Trial Outcomes & Findings for Combination Therapy for Patients With Untreated Metastatic Pancreatic Ductal Adenocarcinoma (NCT NCT02754726)
NCT ID: NCT02754726
Last Updated: 2025-08-27
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete response (CR) rate as defined by CT scan using RECIST 1.1 criteria - disappearance of all target lesions and no new sites or disease-related symptoms confirmed at least 4 weeks after initial documentation and CA 19-9 (or CA 125, or CEA if not expressers of CA 19-9) down to normal limits; Partial Response (PR), at least a 30% decrease in the sum of the diameters of target lesions; Overall Response (OR) = CR + PR. When a complete response is documented, a Positron emission tomography (PET) scan will be obtained to confirm.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 84 months
Results posted on
2025-08-27
Participant Flow
Participant milestones
| Measure |
Single Arm
open label using combination therapy
Nivolumab: Nivolumab 240mg 240 mg as a 60 minute infusion on days 1, 15, 29 per 42 day cycle
Albumin-bound paclitaxel: 125 mg/m2 over 30 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle
Paricalcitol: 25 micrograms IV on days 1,4,8,12,15,18,22,26,29,32,36,39 (+/-1 day allowed for dosing per 42 day cycle
Cisplatin: 25 mg/m2 over 60 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle
Gemcitabine: 1000 mg/m2 over 30 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
35
|
Reasons for withdrawal
| Measure |
Single Arm
open label using combination therapy
Nivolumab: Nivolumab 240mg 240 mg as a 60 minute infusion on days 1, 15, 29 per 42 day cycle
Albumin-bound paclitaxel: 125 mg/m2 over 30 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle
Paricalcitol: 25 micrograms IV on days 1,4,8,12,15,18,22,26,29,32,36,39 (+/-1 day allowed for dosing per 42 day cycle
Cisplatin: 25 mg/m2 over 60 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle
Gemcitabine: 1000 mg/m2 over 30 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle
|
|---|---|
|
Overall Study
Progressive Disease by RECIST
|
13
|
|
Overall Study
Achieved Best Response and converted to maintenance treatment off study
|
12
|
|
Overall Study
Clinical Disease Progression
|
5
|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Tolerability
|
1
|
Baseline Characteristics
CA19-9 Non-secreters
Baseline characteristics by cohort
| Measure |
Single Arm
n=35 Participants
open label using combination therapy
Nivolumab: Nivolumab 240mg 240 mg as a 60 minute infusion on days 1, 15, 29 per 42 day cycle
Albumin-bound paclitaxel: 125 mg/m2 over 30 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle
Paricalcitol: 25 micrograms IV on days 1,4,8,12,15,18,22,26,29,32,36,39 (+/-1 day allowed for dosing per 42 day cycle
Cisplatin: 25 mg/m2 over 60 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle
Gemcitabine: 1000 mg/m2 over 30 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle
|
|---|---|
|
Age, Continuous
|
63.0 years
n=35 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=35 Participants
|
|
KARNOFSKY PERFORMANCE STATUS
100%
|
7 Participants
n=35 Participants
|
|
KARNOFSKY PERFORMANCE STATUS
90%
|
18 Participants
n=35 Participants
|
|
KARNOFSKY PERFORMANCE STATUS
80%
|
7 Participants
n=35 Participants
|
|
KARNOFSKY PERFORMANCE STATUS
70%
|
3 Participants
n=35 Participants
|
|
Prior Treatment
Prior chemotherapy
|
4 participants
n=35 Participants
|
|
Prior Treatment
Prior radiation
|
2 participants
n=35 Participants
|
|
Prior Treatment
Prior Surgery
|
4 participants
n=35 Participants
|
|
Primary Tumor Location
pancreatic head
|
13 participants
n=35 Participants
|
|
Primary Tumor Location
pancreatic body
|
9 participants
n=35 Participants
|
|
Primary Tumor Location
pancreatic tail
|
13 participants
n=35 Participants
|
|
Cancer Antigen (CA) 19-9 at C1/D1
Normal (≤ 35) (U/mL)
|
5 Participants
n=35 Participants
|
|
Cancer Antigen (CA) 19-9 at C1/D1
Elevated (> 35) (U/mL)
|
30 Participants
n=35 Participants
|
|
Tumor Markers CA125 or CEA at C1/D1
Elevated CA125 and CA19-9 non-secreters
|
3 Participants
n=5 Participants • CA19-9 Non-secreters
|
|
Tumor Markers CA125 or CEA at C1/D1
Elevated CEA and CA19-9 non-secreters
|
2 Participants
n=5 Participants • CA19-9 Non-secreters
|
|
Vitamin D, ng/mL
|
38.5 ng/mL
n=35 Participants
|
PRIMARY outcome
Timeframe: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 84 monthsPopulation: Not evaluable for overall response as subject did not have post baseline scans (n=3)
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete response (CR) rate as defined by CT scan using RECIST 1.1 criteria - disappearance of all target lesions and no new sites or disease-related symptoms confirmed at least 4 weeks after initial documentation and CA 19-9 (or CA 125, or CEA if not expressers of CA 19-9) down to normal limits; Partial Response (PR), at least a 30% decrease in the sum of the diameters of target lesions; Overall Response (OR) = CR + PR. When a complete response is documented, a Positron emission tomography (PET) scan will be obtained to confirm.
