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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/NCT05061823




Registration number
NCT05061823
Ethics application status
Date submitted
20/09/2021
Date registered
30/09/2021
Date last updated
7/11/2023

Titles & IDs
Public title
Bintrafusp Alfa Program Rollover Study
Scientific title
An Open-label, Multicenter Follow-up Study to Collect Long-term Data on Participants From Multiple Bintrafusp Alfa (M7824) Clinical Studies
Secondary ID [1] 0 0
2021-000179-36
Secondary ID [2] 0 0
MS200647_0054
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer 0 0
Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Bintrafusp alfa

Experimental: Bintrafusp alfa -


Treatment: Drugs: Bintrafusp alfa
Participants who are continuing treatment with bintrafusp alfa and were previously assigned to a bintrafusp alfa dose based on body weight which is (i.e.) milligrams per kilogram (mg/kg) per dose in a parent protocol, will receive an intravenous infusion of bintrafusp alfa at the dose specified based upon the participant's parent protocol once every 2 week or, 2400 mg once every 3 weeks. Participants who are entering the rollover study after discontinuation of treatment in a parent study will receive bintrafusp alfa at a dose of either 1200 or 2400 mg once every 2 weeks or 2400 mg once every 3 weeks until confirmed disease progression, death, unacceptable toxicity or study withdrawal.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Occurrence of Adverse Events and Treatment-Related Adverse Events
Timepoint [1] 0 0
Time from first treatment in parent study to planned final assessment at approximately up to 5 years
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Time from first treatment in parent study to planned final assessment at approximately up to 5 years

Eligibility
Key inclusion criteria
- Participants who are currently enrolled in an eligible bintrafusp alfa parent study
where the primary/main analysis has been completed or after discontinuation of study
before primary/main analysis has been completed or after discontinuation of study
before primary/main analysis has been completed

- Participants who are currently on active bintrafusp alfa treatment alone as a
monotherapy or following discontinuation of other combination treatment agents in the
parent study and without treatment interruption at the time of rollover study
enrollment

- Participants who experienced a confirmed complete response (CR), partial response
(PR), or stable disease (SD) in an eligible parent study, discontinued bintrafusp alfa
treatment according to the parent study protocol, and subsequently developed disease
progression and are willing to re-start bintrafusp alfa treatment deemed potentially
beneficial by the participants' physicians

- Participants who are.discontinued from bintrafusp alfa treatment in an eligible parent
study due to an adverse events (AEs) that was subsequently well controlled or
completely resolved after stopping therapy, provided that the parent study protocol
permits reinitiation of bintrafusp alfa if a participant discontinued treatment due to
toxicity and these participants are willing to re-start bintrafusp alfa treatment
deemed potentially beneficial by the participants' physicians. Participants who have
had AEs requiring permanent treatment discontinuation, like certain immune-related
adverse events (irAEs) or certain bleeding events are excluded from participation in
this Rollover study

- Participants with only SD at the time of discontinuation, the Investigator should
confirm that no other reasonable treatment options are available

- Participants who have completed End of treatment (EoT) assessment of a parent study

- The investigator confirms that each participant agrees to use appropriate
contraception and barriers, if applicable. The contraception, barrier, and pregnancy
testing requirements are below:

- For female participants of childbearing potential or for male participants who have
female partners of childbearing potential, the following applies:

- Participants on active treatment must agree to continue to use highly effective
contraception for both male and female participants if the risk of conception exists
thus, women of childbearing potential and men must agree to use highly effective
contraception as stipulated in national or local guidelines

- Highly effective contraception must be used 28 days prior to the first study
intervention administration, for the duration of study intervention, and at least for
2 months (for female participants) or 4 months (for male participants) after stopping
study intervention

- Should a woman become pregnant or suspect she is pregnant while she or her partner is
participating in this study, the treating physician should be informed immediately
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participants who are pregnant or currently in lactation

- Participants with known hypersensitivity to any of the study intervention ingredients.

- Participants reinitiating treatment with bintrafusp alfa at study entry: have received
any systemic anticancer therapies/treatments since discontinuing bintrafusp alfa
treatment.

- Participants who has withdrawn consent from the parent study for any reason

- Any other reason that, in the opinion of the Investigator, precludes the participant
from participating in the study

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
20/06/2025
Actual
Sample size
Target
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Maryland
Country [2] 0 0
Belgium
State/province [2] 0 0
Libramont
Country [3] 0 0
China
State/province [3] 0 0
Harbin
Country [4] 0 0
Germany
State/province [4] 0 0
Dresden
Country [5] 0 0
Italy
State/province [5] 0 0
Lazio
Country [6] 0 0
Japan
State/province [6] 0 0
Chuo-ku
Country [7] 0 0
Japan
State/province [7] 0 0
Hidaka-shi
Country [8] 0 0
Japan
State/province [8] 0 0
Kashiwa-shi
Country [9] 0 0
Korea, Republic of
State/province [9] 0 0
Incheon
Country [10] 0 0
Korea, Republic of
State/province [10] 0 0
Seoul
Country [11] 0 0
Russian Federation
State/province [11] 0 0
Omsk
Country [12] 0 0
Spain
State/province [12] 0 0
Madrid
Country [13] 0 0
Spain
State/province [13] 0 0
Valencia
Country [14] 0 0
Taiwan
State/province [14] 0 0
Taichung
Country [15] 0 0
Taiwan
State/province [15] 0 0
Taoyuan County
Country [16] 0 0
Turkey
State/province [16] 0 0
Adana
Country [17] 0 0
Ukraine
State/province [17] 0 0
Lutsk

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
This study is designed to provide continuous access to treatment with bintrafusp alfa for
eligible participants from ongoing bintrafusp alfa parent studies (NCT02517398, NCT03840902,
NCT02699515, NCT04246489, NCT04489940, NCT03840915, NCT03631706, NCT04551950, NCT03833661 and
NCT04066491) and to collect long-term safety and efficacy data.

Study Duration: All participants in this rollover study will be treated with bintrafusp alfa
until meeting defined criteria in the protocol for discontinuation, until study intervention
is commercially accessible and provisioned via marketed product, or until end of study.

The study also includes a 5 years survival follow-up after last dose of the study treatment.

Treatment Duration: Treatment under the rollover protocol according to the interval and
dosing schedule in the parent protocol until discontinuation.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05061823
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05061823