A Phase 2 Randomized Study of BMS-986207 in Combination With Nivolumab and Ipilimumab as First-line Treatment for Participants With Stage IV Non-Small Cell Lung Cancer

CompletadoFase 2ClinicalTrials.gov

ID: NCT05005273Tipo: INTERVENTIONALInicio: 3 de oct de 2022Fin estimado: 27 de dic de 2022

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to determine the safety and efficacy of BMS-986207 in combination with nivolumab and ipilimumab as first-line treatment for participants with stage IV non-small cell lung cancer (NSCLC).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Histologically confirmed metastatic 1L Stage IV non-small cell lung cancer (NSCLC) of squamous or nonsquamous histology
No prior systemic anti-cancer treatment given as primary therapy for advanced or metastatic NSCLC
Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
A formalin-fixed, paraffin-embedded (FFPE) tumor tissue block or a minimum of 20 unstained slides of tumor tissue obtained during screening or prior to enrollment
Life expectancy of at least 3 months at the time of first dose

Criterios de exclusión

Participants with epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or c-ros oncogene 1 (ROS-1) mutations which are sensitive to available targeted inhibitor therapy. Participants with nonsquamous histology and unknown EGFR, ALK, or ROS-1 status are also excluded
Participants with known B-rapidly accelerated fibrosarcoma proto-oncogene (BRAF) V600E mutations that are sensitive to available targeted inhibitor therapy. Participants with unknown or indeterminate BRAF mutation status are eligible.
Untreated central nervous system metastases
Leptomeningeal metastases (carcinomatous meningitis)
Concurrent malignancy requiring treatment
Active, known, or suspected autoimmune disease
Interstitial lung disease
Uncontrolled or significant cardiovascular disease

Intervenciones

drug

Nivolumab

Specified dose on specified days

drug

Ipilimumab

Specified dose on specified days

drug

BMS-986207

Specified dose on specified days

other

Placebo

Specified dose on specified days

Ubicaciones

Local Institution - 0009

Pergamino, Buenos Aires, Argentina

Local Institution - 0054

Rosario, Santa Fe Province, Argentina

Local Institution - 0062

Buenos Aires, Argentina

Local Institution - 0021

Buenos Aires, Argentina

Local Institution - 0011

Buenos Aires, Argentina

Local Institution - 0048

Buenos Aires, Argentina

Local Institution - 0057

San Juan, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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