Trial Outcomes & Findings for Evaluating Combination Immunotherapy for Advanced Cholangiocarcinoma With Pembrolizumab and PEG-Intron (NCT NCT02982720)
NCT ID: NCT02982720
Last Updated: 2022-02-16
Results Overview
Defined as the proportion of subjects who achieve the best response (CR and PR) determined by RECIST1.1
TERMINATED
PHASE2
4 participants
12 months
2022-02-16
Participant Flow
Participant milestones
| Measure |
Pembrolizumab and Sylatron
Pembrolizumab will be administered intravenously at a dose of 200 mg every 3 weeks starting week 4. Sylatron will be administered at a dose of 200mcg subcutaneously weekly starting at week 1.
Pembrolizumab: Pembrolizumab will be administered intravenously.
Sylatron: Sylatron will be administered subcutaneously.
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Pembrolizumab and Sylatron
Pembrolizumab will be administered intravenously at a dose of 200 mg every 3 weeks starting week 4. Sylatron will be administered at a dose of 200mcg subcutaneously weekly starting at week 1.
Pembrolizumab: Pembrolizumab will be administered intravenously.
Sylatron: Sylatron will be administered subcutaneously.
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Evaluating Combination Immunotherapy for Advanced Cholangiocarcinoma With Pembrolizumab and PEG-Intron
Baseline characteristics by cohort
| Measure |
Pembrolizumab and Sylatron
n=4 Participants
Pembrolizumab will be administered intravenously at a dose of 200 mg every 3 weeks starting week 4. Sylatron will be administered at a dose of 200mcg subcutaneously weekly starting at week 1.
Pembrolizumab: Pembrolizumab will be administered intravenously.
Sylatron: Sylatron will be administered subcutaneously.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
|
Age, Continuous
|
66.5 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=99 Participants
|
|
Disease Subtype
Extrahepatic
|
1 Participants
n=99 Participants
|
|
Disease Subtype
Gallbladder
|
0 Participants
n=99 Participants
|
|
Disease Subtype
Hilum
|
0 Participants
n=99 Participants
|
|
Disease Subtype
Intrahepatic
|
3 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: No data was collected or analyzed for this objective due to the early termination of the study by the funder.
Defined as the proportion of subjects who achieve the best response (CR and PR) determined by RECIST1.1
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 36 monthsPopulation: No data was collected or analyzed for this objective due to the early termination of the study by the funder.
Defined as time from start of the treatment till the patient's disease progression or death from any cause (those for whom event of progression or death not observed will be censored).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 36 monthsPopulation: No data was collected or analyzed for this objective due to the early termination of the study by the funder.
Defined as time from start of the treatment till the patient's death from any cause (patient who are still alive at the end of the study will be censored).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 36 monthsPopulation: No data was collected or analyzed for this objective due to the early termination of the study by the funder.
the sum of complete response (CR) + confirmed partial response (PR) and will be determined as per irRC.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 36 monthsPopulation: No data was collected or analyzed for this objective due to the early termination of the study by the funder.
the combination of Sylatron and pembrolizumab as assessed by CTCAE v4
Outcome measures
Outcome data not reported
Adverse Events
Pembrolizumab and Sylatron
Serious adverse events
| Measure |
Pembrolizumab and Sylatron
n=4 participants at risk
Pembrolizumab will be administered intravenously at a dose of 200 mg every 3 weeks starting week 4. Sylatron will be administered at a dose of 200mcg subcutaneously weekly starting at week 1.
Pembrolizumab: Pembrolizumab will be administered intravenously.
Sylatron: Sylatron will be administered subcutaneously.
|
|---|---|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
50.0%
2/4 • Number of events 2 • 6 months
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
General disorders
FEVER
|
50.0%
2/4 • Number of events 2 • 6 months
|
Other adverse events
| Measure |
Pembrolizumab and Sylatron
n=4 participants at risk
Pembrolizumab will be administered intravenously at a dose of 200 mg every 3 weeks starting week 4. Sylatron will be administered at a dose of 200mcg subcutaneously weekly starting at week 1.
Pembrolizumab: Pembrolizumab will be administered intravenously.
Sylatron: Sylatron will be administered subcutaneously.
|
|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
50.0%
2/4 • Number of events 3 • 6 months
|
|
Investigations
ALKALINE PHOSPHATASE INCREASED
|
75.0%
3/4 • Number of events 6 • 6 months
|
|
Blood and lymphatic system disorders
ANEMIA
|
50.0%
2/4 • Number of events 2 • 6 months
|
|
Metabolism and nutrition disorders
ANOREXIA
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
100.0%
4/4 • Number of events 5 • 6 months
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
25.0%
1/4 • Number of events 2 • 6 months
|
|
Eye disorders
BLURRED VISION
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
DIARRHEA
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Endocrine disorders
ENDOCRINE DISORDERS
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
General disorders
FATIGUE
|
100.0%
4/4 • Number of events 4 • 6 months
|
|
Eye disorders
GLAUCOMA
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
25.0%
1/4 • Number of events 2 • 6 months
|
|
Endocrine disorders
HYPERTHYROIDISM
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Metabolism and nutrition disorders
HYPOALBUMINEMIA
|
75.0%
3/4 • Number of events 5 • 6 months
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATEMIA
|
25.0%
1/4 • Number of events 2 • 6 months
|
|
Gastrointestinal disorders
NAUSEA
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
General disorders
PAIN
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Investigations
WHITE BLOOD CELL DECREASED
|
25.0%
1/4 • Number of events 1 • 6 months
|
Additional Information
Clinicaltrials.gov Results Coordinator
Hoosier Cancer Research Network
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place