Trial Outcomes & Findings for MK-3475 as Maintenance Therapy in Extensive Stage SCLC (NCT NCT02359019)
NCT ID: NCT02359019
Last Updated: 2022-10-14
Results Overview
Progression is defined using RECIST 1.1. PFS will be estimated with the standard Kaplan-Meier method, from which summary statistics of interest (median, 1-year rate, etc.) will be derived. Both point and 95% confidence interval estimates of PFS will be calculated.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
Time from registration to time of progression, assessed up to 6 months after completion of study treatment.
Results posted on
2022-10-14
Participant Flow
Participant milestones
| Measure |
Treatment (Pembrolizumab)
Patients receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
45
|
|
Overall Study
COMPLETED
|
45
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
MK-3475 as Maintenance Therapy in Extensive Stage SCLC
Baseline characteristics by cohort
| Measure |
Treatment (Pembrolizumab)
n=45 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
25 Participants
n=5 Participants
|
|
Age, Continuous
|
65.6 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
37 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Middle Eastern
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Time from registration to time of progression, assessed up to 6 months after completion of study treatment.Progression is defined using RECIST 1.1. PFS will be estimated with the standard Kaplan-Meier method, from which summary statistics of interest (median, 1-year rate, etc.) will be derived. Both point and 95% confidence interval estimates of PFS will be calculated.
Outcome measures
| Measure |
Treatment (Pembrolizumab)
n=45 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
PFS Using RECIST 1.1
|
1.4 months
Interval 1.3 to 2.8
|
SECONDARY outcome
Timeframe: Time from registration to time of progression, assessed up to 6 months after completion of study treatment.Progression is defined using RECIST 1.1. Estimated using standard Kaplan-Meier methods, from which the median and a 90% confidence interval will be calculated.
Outcome measures
| Measure |
Treatment (Pembrolizumab)
n=45 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Modified PFS Defined by RECIST as Progression That is Confirmed by a Second Scan at Least 4 Weeks Apart
|
6.3 months
Interval 2.6 to 9.5
|
SECONDARY outcome
Timeframe: Time from registration to time of death, assessed up to 12 months after completion of study treatment.Estimated using standard Kaplan-Meier methods, from which the median and a 95% confidence interval will be calculated.
Outcome measures
| Measure |
Treatment (Pembrolizumab)
n=45 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Overall Survival
|
9.6 months
Interval 7.0 to 12.0
|
Adverse Events
Treatment (Pembrolizumab)
Serious events: 18 serious events
Other events: 42 other events
Deaths: 34 deaths
Serious adverse events
| Measure |
Treatment (Pembrolizumab)
n=45 participants at risk
Patients receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Cardiac disorders
Acute Coronary Syndrome
|
2.2%
1/45 • Number of events 1 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Blood and lymphatic system disorders
Alkaline phosphatase increased
|
2.2%
1/45 • Number of events 1 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
4.4%
2/45 • Number of events 2 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Blood and lymphatic system disorders
Aspartate aminotransferase increase
|
4.4%
2/45 • Number of events 2 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Vascular disorders
Atrioventricular block complete
|
2.2%
1/45 • Number of events 1 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.4%
2/45 • Number of events 3 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Eye disorders
Cataract
|
2.2%
1/45 • Number of events 1 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
General disorders
Dehydration
|
2.2%
1/45 • Number of events 1 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.2%
1/45 • Number of events 1 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Endocrine disorders
Endocrine disorders - Type 1 Diabetes
|
2.2%
1/45 • Number of events 1 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
General disorders
Fatigue
|
2.2%
1/45 • Number of events 1 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Blood and lymphatic system disorders
Hematoma
|
2.2%
1/45 • Number of events 1 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.2%
1/45 • Number of events 1 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
2.2%
1/45 • Number of events 1 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.2%
1/45 • Number of events 1 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.2%
1/45 • Number of events 1 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.9%
4/45 • Number of events 6 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Infections and infestations
Lung infection- Pneumonia
|
4.4%
2/45 • Number of events 2 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Investigations
Lymphocyte count decreased
|
2.2%
1/45 • Number of events 1 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
4.4%
2/45 • Number of events 2 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Cardiac disorders
Myocardial infarction
|
4.4%
2/45 • Number of events 2 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
4.4%
2/45 • Number of events 2 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and
|
2.2%
1/45 • Number of events 1 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
General disorders
Pain
|
2.2%
1/45 • Number of events 1 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Nervous system disorders
Paresthesia
|
2.2%
1/45 • Number of events 1 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.2%
1/45 • Number of events 1 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
2.2%
1/45 • Number of events 1 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Infections and infestations
Right lower/middle lobe pneumonia
|
2.2%
1/45 • Number of events 1 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Nervous system disorders
Spinal cord compression
|
2.2%
1/45 • Number of events 1 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
2.2%
1/45 • Number of events 1 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
2.2%
1/45 • Number of events 1 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Nervous system disorders
Syncope
|
2.2%
1/45 • Number of events 1 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Vascular disorders
Thromboembolic event
|
2.2%
1/45 • Number of events 1 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Nervous system disorders
Transient ischemic attacks
|
2.2%
1/45 • Number of events 1 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
Other adverse events
| Measure |
Treatment (Pembrolizumab)
n=45 participants at risk
Patients receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Endocrine disorders
Hypothyroidism
|
8.9%
4/45 • Number of events 5 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.9%
4/45 • Number of events 10 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
5/45 • Number of events 5 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
8.9%
4/45 • Number of events 5 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Investigations
Alkaline phosphatase increased
|
8.9%
4/45 • Number of events 6 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
8.9%
4/45 • Number of events 5 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Psychiatric disorders
Anxiety
|
8.9%
4/45 • Number of events 4 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.9%
4/45 • Number of events 5 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
13.3%
6/45 • Number of events 10 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.3%
6/45 • Number of events 9 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
22.2%
10/45 • Number of events 13 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.2%
10/45 • Number of events 12 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Investigations
Creatinine increased
|
8.9%
4/45 • Number of events 4 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
15.6%
7/45 • Number of events 8 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Nervous system disorders
Dizziness
|
20.0%
9/45 • Number of events 10 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
9/45 • Number of events 12 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
General disorders
Edema limbs
|
8.9%
4/45 • Number of events 4 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
General disorders
Fatigue
|
40.0%
18/45 • Number of events 22 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
11.1%
5/45 • Number of events 6 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Nervous system disorders
Headache
|
13.3%
6/45 • Number of events 6 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
8.9%
4/45 • Number of events 8 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
8.9%
4/45 • Number of events 5 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.9%
4/45 • Number of events 5 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Investigations
Lymphocyte count decreased
|
11.1%
5/45 • Number of events 10 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.9%
4/45 • Number of events 4 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
26.7%
12/45 • Number of events 15 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
General disorders
Non-cardiac chest pain
|
13.3%
6/45 • Number of events 8 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
General disorders
Pain
|
11.1%
5/45 • Number of events 5 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.9%
4/45 • Number of events 6 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
11.1%
5/45 • Number of events 6 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Investigations
Platelet count decreased
|
8.9%
4/45 • Number of events 6 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
8.9%
4/45 • Number of events 4 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
22.2%
10/45 • Number of events 23 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
17.8%
8/45 • Number of events 16 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
8.9%
4/45 • Number of events 4 • Time from registration until off study, assessed up to 6 months after completion of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place