Trial Outcomes & Findings for Study of Pembrolizumab With Lanreotide Depot for Gastroenteropancreatic Neuroendocrine Tumors (NCT NCT03043664)
NCT ID: NCT03043664
Last Updated: 2023-06-29
Results Overview
ORR is calculated as the number of people with a complete response (CR) or partial response (PR), divided by the total number of people treated. Complete response is defined as disappearance of all target lesions. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. A lower limit of the true ORR will be estimated by the 90% exact lower confidence bound (LCB) for the binomial proportion. A 90% LCB of \< 0.1 will be considered not to be of clinical value. If the 90% LCB is ≥ 0.1, the regimen will be considered efficacious.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
22 participants
Primary outcome timeframe
Approximately every 12 weeks until study completion (up to 2 years)
Results posted on
2023-06-29
Participant Flow
Subjects were recruited at Duke University Medical Center from 5/15/2017 to 2/13/2020.
Participant milestones
| Measure |
Somatuline Depot and Keytruda
Keytruda (pembrolizumab) 200 mg intravenous (IV) infusion every 3 weeks and Somatuline Depot (lanreotide) 90 mg subcutaneous (SQ) injection every 3 weeks.
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Somatuline Depot and Keytruda
Keytruda (pembrolizumab) 200 mg intravenous (IV) infusion every 3 weeks and Somatuline Depot (lanreotide) 90 mg subcutaneous (SQ) injection every 3 weeks.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Study of Pembrolizumab With Lanreotide Depot for Gastroenteropancreatic Neuroendocrine Tumors
Baseline characteristics by cohort
| Measure |
Somatuline Depot and Keytruda
n=22 Participants
Keytruda (pembrolizumab) 200 mg intravenous (IV) infusion every 3 weeks and Somatuline Depot (lanreotide) 90 mg subcutaneous (SQ) injection every 3 weeks.
|
|---|---|
|
Age, Continuous
|
61.2 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 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
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Approximately every 12 weeks until study completion (up to 2 years)ORR is calculated as the number of people with a complete response (CR) or partial response (PR), divided by the total number of people treated. Complete response is defined as disappearance of all target lesions. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. A lower limit of the true ORR will be estimated by the 90% exact lower confidence bound (LCB) for the binomial proportion. A 90% LCB of \< 0.1 will be considered not to be of clinical value. If the 90% LCB is ≥ 0.1, the regimen will be considered efficacious.
Outcome measures
| Measure |
Somatuline Depot and Keytruda
n=22 Participants
Keytruda (pembrolizumab) 200 mg intravenous (IV) infusion every 3 weeks and Somatuline Depot (lanreotide) 90 mg subcutaneous (SQ) injection every 3 weeks.
|
|---|---|
|
Objective Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
|
0.045 proportion of participants
Interval 0.0 to 0.12
|
SECONDARY outcome
Timeframe: First 12 weeks of treatmentAdverse events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Outcome measures
| Measure |
Somatuline Depot and Keytruda
n=22 Participants
Keytruda (pembrolizumab) 200 mg intravenous (IV) infusion every 3 weeks and Somatuline Depot (lanreotide) 90 mg subcutaneous (SQ) injection every 3 weeks.
|
|---|---|
|
Number of Participants Experiencing Treatment-related AEs Leading to Drug Discontinuations During the First 12 Weeks of Treatment
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsMonths from treatment start date until the date of first documented radiographic progression or date of death from any cause (whichever is first); assessed up to 48 weeks after the last subject has finished study drug regimen. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
Outcome measures
| Measure |
Somatuline Depot and Keytruda
n=22 Participants
Keytruda (pembrolizumab) 200 mg intravenous (IV) infusion every 3 weeks and Somatuline Depot (lanreotide) 90 mg subcutaneous (SQ) injection every 3 weeks.
