Bintrafusp Alfa Monotherapy in Platinum-Experienced Cervical Cancer

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 2

Conditions: Uterine Cervical Neoplasms

Treatments: Drug: Bintrafusp alfa

Study type: Interventional

Funder types: Industry

Identifiers

NCT04246489

MS200647_0017

2019-003583-40 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 146 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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:

  1. 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
  2. Participants who previously only received platinum as a radiosensitizer are not eligible
  3. 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:

  1. Clinically indicated participants must be stable on antiretroviral therapy (ART) for at least 4 weeks and agree to adhere to ART
  2. had no evidence of documented multi-drug resistance that would prevent effective ART
  3. had an HIV viral load of < 400 copies per milliliter (/mL) at Screening
  4. had CD4+ T-cell (CD4+) counts >= 350 cells/microliter
  5. 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
  6. 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:

  1. 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
  2. Participants with a history of HCV infection should have completed curative antiviral treatment and require HCV viral load below the limit of quantification
  3. Participants on concurrent HCV treatment should have HCV below the limit of quantification

• Other protocol defined inclusion criteria could apply

Exclusion criteria

• 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
• Other protocol defined exclusion criteria could apply

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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146 participants in 1 patient group

Bintrafusp alfa

Experimental group

Treatment:

Drug: Bintrafusp alfa