Trial Outcomes & Findings for SBRT Plus Pembrolizumab and Trametinib for Pancreatic Cancer (NCT NCT02704156)
NCT ID: NCT02704156
Last Updated: 2022-05-13
Results Overview
The time from the start of treatment to death
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
170 participants
Primary outcome timeframe
3 years
Results posted on
2022-05-13
Participant Flow
Recruitment date was from October 2016 to October 2017. Patients were enrolled in our center.
Participant milestones
| Measure |
SBRT Plus Gemcitabine
Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine.
Cyberknife plus Gemcitabine: Radiation therapy plus drug
|
SBRT Plus Pembrolizumab and Trametinib
Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine.
Cyberknife plus Pembrolizumab and Trametinib: Radiation therapy plus drug
|
|---|---|---|
|
Overall Study
STARTED
|
85
|
85
|
|
Overall Study
COMPLETED
|
85
|
85
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SBRT Plus Pembrolizumab and Trametinib for Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
SBRT Plus Gemcitabine
n=85 Participants
Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine.
Cyberknife plus Gemcitabine: Radiation therapy plus drug
|
SBRT Plus Pembrolizumab and Trametinib
n=85 Participants
Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine.
Cyberknife plus Pembrolizumab and Trametinib: Radiation therapy plus drug
|
Total
n=170 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66 years
n=5 Participants
|
65 years
n=7 Participants
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
85 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
170 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
85 participants
n=5 Participants
|
85 participants
n=7 Participants
|
170 participants
n=5 Participants
|
|
PD-L1 intensity
IC1 or TC1
|
56 participants
n=5 Participants
|
60 participants
n=7 Participants
|
116 participants
n=5 Participants
|
|
PD-L1 intensity
IC2 or TC2
|
23 participants
n=5 Participants
|
20 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
PD-L1 intensity
IC3 or TC3
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 yearsThe time from the start of treatment to death
Outcome measures
| Measure |
SBRT Plus Gemcitabine
n=85 Participants
Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine.
Cyberknife plus Gemcitabine: Radiation therapy plus drug
|
SBRT Plus Pembrolizumab and Trametinib
n=85 Participants
Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine.
Cyberknife plus Pembrolizumab and Trametinib: Radiation therapy plus drug
|
|---|---|---|
|
The Median Survival Time Will be Determined.
|
12.8 months
Interval 11.2 to 14.4
|
14.9 months
Interval 12.7 to 17.1
|
SECONDARY outcome
Timeframe: 2 yearThe number of patients alive at 1 year and 2 years.
Outcome measures
| Measure |
SBRT Plus Gemcitabine
n=85 Participants
Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine.
Cyberknife plus Gemcitabine: Radiation therapy plus drug
|
SBRT Plus Pembrolizumab and Trametinib
n=85 Participants
Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine.
Cyberknife plus Pembrolizumab and Trametinib: Radiation therapy plus drug
|
|---|---|---|
|
One- and Two-year Overall Survival Rate Will be Determined.
1-year OS rate
|
48 Participants
|
53 Participants
|
|
One- and Two-year Overall Survival Rate Will be Determined.
2-year OS rate
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 3 yearsTreatment-related adverse effects are determined by National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Outcome measures
| Measure |
SBRT Plus Gemcitabine
n=85 Participants
Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine.
Cyberknife plus Gemcitabine: Radiation therapy plus drug
|
SBRT Plus Pembrolizumab and Trametinib
n=85 Participants
Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine.
Cyberknife plus Pembrolizumab and Trametinib: Radiation therapy plus drug
|
|---|---|---|
|
Treatment-related Adverse Effects Will be Determined.
Grade 3 pyrexia
|
0 Participants
|
2 Participants
|
|
Treatment-related Adverse Effects Will be Determined.
Grade 3 vomitting
|
2 Participants
|
1 Participants
|
|
Treatment-related Adverse Effects Will be Determined.
Grade 3 and 4 increased ALT or AST
|
6 Participants
|
10 Participants
|
|
Treatment-related Adverse Effects Will be Determined.
Grade 3 stomatitis
|
0 Participants
|
1 Participants
|
|
Treatment-related Adverse Effects Will be Determined.
Grade 3 rash
|
0 Participants
|
2 Participants
|
|
Treatment-related Adverse Effects Will be Determined.
Grade 3 and 4 neutropenia
|
9 Participants
|
1 Participants
|
|
Treatment-related Adverse Effects Will be Determined.
Grade 3 thrombocytopenia
|
4 Participants
|
1 Participants
|
|
Treatment-related Adverse Effects Will be Determined.
Grade 3 increased blood bilirubin
|
0 Participants
|
4 Participants
|
|
Treatment-related Adverse Effects Will be Determined.
Grade 3 hypokalemia
|
0 Participants
|
1 Participants
|
|
Treatment-related Adverse Effects Will be Determined.
