizumab CT Scan
Cardiac disorders Chest pain - cardiac	11.1% 1/9 • 24 months
Eye disorders Blurred vision	11.1% 1/9 • 24 months
Gastrointestinal disorders Abdominal pain	11.1% 1/9 • 24 months
Gastrointestinal disorders Constipation	11.1% 1/9 • 24 months
Gastrointestinal disorders Diarrhea	11.1% 1/9 • 24 months
Gastrointestinal disorders Other gastrointestinal disorders	22.2% 2/9 • 24 months
General disorders Edema limbs	11.1% 1/9 • 24 months
General disorders Fatigue	44.4% 4/9 • 24 months
General disorders Fever	11.1% 1/9 • 24 months
General disorders Non-cardiac chest pain	22.2% 2/9 • 24 months
General disorders Pain	22.2% 2/9 • 24 months
Infections and infestations Other infections and infestations	11.1% 1/9 • 24 months
Infections and infestations Upper respiratory infection	33.3% 3/9 • 24 months
Musculoskeletal and connective tissue disorders Muscle weakness right-sided	11.1% 1/9 • 24 months
Musculoskeletal and connective tissue disorders Pain in extremity	22.2% 2/9 • 24 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Other neoplasms benign, malignant and unspecified	11.1% 1/9 • 24 months
Nervous system disorders Depressed level of consciousness	11.1% 1/9 • 24 months
Nervous system disorders Dysarthria	11.1% 1/9 • 24 months
Nervous system disorders Headache	11.1% 1/9 • 24 months
Nervous system disorders Other nervous system disorders	11.1% 1/9 • 24 months
Nervous system disorders Peripheral sensory neuropathy	11.1% 1/9 • 24 months
Respiratory, thoracic and mediastinal disorders Cough	33.3% 3/9 • 24 months
Skin and subcutaneous tissue disorders Hyperhidrosis	11.1% 1/9 • 24 months
Skin and subcutaneous tissue disorders Other skin and subcutaneous tissue disorders	33.3% 3/9 • 24 months
Skin and subcutaneous tissue disorders Pruritus	11.1% 1/9 • 24 months
Skin and subcutaneous tissue disorders Rash acneiform	11.1% 1/9 • 24 months
Skin and subcutaneous tissue disorders Rash maculo-papular	33.3% 3/9 • 24 months
Vascular disorders Hypertension	11.1% 1/9 • 24 months

Additional Information

Janet Dancey

Canadian Cancer Trials Group

Phone: 613-533-2430

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place