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Nivolumab + CCR2/5-inhibitor/Anti-IL-8 for Lung Cancer

Phase 2

Waitlist Available

Led By Thomas Marron, MD

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of NSCLC or HCC

Willing to undergo leukapheresis at Mount Sinai Hospital or New York Blood Bank

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is studying nivolumab with or without CCR2/5-inhibitor or anti-IL-8 in treating patients with stage III or stage IV melanoma.

Who is the study for?

This trial is for adults with operable lung or liver cancer (NSCLC or HCC) who have functioning organs and marrow. They must agree to use birth control, provide blood samples, undergo leukapheresis at specified locations, and have biopsies. Excluded are those on other trials, with uncontrolled illness, recent chemo/radiotherapy for another tumor, metastatic disease not curable by surgery, pregnant/nursing women, certain immune conditions including active autoimmune diseases treated within a year or current immunosuppressives.Check my eligibility

What is being tested?

The study tests the effect of Nivolumab combined with either CCR2/5-inhibitor (BMS-813160) or anti-IL-8 (BMS-986253) before and after surgery in NSCLC/HCC patients. It aims to see if these drugs boost immune response against tumors seen during surgery and improve survival rates.See study design

What are the potential side effects?

Potential side effects may include immune-related reactions like inflammation in various organs due to Nivolumab's action on the immune system; infusion reactions; fatigue; digestive issues; changes in blood counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with non-small cell lung cancer or liver cancer.

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I am willing to have a leukapheresis procedure at Mount Sinai Hospital or New York Blood Bank.

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I am 18 years old or older.

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My doctor says I can have surgery to remove my tumor.

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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Major Pathologic Response (MPR)

Significant Tumor Necrosis (STN)

Secondary outcome measures

Overall Survival (OS)

