Phase 2, Single-Arm Trial of BMS-986340 in Combination With Nivolumab, Gemcitabine and Nab-Paclitaxel in the First Line Setting of Advanced Pancreatic Adenocarcinoma

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Investigational drug late phase More information No known activity More information High burden on patient More information

Trial Details

Sponsor: Mayo Clinic (other)

Phase: 2

Start date: Dec. 12, 2025

Planned enrollment: 43

Trial ID: NCT07226856
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More trial details at ClinicalTrials.gov More info

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Investigational Drug AI Analysis

chevron Show for: BMS-986340 (anti-CCR8, imzokitug)

TrialFetch AI Analysis

Goal: To evaluate safety/tolerability, identify an acceptable dose strategy in an initial safety run-in, and estimate antitumor activity of adding the investigational anti-CCR8 antibody BMS-986340 (imzokitug) to nivolumab plus gemcitabine/nab-paclitaxel as first-line therapy for advanced pancreatic adenocarcinoma.

Patients: Adults (≥18 years) with histologically confirmed pancreatic adenocarcinoma presenting with metastatic disease or recurrent disease, ECOG performance status 0–1, and measurable disease by RECIST v1.1. Key requirements include adequate hematologic, hepatic, renal, and coagulation parameters and acceptable baseline ECG (QTcF ≤450 ms). Key exclusions include prior systemic therapy for metastatic pancreatic cancer (adjuvant/neoadjuvant allowed only if completed ≥12 months prior), prior PD-1/PD-L1/CTLA-4/CCR8 therapy, active/suspected autoimmune disease requiring immunosuppression, uncontrolled intercurrent illness or significant recent cardiovascular events, CNS metastases, and low serum albumin (<3 g/dL).

Design: Phase 2, single-arm, open-label study with an early safety run-in focused on significant adverse events in cycle 1, followed by an efficacy phase assessing response per RECIST. Treatment continues in 28-day cycles for up to 2 years or until progression or unacceptable toxicity.

Treatments: All patients receive combination therapy each 28-day cycle: nivolumab IV on day 1; BMS-986340 (imzokitug) IV on day 1; nab-paclitaxel IV and gemcitabine IV on days 1 and 15. Nivolumab is an anti–PD-1 immune checkpoint inhibitor. Gemcitabine plus nab-paclitaxel is a standard first-line chemotherapy backbone for metastatic pancreatic adenocarcinoma. BMS-986340 (imzokitug) is an investigational, nonfucosylated IgG1 monoclonal antibody targeting CCR8, a receptor enriched on tumor-infiltrating regulatory T cells; it is designed to block CCR8 signaling and deplete CCR8+ Tregs via ADCC to relieve local immunosuppression and potentially enhance anti–PD-1 activity. Clinical efficacy and safety outcomes for BMS-986340 remain investigational with no definitive published results to date in pancreatic adenocarcinoma.

Outcomes: Primary endpoints are (1) incidence of significant adverse events during cycle 1 (CTCAE v5.0) in the safety run-in and (2) objective response rate (CR+PR) by RECIST v1.1 in the phase II portion, assessed by 6 months or earlier if treatment stops. Secondary endpoints include overall survival, progression-free survival, disease control rate (CR/PR or stable disease ≥6 weeks), duration of response, and incidence of grade ≥3 adverse events over up to 2 years.

Burden on patient: Moderate to high. The regimen requires IV infusions on day 1 and day 15 of each 28-day cycle (with two immunotherapy infusions on day 1), which is more time-intensive than some standard schedules and may necessitate frequent clinic visits. Imaging with CT is performed throughout the study (at least to the point of response assessment by the third scan around 6 months), and there are mandatory blood collections and mandatory tissue biopsies for correlative research, increasing procedural burden beyond standard-of-care chemotherapy. Additional brain MRI may be required for patients with suspected/known brain metastases, and long on-treatment follow-up (up to 2 years) further adds visit and monitoring demands.

Last updated: Jan 2026

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Sites (3)

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Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

[email protected] / 855-776-0015

Status: Recruiting

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

[email protected] / 855-776-0015

Status: Recruiting

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

[email protected] / 855-776-0015

Status: Recruiting