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Bintrafusp Alfa Combination Therapy in Participants With Cervical Cancer (INTR@PID 046)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04551950
Recruitment Status : Active, not recruiting
First Posted : September 16, 2020
Last Update Posted : July 6, 2022
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 September 7, 2020
First Posted Date  ICMJE September 16, 2020
Last Update Posted Date July 6, 2022
Actual Study Start Date  ICMJE October 19, 2020
Actual Primary Completion Date June 15, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2020)
  • Incidence of Dose-Limiting Toxicity (DLT) [ Time Frame: Week 1 Day 1 up to Week 4 ]
  • Number of Participants With Adverse Events (AEs) [ 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: September 10, 2020)
  • Concentration of Bintrafusp alfa Immediately at the End of Infusion (Ceoi) [ Time Frame: Before the first infusion up to 28 days after the last treatment, assessed up to 2 years ]
  • Concentration of Bintrafusp alfa Immediately Before Next Dosing (Ctrough) [ Time Frame: Before the first infusion up to 28 days after the last treatment, assessed up to 2 years ]
  • Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Bintrafusp alfa [ Time Frame: Before the first infusion up to 28 days after the last treatment, assessed up to 2 years ]
  • Area Under the Serum Concentration-Time Curve From Time Zero to Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of Bintrafusp alfa [ Time Frame: Before the first infusion up to 28 days after the last treatment, assessed up to 2 years ]
  • Maximum Serum Concentration Observed (Cmax) of Bintrafusp alfa [ Time Frame: Before the first infusion up to 28 days after the last treatment, assessed up to 2 years ]
  • Time at which Cmax Occurs (tmax) of Bintrafusp alfa [ Time Frame: Before the first infusion up to 28 days after the last treatment, assessed up to 2 years ]
  • Elimination Half-life (t½) of Bintrafusp alfa [ Time Frame: Before the first infusion up to 28 days after the last treatment, assessed up to 2 years ]
  • Immunogenicity of Bintrafusp alfa, as Assessed by Anti-drug Anti-body (ADA) Assay [ Time Frame: Prior to the first infusion up to 28 days after the last treatment,assessed up to 2 years ]
  • Incidence of Dose-Limiting Toxicity (DLT) in Japanese Participants [ Time Frame: Week 1 Day 1 up to Week 4 ]
  • Number of Japanese Participants With Adverse Events (AE) [ Time Frame: Time from first treatment to planned final assessment at approximately 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bintrafusp Alfa Combination Therapy in Participants With Cervical Cancer (INTR@PID 046)
Official Title  ICMJE Safety Study of Bintrafusp Alfa in Combination With Other Anti-cancer Therapies in Participants With Locally Advanced or Advanced Cervical Cancer (INTR@PID 046)
Brief Summary This study is to evaluate the safety and tolerability of bintrafusp alfa in combination with other anti-cancer therapies in participants with locally advanced or advanced cervical cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cervical Cancer
Intervention  ICMJE
  • Drug: M7824
    Participants will receive bintrafusp alfa until confirmed disease progression, death, unacceptable toxicity and study withdrawal maximum of 2 years (at the discretion of the Investigator).
    Other Name: Bintrafusp alfa
  • Drug: Carboplatin
    Carboplatin will be administered intravenously as per standard of care.
  • Drug: Paclitaxel
    Paclitaxel will be administered intravenously as per standard of care.
  • Drug: Bevacizumab
    Bevacizumab will be administrated as indicated for standard of care.
  • Drug: Cisplatin
    Cisplatin will be administered intravenously as per standard of care.
  • Radiation: Radiotherapy
    Participants will receive radiotherapy as per standard of care.
Study Arms  ICMJE
  • Experimental: Cohort 1A:M7824+cisplatin/carboplatin+paclitaxel+bevacizumab
    Interventions:
    • Drug: M7824
    • Drug: Carboplatin
    • Drug: Paclitaxel
    • Drug: Bevacizumab
    • Drug: Cisplatin
  • Experimental: Cohort1B:M7824+cisplatin or carboplatin+paclitaxel
    Interventions:
    • Drug: M7824
    • Drug: Carboplatin
    • Drug: Paclitaxel
    • Drug: Cisplatin
  • Experimental: Cohort 2: M7824+cisplatin+ radiotherapy
    Interventions:
    • Drug: M7824
    • Drug: Cisplatin
    • Radiation: Radiotherapy
Publications * Not Provided

