Clinical trial · Interventional
Nivolumab + Cabiralizumab + Gemcitabine in Patients With Stage IV Pancreatic Cancer
Open Label Randomized Phase II Trial of Nivolumab + Cabiralizumab (BMS-986227, FPA008) + Gemcitabine in Patients With Stage IV Pancreatic Cancer Achieving Disease Control in Response to First-line Chemotherapy (GemCaN Trial)
NCT03697564CI-TRIAL-00093216completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer Stage IV | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cabiralizumab | Drug | — | UNRESOLVED |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Nivolumab 10 MG/ML Intravenous Solution [OPDIVO] | Drug | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- gemcitabine +nivolumab + cabiralizumab
- description
- gemcitabine +nivolumab + cabiralizumab
- interventionNames
- Drug: Gemcitabine
- Drug: Nivolumab 10 MG/ML Intravenous Solution [OPDIVO]
- Drug: Cabiralizumab
Primary outcomes (1)
- measure
- Number of Participants With Progression Free Survival (PFS)
- timeFrame
- 6 months
- description
- 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 outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.