Non-small Cell Lung CancerPhase 2NCT04123379
Neoadjuvant Nivolumab With CCR2/5-inhibitor or Anti-IL-8) for Non-small Cell Lung Cancer (NSCLC) or Hepatocellular Carcinoma (HCC)
A Phase 2 study testing Nivolumab, BMS-813160 and BMS-986253 in people with Non-small Cell Lung Cancer and Hepatocellular Carcinoma, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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 results in: 1. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Non-small Cell Lung Cancer, Hepatocellular Carcinoma
- What is being tested?
- Nivolumab, BMS-813160 and BMS-986253
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2020to 13 Jul 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Surgical candidate for resection of their tumor
- Agree to use adequate contraception
- Adequate organ and marrow function
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Tisch Cancer Institute - BMS Study # CA027-005: Neoadjuvant Nivolumab + BMS-813160 (CCR2/5-inhibitor) or BMS-986253 (Anti-IL-8) for NSCLC or HCC
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:
- 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)
- Improvement in long term survival rates
Read the 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):
Primary Objective: Significant tumor necrosis (STN) Secondary Objectives: Time to surgery, tolerability and safety, radiographic response
Diagnosis and Main Inclusion Criteria:
Patients must have disease deemed resectable before enrollment.
Study Product:
Nivolumab 480mg (q4w, dosed twice before surgery and three times following recovery from surgery) BMS-813160 (CCR2/5-inhibitor) 300mg oral twice a day for 28 days BMS-986253 (anti-IL-8) 2400mg once
- Being tested
- Nivolumab, BMS-813160, BMS-986253
- Keywords
- Nivolumab, CCR2/5-inhibitor, anti-IL-8
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
q4w, dosed twice before surgery and three times following recovery from surgery by injection
BMS-813160Drug
Also called CCR2/5-inhibitor
300mg oral twice a day for 28 days
BMS-986253Drug
Also called anti-IL-8
2400mg once by injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | NSCLC: Nivolumab + BMS-813160 Receives: Drug: Nivolumab; Drug: BMS-813160 |
| Cohort B | Experimental | NSCLC: Nivolumab + BMS-986253 Receives: Drug: Nivolumab; Drug: BMS-986253 |
| Cohort C | Experimental | HCC: Nivolumab Receives: Drug: Nivolumab |
| Cohort D | Experimental | HCC: Nivolumab + BMS-813160 Receives: Drug: Nivolumab; Drug: BMS-813160 |
| Cohort E | Experimental | HCC: Nivolumab + BMS-986253 Receives: Drug: Nivolumab; Drug: BMS-986253 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Pathologic Response (MPR)
MPR is defined as <10% viable tumor within resection, at time of surgery.
Measured: 2 Years
Significant Tumor Necrosis (STN)
STN is defined as necrosis of >70% of tumor base on pathologic analysis of gross tumor resection at time of surgery.
Measured: 2 Years
Secondary outcomes (5)
Time to Surgery
Measured as the time in days that elapses between the first dose of neoadjuvant therapy and surgical resection.
Measured: 2 Years
Percent of individuals who experience adverse events
Safety and Tolerability defined by the percent of individuals who experience adverse events at any point during the neoadjuvant period, or within 30 days following the final dose of nivolumab received.
Measured: 2 Years
Percent of individuals who experience radiographic response
As per RECIST v1.1 as determined by pre-surgical imaging, following receipt of the neoadjuvant therapy. For NSCLC this will be based on CT imaging, while for HCC this imaging will be based on MRI radiographic post-contract subtraction.
Measured: 2 Years
Progression-free survival (PFS)
Defined as the time, in days, between treatment initiation and when the patient is found to have recurrent and/or metastatic disease on imaging, or death for any reason.
Measured: 2 Years
Overall Survival (OS)
Defined as the time, in days, between treatment initiation and when the patient dies from any cause regardless of etiology.
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start5 Mar 2020
- Primary completion24 Aug 2023
- Study completion13 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Principal investigator, Thomas Marron, Icahn School of Medicine at Mount Sinai
- Investigators
- Thomas Marron, MD PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04123379
- Sponsor's protocol ID
- GCO 19-1754
- Status last verified
- Sep 2026
- First submitted
- 9 Oct 2019
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tisch Cancer Institute - BMS Study # CA027-005: Neoadjuvant Nivolumab + BMS-813160 (CCR2/5-inhibitor) or BMS-986253 (Anti-IL-8) for NSCLC or HCC
- ClinicalTrials.gov ID
- NCT04123379
- Acronym / sponsor ID
- GCO 19-1754
- Keywords
- Nivolumab, CCR2/5-inhibitor, anti-IL-8
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 5 Mar 2020 (actual)
- Primary completion
- 24 Aug 2023 (actual)
- Study completion
- 13 Jul 2028 (estimated)
- First posted
- 10 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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)
- Improvement in long term survival rates
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):
Primary Objective: Significant tumor necrosis (STN) Secondary Objectives: Time to surgery, tolerability and safety, radiographic response
Diagnosis and Main Inclusion Criteria:
Patients must have disease deemed resectable before enrollment.
Study Product:
Nivolumab 480mg (q4w, dosed twice before surgery and three times following recovery from surgery) BMS-813160 (CCR2/5-inhibitor) 300mg oral twice a day for 28 days BMS-986253 (anti-IL-8) 2400mg once
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: Nivolumab, Drug: BMS-813160NSCLC: Nivolumab + BMS-813160 |
| Cohort B | Experimental | Drug: Nivolumab, Drug: BMS-986253NSCLC: Nivolumab + BMS-986253 |
| Cohort C | Experimental | Drug: NivolumabHCC: Nivolumab |
| Cohort D | Experimental | Drug: Nivolumab, Drug: BMS-813160HCC: Nivolumab + BMS-813160 |
| Cohort E | Experimental | Drug: Nivolumab, Drug: BMS-986253HCC: Nivolumab + BMS-986253 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nivolumabq4w, dosed twice before surgery and three times following recovery from surgery by injection | Drug | Cohort A, Cohort B, Cohort C, Cohort D, Cohort E |
| BMS-813160Also: CCR2/5-inhibitor300mg oral twice a day for 28 days | Drug | Cohort A, Cohort D |
| BMS-986253Also: anti-IL-82400mg once by injection | Drug | Cohort B, Cohort E |
Primary outcome
Major Pathologic Response (MPR)
Time frame: 2 Years
MPR is defined as <10% viable tumor within resection, at time of surgery.
Significant Tumor Necrosis (STN)
Time frame: 2 Years
STN is defined as necrosis of >70% of tumor base on pathologic analysis of gross tumor resection at time of surgery.
5 secondary outcomes
Time to Surgery
Time frame: 2 Years
Percent of individuals who experience adverse events
Time frame: 2 Years
Percent of individuals who experience radiographic response
Time frame: 2 Years
Progression-free survival (PFS)
Time frame: 2 Years
Overall Survival (OS)
Time frame: 5 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Marron, MD PhD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab, BMS-813160 and BMS-986253 in people with Non-small Cell Lung Cancer and Hepatocellular Carcinoma, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Pathologic Response (MPR) (time frame: 2 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.