Nivolumab + Cabiralizumab + Gemcitabine in Patients With Stage IV Pancreatic Cancer

NCT03697564 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 181395
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer Stage IV

Keywords

Pancreating Cancer; Cancer; Stage IV; gemcitabine; nivolumab; cabiralizumab; BMS-986227; FPA008; GemCaN; Stand Up to Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (1)

• Number of Participants With Overall Survival (OS)

  6 months

Study Arms (1)

gemcitabine +nivolumab + cabiralizumab

EXPERIMENTAL

gemcitabine +nivolumab + cabiralizumab

Drug: Gemcitabine; Drug: Nivolumab 10 MG/ML Intravenous Solution [OPDIVO]; Drug: Cabiralizumab

Interventions

Gemcitabine DRUG

1000 mg/m2 IV on days 1, 8, and 15 Q4W

Also known as: Gemzar and Infugem

gemcitabine +nivolumab + cabiralizumab

Nivolumab 10 MG/ML Intravenous Solution [OPDIVO] DRUG

480mg IV on Day 1 Q4W

Also known as: Opdivo

gemcitabine +nivolumab + cabiralizumab

Cabiralizumab DRUG

4mg/kg IV on day 1 and 15 Q4W

Also known as: FPA 008

gemcitabine +nivolumab + cabiralizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hitendra Patel: lead
• Stand Up To Cancer: collaborator
• Lustgarten Foundation: collaborator

Study Sites (1)

UCSD Moores Cancer Center

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasms

Interventions

Gemcitabine; Nivolumab; cabiralizumab

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr. Hitendra Patel
• Organization: University of California, San Diego

CancerCTO@health.ucsd.edu

(858) 822-5354

Study Officials

• Hitendra Patel, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

• Andrew Lowy, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 28, 2018
• First Posted: October 5, 2018
• Study Start: October 31, 2019
• Primary Completion: April 12, 2023
• Study Completion: July 13, 2023
• Last Updated: August 6, 2025
• Results First Posted: August 6, 2025

Record last verified: 2025-07

Locations

US (1)