Pancreatic Cancer Stage IVPhase 2NCT03697564
Nivolumab + Cabiralizumab + Gemcitabine in Patients With Stage IV Pancreatic Cancer
A Phase 2 study testing Gemcitabine, Nivolumab 10 MG/ML Intravenous Solution [OPDIVO] and Cabiralizumab in people with Pancreatic Cancer Stage IV, run by Hitendra Patel at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer Stage IV
- What is being tested?
- Gemcitabine, Nivolumab 10 MG/ML Intravenous Solution [OPDIVO] and Cabiralizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2019to 13 Jul 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSD Moores Cancer Center
La Jolla, California, 92093
About this study
Official title: 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)
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.
Read the 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
- Conditions
- Pancreatic Cancer Stage IV
- Being tested
- Gemcitabine, Nivolumab 10 MG/ML Intravenous Solution [OPDIVO], Cabiralizumab
- Keywords
- Pancreating Cancer, Cancer, Stage IV, gemcitabine, nivolumab, cabiralizumab, BMS-986227, FPA008, GemCaN, Stand Up to Cancer
- Medical subject headings
- Pancreatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Also called Gemzar and Infugem
1000 mg/m2 IV on days 1, 8, and 15 Q4W
Nivolumab 10 MG/ML Intravenous Solution [OPDIVO]Drug
Also called Opdivo
480mg IV on Day 1 Q4W
CabiralizumabDrug
Also called FPA 008
4mg/kg IV on day 1 and 15 Q4W
| Study group | Role | What they receive |
|---|---|---|
| gemcitabine +nivolumab + cabiralizumab | Experimental | gemcitabine +nivolumab + cabiralizumab Receives: Drug: Gemcitabine; Drug: Nivolumab 10 MG/ML Intravenous Solution [OPDIVO]; Drug: Cabiralizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
Number of Participants With Overall Survival (OS)
Overall Survival (OS)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start31 Oct 2019
- Primary completion12 Apr 2023
- Study completion13 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pancreatic Cancer Stage IVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hitendra Patel
- Sponsor type
- University, hospital or other
- Collaborators
- Stand Up To Cancer, Lustgarten Foundation
- Responsible party
- Sponsor-investigator, Hitendra Patel, University of California, San Diego
- Investigators
- Hitendra Patel, MD, Principal investigator, University of California, San DiegoAndrew Lowy, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03697564
- Sponsor's protocol ID
- 181395
- Status last verified
- Jul 2025
- First submitted
- 28 Sep 2018
- Last updated
- 6 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03697564
- Acronym / sponsor ID
- 181395
- Conditions
- Pancreatic Cancer Stage IV
- Keywords
- Pancreating Cancer, Cancer, Stage IV, gemcitabine, nivolumab, cabiralizumab, BMS-986227, FPA008
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Hitendra PatelUniversity, hospital or other
- Collaborators
- Stand Up To Cancer, Lustgarten Foundation
- Study start
- 31 Oct 2019 (actual)
- Primary completion
- 12 Apr 2023 (actual)
- Study completion
- 13 Jul 2023 (actual)
- First posted
- 5 Oct 2018 (actual)
- Results
- Posted 6 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gemcitabine +nivolumab + cabiralizumab | Experimental | Drug: Gemcitabine, Drug: Nivolumab 10 MG/ML Intravenous Solution [OPDIVO], Drug: Cabiralizumabgemcitabine +nivolumab + cabiralizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GemcitabineAlso: Gemzar and Infugem1000 mg/m2 IV on days 1, 8, and 15 Q4W | Drug | gemcitabine +nivolumab + cabiralizumab |
| Nivolumab 10 MG/ML Intravenous Solution [OPDIVO]Also: Opdivo480mg IV on Day 1 Q4W | Drug | gemcitabine +nivolumab + cabiralizumab |
| CabiralizumabAlso: FPA 0084mg/kg IV on day 1 and 15 Q4W | Drug | gemcitabine +nivolumab + cabiralizumab |
Primary outcome
Number of Participants With Progression Free Survival (PFS)
Time frame: 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.
1 secondary outcome
Number of Participants With Overall Survival (OS)
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hitendra Patel, MD principal investigator
University of California, San Diego
Andrew Lowy, MD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine, Nivolumab 10 MG/ML Intravenous Solution [OPDIVO] and Cabiralizumab in people with Pancreatic Cancer Stage IV, run by Hitendra Patel at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Progression Free Survival (PFS) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.