A Phase II, Multicenter, Open Label Study of Bintrafusp Alfa (M7824) Monotherapy in Participants With Advanced, Unresectable Cervical Cancer With Disease Progression During or After Platinum-Containing Chemotherapy

CompletadoFase 2ClinicalTrials.gov

ID: NCT04246489Tipo: INTERVENTIONALInicio: 30 de mar de 2020Fin estimado: 14 de dic de 2022

Traducción no disponible, mostrando original

Resumen

The main purpose of this study was to evaluate clinical efficacy and safety of bintrafusp alfa in participants with advanced, unresectable cervical cancer with disease progression during or after platinum-containing chemotherapy.

Elegibilidad

Edad mínima: 18 YearsSexo: FEMALE

Criterios de inclusión

Participants who had advanced unresectable and/or metastatic cervical cancer (squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma) with disease progression during or after the prior platinum-containing chemotherapy:
The prior platinum-containing chemotherapy may be a systemic treatment for advanced unresectable, recurrent, persistent or metastatic disease or treatment in the adjuvant or neo-adjuvant setting with disease progression or recurrence within 6 months of completion of platinum-containing chemotherapy
Participants who previously only received platinum as a radiosensitizer are not eligible
Participants must be naïve to checkpoint inhibitors
Participants who had measurable disease
Participants who provide a tumor tissue sample, either from archival tissue or newly obtained core or excisional biopsy. If the participant received local therapy (For example: radiation therapy or chemoradiotherapy) after the archival tissue was taken, a new biopsy was required
Participants who had Eastern Cooperative Oncology Group (ECOG) PS of 0 to 1
Life expectancy greater than or equals to (\>=) 12 weeks as judged by the Investigator
Adequate hematological, hepatic and renal function as defined in the protocol
Participants with known Human Immunodeficiency Virus (HIV) infections were in general eligible if the following criteria are met:
Clinically indicated participants must be stable on antiretroviral therapy (ART) for at least 4 weeks and agree to adhere to ART
had no evidence of documented multi-drug resistance that would prevent effective ART
had an HIV viral load of \< 400 copies per milliliter (/mL) at Screening
had CD4+ T-cell (CD4+) counts \>= 350 cells/microliter
For participants with a history of an Acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within the last 12 months, participants may be eligible only after consultation and agreement with the study Medical Monitor
If prophylactic antimicrobial drugs were indicated, participants would still be considered eligible upon agreement with the study Medical Monitor
Participants with hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infections were in general eligible if the following criteria are met:
HBV viral load below the limit of quantification. If medically indicated, participants infected with HBV must be treated and on a stable dose of antivirals at study entry and with planned monitoring and management according to appropriate labeling guidance
Participants with a history of HCV infection should have completed curative antiviral treatment and require HCV viral load below the limit of quantification
Participants on concurrent HCV treatment should have HCV below the limit of quantification

Criterios de exclusión

Participants with active central nervous system (CNS) metastases causing clinical symptoms or require therapeutic intervention are excluded. Participants with a history of treated CNS metastases (by surgery or radiation therapy) are not eligible unless they have fully recovered from treatment, demonstrated no progression for at least 4 weeks, and are not using steroids for at least 7 days prior to the start of study treatment
Participants with interstitial lung disease or has had a history of pneumonitis that has required oral or intravenous (IV) steroids
Participants with significant acute or chronic infections
Participants with active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
Participants with clinically significant cardiovascular/cerebrovascular disease including: cerebral vascular accident/stroke, myocardial infarction, unstable angina, congestive heart failure, or serious cardiac arrhythmia

Intervenciones

drug

Bintrafusp alfa

Participants received an intravenous infusion of 1200 milligrams (mg) bintrafusp alfa once every 2 weeks until confirmed disease progression, death, unacceptable toxicity and study withdrawal.

Ubicaciones

Centro Oncologico Riojano Integral (CORI)

La Rioja, Argentina

Sanatorio El Parque

Salta, Argentina

Centro Medico San Roque S.R.L.

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalEMD Serono Research & Development Institute, Inc.

ColaboradorMerck KGaA, Darmstadt, Germany

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