Trial Outcomes & Findings for Study of Nivolumab, Cabiralizumab, and Stereotactic Body Radiotherapy (SBRT) for Locally Advanced Unresectable Pancreatic Cancer (NCT NCT03599362)
NCT ID: NCT03599362
Last Updated: 2021-10-19
Results Overview
Measure of safety of combined cabiralizumab, nivolumab and radiotherapy in the treatment of locally advanced pancreatic cancer measured by unacceptable toxicity, which includes: * Grade 3 fatigue lasting \> 2 Weeks * Grade 3 Nausea lasting \> 7 days despite maximal medical management * Grade 3 or more anorexia * Grade 3 or more vomiting * Grade 3 or more diarrhea * Grade 3 or more pancreatitis * Grade 3 abdominal pain * Grade 3 or more radiation dermatitis * Grade 3 or more GI hemorrhage * Grade 3 or more GI fistula * Grade 3 or more GI stenosis * Grade 3 or more GI perforation
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
24 Months
Results posted on
2021-10-19
Participant Flow
Participant milestones
| Measure |
Multi Agent Chemotherapy Cancer Patients
Subjects will be enrolled into this study following completion of 2-6 months of multi agent chemotherapy with documentation of stable or responsive disease.
Nivolumab + Cabiralizumab: Will be administered on Day 1 and Day 14; Subjects will continue treatment every 2 weeks with subsequent imaging every 8 weeks.
Stereotactic Body Radiotherapy (SBRT): Patients will be simulated supine with the addition of a 4D C T if appropriate. A stereotactic immobilization device with abdominal compression will be used.
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Multi Agent Chemotherapy Cancer Patients
Subjects will be enrolled into this study following completion of 2-6 months of multi agent chemotherapy with documentation of stable or responsive disease.
Nivolumab + Cabiralizumab: Will be administered on Day 1 and Day 14; Subjects will continue treatment every 2 weeks with subsequent imaging every 8 weeks.
Stereotactic Body Radiotherapy (SBRT): Patients will be simulated supine with the addition of a 4D C T if appropriate. A stereotactic immobilization device with abdominal compression will be used.
|
|---|---|
|
Overall Study
Screen Failure
|
3
|
Baseline Characteristics
Study of Nivolumab, Cabiralizumab, and Stereotactic Body Radiotherapy (SBRT) for Locally Advanced Unresectable Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Multi Agent Chemotherapy Cancer Patients
n=4 Participants
Subjects will be enrolled into this study following completion of 2-6 months of multi agent chemotherapy with documentation of stable or responsive disease.
Nivolumab + Cabiralizumab: Will be administered on Day 1 and Day 14; Subjects will continue treatment every 2 weeks with subsequent imaging every 8 weeks.
Stereotactic Body Radiotherapy (SBRT): Patients will be simulated supine with the addition of a 4D C T if appropriate. A stereotactic immobilization device with abdominal compression will be used.
|
|---|---|
|
Age, Continuous
|
68 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 MonthsMeasure of safety of combined cabiralizumab, nivolumab and radiotherapy in the treatment of locally advanced pancreatic cancer measured by unacceptable toxicity, which includes: * Grade 3 fatigue lasting \> 2 Weeks * Grade 3 Nausea lasting \> 7 days despite maximal medical management * Grade 3 or more anorexia * Grade 3 or more vomiting * Grade 3 or more diarrhea * Grade 3 or more pancreatitis * Grade 3 abdominal pain * Grade 3 or more radiation dermatitis * Grade 3 or more GI hemorrhage * Grade 3 or more GI fistula * Grade 3 or more GI stenosis * Grade 3 or more GI perforation
Outcome measures
| Measure |
Multi Agent Chemotherapy Cancer Patients
n=4 Participants
Subjects will be enrolled into this study following completion of 2-6 months of multi agent chemotherapy with documentation of stable or responsive disease.
Nivolumab + Cabiralizumab: Will be administered on Day 1 and Day 14; Subjects will continue treatment every 2 weeks with subsequent imaging every 8 weeks.
Stereotactic Body Radiotherapy (SBRT): Patients will be simulated supine with the addition of a 4D C T if appropriate. A stereotactic immobilization device with abdominal compression will be used.
|
|---|---|
|
Number of Participants With Incidence of Unacceptable Toxicity
|
4 Participants
|
PRIMARY outcome
Timeframe: 24 MonthsSurgical resection rate following treatment with combined cabiralizumab, nivolumab and radiotherapy in subjects with locally advanced unresectable pancreatic cancer. This will be measured by tabulating adverse events
Outcome measures
| Measure |
Multi Agent Chemotherapy Cancer Patients
n=4 Participants
Subjects will be enrolled into this study following completion of 2-6 months of multi agent chemotherapy with documentation of stable or responsive disease.
Nivolumab + Cabiralizumab: Will be administered on Day 1 and Day 14; Subjects will continue treatment every 2 weeks with subsequent imaging every 8 weeks.
