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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-002457-29 | EudraCT Number | ||
| 2023-509466-38-00 | Registry Identifier | CTIS (EU) |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Avelumab monotherapy as specified by sub-study protocol B9991001C |
|
| Arm 2 | Experimental | Avelumab in combination with CMP 001, Utomilumab or PF04518600 as specified by sub-study protocol B9991004C |
|
| Arm 3 | Experimental | Avelumab in combination with Loratanib as specified by sub-study protocol B9991005C |
|
| Arm 4 | Experimental | Avelumab monotherapy as specified by sub-study protocol B9991009C |
|
| Arm 5 | Experimental | Avelumab monotherapy or in combination with Pemetrexed as specified by sub-study protocol B9991023C |
|
| Arm 6 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avelumab | Drug | oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events leading to permanent discontinuation of study intervention | Baseline up to approximately 5 years | |
| Number serious adverse events reported for all participants | Baseline up to approximately 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Highlands Oncology Group, PA | Fayetteville | Arkansas | 72703 | United States | ||
| Highlands Oncology Group, PA |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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Avelumab in combination with Talazoparib as specified by sub-study B9991025C. |
|
| Arm 7 | Experimental | Avelumab in combination with Axitinib as specified by sub-study B9991027C. |
|
| Arm 8 | Experimental | Avelumab in combination with Talazoparib as specified by sub-study B9991032C. |
|
| Arm 9 | Experimental | Avelumab in combination with Axitinib as specified by sub-study protocol B9991003C |
|
| Lorlatanib | Drug | oral |
|
| Talazoparib | Drug | oral |
|
| Pemetrexed | Drug | IV (intravenous) infusion |
|
| Axitinib | Drug | oral |
|
| CMP 001 | Drug | IT (intratumoral) or SC (subcutaneous) |
|
| Utomilumab | Drug | IV infusion |
|
| PF04518600 | Drug | IV infusion |
|
| Rogers |
| Arkansas |
| 72758 |
| United States |
| Highlands Oncology Group, PA | Springdale | Arkansas | 72762 | United States |
| The Regents of the University of California | Los Angeles | California | 900095 | United States |
| UCLA Hematology/Oncology | Los Angeles | California | 90095 | United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| MSK Basking Ridge | Basking Ridge | New Jersey | 07920 | United States |
| MSK Monmouth | Middletown | New Jersey | 07748 | United States |
| MSK Bergen | Montvale | New Jersey | 07645 | United States |
| MSK Commack | Commack | New York | 11725 | United States |
| MSK Westchester | Harrison | New York | 10604 | United States |
| Memorial Sloan Kettering Cancer Center (IDS Pharmacy) | Long Island City | New York | 11101 | United States |
| Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street). | New York | New York | 10021 | United States |
| Memorial Sloan Kettering Cancer Center 53rd street. | New York | New York | 10022 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| MSK Nassau | Uniondale | New York | 11553 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| The Trustees of the University of Pennsylvania, Clinical Research (OCR) | Philadelphia | Pennsylvania | 19104 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | United States |
| Macquarie University | North Ryde | New South Wales | 2109 | Australia |
| Mater Hospital Sydney | Wollstonecraft | New South Wales | 2060 | Australia |
| Melanoma Institute Australia | Wollstonecraft | New South Wales | 2065 | Australia |
| The Prince Charles Hospital | Chermside | Queensland | 4032 | Australia |
| UZ Gent | Ghent | Oost-vlaanderen | 9000 | Belgium |
| Grand Hôpital de Charleroi | Gilly | 6060 | Belgium |
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
| Kingston Health Sciences Centre-Kingston General Hospital Site | Kingston | Ontario | K7L 2V7 | Canada |
