Pancreatic Cancer Stage IV
Conditions
Keywords
Pancreating Cancer, Cancer, Stage IV, gemcitabine, nivolumab, cabiralizumab, BMS-986227, FPA008, GemCaN, Stand Up to Cancer
Brief summary
The purpose of this study is to see if the combination of nivolumab + cabiralizumab + gemcitabine can give prolonged disease control in patients with advanced pancreatic cancer compared to gemcitabine alone.
Detailed description
The purpose of this study is to see if the combination of nivolumab + cabiralizumab + gemcitabine can give prolonged disease control in patients with advanced pancreatic cancer compared to gemcitabine alone. Cabiralizumab is an antibody (a type of protein) that binds to a molecule called CSF-1r. CSF-1r is a molecule present on different types of cells in your immune system that controls parts of your immune system. Blocking CSF-lr could potentially stop the cancer cells which it appears on from escaping the immune system, which could then act to kill the cancer cells. Nivolumab is an anti-PD-1 antibody that boost the body's immune system. It works by attaching to and blocking a molecule on white blood cells called PD-1. PD-1 is a protein that is present on different types of cells in your immune system and controls parts of your immune system by shutting it down. Antibodies that block PD-1 can potentially prevent PD-1 from shutting down the immune system, thus allowing immune cells to recognize and destroy cancer cells. Gemcitabine is currently used to treat advanced or metastasized (spread) pancreatic cancer. It is used in patients whose disease cannot be removed by surgery and who have already been treated with other chemotherapy
Interventions
DRUGGemcitabine
1000 mg/m2 IV on days 1, 8, and 15 Q4W
480mg IV on Day 1 Q4W
DRUGCabiralizumab
4mg/kg IV on day 1 and 15 Q4W
Sponsors
Stand Up To Cancer
Lustgarten Foundation
Hitendra Patel
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed pancreatic adenocarcinoma with metastasis * Must be off their prior cytotoxic regimen a minimum of two weeks but no more than four weeks from initiating trial treatment. Measurable disease by RECIST 1.1. Demonstrate adequate organ function Normal Vitamin D level. Able to submit an archival tumor specimen (primary or metastatic site). Patients with cytology only that do not have adequate archived tumor specimen available, will require a baseline biopsy.
Exclusion criteria
* Is currently participating and receiving trial therapy or has participated in a trial of an investigational agent and received trial therapy or used an investigational device within 3 weeks of the first dose of trial treatment. * Hypersensitivity to cabiralizumab, nivolumab, or gemcitabine or any of its excipients. * Previous malignancies (except non-melanoma skin cancers, and in situ bladder, gastric, colorectal, endometrial, cervical/dysplasia, melanoma, or breast cancers) unless complete remission was achieved at least 2 years prior to study entry and no additional therapy is required during the study period. * Evidence of central nervous system (CNS) metastasis * Participants with active, known, or suspected autoimmune disease. * Current or history of clinically significant muscle disorders (e.g., myositis), recent unresolved muscle injury, or any condition known to elevate serum CK levels. * Uncontrolled or significant cardiovascular disease * Prior organ allograft or allogeneic bone marrow transplantation. * Any uncontrolled inflammatory GI disease including Crohn's Disease and ulcerative colitis. * Evidence of coagulopathy or bleeding diathesis. * Has received prior therapy with a CSF-1R pathway inhibitors, anti-PD-1, anti-PD-L1, anti PD-L2, anti-CTLA-4.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Progression Free Survival (PFS) | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Overall Survival (OS) | 6 months | Overall Survival (OS) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | Gemcitabine +Nivolumab + Cabiralizumab |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Number of Participants Negative for PDL-1 | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 2 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 2 |
| other Total, other adverse events | 2 / 2 |
| serious Total, serious adverse events | 1 / 2 |
Outcome results
Primary
Number of Participants With Progression Free Survival (PFS)
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.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gemcitabine +Nivolumab + Cabiralizumab | Number of Participants With Progression Free Survival (PFS) | 1 participants |
Secondary
Number of Participants With Overall Survival (OS)
Overall Survival (OS)
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gemcitabine +Nivolumab + Cabiralizumab | Number of Participants With Overall Survival (OS) | 1 participants |