Stereotactic Body Radiotherapy (SBRT): Patients will be simulated supine with the addition of a 4D C T if appropriate. A stereotactic immobilization device with abdominal compression will be used.
|
|---|---|
|
Number of Participants Who Proceeded to Surgical Resection
|
1 Participants
|
Adverse Events
Multi Agent Chemotherapy Cancer Patients
Serious events: 3 serious events
Other events: 4 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Multi Agent Chemotherapy Cancer Patients
n=4 participants at risk
Subjects will be enrolled into this study following completion of 2-6 months of multi agent chemotherapy with documentation of stable or responsive disease.
Nivolumab + Cabiralizumab: Will be administered on Day 1 and Day 14; Subjects will continue treatment every 2 weeks with subsequent imaging every 8 weeks.
Stereotactic Body Radiotherapy (SBRT): Patients will be simulated supine with the addition of a 4D C T if appropriate. A stereotactic immobilization device with abdominal compression will be used.
|
|---|---|
|
Hepatobiliary disorders
Liver dysfunction
|
25.0%
1/4 • 24 months
|
|
Cardiac disorders
Chest Pain
|
25.0%
1/4 • 24 months
|
|
Vascular disorders
Hypertension
|
25.0%
1/4 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
25.0%
1/4 • 24 months
|
Other adverse events
| Measure |
Multi Agent Chemotherapy Cancer Patients
n=4 participants at risk
Subjects will be enrolled into this study following completion of 2-6 months of multi agent chemotherapy with documentation of stable or responsive disease.
Nivolumab + Cabiralizumab: Will be administered on Day 1 and Day 14; Subjects will continue treatment every 2 weeks with subsequent imaging every 8 weeks.
Stereotactic Body Radiotherapy (SBRT): Patients will be simulated supine with the addition of a 4D C T if appropriate. A stereotactic immobilization device with abdominal compression will be used.
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
50.0%
2/4 • 24 months
|
|
Psychiatric disorders
Agitation
|
25.0%
1/4 • 24 months
|
|
Investigations
Increase in ALT
|
100.0%
4/4 • 24 months
|
|
Investigations
Increase in AST
|
100.0%
4/4 • 24 months
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
2/4 • 24 months
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
2/4 • 24 months
|
|
Investigations
Increase in Alkaline Phosphatase
|
75.0%
3/4 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
75.0%
3/4 • 24 months
|
|
Gastrointestinal disorders
Bloating
|
25.0%
1/4 • 24 months
|
|
Injury, poisoning and procedural complications
Bruising
|
25.0%
1/4 • 24 months
|
|
General disorders
Chills
|
50.0%
2/4 • 24 months
|
|
Psychiatric disorders
Confusion
|
25.0%
1/4 • 24 months
|
|
Gastrointestinal disorders
Constipation
|
50.0%
2/4 • 24 months
|
|
Investigations
Increase in CPK
|
100.0%
4/4 • 24 months
|
|
Investigations
Increase in Creatinine
|
25.0%
1/4 • 24 months
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
1/4 • 24 months
|
|
Gastrointestinal disorders
Dry Mouth
|
25.0%
1/4 • 24 months
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
2/4 • 24 months
|
|
Ear and labyrinth disorders
Ear and Labyrinth Disorder
|
25.0%
1/4 • 24 months
|
|
Ear and labyrinth disorders
Ear Pain
|
25.0%
1/4 • 24 months
|
|
General disorders
Edema Face
|
25.0%
1/4 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Epis Taxis
|
25.0%
1/4 • 24 months
|
|
Injury, poisoning and procedural complications
Fall
|
50.0%
2/4 • 24 months
|
|
General disorders
Fatigue
|
25.0%
1/4 • 24 months
|
|
General disorders
Gait Disturbance
|
25.0%
1/4 • 24 months
|
|
Gastrointestinal disorders
Gastritis
|
50.0%
2/4 • 24 months
|
|
General disorders
General Disorders and Administration Site Conditions
|
25.0%
1/4 • 24 months
|
|
Nervous system disorders
Headache
|
50.0%
2/4 • 24 months
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
25.0%
1/4 • 24 months
|
|
Investigations
Hypoalbuminemia
|
25.0%
1/4 • 24 months
|
|
Investigations
Hyponatremia
|
25.0%
1/4 • 24 months
|
|
Investigations
Increase in Lipase
|
100.0%
4/4 • 24 months
|
|
General disorders
Localized Edema
|
25.0%
1/4 • 24 months
|
|
Investigations
Decrease in Lymphocyte Count
|
75.0%
3/4 • 24 months
|
|
Gastrointestinal disorders
Nausea
|
75.0%
3/4 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
25.0%
1/4 • 24 months
|
|
Nervous system disorders
Paresthesia
|
25.0%
1/4 • 24 months
|
|
Eye disorders
Periorbital Edema
|
25.0%
1/4 • 24 months
|
|
Investigations
Decrease in Platelet Count
|
50.0%
2/4 • 24 months
|
|
General disorders
Pruritus
|
25.0%
1/4 • 24 months
|
|
Skin and subcutaneous tissue disorders
Rash Maculo
|
50.0%
2/4 • 24 months
|
|
Investigations
Increase in Serum Amylase
|
50.0%
2/4 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
25.0%
1/4 • 24 months
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • 24 months
|
|
Investigations
Decrease in WBC
|
25.0%
1/4 • 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place