Ovarian Cancer Clinical Trial
Official title:
Avelumab Master Protocol: An Open-label Continuation Study for Participants Continuing From Pfizer-sponsored Avelumab Clinical Studies.
| Verified date | May 2024 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 62 |
| Est. completion date | September 30, 2026 |
| Est. primary completion date | September 30, 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. 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. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | The Prince Charles Hospital | Chermside | Queensland |
| Australia | Macquarie University | North Ryde | New South Wales |
| Australia | Mater Hospital Sydney | Wollstonecraft | New South Wales |
| Australia | Melanoma Institute Australia | Wollstonecraft | New South Wales |
| Belgium | Grand Hôpital de Charleroi | Charleroi | Hainaut |
| Belgium | UZ Gent | Gent | Oost-vlaanderen |
| Canada | Cross Cancer Institute | Edmonton | Alberta |
| Canada | Kingston Health Sciences Centre-Kingston General Hospital Site | Kingston | Ontario |
| Denmark | Aalborg Universitetshospital, Syd | Aalborg | Nordjylland |
| France | Institut de Cancérologie de Lorraine Alexis Vautrin | Vandoeuvre-lès-Nancy | Lorraine |
| Hungary | Országos Onkológiai Intézet | Budapest | |
| Israel | Rabin Medical Center | Petah Tikva | Hamerkaz |
| Italy | Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi | Ancona | |
| Italy | Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | Lombardia |
| Italy | Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | Milano |
| Italy | S.C. Farmacia Ospedaliera | Milano | Lombardia |
| Italy | AOU Policlinico Umberto I | Roma | |
| Italy | Istituto Clinico Humanitas | Rozzano | Milano |
| Japan | National Cancer Center Hospital | Chuo-ku | Tokyo |
| Japan | National Hospital Organization Kyushu Cancer Center | Fukuoka | |
| Japan | Japanese Foundation for Cancer Research | Koto | Tokyo |
| Japan | Oita University Hospital | Yufu | Oita |
| Korea, Republic of | National Cancer Center | Goyang-si | Kyonggi-do |
| Korea, Republic of | Gachon University Gil Medical Center | Namdong-gu | Incheon-gwangyeoksi [incheon] |
| Korea, Republic of | Seoul National University Bundang Hospital | Seongnam | Kyonggi-do |
| Korea, Republic of | Asan Medical Center | Seoul | Seoul-teukbyeolsi [seoul] |
| Korea, Republic of | Samsung Medical Center | Seoul | Seoul-teukbyeolsi [seoul] |
| Korea, Republic of | Seoul National University Hospital | Seoul | Seoul-teukbyeolsi [seoul] |
| Mexico | Hospital Universitario "Dr. Jose Eleuterio Gonzalez" | Monterrey | Nuevo LEÓN |
| Mexico | Oaxaca Site Management Organization S.C. | Oaxaca | |
| New Zealand | Auckland City Hospital | Auckland | |
| Poland | Centralny Szpital Kliniczny MSWiA w Warszawie | Warszawa | |
| Poland | Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie | Warszawa | |
| Russian Federation | Moscow Scientific Research Oncology Institute n.a. P.A. Hertzen | Moscow | |
| Russian Federation | FBIH "Privolzhskiy Regional Medical Center" of FMBA | Nizhniy Novgorod | |
| Russian Federation | Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Dispensary" | Omsk | Omskaya Oblast' |
| Russian Federation | Private Medical Institution "Euromedservice" | Pushkin | Saint - Petersburg |
| Russian Federation | GBUZ SK Pyatigorsk Interdistrict Oncology dispensary | Pyatigorsk | Stavropol'skiy KRAY |
| Russian Federation | SAHI Republican Clinical Oncology Dispensary under the Ministry of Health, Republic of Bashkortostan | Ufa | |
| Serbia | Institute for Oncology and Radiology of Serbia | Belgrade | |
| Spain | Hospital Clínic de Barcelona | Barcelona | Barcelona [barcelona] |
| Spain | Hospital Universitari Vall d'Hebron | Barcelona | |
| Spain | Hospital Universitari Vall d'Hebron | Barcelona | Barcelona [barcelona] |
| Spain | Institut Català d'Oncologia - L'Hospitalet | Hospitalet de Llobregat | Barcelona |
| Spain | Hospital Universitario Fundación Jiménez Díaz | Madrid | |
| Spain | Hospital Universitario HM Sanchinarro | Madrid | |
| Spain | Hospital Universitario Virgen de Valme | Sevilla | |
| Taiwan | National Cheng Kung University Hospital | Tainan | |
| Taiwan | National Taiwan University Hospital | Taipei | |
| Taiwan | Chang Gung Medical Foundation-Linkou Branch | Taoyuan | |
| United Kingdom | Royal Marsden Hospital (Chelsea) | London | Kensington AND Chelsea |
| United Kingdom | The Newcastle Upon Tyne Hospitals NHS Foundation Trust | Newcastle Upon Tyne | |
| United Kingdom | Royal Cornwall Hospitals NHS Trust | Truro | |
| United States | MSK Basking Ridge | Basking Ridge | New Jersey |
| United States | MSK Commack | Commack | New York |
| United States | Highlands Oncology Group, PA | Fayetteville | Arkansas |
| United States | MSK Westchester | Harrison | New York |
| United States | The University of Texas MD Anderson Cancer Center | Houston | Texas |
| United States | Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy | Long Island City | New York |
| United States | Ronald Reagan UCLA Medical Center - Drug Information Center, Pharmaceutical Services | Los Angeles | California |
| United States | UCLA Hematology/Oncology | Los Angeles | California |
| United States | UCLA Hematology/Oncology - Administrative Office | Los Angeles | California |
| United States | MSK Monmouth | Middletown | New Jersey |
| United States | MSK Bergen | Montvale | New Jersey |
| United States | Memorial Sloan Kettering Cancer Center | New York | New York |
| United States | Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street). | New York | New York |
| United States | Memorial Sloan Kettering Cancer Center 53rd street. | New York | New York |
| United States | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania |
| United States | Highlands Oncology Group, PA | Rogers | Arkansas |
| United States | Fred Hutchinson Cancer Center | Seattle | Washington |
| United States | Highlands Oncology Group, PA | Springdale | Arkansas |
| United States | Moffitt Cancer Center | Tampa | Florida |
| United States | MSK Nassau | Uniondale | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Australia, Belgium, Canada, Denmark, France, Hungary, Israel, Italy, Japan, Korea, Republic of, Mexico, New Zealand, Poland, Russian Federation, Serbia, Spain, Taiwan, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of participants with adverse events leading to permanent discontinuation of study intervention | Baseline up to approximately 5 years | ||
| Primary | Number serious adverse events reported for all participants | Baseline up to approximately 5 years |
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