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Trial Outcomes & Findings for Pembrolizumab Effects on NK Cell Exhaustion in Melanoma (Merck NK-IIT) (NCT NCT03241927)

NCT ID: NCT03241927

Last Updated: 2020-11-23

Results Overview

NK cell exhaustion will be assess by flow cytometry and expressed as % of LAMP-1 positive cells.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

up to 3 years

Results posted on

2020-11-23

Participant Flow

4 Participants consented, 1 with unstable CNS and not eligible, 2 withdrew consent. and 1 enrolled.

Participant milestones

Participant milestones
Measure
Pembrolizumab
200 mg IV infusion every 3 weeks Pembrolizumab: Day 1 of each 3 week cycle
Healthy Donors
Healthy participants
Overall Study
STARTED
1
0
Overall Study
COMPLETED
0
0
Overall Study
NOT COMPLETED
1
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Pembrolizumab
200 mg IV infusion every 3 weeks Pembrolizumab: Day 1 of each 3 week cycle
Healthy Donors
Healthy participants
Overall Study
study terminated
1
0

Baseline Characteristics

Pembrolizumab Effects on NK Cell Exhaustion in Melanoma (Merck NK-IIT)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Pembrolizumab
n=1 Participants
200 mg IV infusion every 3 weeks Pembrolizumab: Day 1 of each 3 week cycle
Age, Customized
60-69 years
1 Participants
n=5 Participants
Age, Customized
70-79 years
0 Participants
n=5 Participants
Age, Customized
80-89 years
0 Participants
n=5 Participants
Sex: Female, Male
Female
1 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
Race (NIH/OMB)
White
1 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants

PRIMARY outcome

Timeframe: up to 3 years

Population: Data not collected

NK cell exhaustion will be assess by flow cytometry and expressed as % of LAMP-1 positive cells.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: up to 3 years

Population: Data not collected

IFN gamma will be assess by flow cytometry and then expressed as % of positive cell for IFN gamma.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: up to 3 years

Population: Data not collected

NK proliferation will be assess by flow cytometry and then expressed as percentage of proliferating cells.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 104 levels

Population: Data not collected

MICA plasma biomarker level associated with reversal of NK cell exhaustion will be assessed by ELISA.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 104 weeks

Population: Data not collected

HMGB-1 plasma biomarker level associated with reversal of NK cell exhaustion will be assessed by ELISA.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 104 weeks

Population: Data not collected

CEACAM-1 expression will be assessed by flow cytometry and express as % of positive NK cells for CEACAM-1

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Population: Data not collected

One year survival following pembrolizumab treatment in patients with Unresectable stage III or IV melanoma using Immune-Related Response Criteria.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: only one subject in study

Progression free survival in pembrolizumab treated patients with unresectable stage III or IV melanoma using Immune-Related Response Criteria.

Outcome measures

Outcome measures
Measure
Pembrolizumab
n=1 Participants
200 mg IV infusion every 3 weeks Pembrolizumab: Day 1 of each 3 week cycle
Healthy Donors
Healthy participants
Progression Free Survival (PFS) Rate
18 weeks
—

Adverse Events

Pembrolizumab

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Healthy Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Pembrolizumab
n=1 participants at risk
200 mg IV infusion every 3 weeks Pembrolizumab: Day 1 of each 3 week cycle
Healthy Control
Healthy Participants
General disorders
Bilateral Leg Edema
100.0%
1/1 • Number of events 1 • 18 weeks
there was only one person in this study. No participants in Healthy Control arm.
—
0/0 • 18 weeks
there was only one person in this study. No participants in Healthy Control arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor Pain
100.0%
1/1 • Number of events 1 • 18 weeks
there was only one person in this study. No participants in Healthy Control arm.
—
0/0 • 18 weeks
there was only one person in this study. No participants in Healthy Control arm.
Blood and lymphatic system disorders
Anemia
100.0%
1/1 • Number of events 3 • 18 weeks
there was only one person in this study. No participants in Healthy Control arm.
—
0/0 • 18 weeks
there was only one person in this study. No participants in Healthy Control arm.
Investigations
Creatinine Increased
100.0%
1/1 • Number of events 1 • 18 weeks
there was only one person in this study. No participants in Healthy Control arm.
—
0/0 • 18 weeks
there was only one person in this study. No participants in Healthy Control arm.
Skin and subcutaneous tissue disorders
Hair thinning
100.0%
1/1 • Number of events 1 • 18 weeks
there was only one person in this study. No participants in Healthy Control arm.
—
0/0 • 18 weeks
there was only one person in this study. No participants in Healthy Control arm.
Metabolism and nutrition disorders
Hyperuricemia
100.0%
1/1 • Number of events 2 • 18 weeks
there was only one person in this study. No participants in Healthy Control arm.
—
0/0 • 18 weeks
there was only one person in this study. No participants in Healthy Control arm.
Respiratory, thoracic and mediastinal disorders
Pneumonitis
100.0%
1/1 • Number of events 1 • 18 weeks
there was only one person in this study. No participants in Healthy Control arm.
—
0/0 • 18 weeks
there was only one person in this study. No participants in Healthy Control arm.

Additional Information

Dr. Nina Bhardwaj

Icahn School of Medicine at Mount Sinai

Phone: 212-824-8427

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place