|
|---|---|
|
Months of Progression-free Survival (PFS)
|
5.04 months
Interval 2.7 to 11.3
|
SECONDARY outcome
Timeframe: Up to 59 monthsMonths from treatment start date until the date of death from any cause; assessed up to 48 weeks after the last subject has finished the study drug regimen
Outcome measures
| Measure |
Somatuline Depot and Keytruda
n=22 Participants
Keytruda (pembrolizumab) 200 mg intravenous (IV) infusion every 3 weeks and Somatuline Depot (lanreotide) 90 mg subcutaneous (SQ) injection every 3 weeks.
|
|---|---|
|
Months of Overall Survival (OS)
|
28.6 months
Interval 21.0 to
There is not a sufficient number of events after the median time point to estimate the upper confidence limit. Most patients past the median are censored.
|
SECONDARY outcome
Timeframe: Approximately every 12 weeks until study completion (up to 2 years)Treatment response as assessed by irRC instead of RECIST v1.1. ORR is calculated as the number of people with a complete response (CR) or partial response (PR), divided by the total number of people treated. Complete response is defined as complete disappearance of all lesions (whether measurable or not, and no new lesions), confirmed by a repeat, consecutive assessment no less than 4 weeks from the date first documented. Partial response is defined as a decrease in tumor burden ≥ 50% relative to baseline, confirmed by a consecutive assessment at least 4 weeks after first documentation. A lower limit of the true ORR will be estimated by the 90% exact lower confidence bound (LCB) for the binomial proportion.
Outcome measures
| Measure |
Somatuline Depot and Keytruda
n=22 Participants
Keytruda (pembrolizumab) 200 mg intravenous (IV) infusion every 3 weeks and Somatuline Depot (lanreotide) 90 mg subcutaneous (SQ) injection every 3 weeks.
|
|---|---|
|
ORR as Measured by Immune-related Response Criteria (irRC)
|
0.045 proportion of participants
Interval 0.0 to 0.12
|
Adverse Events
Somatuline Depot and Keytruda
Serious events: 6 serious events
Other events: 22 other events
Deaths: 15 deaths
Serious adverse events
| Measure |
Somatuline Depot and Keytruda
n=22 participants at risk
Keytruda (pembrolizumab) 200 mg intravenous (IV) infusion every 3 weeks and Somatuline Depot (lanreotide) 90 mg subcutaneous (SQ) injection every 3 weeks.
|
|---|---|
|
Cardiac disorders
Chest pain - cardiac
|
4.5%
1/22 • Number of events 1 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Gastrointestinal disorders
Abdominal pain
|
9.1%
2/22 • Number of events 4 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Gastrointestinal disorders
Colitis
|
9.1%
2/22 • Number of events 3 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Gastrointestinal disorders
Nausea
|
4.5%
1/22 • Number of events 2 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Infections and infestations
Infections and infestations - Other, Specify, Salmonella
|
4.5%
1/22 • Number of events 1 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
9.1%
2/22 • Number of events 4 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.5%
1/22 • Number of events 1 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Vascular disorders
Flushing
|
4.5%
1/22 • Number of events 1 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Vascular disorders
Hypertension
|
4.5%
1/22 • Number of events 1 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Vascular disorders
Thromboembolic event
|
4.5%
1/22 • Number of events 1 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
Other adverse events
| Measure |
Somatuline Depot and Keytruda
n=22 participants at risk
Keytruda (pembrolizumab) 200 mg intravenous (IV) infusion every 3 weeks and Somatuline Depot (lanreotide) 90 mg subcutaneous (SQ) injection every 3 weeks.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.6%
3/22 • Number of events 3 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.6%
3/22 • Number of events 3 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.5%
1/22 • Number of events 1 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
4.5%
1/22 • Number of events 1 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.5%
1/22 • Number of events 1 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Nervous system disorders
Headache
|
4.5%
1/22 • Number of events 1 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Psychiatric disorders
Anxiety
|
9.1%
2/22 • Number of events 2 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Psychiatric disorders
Insomnia
|
4.5%
1/22 • Number of events 1 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Renal and urinary disorders
Proteinuria
|
9.1%
2/22 • Number of events 2 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
18.2%
4/22 • Number of events 4 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.6%
3/22 • Number of events 4 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
13.6%
3/22 • Number of events 3 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
4.5%
