Trial Outcomes & Findings for Nivolumab + Cabiralizumab + Gemcitabine in Patients With Stage IV Pancreatic Cancer (NCT NCT03697564)
NCT ID: NCT03697564
Last Updated: 2025-08-06
Results Overview
To estimate Progression Free Survival (PFS rates) at 6 months per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
2 participants
Primary outcome timeframe
6 months
Results posted on
2025-08-06
Participant Flow
Participant milestones
| Measure |
Gemcitabine +Nivolumab + Cabiralizumab
gemcitabine +nivolumab + cabiralizumab
Gemcitabine: 1000 mg/m2 IV on days 1, 8, and 15 Q4W
Nivolumab 10 MG/ML Intravenous Solution \[OPDIVO\]: 480mg IV on Day 1 Q4W
Cabiralizumab: 4mg/kg IV on day 1 and 15 Q4W
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nivolumab + Cabiralizumab + Gemcitabine in Patients With Stage IV Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Gemcitabine +Nivolumab + Cabiralizumab
n=2 Participants
gemcitabine +nivolumab + cabiralizumab
Gemcitabine: 1000 mg/m2 IV on days 1, 8, and 15 Q4W
Nivolumab 10 MG/ML Intravenous Solution \[OPDIVO\]: 480mg IV on Day 1 Q4W
Cabiralizumab: 4mg/kg IV on day 1 and 15 Q4W
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=93 Participants
|
|
Number of Participants Negative for PDL-1
|
2 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 6 monthsTo estimate Progression Free Survival (PFS rates) at 6 months per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Gemcitabine +Nivolumab + Cabiralizumab
n=2 Participants
gemcitabine +nivolumab + cabiralizumab
Gemcitabine: 1000 mg/m2 IV on days 1, 8, and 15 Q4W
Nivolumab 10 MG/ML Intravenous Solution \[OPDIVO\]: 480mg IV on Day 1 Q4W
Cabiralizumab: 4mg/kg IV on day 1 and 15 Q4W
|
|---|---|
|
Number of Participants With Progression Free Survival (PFS)
|
1 participants
|
SECONDARY outcome
Timeframe: 6 monthsOverall Survival (OS)
Outcome measures
| Measure |
Gemcitabine +Nivolumab + Cabiralizumab
n=2 Participants
gemcitabine +nivolumab + cabiralizumab
Gemcitabine: 1000 mg/m2 IV on days 1, 8, and 15 Q4W
Nivolumab 10 MG/ML Intravenous Solution \[OPDIVO\]: 480mg IV on Day 1 Q4W
Cabiralizumab: 4mg/kg IV on day 1 and 15 Q4W
|
|---|---|
|
Number of Participants With Overall Survival (OS)
|
1 participants
|
Adverse Events
Gemcitabine +Nivolumab + Cabiralizumab
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Gemcitabine +Nivolumab + Cabiralizumab
n=2 participants at risk
gemcitabine +nivolumab + cabiralizumab
Gemcitabine: 1000 mg/m2 IV on days 1, 8, and 15 Q4W
Nivolumab 10 MG/ML Intravenous Solution \[OPDIVO\]: 480mg IV on Day 1 Q4W
Cabiralizumab: 4mg/kg IV on day 1 and 15 Q4W
|
|---|---|
|
General disorders
Death
|
50.0%
1/2 • Number of events 1 • Through study completion (3 years & 8 months; 44 months)
|
Other adverse events
| Measure |
Gemcitabine +Nivolumab + Cabiralizumab
n=2 participants at risk
gemcitabine +nivolumab + cabiralizumab
Gemcitabine: 1000 mg/m2 IV on days 1, 8, and 15 Q4W
Nivolumab 10 MG/ML Intravenous Solution \[OPDIVO\]: 480mg IV on Day 1 Q4W
Cabiralizumab: 4mg/kg IV on day 1 and 15 Q4W
|
|---|---|
|
General disorders
Syncope
|
50.0%
1/2 • Number of events 1 • Through study completion (3 years & 8 months; 44 months)
|
|
Musculoskeletal and connective tissue disorders
Right flank pain
|
50.0%
1/2 • Number of events 1 • Through study completion (3 years & 8 months; 44 months)
|
|
Metabolism and nutrition disorders
Elevated Creatinine Kinase
|
50.0%
1/2 • Number of events 2 • Through study completion (3 years & 8 months; 44 months)
|
|
Blood and lymphatic system disorders
Thrombocytopenia - Grade 3
|
50.0%
1/2 • Number of events 1 • Through study completion (3 years & 8 months; 44 months)
|
|
General disorders
Fatigue
|
50.0%
1/2 • Number of events 1 • Through study completion (3 years & 8 months; 44 months)
|
Additional Information
Dr. Hitendra Patel
University of California, San Diego
Phone: (858) 822-5354
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place