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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/NCT05059522




Registration number
NCT05059522
Ethics application status
Date submitted
17/09/2021
Date registered
28/09/2021
Date last updated
22/05/2024

Titles & IDs
Public title
Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing
Scientific title
Avelumab Master Protocol: An Open-label Continuation Study for Participants Continuing From Pfizer-sponsored Avelumab Clinical Studies.
Secondary ID [1] 0 0
2021-002457-29
Secondary ID [2] 0 0
B9991046
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Malignancies 0 0
NSCLC 0 0
Ovarian Cancer 0 0
Urothelial Cancer 0 0
Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Avelumab
Treatment: Drugs - Lorlatanib
Treatment: Drugs - Talazoparib
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Axitinib
Treatment: Drugs - CMP 001
Treatment: Drugs - Utomilumab
Treatment: Drugs - PF04518600

Experimental: Arm 1 - Avelumab monotherapy as specified by sub-study protocol B9991001C

Experimental: Arm 2 - Avelumab in combination with CMP 001, Utomilumab or PF04518600 as specified by sub-study protocol B9991004C

Experimental: Arm 3 - Avelumab in combination with Loratanib as specified by sub-study protocol B9991005C

Experimental: Arm 4 - Avelumab monotherapy as specified by sub-study protocol B9991009C

Experimental: Arm 5 - Avelumab monotherapy or in combination with Pemetrexed as specified by sub-study protocol B9991023C

Experimental: Arm 6 - Avelumab in combination with Talazoparib as specified by sub-study B9991025C.

Experimental: Arm 7 - Avelumab in combination with Axitinib as specified by sub-study B9991027C.

Experimental: Arm 8 - Avelumab in combination with Talazoparib as specified by sub-study B9991032C.


Treatment: Drugs: Avelumab
oral

Treatment: Drugs: Lorlatanib
oral

Treatment: Drugs: Talazoparib
oral

Treatment: Drugs: Pemetrexed
IV (intravenous) infusion

Treatment: Drugs: Axitinib
oral

Treatment: Drugs: CMP 001
IT (intratumoral) or SC (subcutaneous)

Treatment: Drugs: Utomilumab
IV infusion

Treatment: Drugs: PF04518600
IV infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with adverse events leading to permanent discontinuation of study intervention
Timepoint [1] 0 0
Baseline up to approximately 5 years
Primary outcome [2] 0 0
Number serious adverse events reported for all participants
Timepoint [2] 0 0
Baseline up to approximately 5 years

Eligibility
Key inclusion criteria
1. Any participant who is receiving study treatment and deriving significant clinical
benefit or is in the safety and/or survival follow-up period in a Pfizer-sponsored
Avelumab Parent Study.

2. Participants must agree to follow the reproductive criteria.

3. Participants must be willing and able to comply with all scheduled visits, treatment
plan, and other study procedures.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Female participants who are pregnant or breastfeeding.

2. Any medical reason that, in the opinion of the Investigator or Sponsor, precludes the
participant from inclusion in the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Parallel
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
29/09/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2026
Actual
Sample size
Target
Accrual to date
Final
62
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Macquarie University - North Ryde
Recruitment hospital [2] 0 0
Mater Hospital Sydney - Wollstonecraft
Recruitment hospital [3] 0 0
Melanoma Institute Australia - Wollstonecraft
Recruitment hospital [4] 0 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 0 0
2109 - North Ryde
Recruitment postcode(s) [2] 0 0
2060 - Wollstonecraft
Recruitment postcode(s) [3] 0 0
2065 - Wollstonecraft
Recruitment postcode(s) [4] 0 0
4032 - Chermside
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
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
New Jersey
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Pennsylvania
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Washington
Country [9] 0 0
Belgium
State/province [9] 0 0
Hainaut
Country [10] 0 0
Belgium
State/province [10] 0 0
Oost-vlaanderen
Country [11] 0 0
Canada
State/province [11] 0 0
Alberta
Country [12] 0 0
Canada
State/province [12] 0 0
Ontario
Country [13] 0 0
Denmark
State/province [13] 0 0
Nordjylland
Country [14] 0 0
France
State/province [14] 0 0
Lorraine
Country [15] 0 0
Hungary
State/province [15] 0 0
Budapest
Country [16] 0 0
Israel
State/province [16] 0 0
Hamerkaz
Country [17] 0 0
Italy
State/province [17] 0 0
Lombardia
Country [18] 0 0
Italy
State/province [18] 0 0
Milano
Country [19] 0 0
Italy
State/province [19] 0 0
Ancona
Country [20] 0 0
Italy
State/province [20] 0 0
Roma
Country [21] 0 0
Japan
State/province [21] 0 0
Tokyo
Country [22] 0 0
Japan
State/province [22] 0 0
Fukuoka
Country [23] 0 0
Japan
State/province [23] 0 0
Oita
Country [24] 0 0
Korea, Republic of
State/province [24] 0 0
Incheon-gwangyeoksi [incheon]
Country [25] 0 0
Korea, Republic of
State/province [25] 0 0
Kyonggi-do
Country [26] 0 0
Korea, Republic of
State/province [26] 0 0
Seoul-teukbyeolsi [seoul]
Country [27] 0 0
Mexico
State/province [27] 0 0
Nuevo LEÓN
Country [28] 0 0
Mexico
State/province [28] 0 0
Oaxaca
Country [29] 0 0
New Zealand
State/province [29] 0 0
Auckland
Country [30] 0 0
Poland
State/province [30] 0 0
Warszawa
Country [31] 0 0
Russian Federation
State/province [31] 0 0
Omskaya Oblast'
Country [32] 0 0
Russian Federation
State/province [32] 0 0
Saint - Petersburg
Country [33] 0 0
Russian Federation
State/province [33] 0 0
Stavropol'skiy KRAY
Country [34] 0 0
Russian Federation
State/province [34] 0 0
Moscow
Country [35] 0 0
Russian Federation
State/province [35] 0 0
Nizhniy Novgorod
Country [36] 0 0
Russian Federation
State/province [36] 0 0
Ufa
Country [37] 0 0
Serbia
State/province [37] 0 0
Belgrade
Country [38] 0 0
Spain
State/province [38] 0 0
Barcelona [barcelona]
Country [39] 0 0
Spain
State/province [39] 0 0
Barcelona
Country [40] 0 0
Spain
State/province [40] 0 0
Madrid
Country [41] 0 0
Spain
State/province [41] 0 0
Sevilla
Country [42] 0 0
Taiwan
State/province [42] 0 0
Tainan
Country [43] 0 0
Taiwan
State/province [43] 0 0
Taipei
Country [44] 0 0
Taiwan
State/province [44] 0 0
Taoyuan
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Kensington AND Chelsea
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Newcastle Upon Tyne
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Truro

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This Master Protocol for Avelumab Continuation Sub-Studies is to provide continued treatment
access, safety follow-up, and when applicable, overall survival follow-up for eligible
participants who continue to derive a benefit from study intervention in the Pfizer-sponsored
Avelumab parent studies.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05059522
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
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