*   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: April 26, 2021)
25
Original Estimated Enrollment  ICMJE
 (submitted: September 10, 2020)
24
Estimated Study Completion Date  ICMJE May 24, 2024
Actual Primary Completion Date June 15, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Inclusion Criteria for participants enrolling into Cohort 1:
  • Study participants have documented persistent, recurrent, or metastatic squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix
  • Study participants have not been treated with systemic chemotherapy and are not amenable to curative treatment
  • Prior radiation with or without radio-sensitizing chemotherapy is allowed
  • Inclusion Criteria for participants enrolling into Cohort 2:
  • Participants have documented evidence of cervical adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma International Federation of Gynecology and Obstetrics (FIGO) 2018 Stages 1B2 to 4A
  • Participants have not received prior chemotherapy or radiotherapy for cervical cancer
  • Inclusion Criteria for all participants:
  • Archival tumor tissue sample or newly obtained core or excisional biopsy is required
  • Participants who have Eastern Cooperative Oncology Group (ECOG) Performance status (PS) of 0 to 1
  • Participants have a life expectancy greater than or equal to 12 weeks
  • Participants have adequate hematological, hepatic, renal and coagulation function as defined in the protocol
  • Participants with known Human immunodeficiency virus (HIV) infections are eligible if the criteria described in the protocol are met
  • Participants with Hepatitis B virus (HBV) and/or Hepatitis C virus (HCV) infections are eligible if the criteria described in the protocol are met
  • Other protocol defined inclusion criteria could apply

Exclusion Criteria:

  • Exclusion Criteria for All Participants:
  • Participants with active central nervous system (CNS) metastases causing clinical symptoms or metastases that 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 intervention
  • Participants that received any organ transplantation, including allogeneic stem-cell transplantation, but with the exception of transplants that do not require immuno-suppression
  • Participants with significant acute or chronic infections
  • Participants with active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent
  • Participants with clinically significant cardiovascular/cerebrovascular disease including: cerebral vascular accident/stroke, myocardial infarction, unstable angina, congestive heart failure, or serious cardiac arrhythmia
  • Participants with history of bleeding diathesis or recent major bleeding events
  • Participant that has received prior cancer treatment with any other immunotherapy or checkpoint inhibitors or any other immune-modulating monoclonal antibody (mAb)
  • Exclusion Criteria for Participants in Cohort 1A related to use of bevacizumab:
  • Participants with inadequately controlled hypertension
  • Prior history of hypertensive crisis or hypertensive encephalopathy
  • Participants with significant vascular disease within 6 months prior to Screening
  • Participants with history of hemoptysis within 1 month prior to Screening
  • Current use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes
  • Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to the first dose of bevacizumab
  • Participants with a history of abdominal or trache-oesophageal fistula or gastrointestinal (GI) perforation within 6 months prior to Screening
  • Participants with clinical signs of GI obstruction or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding
  • Participants with evidence of abdominal free air not explained by paracentesis or recent surgical procedure
  • Participants with serious, non-healing wound, active ulcer, or untreated bone fracture
  • Participants with proteinuria
  • 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 Japan,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04551950
Other Study ID Numbers  ICMJE MS200647_0046
2020-001561-36 ( EudraCT Number )
Has Data Monitoring Committee Yes
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: No
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
Current Responsible Party EMD Serono ( EMD Serono Research & Development Institute, Inc. )
Original Responsible Party Same as current
Current Study Sponsor  ICMJE EMD Serono Research & Development Institute, Inc.
Original Study Sponsor  ICMJE Same as current
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 June 2022

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