Grade 3 hyponatremia
|
0 Participants
|
3 Participants
|
|
Treatment-related Adverse Effects Will be Determined.
Grade 3 pneumonia
|
0 Participants
|
1 Participants
|
|
Treatment-related Adverse Effects Will be Determined.
Grade 3 hypertension
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 3 yearsThe time from the start of treatment until documentation of any clinical or radiological disease progression or death, whichever occurred first. Progression is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST; version 1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
SBRT Plus Gemcitabine
n=85 Participants
Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine.
Cyberknife plus Gemcitabine: Radiation therapy plus drug
|
SBRT Plus Pembrolizumab and Trametinib
n=85 Participants
Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine.
Cyberknife plus Pembrolizumab and Trametinib: Radiation therapy plus drug
|
|---|---|---|
|
The Median Progression Free Survival Time Will be Determined.
|
5.4 months
Interval 3.2 to 7.6
|
8.2 months
Interval 6.9 to 9.5
|
SECONDARY outcome
Timeframe: 2 yearsThe proportion of patients without disease progressions at 1 year and 2 years.
Outcome measures
| Measure |
SBRT Plus Gemcitabine
n=85 Participants
Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine.
Cyberknife plus Gemcitabine: Radiation therapy plus drug
|
SBRT Plus Pembrolizumab and Trametinib
n=85 Participants
Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine.
Cyberknife plus Pembrolizumab and Trametinib: Radiation therapy plus drug
|
|---|---|---|
|
One- and Two-year Progression Survival Rate Will be Determined. Will be Determined.
1-year PFS rate
|
7 Participants
|
18 Participants
|
|
One- and Two-year Progression Survival Rate Will be Determined. Will be Determined.
2-year PFS rate
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 yearsThe analysis of quality of life is based on European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30). All scales and subscales range from 0 to 100. Regarding physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning and global health, higher scores may indicate better outcomes. In the case of fatigue, nausea and vomitting, pain, dyspnea, insomina, appetite loss, constipation, diarrhea and financial difficulties, lower scores may indicate better outcomes. Scales of all items are independent and not combined to compute a total score.
Outcome measures
| Measure |
SBRT Plus Gemcitabine
n=85 Participants
Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine.
Cyberknife plus Gemcitabine: Radiation therapy plus drug
|
SBRT Plus Pembrolizumab and Trametinib
n=85 Participants
Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine.
Cyberknife plus Pembrolizumab and Trametinib: Radiation therapy plus drug
|
|---|---|---|
|
The Quality of Life Will be Analyzed.
Physical functioning
|
86.2 units on a scale
Interval 80.0 to 93.3
|
83.7 units on a scale
Interval 73.3 to 93.3
|
|
The Quality of Life Will be Analyzed.
Role functioning
|
81.8 units on a scale
Interval 66.7 to 100.0
|
84.5 units on a scale
Interval 66.7 to 100.0
|
|
The Quality of Life Will be Analyzed.
Emotional functioning
|
73.9 units on a scale
Interval 58.3 to 91.7
|
72.1 units on a scale
Interval 58.3 to 83.3
|
|
The Quality of Life Will be Analyzed.
Cognitive functioning
|
84.7 units on a scale
Interval 66.7 to 100.0
|
83.3 units on a scale
Interval 66.7 to 100.0
|
|
The Quality of Life Will be Analyzed.
Social functioning
|
85.5 units on a scale
Interval 83.3 to 100.0
|
84.1 units on a scale
Interval 66.7 to 100.0
|
|
The Quality of Life Will be Analyzed.
Global health
|
83.6 units on a scale
Interval 75.0 to 91.7
|
83.2 units on a scale
Interval 75.0 to 91.7
|
|
The Quality of Life Will be Analyzed.
Fatigue
|
29.6 units on a scale
Interval 10.0 to 43.3
|
26.6 units on a scale
Interval 10.0 to 43.3
|
|
The Quality of Life Will be Analyzed.
Nausea and vomitting
|
29.4 units on a scale
Interval 16.7 to 50.0
|
28.8 units on a scale
Interval 0.0 to 50.0
|
|
The Quality of Life Will be Analyzed.
Pain
|
23.9 units on a scale
Interval 0.0 to 50.0
|
26.5 units on a scale
Interval 16.7 to 50.0
|
|
The Quality of Life Will be Analyzed.
Dyspnea
|
16.1 units on a scale
Interval 0.0 to 33.3
|
13.7 units on a scale
Interval 0.0 to 33.3
|
|
The Quality of Life Will be Analyzed.
Insomina
|
14.9 units on a scale
Interval 0.0 to 33.3
|
17.6 units on a scale
Interval 0.0 to 33.3
|
|
The Quality of Life Will be Analyzed.
Appetite loss
|
31.0 units on a scale
Interval 0.0 to 66.7
|
33.3 units on a scale
Interval 0.0 to 66.7
|
|
The Quality of Life Will be Analyzed.
