Nivolumab + Cabiralizumab + Gemcitabine in Patients With Stage IV Pancreatic Cancer Achieving Disease Control in Response to First-line Chemotherapy (GemCaN Trial).

Sponsor

Hitendra Patel (Other)

Overall Status

Suspended

CT.gov ID

NCT03697564

Collaborator

Stand Up To Cancer (Other), Lustgarten Foundation (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

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

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer Stage IV	Drug: Gemcitabine Drug: Nivolumab 10 MG/ML Intravenous Solution [OPDIVO] Drug: Cabiralizumab	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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).

Actual Study Start Date :

Oct 31, 2019

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: gemcitabine +nivolumab + cabiralizumab	Drug: Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 Q4W Drug: Nivolumab 10 MG/ML Intravenous Solution [OPDIVO] 480mg IV on Day 1 Q4W Other Names: Opdivo Drug: Cabiralizumab 4mg/kg IV on day 1 and 15 Q4W

Arm

Intervention/Treatment

Experimental: gemcitabine +nivolumab + cabiralizumab

Drug: Gemcitabine

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

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

480mg IV on Day 1 Q4W

Other Names:

Opdivo

Drug: Cabiralizumab

4mg/kg IV on day 1 and 15 Q4W

Outcome Measures

Primary Outcome Measures

Progression Free Survival (PFS) [6 months]
To estimate Progression Free Survival (PFS rates) at 6 months by RECIST1.1

Secondary Outcome Measures

Incidence of Treatment-Emergent Grade 2-5 Adverse Events assessed using NCI CTCAE v5.0 toxicity criteria [6 months]
Overall Survival (OS) [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.