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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/NCT03815643




Registration number
NCT03815643
Ethics application status
Date submitted
22/01/2019
Date registered
24/01/2019
Date last updated
16/05/2024

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
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
22/03/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2024
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
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Arizona
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Arkansas
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California
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Connecticut
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Florida
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Georgia
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Maryland
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Michigan
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Minnesota
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Missouri
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Ohio
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Oregon
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Rhode Island
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South Carolina
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United States of America
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Tennessee
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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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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
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Russian Federation
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Saint-Petersburg
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Mataro
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Thailand
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Songkla
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Turkey
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Adana
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Ankara
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Istanbul
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Izmir
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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
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United Kingdom
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Northwood
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United Kingdom
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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
The main purpose of this study is to monitor the safety and tolerability of avelumab in
participants with solid tumors who continue treatment with avelumab under the same treatment
regimen as in the parent avelumab study.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03815643
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