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Bintrafusp Alfa Monotherapy in Platinum-Experienced Cervical Cancer

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ClinicalTrials.gov Identifier: NCT04246489
Recruitment Status : Active, not recruiting
First Posted : January 29, 2020
Last Update Posted : February 16, 2021
Sponsor:
Collaborator:
Merck KGaA, Darmstadt, Germany
Information provided by (Responsible Party):
EMD Serono ( EMD Serono Research & Development Institute, Inc. )

Tracking Information
First Submitted Date  ICMJE January 28, 2020
First Posted Date  ICMJE January 29, 2020
Last Update Posted Date February 16, 2021
Actual Study Start Date  ICMJE March 30, 2020
Estimated Primary Completion Date December 3, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2020)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2020)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Overall Survival (OS) [ Time Frame: Time from first treatment to planned final assessment at approximately 2 years ]
  • Concentration of bintrafusp alfa at the end of Infusion (Ceoi) [ Time Frame: Time from first treatment to planned final assessment at approximately 2 years ]
  • Concentration of bintrfusp alfa at the end of the Dosing Interval (C trough) [ Time Frame: Time from first treatment to planned final assessment at approximately 2 years ]
  • Immunogenicity as measured by Anti-drug Antibodies Concentration [ Time Frame: Time from first treatment to planned final assessment at approximately 2 years ]
  • 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 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2020)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Overall Survival (OS) [ Time Frame: Time from first treatment to planned final assessment at approximately 2 years ]
  • Concentration of M7824 at the end of Infusion (Ceoi) [ Time Frame: Time from first treatment to planned final assessment at approximately 2 years ]
  • 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 ]
  • Immunogenicity as measured by Anti-drug Antibodies Concentration [ Time Frame: Time from first treatment to planned final assessment at approximately 2 years ]
  • 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 ]
  • 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 ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bintrafusp Alfa Monotherapy in Platinum-Experienced Cervical Cancer
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Uterine Cervical Neoplasms
Intervention  ICMJE Drug: Bintrafusp alfa
Participants will receive an intravenous infusion of 1200 milligrams (mg) bintrafusp alfa once every 2 weeks until confirmed disease progression, death, unacceptable toxicity and study withdrawal.
Other Name: M7824
Study Arms  ICMJE Experimental: Bintrafusp alfa
Intervention: Drug: Bintrafusp alfa
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 15, 2021)
146
Original Estimated Enrollment  ICMJE
 (submitted: January 28, 2020)
135
Estimated Study Completion Date  ICMJE December 20, 2022
Estimated Primary Completion Date December 3, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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 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. 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Brazil,   China,   France,   Hungary,   Japan,   Korea, Republic of,   Russian Federation,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04246489
Other Study ID Numbers  ICMJE MS200647_0017
2019-003583-40 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, EMD Serono will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.emdgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html
Responsible Party EMD Serono ( EMD Serono Research & Development Institute, Inc. )
Study Sponsor  ICMJE EMD Serono Research & Development Institute, Inc.
Collaborators  ICMJE Merck KGaA, Darmstadt, Germany
Investigators  ICMJE
Study Director: Medical Responsible Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
PRS Account EMD Serono
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP