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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04246489




Registration number
NCT04246489
Ethics application status
Date submitted
28/01/2020
Date registered
29/01/2020

Titles & IDs
Public title
Bintrafusp Alfa Monotherapy in Platinum-Experienced Cervical Cancer
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
Secondary ID [1] 0 0
2019-003583-40
Secondary ID [2] 0 0
MS200647_0017
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Uterine Cervical Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Cervical (cervix)

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
Time from first treatment up to 688 days
Secondary outcome [1] 0 0
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)
Timepoint [1] 0 0
Time from first treatment up to 688 days
Secondary outcome [2] 0 0
Durable Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC)
Timepoint [2] 0 0
Time from first treatment up to 688 days
Secondary outcome [3] 0 0
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs, Including Adverse Event of Special Interests (AESIs)
Timepoint [3] 0 0
Time from first treatment up to 688 days
Secondary outcome [4] 0 0
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Independent Review Committee (IRC)
Timepoint [4] 0 0
Time from first administration of study drug until the first documentation of PD or death, assessed up to 688 days
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
Time from first treatment up to 688 days
Secondary outcome [6] 0 0
Overall Survival (OS)
Timepoint [6] 0 0
Time from first administration of study drug up to data cutoff (assessed up to 688 days)
Secondary outcome [7] 0 0
Serum Pre-Dose Concentrations (Ctrough) of Bintrafusp Alfa
Timepoint [7] 0 0
At Day 15, Day 29, Day 43, Day 85, Day 127, Day 169, Day 253, Day 337, Day 421, Day 505 and Day 589
Secondary outcome [8] 0 0
Serum Concentration at End of Infusion (CEOI) of Bintrafusp Alfa
Timepoint [8] 0 0
At Day 1 and Day 29
Secondary outcome [9] 0 0
Number of Participants With Positive Antidrug Antibodies (ADA)
Timepoint [9] 0 0
Time from first treatment up to 688 days
Secondary outcome [10] 0 0
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
Timepoint [10] 0 0
Time from first treatment up to 688 days
Secondary outcome [11] 0 0
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
Timepoint [11] 0 0
Time from first administration of study drug until the first documentation of PD or death, assessed up to 688 days
Secondary outcome [12] 0 0
Overall Survival (OS) as Assessed According to Programmed Death Ligand 1 (PD-L1) Expression
Timepoint [12] 0 0
Time from first administration of study drug up to 688 days

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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/03/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/12/2022
Sample size
Target
Accrual to date
Final
146
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre-East Melbourne - Melbourne
Recruitment hospital [2] 0 0
Linear Clinical Research Limited - Nedlands
Recruitment hospital [3] 0 0
Calvary Mater Newcastle - Waratah
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment postcode(s) [2] 0 0
- Nedlands
Recruitment postcode(s) [3] 0 0
- Waratah
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
Nevada
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Oregon
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
Argentina
State/province [10] 0 0
La Rioja
Country [11] 0 0
Argentina
State/province [11] 0 0
Salta
Country [12] 0 0
Argentina
State/province [12] 0 0
San Miguel de Tucuman
Country [13] 0 0
Belgium
State/province [13] 0 0
Bruxelles
Country [14] 0 0
Belgium
State/province [14] 0 0
Gent
Country [15] 0 0
Belgium
State/province [15] 0 0
Kortrijk
Country [16] 0 0
Belgium
State/province [16] 0 0
Liège
Country [17] 0 0
Belgium
State/province [17] 0 0
Pellenberg
Country [18] 0 0
Belgium
State/province [18] 0 0
Wilrijk
Country [19] 0 0
Brazil
State/province [19] 0 0
Porto Alegre
Country [20] 0 0
Brazil
State/province [20] 0 0
São Paulo
Country [21] 0 0
China
State/province [21] 0 0
Chongqing
Country [22] 0 0
China
State/province [22] 0 0
Guangzhou
Country [23] 0 0
China
State/province [23] 0 0
Hangzhou
Country [24] 0 0
China
State/province [24] 0 0
Hefei
Country [25] 0 0
China
State/province [25] 0 0
Shanghai
Country [26] 0 0
China
State/province [26] 0 0
Wuhan
Country [27] 0 0
China
State/province [27] 0 0
Zhengzhou
Country [28] 0 0
France
State/province [28] 0 0
Bordeaux cedex
Country [29] 0 0
France
State/province [29] 0 0
Lille cedex
Country [30] 0 0
France
State/province [30] 0 0
Lyon
Country [31] 0 0
France
State/province [31] 0 0
Nice
Country [32] 0 0
France
State/province [32] 0 0
Paris
Country [33] 0 0
France
State/province [33] 0 0
Pierre Benite cedex
Country [34] 0 0
France
State/province [34] 0 0
Plérin
Country [35] 0 0
France
State/province [35] 0 0
Reims cedex
Country [36] 0 0
France
State/province [36] 0 0
Saint Herblain
Country [37] 0 0
France
State/province [37] 0 0
Strasbourg
Country [38] 0 0
Hungary
State/province [38] 0 0
Budapest
Country [39] 0 0
Hungary
State/province [39] 0 0
Nyiregyhaza
Country [40] 0 0
Japan
State/province [40] 0 0
Chuo-ku
Country [41] 0 0
Japan
State/province [41] 0 0
Fukuoka-shi
Country [42] 0 0
Japan
State/province [42] 0 0
Hidaka-shi
Country [43] 0 0
Japan
State/province [43] 0 0
Koto-ku
Country [44] 0 0
Japan
State/province [44] 0 0
Kurume-shi
Country [45] 0 0
Japan
State/province [45] 0 0
Minato-ku
Country [46] 0 0
Japan
State/province [46] 0 0
Nakagami-gun
Country [47] 0 0
Japan
State/province [47] 0 0
Osaka-shi
Country [48] 0 0
Japan
State/province [48] 0 0
Sapporo-shi
Country [49] 0 0
Japan
State/province [49] 0 0
Yokohama-shi
Country [50] 0 0
Korea, Republic of
State/province [50] 0 0
Goyang-si
Country [51] 0 0
Korea, Republic of
State/province [51] 0 0
Seoul
Country [52] 0 0
Korea, Republic of
State/province [52] 0 0
Suwon
Country [53] 0 0
Russian Federation
State/province [53] 0 0
Omsk
Country [54] 0 0
Russian Federation
State/province [54] 0 0
Pyatigorsk
Country [55] 0 0
Spain
State/province [55] 0 0
Barcelona
Country [56] 0 0
Spain
State/province [56] 0 0
Girona
Country [57] 0 0
Spain
State/province [57] 0 0
Madrid
Country [58] 0 0
Spain
State/province [58] 0 0
Málaga
Country [59] 0 0
Spain
State/province [59] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
EMD Serono Research & Development Institute, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Merck KGaA, Darmstadt, Germany
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Responsible
Address 0 0
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR), Analytic code
When will data be available (start and end dates)?
Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
Available to whom?
Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://bit.ly/IPD21


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04246489