Neoadjuvant Nivolumab med CCR2/5-hemmer eller anti-IL-8) for ikke-småcellet lungekreft (NSCLC) eller hepatocellulært karsinom (HCC)
Tisch Cancer Institute - BMS-studie nr. CA027-005: Neoadjuvant Nivolumab + BMS-813160 (CCR2/5-hemmer) eller BMS-986253 (Anti-IL-8) for NSCLC eller 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
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
New York
-
New York, New York, Forente stater, 10029
- Icahn School of Medicine at Mount Sinai
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- 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 Criteria:
- 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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Cohort A
NSCLC: Nivolumab + BMS-813160 |
q4w, dosed twice before surgery and three times following recovery from surgery by injection 300mg oral twice a day for 28 days
Andre navn:
|
|
Eksperimentell: Cohort B
NSCLC: Nivolumab + BMS-986253 |
q4w, dosed twice before surgery and three times following recovery from surgery by injection 2400mg once by injection
Andre navn:
|
|
Eksperimentell: Cohort C
HCC: Nivolumab |
q4w, dosed twice before surgery and three times following recovery from surgery by injection |
|
Eksperimentell: Cohort D
HCC: Nivolumab + BMS-813160 |
q4w, dosed twice before surgery and three times following recovery from surgery by injection 300mg oral twice a day for 28 days
Andre navn:
|
|
Eksperimentell: Cohort E
HCC: Nivolumab + BMS-986253 |
q4w, dosed twice before surgery and three times following recovery from surgery by injection 2400mg once by injection
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Major Pathologic Response (MPR)
Tidsramme: 2 Years
|
MPR is defined as <10% viable tumor within resection, at time of surgery. |
2 Years
|
|
Significant Tumor Necrosis (STN)
Tidsramme: 2 Years
|
STN is defined as necrosis of >70% of tumor base on pathologic analysis of gross tumor resection at time of surgery. |
2 Years
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Time to Surgery
Tidsramme: 2 Years
|
Measured as the time in days that elapses between the first dose of neoadjuvant therapy and surgical resection. |
2 Years
|
|
Percent of individuals who experience adverse events
Tidsramme: 2 Years
|
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. |
2 Years
|
|
Percent of individuals who experience radiographic response
Tidsramme: 2 Years
|
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. |
2 Years
|
|
Progression-free survival (PFS)
Tidsramme: 2 Years
|
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. |
2 Years
|
|
Overall Survival (OS)
Tidsramme: 5 Years
|
Defined as the time, in days, between treatment initiation and when the patient dies from any cause regardless of etiology. |
5 Years
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Thomas Marron, MD PhD, Icahn School of Medicine at Mount Sinai
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter nettsted
- Neoplasmer
- Sykdommer i luftveiene
- Neoplasmer etter histologisk type
- Neoplasmer i fordøyelsessystemet
- Sykdommer i fordøyelsessystemet
- Lungesykdommer
- Leversykdommer
- Neoplasmer, kjertel og epitel
- Adenokarsinom
- Neoplasmer i leveren
- Neoplasmer i luftveiene
- Thoracale neoplasmer
- Lungeneoplasmer
- Karsinom
- Karsinom, bronkogent
- Bronkiale neoplasmer
- Karsinom, hepatocellulært
- Karsinom, ikke-småcellet lunge
- Aminosyrer, peptider og proteiner
- Proteiner
- Antistoffer, monoklonalt, humanisert
- Antistoffer, monoklonalt
- Antistoffer
- Immunoglobuliner
- Immunoproteiner
- Blodproteiner
- Serumglobuliner
- Globuliner
- Nivolumab
- Humax-il8
- BMS-813160
Andre studie-ID-numre
- GCO 19-1754
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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