Phase 2
Completed N=205
A Study of Cabiralizumab Given With Nivolumab With and Without Chemotherapy in Patients With Advanced Pancreatic Cancer
Source: ClinicalTrials.gov NCT03336216 ↗Enrolled (actual)
205
Serious AEs
76.0%
Results posted
Jul 2024
Primary outcomePrimary: Progression Free Survival (PFS) by BICR — 3.52; 1.92; 3.68; 3.22 Months
Summary
The purpose of this study is to determine whether an investigational immuno-therapy, cabiralizumab in combination with nivolumab, with or without chemotherapy, is effective for the treatment of advanced pancreatic cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) by BICR |
3.52; 1.92; 3.68; 3.22 | — |
| SECONDARY Progression Free Survival (PFS) by Investigator |
3.38; 1.81; 3.68; 2.92 | — |
| SECONDARY Progression Free Survival Rate (PFSR) by BICR |
15.5; 13.1; 21.7; 17.7; 5.2; 6.5 | — |
| SECONDARY Progression Free Survival Rate (PFSR) by Investigator |
14.9; 16.3; 17.6; 14.7; 11.2; 8.2 | — |
| SECONDARY Objective Response Rate (ORR) by BICR |
2.5; 4.1; 12.5; 9.5 | 0.6537 |
| SECONDARY Objective Response Rate (ORR) by Investigator |
5.0; 4.1; 6.3; 4.8 | 0.8505 |
| SECONDARY Duration of Response (DOR) by BICR |
NA; 4.2; 4.6; NA | — |
| SECONDARY Duration of Response (DOR) by Investigator |
10.2; 7.3; NA; NA | — |
| SECONDARY Overall Survival (OS) |
6.28; 4.44; 6.72; 5.68 | — |
| SECONDARY Overall Survival Rates (OSR) |
55.8; 40.1; 54.2; 44.8; 14.7; 20.1 | — |
| SECONDARY The Number of Participants With Adverse Events (AEs) |
40; 49; 48; 42 | — |
| SECONDARY The Number of Participants With Serious Adverse Events (SAEs) |
23; 41; 39; 33 | — |
| SECONDARY The Number of Participants With Adverse Events (AEs) Leading to Discontinuation |
6; 11; 11; 8 | — |
| SECONDARY The Number of Participants Who Died |
25; 33; 30; 28 | — |
| SECONDARY The Number of Participants Who Experienced Abnormal Hepatic Tests |
2; 21; 37; 34; 0; 10 | — |
| SECONDARY The Number of Participants With On-Treatment Laboratory Abnormalities in Specific Thyroid Tests |
3; 4; 10; 6; 0; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Must have histological or cytological confirmed diagnosis of locally advanced or metastatic adenocarcinoma of the pancreas, which has progressed on or after one line of chemotherapy
- ECOG Performance status 0-1
- Adequate organ functions
- Measurable disease
Exclusion Criteria
- Suspected or known CNS metastasis
- Participants with active, known, or suspected autoimmune disease
- Uncontrolled or significant cardiovascular disease
- Prior exposure to selected immune cell-modulating antibody regimens
Data sourced from ClinicalTrials.gov (NCT03336216). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.