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Immune dynamics and biomarkers of anti-tumor response in BMS-986340 (anti-CCR8) and nivolumab (anti-PD-1) co-treatment of metastatic tumors

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-524125-40-01
Enrollment
30
Registered
2026-07-23
Start date
Unknown
Completion date
Unknown
Last updated
2026-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic solid tumors, with the following specific indications: Non–Small Cell Lung Cancer (NSCLC), metastatic, PD-(L)1–refractory/resistant Gastric adenocarcinoma, PD-(L)1–refractory/resistant Colorectal cancer (microsatellite stable, MSS), immunotherapy‑naïve Pancreatic adenocarcinoma, immunotherapy‑naïve

Brief summary

Identification of circulating and tissue biomarkers (mediators of inflammation, key immune populations, specific gene expression patterns) induced by combination treatment. We will monitor immune responses longitudinally in the peripheral blood and at multiple tissue sites (tumor, LNs, skin) to investigate immune changes induced by combination treatment, Disease control rate (DCR) defined as the proportion of patients who achieve complete response (CR), partial response (PR), or stable disease (SD) as their best overall response to treatment, according to RECIST 1.1 by investigator assessment

Detailed description

Identification of circulating and tissue biomarkers (mediators of inflammation, key immune populations, specific gene expression patterns) that are differentially occurring in responders vs. non-responders to combination treatment (for exploratory purposes only)., Objective response and duration of response (DOR), defined as defined as the time from the first documentation of objective response (complete response [CR] or partial response [PR]) to the first documentation of disease progression or death from any cause, whichever occurs first; progression-free survival (PFS); overall survival (OS) ., Safety assessment

Interventions

DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

Sponsors

Humanitas Mirasole S.p.A., Fondazione Humanitas Per La Ricerca Ets
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Identification of circulating and tissue biomarkers (mediators of inflammation, key immune populations, specific gene expression patterns) induced by combination treatment. We will monitor immune responses longitudinally in the peripheral blood and at multiple tissue sites (tumor, LNs, skin) to investigate immune changes induced by combination treatment, Disease control rate (DCR) defined as the proportion of patients who achieve complete response (CR), partial response (PR), or stable disease (SD) as their best overall response to treatment, according to RECIST 1.1 by investigator assessment

Secondary

MeasureTime frame
Identification of circulating and tissue biomarkers (mediators of inflammation, key immune populations, specific gene expression patterns) that are differentially occurring in responders vs. non-responders to combination treatment (for exploratory purposes only)., Objective response and duration of response (DOR), defined as defined as the time from the first documentation of objective response (complete response [CR] or partial response [PR]) to the first documentation of disease progression or death from any cause, whichever occurs first; progression-free survival (PFS); overall survival (OS) ., Safety assessment

Outcome results

None listed

Source: EU CTIS · Data processed: Jul 24, 2026