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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03815643




Registration number
NCT03815643
Ethics application status
Date submitted
22/01/2019
Date registered
24/01/2019

Titles & IDs
Public title
Avelumab Program Rollover Study
Scientific title
An Open-Label, Multicenter Follow-up Study to Collect Long-term Data on Participants From Multiple Avelumab (MSB0010718C) Clinical Studies
Secondary ID [1] 0 0
2018-003711-21
Secondary ID [2] 0 0
MS100070_0176
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumors 0 0
Condition category
Condition code

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

Experimental: Avelumab -


Treatment: Drugs: Avelumab
Participants entering this roll over study will receive avelumab as a 1-hour intravenous (IV) infusion at 10 milligram per kilogram (mg/kg) once every 2 weeks until progressive disease, according to respective parent studies (EMR100070-001, EMR100070-002, EMR100070-004 and EMR100070-008).
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Occurrence of Treatment-related Non-serious Treatment-Emergent Adverse Events (TEAEs), All Serious AEs, Immunerelated AEs and Infusion-related Reactions According to Version of National Cancer Institute Common Technology Criteria for Adverse Events
Timepoint [1] 0 0
From enrollment to end of survival follow-up (up to 5 years after the last participant receives the last dose of avelumab)
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
From baseline up to 5 years
Secondary outcome [2] 0 0
Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Timepoint [2] 0 0
From baseline up to 5 years
Secondary outcome [3] 0 0
Duration of Response (DOR) Assessed From Complete Response (CR) or Partial Response (PR)
Timepoint [3] 0 0
From baseline up to 5 years

Eligibility
Key inclusion criteria
* Participants under enrollment and treatment in an avelumab clinical study under the sponsorship of EMD Serono Research & Development Institute, Inc. / Merck KGaA, Darmstadt, Germany

* Merck Serono Co., Ltd (Japan)
* Participants currently enrolled in an avelumab parent study and are on active treatment with avelumab or in long-term survival follow-up after treatment
* Participants on active treatment must agree to continue to use highly effective contraception (that is, methods with a failure rate of less than 1% per year) for both male and female participants if the risk of conception exists
* Other protocol defined inclusion criteria could apply.
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 breastfeeding
* Participants still on active treatment: Known hypersensitivity to any of the study intervention ingredients
* Participant has been enrolled in the comparator arm of avelumab parent study
* Participant has been withdrawn from avelumab parent study for any reason
* Any other reason that, in the opinion of the Investigator, precludes the participant from participating in the study
* Other protocol defined exclusion criteria could apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
22/03/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
20/02/2026
Actual
Sample size
Target
Accrual to date
Final
205
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Ballarat Health Services - Ballarat
Recruitment hospital [2] 0 0
Monash Medical Centre Clayton - Clayton
Recruitment postcode(s) [1] 0 0
- Ballarat
Recruitment postcode(s) [2] 0 0
- Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
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Arkansas
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United States of America
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California
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United States of America
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Connecticut
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Maryland
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United States of America
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Michigan
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United States of America
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Minnesota
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United States of America
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Missouri
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Ohio
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United States of America
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Oregon
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United States of America
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Rhode Island
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United States of America
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South Carolina
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Vermont
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Argentina
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Ciudad Autonoma Buenos Aires
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Argentina
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Cordoba
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Belgium
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Libramont
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Belgium
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Liège
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Brazil
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Barretos
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Bulgaria
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Sofia
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Czechia
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Benesov
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Czechia
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Brno
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France
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Besancon Cedex
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France
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Lille cedex
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France
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Nantes Cedex 01
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France
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Nice
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France
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Paris Cedex 05
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France
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Pessac
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France
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Poitiers cedex
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France
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Strasbourg Cedex
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France
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Toulouse Cedex 9
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Germany
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Essen
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Hungary
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Gyor
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Hungary
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Zalaegerszeg
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Italy
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Napoli
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Italy
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Padova
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Italy
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Roma
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Italy
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Rozzano
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Japan
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Chuo-ku
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Japan
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Habikino-shi
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Japan
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Koto-ku
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Japan
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Kurume-shi
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Japan
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Osaka-shi
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Japan
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Sendai-shi
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Japan
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Suita-shi
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Korea, Republic of
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Cheongju-si
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Korea, Republic of
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Daejeon
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Korea, Republic of
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Goyang
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seoul
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Mexico
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Mexico
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Poland
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Warszawa
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Romania
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Cluj Napoca
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Romania
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Comuna Floresti
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Romania
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Iasi
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Romania
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Oradea
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Romania
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Timisoara
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Russian Federation
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Kursk
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Russian Federation
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Novosibirsk
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Russian Federation
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Omsk
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Russian Federation
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Saint Petersburg
Country [65] 0 0
Russian Federation
State/province [65] 0 0
Saint-Petersburg
Country [66] 0 0
Spain
State/province [66] 0 0
Barcelona
Country [67] 0 0
Spain
State/province [67] 0 0
Madrid
Country [68] 0 0
Spain
State/province [68] 0 0
Mataro
Country [69] 0 0
Thailand
State/province [69] 0 0
Songkla
Country [70] 0 0
Turkey
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Adana
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Turkey
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Ankara
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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Mersin
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Ukraine
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Kherson
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Ukraine
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Vinnytsia
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United Kingdom
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London
Country [78] 0 0
United Kingdom
State/province [78] 0 0
Northwood
Country [79] 0 0
United Kingdom
State/province [79] 0 0
Plymouth

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 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?
We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports 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 bit.ly/IPD21

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?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03815643