| Aalborg Universitetshospital, Syd | Aalborg | North Denmark | 9000 | Denmark |
| Institut de Cancérologie de Lorraine Alexis Vautrin | Vandœuvre-lès-Nancy | Lorraine | 54519 | France |
| Országos Onkológiai Intézet | Budapest | 1122 | Hungary |
| Rabin Medical Center | Petah Tikva | Central District | 4941492 | Israel |
| Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | Lombardy | 20133 | Italy |
| Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | Milano | 20133 | Italy |
| IRCCS Istituto Clinico Humanitas | Rozzano | Milano | 20089 | Italy |
| Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi | Ancona | 60126 | Italy |
| Oita University Hospital | Yufu | Oita Prefecture | 879-5593 | Japan |
| National Cancer Center Hospital | Chuo-ku | Tokyo | 104-0045 | Japan |
| Japanese Foundation for Cancer Research | Koto | Tokyo | 135-8550 | Japan |
| National Hospital Organization Kyushu Cancer Center | Fukuoka | 811-1395 | Japan |
| Hospital Universitario "Dr. Jose Eleuterio Gonzalez" | Monterrey | Nuevo León | 64460 | Mexico |
| Oaxaca Site Management Organization S.C. | Oaxaca City | 68000 | Mexico |
| Auckland City Hospital | Auckland | 1023 | New Zealand |
| Centralny Szpital Kliniczny MSWiA w Warszawie | Warsaw | 02-507 | Poland |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie | Warsaw | 02-781 | Poland |
| Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Dispensary" | Omsk | Omsk Oblast | 644013 | Russia |
| Private Medical Institution "Euromedservice" | Pushkin | Sankt-Peterburg | 196603 | Russia |
| GBUZ SK Pyatigorsk Interdistrict Oncology dispensary | Pyatigorsk | Stavropol Kray | 357502 | Russia |
| Moscow Scientific Research Oncology Institute n.a. P.A. Hertzen | Moscow | 125284 | Russia |
| FBIH "Privolzhskiy Regional Medical Center" of FMBA | Nizhny Novgorod | 603109 | Russia |
| SAHI Republican Clinical Oncology Dispensary under the Ministry of Health, Republic of Bashkortostan | Ufa | 450054 | Russia |
| Institute for Oncology and Radiology of Serbia | Belgrade | 11000 | Serbia |
| Gachon University Gil Medical Center | Namdong-gu | Incheon-gwangyeoksi [incheon] | 21565 | South Korea |
| National Cancer Center | Goyang-si | Kyǒnggi-do | 10408 | South Korea |
| Seoul National University Bundang Hospital | Seongnam | Kyǒnggi-do | 13620 | South Korea |
| Seoul National University Hospital | Seoul | Seoul-teukbyeolsi [seoul] | 03080 | South Korea |
| Asan Medical Center | Seoul | Seoul-teukbyeolsi [seoul] | 05505 | South Korea |
| Samsung Medical Center | Seoul | Seoul-teukbyeolsi [seoul] | 06351 | South Korea |
| Hospital Universitari Vall d'Hebron | Barcelona | Barcelona [barcelona] | 08035 | Spain |
| Hospital Clínic de Barcelona | Barcelona | Barcelona [barcelona] | 08036 | Spain |
| Institut Català d'Oncologia - L'Hospitalet | L'Hospitalet de Llobregat | Barcelona | 08908 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Universitario Fundación Jiménez Díaz | Madrid | 28040 | Spain |
| Hospital Universitario HM Sanchinarro | Madrid | 28050 | Spain |
| Hospital Universitario Virgen de Valme | Seville | 41014 | Spain |
| National Cheng Kung University Hospital | Tainan | 704 | Taiwan |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| Chang Gung Medical Foundation-Linkou Branch | Taoyuan | 333 | Taiwan |
| Royal Marsden NHS Foundation Trust | London | SW3 6JJ | United Kingdom |
| The Newcastle Upon Tyne Hospitals NHS Foundation Trust | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Royal Cornwall Hospitals NHS Trust | Truro | TR1 3LJ | United Kingdom |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| C000609138 | avelumab |
| C586365 | talazoparib |
| D000068437 | Pemetrexed |
| D000077784 | Axitinib |
| C577122 | utomilumab |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D007191 | Indazoles |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
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