Constipation
|
14.5 units on a scale
Interval 0.0 to 33.3
|
16.5 units on a scale
Interval 0.0 to 33.3
|
|
The Quality of Life Will be Analyzed.
Diarrhea
|
15.7 units on a scale
Interval 0.0 to 33.3
|
15.7 units on a scale
Interval 0.0 to 33.3
|
|
The Quality of Life Will be Analyzed.
Financial difficulties
|
16.8 units on a scale
Interval 0.0 to 33.3
|
17.2 units on a scale
Interval 0.0 to 33.3
|
Adverse Events
SBRT Plus Gemcitabine
Serious events: 21 serious events
Other events: 85 other events
Deaths: 85 deaths
SBRT Plus Pembrolizumab and Trametinib
Serious events: 29 serious events
Other events: 85 other events
Deaths: 83 deaths
Serious adverse events
| Measure |
SBRT Plus Gemcitabine
n=85 participants at risk
Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine.
Cyberknife plus Gemcitabine: Radiation therapy plus drug
|
SBRT Plus Pembrolizumab and Trametinib
n=85 participants at risk
Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine.
Cyberknife plus Pembrolizumab and Trametinib: Radiation therapy plus drug
|
|---|---|---|
|
General disorders
Grade 3 pyrexia
|
0.00%
0/85 • 3 years
|
2.4%
2/85 • 3 years
|
|
Gastrointestinal disorders
Grade 3 vomitting
|
2.4%
2/85 • 3 years
|
1.2%
1/85 • 3 years
|
|
Hepatobiliary disorders
Grade 3 and 4 increased ALT or AST
|
7.1%
6/85 • 3 years
|
11.8%
10/85 • 3 years
|
|
Gastrointestinal disorders
Grade 3 stomatitis
|
0.00%
0/85 • 3 years
|
1.2%
1/85 • 3 years
|
|
Skin and subcutaneous tissue disorders
Grade 3 rash
|
0.00%
0/85 • 3 years
|
2.4%
2/85 • 3 years
|
|
Blood and lymphatic system disorders
Grade 3 and 4 neutropenia
|
10.6%
9/85 • 3 years
|
1.2%
1/85 • 3 years
|
|
Blood and lymphatic system disorders
Grade 3 thrombocytopenia
|
4.7%
4/85 • 3 years
|
1.2%
1/85 • 3 years
|
|
Hepatobiliary disorders
Grade 3 increased blood bilirubin
|
0.00%
0/85 • 3 years
|
4.7%
4/85 • 3 years
|
|
Metabolism and nutrition disorders
Grade 3 hypokalemia
|
0.00%
0/85 • 3 years
|
1.2%
1/85 • 3 years
|
|
Metabolism and nutrition disorders
Grade 3 hyponatremia
|
0.00%
0/85 • 3 years
|
3.5%
3/85 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Grade 3 pneumonia
|
0.00%
0/85 • 3 years
|
1.2%
1/85 • 3 years
|
|
Cardiac disorders
Grade 3 hypertension
|
0.00%
0/85 • 3 years
|
2.4%
2/85 • 3 years
|
Other adverse events
| Measure |
SBRT Plus Gemcitabine
n=85 participants at risk
Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine.
Cyberknife plus Gemcitabine: Radiation therapy plus drug
|
SBRT Plus Pembrolizumab and Trametinib
n=85 participants at risk
Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine.
Cyberknife plus Pembrolizumab and Trametinib: Radiation therapy plus drug
|
|---|---|---|
|
Gastrointestinal disorders
Grade 1-2 Nausea and vomitting
|
20.0%
17/85 • 3 years
|
12.9%
11/85 • 3 years
|
|
Gastrointestinal disorders
Grade 1-2 diarrhea
|
18.8%
16/85 • 3 years
|
21.2%
18/85 • 3 years
|
|
Hepatobiliary disorders
Grade 1-2 increased ALT or AST
|
14.1%
12/85 • 3 years
|
18.8%
16/85 • 3 years
|
|
Gastrointestinal disorders
Grade 1-2 stomatitis
|
0.00%
0/85 • 3 years
|
9.4%
8/85 • 3 years
|
|
Skin and subcutaneous tissue disorders
Grade 1-2 rash
|
2.4%
2/85 • 3 years
|
16.5%
14/85 • 3 years
|
|
Blood and lymphatic system disorders
Grade 1-2 neutropenia
|
24.7%
21/85 • 3 years
|
7.1%
6/85 • 3 years
|
|
Blood and lymphatic system disorders
Grade 1-2 thrombocytopenia
|
17.6%
15/85 • 3 years
|
8.2%
7/85 • 3 years
|
|
Renal and urinary disorders
Grade 1-2 proteinuria
|
2.4%
2/85 • 3 years
|
5.9%
5/85 • 3 years
|
Additional Information
Huojun Zhang
Changhai Hospital affiliated to Naval Medical University
Phone: 86-021-31162207
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place