Pancreatic Cancer
Conditions
Keywords
Adenocarcinoma, Metastatic
Brief summary
This study aims to evaluate cabozantinib and pembrolizumab for the treatment of metastatic pancreatic adenocarcinoma.
Interventions
DRUGCabozantinib
Cabozantinib (XL184) is a potent inhibitor of multiple receptor tyrosine kinases (RTKs) known to play important roles in tumor cell proliferation and/or tumor neovascularization.
DRUGPembrolizumab
Pembrolizumab is a potent humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb) with high specificity of binding to the programmed cell death 1 (PD-1) receptor, thus inhibiting its interaction with programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2).
Sponsors
Exelixis
Merck Sharp & Dohme LLC
Joseph Kim
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of pancreatic ductal adenocarcinoma * Evidence of progression or intolerance to previous standard of care pancreatic cancer systemic or locoregional therapies * Patients must have adequate organ function
Exclusion criteria
* Chemotherapy or other locoregional anti-tumoral therapies performed within 28 days of study treatment initiation * Received palliative radiation therapy within 2 weeks or any other radiation therapy within 4 weeks of start of study intervention * Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to allocation * Has a diagnosis of immunodeficiency (autoimmune disease) or is receiving chronic systemic steroid therapy * Clinically significant cardiovascular disease * Uncontrolled hypertension * Inability to swallow tablets
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival | 1 year | Progress-free survival in participants, defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever comes first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Response to Therapy | 1 year | The proportion of participants with overall response to therapy via imaging; Overall Response Rate (%) = (Number of patients achieving Complete responses + Number of patients achieving partial responses / Total Number of patients) × 100 |
| Number of Participants With Complete Response | 1 year | The proportion of participants with a complete response to therapy |
| Number of Participants With Partial Response | 1 year | The proportion of participants with a partial response to therapy |
| Overall Participant Survival Rate | 1 year | Overall survival rate participants |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cabozantinib and Pembrolizumab Cabozantinib: Cabozantinib (XL184) is a potent inhibitor of multiple receptor tyrosine kinases (RTKs) known to play important roles in tumor cell proliferation and/or tumor neovascularization.
Pembrolizumab: Pembrolizumab is a potent humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb) with high specificity of binding to the programmed cell death 1 (PD-1) receptor, thus inhibiting its interaction with programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2). | 21 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 19 |
Baseline characteristics
| Characteristic | Cabozantinib and Pembrolizumab |
|---|---|
| Age, Continuous | 66 years STANDARD_DEVIATION 7.19 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 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 | 1 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 19 / 21 |
| other Total, other adverse events | 20 / 21 |
| serious Total, serious adverse events | 13 / 21 |
Outcome results
Primary
Progression-free Survival
Progress-free survival in participants, defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever comes first.
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cabozantinib and pembrolizumab | Progression-free Survival | 2 Participants |
Secondary
Number of Participants With Complete Response
The proportion of participants with a complete response to therapy
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cabozantinib and pembrolizumab | Number of Participants With Complete Response | 0 Participants |
Secondary
Number of Participants With Partial Response
The proportion of participants with a partial response to therapy
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cabozantinib and pembrolizumab | Number of Participants With Partial Response | 1 Participants |
Secondary
Number of Participants With Response to Therapy
The proportion of participants with overall response to therapy via imaging; Overall Response Rate (%) = (Number of patients achieving Complete responses + Number of patients achieving partial responses / Total Number of patients) × 100
Time frame: 1 year
Population: Number of participants with complete or partial response reported
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cabozantinib and pembrolizumab | Number of Participants With Response to Therapy | 1 Participants |
Secondary
Overall Participant Survival Rate
Overall survival rate participants
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cabozantinib and pembrolizumab | Overall Participant Survival Rate | 2 Participants |