Neoadjuvant Nivolumab With CCR2/5-inhibitor or Anti-IL-8) for Non-small Cell Lung Cancer (NSCLC) or Hepatocellular Carcinoma (HCC)

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT04123379
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    q4w, dosed twice before surgery and three times following recovery from surgery by injection
  • BMS-813160 — DRUG
    300mg oral twice a day for 28 days
  • BMS-986253 — DRUG
    2400mg once by injection

Study Details

The purpose of this research study is to study the effect of giving nivolumab with CCR2/5-inhibitor or anti-IL-8 before surgery, and after surgery, with the goal of determining if this medicine results in: 1. A significant immune response against their tumor (which the study team will see in the tumor that is taken out at the time of surgery) 2. Improvement in long term survival rates

Key Dates

First listed
Oct 10, 2019
Start date
Mar 5, 2020
Status verified
Apr 2026
Primary completion
Aug 24, 2023
Completion
Aug 24, 2025

Study Design

Enrollment
48 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A
    NSCLC: Nivolumab + BMS-813160
  • Experimental: Cohort B
    NSCLC: Nivolumab + BMS-986253
  • Experimental: Cohort C
    HCC: Nivolumab
  • Experimental: Cohort D
    HCC: Nivolumab + BMS-813160
  • Experimental: Cohort E
    HCC: Nivolumab + BMS-986253

Primary Outcome Measure

Major Pathologic Response (MPR) [ Time Frame: 2 Years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-

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By research site
Icahn School of Medicine at Mount Sinai· New York, NY

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