Bintrafusp Alfa Monotherapy in Platinum-Experienced Cervical Cancer
Condition: Uterine Cervical Neoplasms
MeSH terms: Uterine Cervical Neoplasms
Intervention: Bintrafusp alfa
Intervention description: 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 146.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: M7824; INTR@PID; Bintrafusp alfa; programmed death-ligand 1; Cervical Cancer; Transforming growth factor-β (TGF-β)

Summary:

      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.
    

Eligibility criteria:

        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