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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04246489
Registration number
NCT04246489
Ethics application status
Date submitted
28/01/2020
Date registered
29/01/2020
Date last updated
23/10/2023
Titles & IDs
Public title
Bintrafusp Alfa Monotherapy in Platinum-Experienced Cervical Cancer
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Scientific 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
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Secondary ID [1]
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2019-003583-40
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Secondary ID [2]
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MS200647_0017
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Uterine Cervical Neoplasms
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Condition category
Condition code
Cancer
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Womb (Uterine or endometrial cancer)
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Cancer
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0
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Cervical (cervix)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Bintrafusp alfa
Experimental: Bintrafusp alfa -
Treatment: Drugs: Bintrafusp alfa
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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC)
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Assessment method [1]
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Confirmed objective response was defined as the number of participants with a confirmed objective response of complete response (CR) or partial response (PR). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Confirmed CR = at least 2 determinations of CR at least 4 weeks apart and before progression. Confirmed PR = at least 2 determinations of PR at least 4 weeks apart and before progression (and not qualifying for a CR). Confirmed objective response was determined according to RECIST v1.1 and as adjudicated by IRC.
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Timepoint [1]
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Time from first treatment up to 688 days
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Secondary outcome [1]
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Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC)
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Assessment method [1]
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DOR was defined for participants with confirmed response, as the time from first documentation of confirmed objective response (Complete Response [CR] or Partial Response [PR]) according to RECIST 1.1 to the date of first documentation of progression disease (PD) or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. DOR was determined according to RECIST v1.1 and assessed by IRC. Results were calculated based on Kaplan-Meier estimates.
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Timepoint [1]
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Time from first treatment up to 688 days
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Secondary outcome [2]
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Durable Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC)
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Assessment method [2]
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Durable Response was defined as the number of participants with confirmed objective response (CR or PR) according to RECIST 1.1, determined by IRC with duration of at least 6 months. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
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Timepoint [2]
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Time from first treatment up to 688 days
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Secondary outcome [3]
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs, Including Adverse Event of Special Interests (AESIs)
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Assessment method [3]
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Adverse Event (AE) was defined any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs: TEAEs was defined as events with onset date or worsening during the on-treatment period. TEAEs included serious AEs and non-serious AEs. Treatment-related TEAEs: reasonably related to the study intervention. AESIs included Infusion-related reactions, Immune-related AEs, Transforming growth factor- beta (TGF-ß) inhibition mediated skin AE, bleeding and anemia.
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Timepoint [3]
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Time from first treatment up to 688 days
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Secondary outcome [4]
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Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Independent Review Committee (IRC)
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Assessment method [4]
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PFS was defined as the time from first administration of study intervention until date of the first documentation of disease progression (PD) or death due to any cause, whichever occurred first. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. Kaplan-Meier estimates was used to calculate PFS.
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Timepoint [4]
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Time from first administration of study drug until the first documentation of PD or death, assessed up to 688 days
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Secondary outcome [5]
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Number of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by the Investigator
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Assessment method [5]
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Confirmed objective response was defined as the number of participants with a confirmed objective response of complete response (CR) or partial response (PR). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Confirmed CR = at least 2 determinations of CR at least 4 weeks apart and before progression. Confirmed PR = at least 2 determinations of PR at least 4 weeks apart and before progression (and not qualifying for a CR). Confirmed objective response was determined according to RECIST v1.1 and as adjudicated by Investigator.
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Timepoint [5]
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Time from first treatment up to 688 days
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Secondary outcome [6]
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Overall Survival (OS)
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Assessment method [6]
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OS was defined as the time from first administration of study intervention to the date of death due to any cause. The OS was analyzed by using the Kaplan-Meier method.
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Timepoint [6]
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Time from first administration of study drug up to data cutoff (assessed up to 688 days)
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Secondary outcome [7]
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Serum Pre-Dose Concentrations (Ctrough) of Bintrafusp Alfa
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Assessment method [7]
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Ctrough was defined as the concentration observed immediately before next dosing (corresponding to pre-dose or trough concentration for multiple dosing).
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Timepoint [7]
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At Day 15, Day 29, Day 43, Day 85, Day 127, Day 169, Day 253, Day 337, Day 421, Day 505 and Day 589
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Secondary outcome [8]
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Serum Concentration at End of Infusion (CEOI) of Bintrafusp Alfa
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Assessment method [8]
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Serum Concentration at End of Infusion (CEOI) of bintrafusp alfa is reported.
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Timepoint [8]
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At Day 1 and Day 29
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Secondary outcome [9]
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Number of Participants With Positive Antidrug Antibodies (ADA)
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Assessment method [9]
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Serum samples were analyzed by a validated assay method to detect the presence of antidrug antibodies (ADA). Number of participants with positive ADA were reported.
