Clinical Trials /

Bintrafusp Alfa Monotherapy in Platinum-Experienced Cervical Cancer

NCT04246489

Description:

The main purpose of this study is 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.

Related Conditions:
  • Cervical Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Bintrafusp Alfa Monotherapy in Platinum-Experienced Cervical Cancer
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: MS200647_0017
  • SECONDARY ID: 2019-003583-40
  • NCT ID: NCT04246489

Conditions

  • Uterine Cervical Neoplasms

Interventions

DrugSynonymsArms
Bintrafusp alfaM7824Bintrafusp alfa

Purpose

The main purpose of this study is 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.

Trial Arms

NameTypeDescriptionInterventions
Bintrafusp alfaExperimental
  • Bintrafusp alfa

Eligibility Criteria

        Inclusion Criteria:

          -  Participants have 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
                  metastatic disease or in the adjuvant or neo-adjuvant setting.

               2. Participants who were intolerant to or ineligible for platinum-based chemotherapy
                  are also eligible.

               3. Participants must be naïve to checkpoint inhibitors

          -  Participants must have measurable disease.

          -  Participants must 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 will be required.

          -  Participants who have 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 are 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. have no evidence of documented multi-drug resistance that would prevent effective
                  ART.

               3. Have an HIV viral load of < 400 copies per milliliter (/mL) at Screening.

               4. Have 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 are indicated, participants may still be
                  considered eligible upon agreement with the study Medical Monitor

          -  Participants with hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infections
             are in general eligible if the following criteria are met:

               1. HBV viral load below the limit of quantification and be on a stable dose of
                  antiviral therapy.

               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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Confirmed Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) as Evaluated by Independent Review Committee
Time Frame:Time from first treatment to planned final assessment at approximately 2 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Independent Review Committee (IRC)
Time Frame:Time from first treatment to planned final assessment at approximately 2 years
Safety Issue:
Description:
Measure:Durable Response of at Least 6 Months According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Independent Review Committee (IRC)
Time Frame:Time from first treatment to planned final assessment at approximately 2 years
Safety Issue:
Description:
Measure:Occurrence of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related AEs, Including Adverse Events of Special Interest (AESIs)
Time Frame:Time from first treatment to planned final assessment at approximately 2 years
Safety Issue:
Description:
Measure:Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Independent Review Committee (IRC)
Time Frame:Time from first treatment to planned final assessment at approximately 2 years
Safety Issue:
Description:
Measure:Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator
Time Frame:Time from first treatment to planned final assessment at approximately 2 years
Safety Issue:
Description:
Measure:Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator
Time Frame:Time from first treatment to planned final assessment at approximately 2 years
Safety Issue:
Description:
Measure:Durable Response According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator
Time Frame:Time from first treatment to planned final assessment at approximately 2 years
Safety Issue:
Description:
Measure:Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator
Time Frame:Time from first treatment to planned final assessment at approximately 2 years
Safety Issue:
Description:
Measure:Overall Survival (OS)
Time Frame:Time from first treatment to planned final assessment at approximately 2 years
Safety Issue:
Description:
Measure:Concentration of M7824 at the end of Infusion (Ceoi)
Time Frame:Time from first treatment to planned final assessment at approximately 2 years
Safety Issue:
Description:
Measure:Concentration of M7824 at the end of the Dosing Interval (C trough)
Time Frame:Time from first treatment to planned final assessment at approximately 2 years
Safety Issue:
Description:
Measure:Immunogenicity as measured by Anti-drug Antibodies Concentration
Time Frame:Time from first treatment to planned final assessment at approximately 2 years
Safety Issue:
Description:
Measure:Confirmed Objective Response According to RECIST Version 1.1 Assessed by Independent Review Committee (IRC) According to Programmed Death Ligand 1 (PD-L1) Expression
Time Frame:Time from first treatment to planned final assessment at approximately 2 years
Safety Issue:
Description:
Measure:Duration of Response (DOR) According to (RECIST Version 1.1) Assessed by an Independent Review Committee (IRC) According to Programmed Death Ligand 1 (PD-L1) Expression
Time Frame:Time from first treatment to planned final assessment at approximately 2 years
Safety Issue:
Description:
Measure:Durable Response According to RECIST Version 1.1 Assessed by an Independent Review Committee (IRC) According to Programmed Death Ligand 1 (PD-L1) Expression
Time Frame:Time from first treatment to planned final assessment at approximately 2 years
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:EMD Serono Research & Development Institute, Inc.

Trial Keywords

  • M7824
  • INTR@PID
  • Bintrafusp alfa
  • programmed death-ligand 1
  • Cervical Cancer
  • Transforming growth factor-β (TGF-β)

Last Updated

January 28, 2020