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Trial record 1 of 1 for:    bintrafusp cervical
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Bintrafusp Alfa Monotherapy in Platinum-Experienced Cervical Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04246489
Recruitment Status : Not yet recruiting
First Posted : January 29, 2020
Last Update Posted : January 29, 2020
Sponsor:
Collaborator:
Merck KGaA, Darmstadt, Germany
Information provided by (Responsible Party):
EMD Serono ( EMD Serono Research & Development Institute, Inc. )

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.

Condition or disease Intervention/treatment Phase
Uterine Cervical Neoplasms Drug: Bintrafusp alfa Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 135 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : March 2, 2020
Estimated Primary Completion Date : May 16, 2022
Estimated Study Completion Date : March 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
Experimental: Bintrafusp alfa 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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]
  9. Overall Survival (OS) [ Time Frame: Time from first treatment to planned final assessment at approximately 2 years ]
  10. Concentration of M7824 at the end of Infusion (Ceoi) [ Time Frame: Time from first treatment to planned final assessment at approximately 2 years ]
  11. 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 ]
  12. Immunogenicity as measured by Anti-drug Antibodies Concentration [ Time Frame: Time from first treatment to planned final assessment at approximately 2 years ]
  13. 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 ]
  14. 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 ]
  15. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04246489


Contacts
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Contact: US Medical Information 888-275-7376 service@emdgroup.com
Contact: Communication Center +49 6151 72 5200 service@emdgroup.com

Locations
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Sponsors and Collaborators
EMD Serono Research & Development Institute, Inc.
Merck KGaA, Darmstadt, Germany
Investigators
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Study Director: Medical Responsible Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Additional Information:
Publications:
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Responsible Party: EMD Serono Research & Development Institute, Inc.
ClinicalTrials.gov Identifier: NCT04246489    
Other Study ID Numbers: MS200647_0017
2019-003583-40 ( EudraCT Number )
First Posted: January 29, 2020    Key Record Dates
Last Update Posted: January 29, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by EMD Serono ( EMD Serono Research & Development Institute, Inc. ):
M7824
INTR@PID
Bintrafusp alfa
programmed death-ligand 1
Cervical Cancer
Transforming growth factor-β (TGF-β)
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female