Advanced MalignanciesPhase 3NCT05059522
Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing
A Phase 3 study testing Avelumab, Lorlatanib and Talazoparib in people with Advanced Malignancies and NSCLC, run by Pfizer at 71 sites in 19 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignancies, NSCLC, Ovarian Cancer
- What is being tested?
- Avelumab, Lorlatanib and Talazoparib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 71 sitesin 19 countries
- Study dates
- 29 Sep 2021to 31 Dec 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Participants must agree to follow the reproductive criteria.
- Participants must be willing and able to comply with all scheduled visits, treatment plan, and other study procedures.
Who cannot join
- Female participants who are pregnant or breastfeeding.
- Any medical reason that, in the opinion of the Investigator or Sponsor, precludes the participant from inclusion in the study.
Trial locations and contacts
71 sites in 19 countries.
71 sites in 19 countries
United States20 sites
MSK Basking Ridge
Basking Ridge, New Jersey, 07920
MSK Commack
Commack, New York, 11725
Highlands Oncology Group, PA
Fayetteville, Arkansas, 72703
MSK Westchester
Harrison, New York, 10604
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Memorial Sloan Kettering Cancer Center (IDS Pharmacy)
Long Island City, New York, 11101
The Regents of the University of California
Los Angeles, California, 900095
UCLA Hematology/Oncology
Los Angeles, California, 90095
MSK Monmouth
Middletown, New Jersey, 07748
MSK Bergen
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
New York, New York, 10021
Memorial Sloan Kettering Cancer Center 53rd street.
New York, New York, 10022
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
The Trustees of the University of Pennsylvania, Clinical Research (OCR)
Philadelphia, Pennsylvania, 19104
Highlands Oncology Group, PA
Rogers, Arkansas, 72758
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Highlands Oncology Group, PA
Springdale, Arkansas, 72762
Moffitt Cancer Center
Tampa, Florida, 33612
MSK Nassau
Uniondale, New York, 11553
Spain7 sites
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [barcelona], 08035
Hospital Clínic de Barcelona
Barcelona, Barcelona [barcelona], 08036
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Institut Català d'Oncologia - L'Hospitalet
L'Hospitalet de Llobregat, Barcelona, 08908
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
Hospital Universitario HM Sanchinarro
Madrid, 28050
Hospital Universitario Virgen de Valme
Seville, 41014
Russia6 sites
Moscow Scientific Research Oncology Institute n.a. P.A. Hertzen
Moscow, 125284
FBIH "Privolzhskiy Regional Medical Center" of FMBA
Nizhny Novgorod, 603109
Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Dispensary"
Omsk, Omsk Oblast, 644013
Private Medical Institution "Euromedservice"
Pushkin, Sankt-Peterburg, 196603
GBUZ SK Pyatigorsk Interdistrict Oncology dispensary
Pyatigorsk, Stavropol Kray, 357502
SAHI Republican Clinical Oncology Dispensary under the Ministry of Health, Republic of Bashkortostan
Ufa, 450054
South Korea6 sites
National Cancer Center
Goyang-si, Kyǒnggi-do, 10408
Gachon University Gil Medical Center
Namdong-gu, Incheon-gwangyeoksi [incheon], 21565
Seoul National University Bundang Hospital
Seongnam, Kyǒnggi-do, 13620
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul], 03080
Asan Medical Center
Seoul, Seoul-teukbyeolsi [seoul], 05505
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [seoul], 06351
Australia4 sites
The Prince Charles Hospital
Chermside, Queensland, 4032
Macquarie University
North Ryde, New South Wales, 2109
Mater Hospital Sydney
Wollstonecraft, New South Wales, 2060
Melanoma Institute Australia
Wollstonecraft, New South Wales, 2065
Italy4 sites
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi
Ancona, 60126
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Lombardy, 20133
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Milano, 20133
IRCCS Istituto Clinico Humanitas
Rozzano, Milano, 20089
Japan4 sites
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395
Japanese Foundation for Cancer Research
Koto, Tokyo, 135-8550
Oita University Hospital
Yufu, Oita Prefecture, 879-5593
Taiwan3 sites
National Cheng Kung University Hospital
Tainan, 704
National Taiwan University Hospital
Taipei, 10002
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, 333
United Kingdom3 sites
Royal Marsden NHS Foundation Trust
London, SW3 6JJ
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, NE7 7DN
Royal Cornwall Hospitals NHS Trust
Truro, TR1 3LJ
Belgium2 sites
UZ Gent
Ghent, Oost-vlaanderen, 9000
Grand Hôpital de Charleroi
Gilly, 6060
Canada2 sites
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Kingston Health Sciences Centre-Kingston General Hospital Site
Kingston, Ontario, K7L 2V7
Mexico2 sites
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, 64460
Oaxaca Site Management Organization S.C.