1/22 • Number of events 1 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.1%
2/22 • Number of events 2 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
9.1%
2/22 • Number of events 2 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Specify, Injection Site Reaction
|
4.5%
1/22 • Number of events 1 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Vascular disorders
Flushing
|
9.1%
2/22 • Number of events 2 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Vascular disorders
Hypertension
|
4.5%
1/22 • Number of events 1 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Blood and lymphatic system disorders
Anemia
|
13.6%
3/22 • Number of events 3 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Cardiac disorders
Chest pain - cardiac
|
4.5%
1/22 • Number of events 1 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Cardiac disorders
Palpitations
|
4.5%
1/22 • Number of events 1 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Cardiac disorders
Pericardial effusion
|
4.5%
1/22 • Number of events 1 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Endocrine disorders
Hypothyroidism
|
22.7%
5/22 • Number of events 5 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Eye disorders
Blurred vision
|
4.5%
1/22 • Number of events 1 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Gastrointestinal disorders
Abdominal pain
|
27.3%
6/22 • Number of events 6 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Gastrointestinal disorders
Ascites
|
9.1%
2/22 • Number of events 2 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Gastrointestinal disorders
Bloating
|
4.5%
1/22 • Number of events 1 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Gastrointestinal disorders
Constipation
|
9.1%
2/22 • Number of events 2 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Gastrointestinal disorders
Diarrhea
|
18.2%
4/22 • Number of events 5 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Gastrointestinal disorders
Dry mouth
|
4.5%
1/22 • Number of events 1 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Gastrointestinal disorders
Dyspepsia
|
4.5%
1/22 • Number of events 1 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Gastrointestinal disorders
Dysphagia
|
4.5%
1/22 • Number of events 1 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
18.2%
4/22 • Number of events 4 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Gastrointestinal disorders
Hemorrhoids
|
9.1%
2/22 • Number of events 2 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Gastrointestinal disorders
Nausea
|
22.7%
5/22 • Number of events 5 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Gastrointestinal disorders
Stomach pain
|
4.5%
1/22 • Number of events 1 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Gastrointestinal disorders
Vomiting
|
4.5%
1/22 • Number of events 1 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
General disorders
Fatigue
|
54.5%
12/22 • Number of events 12 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
General disorders
Injection site reaction
|
4.5%
1/22 • Number of events 1 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Infections and infestations
Skin infection
|
4.5%
1/22 • Number of events 1 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Infections and infestations
Urinary tract infection
|
22.7%
5/22 • Number of events 6 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Investigations
Alanine aminotransferase increased
|
4.5%
1/22 • Number of events 1 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Investigations
Alkaline phosphatase increased
|
27.3%
6/22 • Number of events 6 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Investigations
Aspartate aminotransferase increased
|
9.1%
2/22 • Number of events 2 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Investigations
Creatinine increased
|
4.5%
1/22 • Number of events 1 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Investigations
Neutrophil count decreased
|
4.5%
1/22 • Number of events 1 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Investigations
Weight loss
|
4.5%
1/22 • Number of events 1 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Metabolism and nutrition disorders
Anorexia
|
36.4%
8/22 • Number of events 8 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Metabolism and nutrition disorders
Dehydration
|
4.5%
1/22 • Number of events 1 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
13.6%
3/22 • Number of events 3 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
18.2%
4/22 • Number of events 4 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
4.5%
1/22 • Number of events 1 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.5%
1/22 • Number of events 1 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, Specify, Non Fasting Hyperglycemia
|
4.5%
1/22 • Number of events 2 • Up to 25 months for adverse events; up to 59 months for all-cause mortality
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place