Outcome measures
| Measure |
Single Arm
n=32 Participants
open label using combination therapy
Nivolumab: Nivolumab 240mg 240 mg as a 60 minute infusion on days 1, 15, 29 per 42 day cycle
Albumin-bound paclitaxel: 125 mg/m2 over 30 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle
Paricalcitol: 25 micrograms IV on days 1,4,8,12,15,18,22,26,29,32,36,39 (+/-1 day allowed for dosing per 42 day cycle
Cisplatin: 25 mg/m2 over 60 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle
Gemcitabine: 1000 mg/m2 over 30 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle
|
|---|---|
|
Complete Response Rate
Overall Response Rate (CR + PR)
|
21 Participants
|
|
Complete Response Rate
Stable Disease (SD)
|
9 Participants
|
|
Complete Response Rate
Progressive Disease (PD)
|
2 Participants
|
SECONDARY outcome
Timeframe: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 84 monthsPopulation: adverse events (grade ≥ 3) observed in the study related to study treatment
Patients will be followed throughout their study participation and every 12 weeks following last dose of treatment until reported date of death.
Outcome measures
| Measure |
Single Arm
n=35 Participants
open label using combination therapy
Nivolumab: Nivolumab 240mg 240 mg as a 60 minute infusion on days 1, 15, 29 per 42 day cycle
Albumin-bound paclitaxel: 125 mg/m2 over 30 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle
Paricalcitol: 25 micrograms IV on days 1,4,8,12,15,18,22,26,29,32,36,39 (+/-1 day allowed for dosing per 42 day cycle
Cisplatin: 25 mg/m2 over 60 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle
Gemcitabine: 1000 mg/m2 over 30 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle
|
|---|---|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
thrombocytopenia
|
22 Participants
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
anemia
|
13 Participants
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
white blood cell decreased
|
5 Participants
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
neutropenia
|
4 Participants
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
peripheral sensory neuropathy
|
4 Participants
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
colitis
|
3 Participants
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
diarrhea
|
3 Participants
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
hypokalemia
|
3 Participants
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
unspecified rash
|
3 Participants
|
Adverse Events
Single Arm
Serious events: 14 serious events
Other events: 35 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Single Arm
n=35 participants at risk
open label using combination therapy
Nivolumab: Nivolumab 240mg 240 mg as a 60 minute infusion on days 1, 15, 29 per 42 day cycle
Albumin-bound paclitaxel: 125 mg/m2 over 30 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle
Paricalcitol: 25 micrograms IV on days 1,4,8,12,15,18,22,26,29,32,36,39 (+/-1 day allowed for dosing per 42 day cycle
Cisplatin: 25 mg/m2 over 60 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle
Gemcitabine: 1000 mg/m2 over 30 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Death
|
2.9%
1/35 • Number of events 1 • 84 months
|
|
Blood and lymphatic system disorders
Anemia
|
2.9%
1/35 • Number of events 1 • 84 months
|
|
Infections and infestations
Bladder infection
|
2.9%
1/35 • Number of events 1 • 84 months
|
|