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Timepoint [9]
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Time from first treatment up to 688 days
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Secondary outcome [10]
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Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) According to Programmed Death Ligand 1 (PD-L1) Expression
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Assessment method [10]
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Confirmed objective response was defined as the percentage of participants with a confirmed objective response of complete response (CR) or partial response (PR). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Confirmed CR = at least 2 determinations of CR at least 4 weeks apart and before progression. Confirmed PR = at least 2 determinations of PR at least 4 weeks apart and before progression (and not qualifying for a CR). Confirmed objective response was determined according to RECIST v1.1 and as adjudicated by IRC through PD-L1 Subgroup. Participants with PD-L1 positive tumors (Combined positive score (CPS) >=1) and PD-L1 negative tumors (CPS<1).
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Timepoint [10]
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Time from first treatment up to 688 days
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Secondary outcome [11]
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PFS According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) According to Programmed Death Ligand 1 (PD-L1) Expression
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Assessment method [11]
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PFS was defined as the time from first administration of study intervention until the first documentation of disease progression (PD) or death due to any cause, whichever occurred first. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. PFS was determined according to RECIST v1.1 and as adjudicated by IRC through PD-L1 Subgroup. Participants with PD-L1 positive tumors (Combined positive score (CPS) >=1) and PD-L1 negative tumors (CPS<1).
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Timepoint [11]
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Time from first administration of study drug until the first documentation of PD or death, assessed up to 688 days
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Secondary outcome [12]
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Overall Survival (OS) as Assessed According to Programmed Death Ligand 1 (PD-L1) Expression
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Assessment method [12]
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OS was defined as the time from first administration of study intervention to the date of death due to any cause. The OS was analyzed by using the Kaplan-Meier method. Participants with PD-L1 positive tumors (Combined positive score (CPS) >=1) and PD-L1 negative tumors (CPS<1).
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Timepoint [12]
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Time from first administration of study drug up to 688 days
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/03/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
14/12/2022
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Sample size
Target
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Accrual to date
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Final
146
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Peter MacCallum Cancer Centre-East Melbourne - Melbourne
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Recruitment hospital [2]
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Linear Clinical Research Limited - Nedlands
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Recruitment hospital [3]
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Calvary Mater Newcastle - Waratah
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Recruitment postcode(s) [1]
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- Melbourne
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Recruitment postcode(s) [2]
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- Nedlands
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Recruitment postcode(s) [3]
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- Waratah
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Recruitment outside Australia
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Arkansas
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California
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Salta
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San Miguel de Tucuman
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Belgium
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Bruxelles
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Gent
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Porto Alegre
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Guangzhou
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Hangzhou
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Hefei
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China
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Wuhan
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China
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Zhengzhou
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France
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Plérin
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Korea, Republic of
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Seoul
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Suwon
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Russian Federation
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Omsk
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Russian Federation
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Pyatigorsk
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Barcelona
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Girona
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Málaga
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Spain
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Valencia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
EMD Serono Research & Development Institute, Inc.
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Merck KGaA, Darmstadt, Germany
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04246489
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Trial related presentations / publications
Strauss J, Heery CR, Schlom J, Madan RA, Cao L, Kang Z, Lamping E, Marte JL, Donahue RN, Grenga I, Cordes L, Christensen O, Mahnke L, Helwig C, Gulley JL. Phase I Trial of M7824 (MSB0011359C), a Bifunctional Fusion Protein Targeting PD-L1 and TGFbeta, in Advanced Solid Tumors. Clin Cancer Res. 2018 Mar 15;24(6):1287-1295. doi: 10.1158/1078-0432.CCR-17-2653. Epub 2018 Jan 3.
Lan Y, Zhang D, Xu C, Hance KW, Marelli B, Qi J, Yu H, Qin G, Sircar A, Hernandez VM, Jenkins MH, Fontana RE, Deshpande A, Locke G, Sabzevari H, Radvanyi L, Lo KM. Enhanced preclinical antitumor activity of M7824, a bifunctional fusion protein simultaneously targeting PD-L1 and TGF-beta. Sci Transl Med. 2018 Jan 17;10(424):eaan5488. doi: 10.1126/scitranslmed.aan5488.
Vugmeyster Y, Grisic AM, Wilkins JJ, Loos AH, Hallwachs R, Osada M, Venkatakrishnan K, Khandelwal A. Model-informed approach for risk management of bleeding toxicities for bintrafusp alfa, a bifunctional fusion protein targeting TGF-beta and PD-L1. Cancer Chemother Pharmacol. 2022 Oct;90(4):369-379. doi: 10.1007/s00280-022-04468-6. Epub 2022 Sep 6.
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Public notes
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Contacts
Principal investigator
Name
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Medical Responsible
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Address
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Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04246489
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