Resumen

Researchers want to know if V940 (the study treatment) given with pembrolizumab and chemotherapy can treat metastatic treatment-naive squamous non-small cell lung cancer (NSCLC). V940 is designed to help a person's immune system attack their specific cancer. The goal of this study is to learn if people who receive V940 with pembrolizumab and chemotherapy live longer overall and without the cancer growing or spreading compared to people who receive placebo with pembrolizumab and chemotherapy. A placebo looks like the study treatment but has no study treatment in it. Using a placebo helps researchers better understand the effects of the study treatment.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Has a histologically or cytologically confirmed diagnosis of squamous non-small cell lung cancer (NSCLC) (Stage IV: M1a, M1b, M1c1, M1c2, AJCC Staging Manual, Version 9). NOTE: Mixed tumors will be characterized by the predominant cell type; however, small cell elements are not permitted.
Has measurable disease per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by the local site investigator/radiology
Has provided a tissue sample that is collected either at the time of or after the diagnosis of metastatic disease AND is from a site not previously irradiated
Adverse events (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible
Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
Hepatitis B surface antigen (HBsAg) positive participants are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization
Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable. NOTE: Participants must have completed curative antiviral therapy at least 4 weeks prior to randomization
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization
Has a life expectancy of at least 3 months
Has adequate organ function

Criterios de exclusión

Has severe hypersensitivity (≥Grade 3) to V940, pembrolizumab, or any of the protocol allowed chemotherapy agents and/or any of their excipients
Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Has received prior treatment with a cancer vaccine, including another personalized cancer vaccine (PCV)
Has received prior systemic anticancer therapy for their metastatic NSCLC
Has received prior therapy with an anti-programmed cell death 1 protein (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-programmed cell death ligand 2 (anti-PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor. NOTE: Prior treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent in the neoadjuvant or adjuvant setting for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC
Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
Has received radiation therapy to the lung that is \>30 gray within 6 months of start of study intervention
Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
Has known additional malignancy that is progressing or has required active treatment within the past 3 years
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Has active autoimmune disease that has required systemic treatment in the past 2 years
Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
Has active infection requiring systemic therapy
Has a history of stem cell/solid organ transplant
Has not adequately recovered from major surgery or has ongoing surgical complications

Ubicaciones

Instituto Alexander Fleming ( Site 0201)

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Study Coordinator · +541132218956

RECRUITING

Instituto de Investigaciones Clínicas Mar del Plata ( Site 0205)

Mar del Plata, Buenos Aires, Argentina

Study Coordinator · +5492235937663

RECRUITING

Clinica Adventista Belgrano ( Site 0206)

Caba., Buenos Aires F.D., Argentina

Study Coordinator · +5491140141500

RECRUITING

Fundacion Estudios Clinicos ( Site 0207)

Rosario, Santa Fe Province, Argentina

Study Coordinator · +5493413168137

RECRUITING

Sanatorio Parque ( Site 0203)

Rosario, Santa Fe Province, Argentina

Study Coordinator · +543874044942

RECRUITING

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of V940 in Combination With Pembrolizumab and Chemotherapy as First-Line Treatment for Participants With Metastatic Squamous NSCLC (INTerpath-013)

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

V940

Pembrolizumab

Carboplatin

Paclitaxel

Nab-paclitaxel

Placebo

Ubicaciones

Instituto Alexander Fleming ( Site 0201)

Instituto de Investigaciones Clínicas Mar del Plata ( Site 0205)

Clinica Adventista Belgrano ( Site 0206)

Fundacion Estudios Clinicos ( Site 0207)

Sanatorio Parque ( Site 0203)

Patrocinadores

Contactos

Toll Free Number