Trial Outcomes & Findings for Pembrolizumab in Advanced/Metastatic Acral Lentiginous Melanoma (NCT NCT02875132)

Results Overview

Overall Response Rate (ORR) is defined as rate of complete response (CR) and partial response (PR) as per RECIST 1.1 in biological treatment-naïve patients with acral lentiginous melanoma treated with pembrolizumab

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

9 participants

Primary outcome timeframe

2 years

Results posted on

2025-04-18

Participant Flow

Participant milestones

Participant milestones
Measure	Pembrolizumab pembrolizumab: pembrolizumab at 200mg IV infusion every 3 weeks
Overall Study STARTED	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pembrolizumab n=9 Participants pembrolizumab: pembrolizumab at 200mg IV infusion every 3 weeks
Age, Continuous	68 years STANDARD_DEVIATION 9.9 • n=9 Participants
Sex: Female, Male Female	3 Participants n=9 Participants
Sex: Female, Male Male	6 Participants n=9 Participants
Region of Enrollment Hong Kong	9 Participants n=9 Participants

PRIMARY outcome

Timeframe: 2 years

Overall Response Rate (ORR) is defined as rate of complete response (CR) and partial response (PR) as per RECIST 1.1 in biological treatment-naïve patients with acral lentiginous melanoma treated with pembrolizumab

Outcome measures

Outcome measures
Measure	Pembrolizumab n=9 Participants pembrolizumab: pembrolizumab at 200mg IV infusion every 3 weeks
Overall Response Rate (ORR)	1 participants Interval 0.0 to 31.6

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	Pembrolizumab n=1 Participants pembrolizumab: pembrolizumab at 200mg IV infusion every 3 weeks
Response Duration	19 months

SECONDARY outcome

Timeframe: 2 years

To determine the Clinical Benefit Rate (CBR) of pembrolizumab treatment naïve acral lentiginous melanoma patients as defined by rate of CR + PR and stable disease (SD) of \>/= 6 months

Outcome measures

Outcome measures
Measure	Pembrolizumab n=9 Participants pembrolizumab: pembrolizumab at 200mg IV infusion every 3 weeks
Clinical Benefit Rate (CBR)	4 Participants

SECONDARY outcome

Timeframe: 3 years

Outcome measures

Outcome measures
Measure	Pembrolizumab n=9 Participants pembrolizumab: pembrolizumab at 200mg IV infusion every 3 weeks
Progression-free Survival (PFS)	3.4 months Interval 1.4 to 21.3

SECONDARY outcome

Timeframe: 3 years

Outcome measures

Outcome measures
Measure	Pembrolizumab n=9 Participants pembrolizumab: pembrolizumab at 200mg IV infusion every 3 weeks
Overall Survival (OS)	7.6 months Interval 2.0 to 34.3

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	Pembrolizumab n=9 Participants pembrolizumab: pembrolizumab at 200mg IV infusion every 3 weeks
Response Assessment as Per the Immune-related Response Criteria (irRC)	0 Participants

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	Pembrolizumab n=9 Participants pembrolizumab: pembrolizumab at 200mg IV infusion every 3 weeks
Number of Participants With Adverse Events	2 participants

Adverse Events

Pembrolizumab

Serious events: 4 serious events

Other events: 2 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Pembrolizumab n=9 participants at risk pembrolizumab: pembrolizumab at 200mg IV infusion every 3 weeks
Respiratory, thoracic and mediastinal disorders Cough	11.1% 1/9 • Number of events 1 • Through study completion, up to 35 months. Number of Participants at Risk: 9
Respiratory, thoracic and mediastinal disorders Dizziness	11.1% 1/9 • Number of events 1 • Through study completion, up to 35 months. Number of Participants at Risk: 9
Nervous system disorders Malaise	11.1% 1/9 • Number of events 1 • Through study completion, up to 35 months. Number of Participants at Risk: 9
Respiratory, thoracic and mediastinal disorders Pleural effusion	11.1% 1/9 • Number of events 1 • Through study completion, up to 35 months. Number of Participants at Risk: 9

Other adverse events

Other adverse events
Measure	Pembrolizumab n=9 participants at risk pembrolizumab: pembrolizumab at 200mg IV infusion every 3 weeks
General disorders Dizziness	11.1% 1/9 • Number of events 1 • Through study completion, up to 35 months. Number of Participants at Risk: 9
Respiratory, thoracic and mediastinal disorders Pleural effusion	11.1% 1/9 • Number of events 1 • Through study completion, up to 35 months. Number of Participants at Risk: 9

Additional Information

Dr. Herbert Ho Fung LOONG

The Chinese University of Hong Kong

Phone: 35052166

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place