Gastrointestinal disorders
colitis
|
8.6%
3/35 • Number of events 3 • 84 months
|
|
Gastrointestinal disorders
constipation
|
2.9%
1/35 • Number of events 1 • 84 months
|
|
Metabolism and nutrition disorders
Dehydration
|
5.7%
2/35 • Number of events 2 • 84 months
|
|
Metabolism and nutrition disorders
diarrhea
|
2.9%
1/35 • Number of events 1 • 84 months
|
|
General disorders
Fatigue
|
5.7%
2/35 • Number of events 2 • 84 months
|
|
Gastrointestinal disorders
diverticulitis
|
2.9%
1/35 • Number of events 1 • 84 months
|
|
General disorders
fever
|
2.9%
1/35 • Number of events 1 • 84 months
|
|
Musculoskeletal and connective tissue disorders
joint effusion
|
2.9%
1/35 • Number of events 1 • 84 months
|
|
Blood and lymphatic system disorders
leukocytosis
|
2.9%
1/35 • Number of events 1 • 84 months
|
|
Infections and infestations
lung infection
|
5.7%
2/35 • Number of events 2 • 84 months
|
|
Gastrointestinal disorders
nausea
|
2.9%
1/35 • Number of events 1 • 84 months
|
|
Infections and infestations
sepsis
|
5.7%
2/35 • Number of events 3 • 84 months
|
|
Cardiac disorders
sinus tachycardia
|
2.9%
1/35 • Number of events 1 • 84 months
|
|
Nervous system disorders
stroke
|
2.9%
1/35 • Number of events 1 • 84 months
|
|
Vascular disorders
thromboembolic event
|
5.7%
2/35 • Number of events 3 • 84 months
|
|
Gastrointestinal disorders
upper gastrointestinal hemorrhage
|
5.7%
2/35 • Number of events 2 • 84 months
|
|
Gastrointestinal disorders
vomiting
|
2.9%
1/35 • Number of events 1 • 84 months
|
Other adverse events
| Measure |
Single Arm
n=35 participants at risk
open label using combination therapy
Nivolumab: Nivolumab 240mg 240 mg as a 60 minute infusion on days 1, 15, 29 per 42 day cycle
Albumin-bound paclitaxel: 125 mg/m2 over 30 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle
Paricalcitol: 25 micrograms IV on days 1,4,8,12,15,18,22,26,29,32,36,39 (+/-1 day allowed for dosing per 42 day cycle
Cisplatin: 25 mg/m2 over 60 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle
Gemcitabine: 1000 mg/m2 over 30 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
37.1%
13/35 • 84 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.9%
1/35 • 84 months
|
|
Gastrointestinal disorders
Colitis
|
2.9%
1/35 • 84 months
|
|
Gastrointestinal disorders
Nausea
|
2.9%
1/35 • 84 months
|
|
General disorders
Fatigue
|
2.9%
1/35 • 84 months
|
|
Investigations
alanine aminotransferease increase
|
2.9%
1/35 • 84 months
|
|
Investigations
neutrophil count decreased
|
11.4%
4/35 • 84 months
|
|
Investigations
platelet count decreased
|
62.9%
22/35 • 84 months
|
|
Investigations
white blood cell decreased
|
14.3%
5/35 • 84 months
|
|
Metabolism and nutrition disorders
diarrhea
|
8.6%
3/35 • 84 months
|
|
Metabolism and nutrition disorders
hypoalbuminemia
|
2.9%
1/35 • 84 months
|
|
Metabolism and nutrition disorders
hypokalemia
|
8.6%
3/35 • 84 months
|
|
Metabolism and nutrition disorders
hypomagnesemia
|
2.9%
1/35 • 84 months
|
|
Metabolism and nutrition disorders
hyponatremia
|
2.9%
1/35 • 84 months
|
|
Metabolism and nutrition disorders
hypophosphatemia
|
5.7%
2/35 • 84 months
|
|
Metabolism and nutrition disorders
vitamin d decreased
|
2.9%
1/35 • 84 months
|
|
Nervous system disorders
peripheral sensory neuropathy
|
11.4%
4/35 • 84 months
|
|
Skin and subcutaneous tissue disorders
unspecified rash
|
8.6%
3/35 • 84 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place