Status:
ACTIVE_NOT_RECRUITING
Neoadjuvant Nivolumab with CCR2/5-inhibitor or Anti-IL-8) for Non-small Cell Lung Cancer (NSCLC) or Hepatocellular Carcinoma (HCC)
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Non-small Cell Lung Cancer
Hepatocellular Carcinoma
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
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 result...
Detailed Description
Objectives: Cohorts A,B (NSCLC): Primary Objective: Major Pathologic Response (MPR) Secondary Objectives: Time to surgery, tolerability and safety, radiographic response Cohorts C,D,E (HCC): Prima...
Eligibility Criteria
Inclusion
- Diagnosis of NSCLC or HCC
- Willing to provide blood samples
- Willing to undergo leukapheresis at Mount Sinai Hospital or New York Blood Bank
- Willing to have excisional or core needle biopsies
- At least 18 years of age
- ECOG 0-1
- Surgical candidate for resection of their tumor
- Agree to use adequate contraception
- Adequate organ and marrow function
Exclusion
- Patients who have had chemotherapy or radiotherapy within 4 months for a different primary tumor or patients who have received locoregional therapy for the target lesion
- Patients receiving any other investigational agents
- Patients with metastatic disease for whom the intent of surgery would not be curative
- Uncontrolled intercurrent illness
- Pregnant or nursing
- Has a diagnosis of primary immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days
- Has active autoimmune disease that has required systemic treatment in the past year
- Has a known additional malignancy that is progressing and/or requires active treatment
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not the in the best interest of the patient to participate
- HIV positive with detectable viral load or anyone not on stable anti-viral regimen
- Has known active Hepatitis B
- History of allogeneic hematopoietic cell transplantation or solid organ transplantation
- Documented allergic or hypersensitivity response to any protein therapeutics
- Patients may not have prolonged QRS or QTc
Key Trial Info
Start Date :
March 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04123379
Start Date
March 5 2020
End Date
December 31 2025
Last Update
January 17 2025
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029