Percent of individuals who experience adverse events

Percent of individuals who experience radiographic response

+2 more

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533

57%

Nausea

54%

Anaemia

51%

Fatigue

39%

Decreased appetite

36%

Malignant neoplasm progression

32%

Constipation

31%

Diarrhoea

30%

Cough

29%

Vomiting

29%

Dyspnoea

25%

Oedema peripheral

24%

Back pain

21%

Pyrexia

21%

Neutropenia

19%

Headache

19%

Hypomagnesaemia

18%

Arthralgia

16%

Asthenia

16%

Dizziness

16%

Neutrophil count decreased

15%

Thrombocytopenia

15%

Insomnia

14%

Hyponatraemia

14%

Rash

14%

Weight decreased

14%

Platelet count decreased

13%

Blood creatinine increased

13%

White blood cell count decreased

12%

Hypokalaemia

12%

Pruritus

12%

Abdominal pain

12%

Pain in extremity

11%

Myalgia

11%

Alanine aminotransferase increased

11%

Aspartate aminotransferase increased

10%

Alopecia

10%

Dry skin

10%

Hypoalbuminaemia

10%

Muscular weakness

10%

Chest pain

10%

Dysgeusia

10%

Pneumonia

10%

Productive cough

Abdominal pain upper

Upper respiratory tract infection

Hypothyroidism

Mucosal inflammation

Peripheral sensory neuropathy

Lacrimation increased

Nasopharyngitis

Non-cardiac chest pain

Epistaxis

Haemoptysis

Stomatitis

Dysphonia

Hypertension

Bronchitis

Dehydration

Hyperglycaemia

Hyperkalaemia

Blood alkaline phosphatase increased

Chills

Lymphocyte count decreased

Anxiety

Hypophosphataemia

Leukopenia

Pleural effusion

Neuropathy peripheral

Pneumonitis

Oropharyngeal pain

Rash maculo-papular

Hypotension

Malaise

Pain

Musculoskeletal chest pain

Dry mouth

Urinary tract infection

Dyspepsia

Gamma-glutamyltransferase increased

Depression

Muscle spasms

Fall

Pulmonary embolism

Metastases to central nervous system

Myocardial infarction

Febrile neutropenia

Musculoskeletal pain

Chronic obstructive pulmonary disease

Malignant pleural effusion

Sepsis

General physical health deterioration

Adrenal insufficiency

Atrial fibrillation

Cardiac failure

Embolism

Small intestinal haemorrhage

Neoplasm progression

Pneumothorax

Atrial flutter

Bone pain

Pericardial effusion malignant

Circulatory collapse

Confusional state

Cancer pain

Hypercalcaemia

Femur fracture

Bronchial obstruction

Superior vena cava syndrome

Syncope

Performance status decreased

Pancytopenia

Colitis

Pericardial effusion

Gastrointestinal haemorrhage

Ileus

Small intestinal obstruction

Lung cancer metastatic

Respiratory tract infection

Respiratory failure

Tumour pain

Appendicitis

Skin infection

Ataxia

Seizure

100%

80%

60%

40%

20%

Study treatment Arm

Investigator Choice of Chemotherapy

Post Chemotherapy Optional Nivolumab

Nivolumab

Trial Design

5Treatment groups

Experimental Treatment

Group I: Cohort EExperimental Treatment2 Interventions

HCC: Nivolumab + BMS-986253

Group II: Cohort DExperimental Treatment2 Interventions

HCC: Nivolumab + BMS-813160

Group III: Cohort CExperimental Treatment1 Intervention

HCC: Nivolumab

Group IV: Cohort BExperimental Treatment2 Interventions

NSCLC: Nivolumab + BMS-986253

Group V: Cohort AExperimental Treatment2 Interventions

NSCLC: Nivolumab + BMS-813160

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BMS-813160

Not yet FDA approved

Nivolumab

FDA approved

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor

860 Previous Clinical Trials

524,440 Total Patients Enrolled

Bristol-Myers SquibbIndustry Sponsor

2,639 Previous Clinical Trials

4,128,996 Total Patients Enrolled

Thomas Marron, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

2 Previous Clinical Trials

19 Total Patients Enrolled

Media Library

Nivolumab Clinical Trial Eligibility Overview. Trial Name: NCT04123379 — Phase 2

Non-Small Cell Lung Cancer Research Study Groups: Cohort D, Cohort C, Cohort E, Cohort A, Cohort B

Nivolumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT04123379 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What pathologies has Nivolumab been proven to ameliorate?

"Nivolumab can be utilized to treat malignancies, unresectable melanomas, and squamous cell carcinomas."

Answered by AI

What aims is this experiment striving to accomplish?

"This two-year clinical trial will measure Significant Tumor Necrosis (STN) as its primary outcome. Secondary objectives include Progression-free Survival, Time to Surgery, and Overall Survival - all of which are mathematically defined in the study's guidelines."

Answered by AI

Is Nivolumab officially sanctioned by the FDA?

"Since this is a Phase 2 trial, our team has rated the safety of Nivolumab to be at a level 2. This signifies that while some data exists supporting its security, there isn't any evidence demonstrating efficacy yet."

Answered by AI

How many participants are being admitted to this clinical trial?

"Yes, research hosted on clinicaltrials.gov affirms that this healthcare study is actively recruiting volunteers. This trial was initially published on March 19th 2020 and revised as recently as November 7th 2022. Up to 50 individuals are required from a single site."

Answered by AI

Are there any open positions to join this experiment?

"Affirmative. Information available on clinicaltrials.gov confirms that this medical trial, which was initially posted on March 19th 2020, is actively seeking participants. Altogether 50 patients need to be sourced from a single research centre."

Answered by AI

Is the age requirement for enrolment into this trial limited to individuals below 20?

"The age range for participants of this trial is 18 to 99. The study database displays 175 studies targeting minors and 4984 investigations with focus on seniors."

Answered by AI

Is this trial pioneering a new approach to treatment?

"As of now, 718 active studies concerning Nivolumab are being conducted across 49 countries and 2354 cities. The inaugural trial was sponsored by Ono Pharmaceutical Co. Ltd in 2012 with 659 participants who completed the Phase 1 & 2 drug assessment steps. In the 8 years since then, 253 additional investigations have been done regarding this medication."

Answered by AI

Have there been any prior experiments conducted utilizing Nivolumab?

"At the moment, 718 scientific studies have been launched to investigate nivolumab's efficacy. 82 of these are in phase 3 and 40237 sites across Basel, BE are hosting trials for this drug."

Answered by AI

To what extent is enrollment eligibility for this trial restricted?

"The eligibility requirements of this clinical trial stipulate that participants must have carcinoma and be between 18-99 years old. The total number of patients accepted is limited to 50 individuals."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Thomas Marron 2020. "Neoadjuvant Nivolumab With CCR2/5-inhibitor or Anti-IL-8) for Non-small Cell Lung Cancer (NSCLC) or Hepatocellular Carcinoma (HCC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04123379.

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