Oaxaca City, 68000
Poland2 sites
Centralny Szpital Kliniczny MSWiA w Warszawie
Warsaw, 02-507
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
Warsaw, 02-781
France1 site
Institut de Cancérologie de Lorraine Alexis Vautrin
Vandœuvre-lès-Nancy, Lorraine, 54519
About this study
Official title: AVELUMAB MASTER PROTOCOL: AN OPEN-LABEL CONTINUATION STUDY FOR PARTICIPANTS CONTINUING FROM PFIZER-SPONSORED AVELUMAB CLINICAL STUDIES.
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.
Read the detailed description
B9991046 is a master protocol that will consist of sub-studies from the following parent studies:
B9991001 - NCT02603432 B9991003 - NCT02684006 B9991004 - NCT02554812 B9991005 - NCT02584634 B9991009 - NCT02580058 B9991023 - NCT03317496 B9991025 - NCT03330405 B9991027 - NCT03472560 B9991032 - NCT03565991
- Conditions
- Advanced Malignancies, NSCLC, Ovarian Cancer, Urothelial Cancer, Solid Tumors
- Being tested
- Avelumab, Lorlatanib, Talazoparib, Pemetrexed, Axitinib
- Keywords
- BRCA Mutant Tumors, ATM Mutant Tumors
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvelumabDrug
oral
LorlatanibDrug
oral
TalazoparibDrug
oral
PemetrexedDrug
IV (intravenous) infusion
AxitinibDrug
oral
CMP 001Drug
IT (intratumoral) or SC (subcutaneous)
UtomilumabDrug
IV infusion
PF04518600Drug
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Avelumab monotherapy as specified by sub-study protocol B9991001C Receives: Drug: Avelumab |
| Arm 2 | Experimental | Avelumab in combination with CMP 001, Utomilumab or PF04518600 as specified by sub-study protocol B9991004C Receives: Drug: Avelumab; Drug: CMP 001; Drug: Utomilumab; Drug: PF04518600 |
| Arm 3 | Experimental | Avelumab in combination with Loratanib as specified by sub-study protocol B9991005C Receives: Drug: Avelumab; Drug: Lorlatanib |
| Arm 4 | Experimental | Avelumab monotherapy as specified by sub-study protocol B9991009C Receives: Drug: Avelumab |
| Arm 5 | Experimental | Avelumab monotherapy or in combination with Pemetrexed as specified by sub-study protocol B9991023C Receives: Drug: Avelumab; Drug: Pemetrexed |
| Arm 6 | Experimental | Avelumab in combination with Talazoparib as specified by sub-study B9991025C. Receives: Drug: Avelumab; Drug: Talazoparib |
| Arm 7 | Experimental | Avelumab in combination with Axitinib as specified by sub-study B9991027C. Receives: Drug: Avelumab; Drug: Axitinib |
| Arm 8 | Experimental | Avelumab in combination with Talazoparib as specified by sub-study B9991032C. Receives: Drug: Avelumab; Drug: Talazoparib |
| Arm 9 | Experimental | Avelumab in combination with Axitinib as specified by sub-study protocol B9991003C Receives: Drug: Avelumab; Drug: Axitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events leading to permanent discontinuation of study intervention
Measured: Baseline up to approximately 5 years
Number serious adverse events reported for all participants
Measured: Baseline up to approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start29 Sep 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced MalignanciesStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05059522
- Sponsor's protocol ID
- B9991046
- Other IDs
- 2021-002457-29, 2023-509466-38-00, 2023
- Status last verified
- Oct 2026
- First submitted
- 17 Sep 2021
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.