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Brief Title: Sasanlimab (PF-06801591, PD-1 Inhibitor) in Participants With Advanced Malignancies
Official Title: A Phase 1b/2 Open-Label Study to Evaluate Pharmacokinetics, Safety, Efficacy, and Pharmacodynamics of PF-06801591 (PD-1 Inhibitor) in Participants With Advanced Malignancies
Study ID: NCT04181788
Brief Summary: This is a Phase 1b/2 protocol to evaluate pharmacokinetics, safety, efficacy, and pharmacodynamics of PF-06801591, a programmed death-1(PD-1) antagonist monoclonal antibody (mAb) in participants with advanced malignancies. This study consists of 2 parts: Phase 1b part (dose escalation and dose expansion) in patients with advanced malignancies in Asia and a global Phase 2 part in non small cell lung cancer (NSCLC) patients.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Beijing Cancer hospital, Beijing, Beijing, China
Chongqing Cancer Hospital, Chongqing, Chongqing, China
Nanjing Drum Tower Hospital, Nanjing, Jiangsu, China
Huashan Hospital Affiliated to Fudan University, Shanghai, Shanghai, China
National Cancer Center Hospital, Chuo-ku, Tokyo, Japan
Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, Korea, Republic of
Gachon University Gil Medical Center, Incheon, , Korea, Republic of
Severance Hospital, Yonsei Univ. Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
SBHI "Chelyabinsk Regional Clinical Hospital", Chelyabinsk, Chelyabinsk Region, Russian Federation
Russian Research Centre for Radiology and Surgical Technologies, Saint Petersburg, Pesochny, Russian Federation
Private Medical Institution "Euromedservice", Pushkin, Saint-petersburg, Russian Federation
Klinika UZI 4D, LLC, Pyatigorsk, Stavropol Region, Russian Federation
State budgetary institution of healthcare of Yaroslavl region "Clinical oncology hospital", Yaroslavl, Yaroslavskaya Oblast', Russian Federation
Evimed Llc, Chelyabinsk, , Russian Federation
Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine, Chelyabinsk, , Russian Federation
NUZ "Railway Clinical Hospital at the station Chelyabinsk of JSC "Russian Railways", Chelyabinsk, , Russian Federation
Ars Medika Center, LLC, Kaliningrad, , Russian Federation
GBUZ Regional Clinical Hospital of Kaliningrad region, Kaliningrad, , Russian Federation
Enlimed Llc, Kopeysk, , Russian Federation
Orenburg Regional Clinical Oncological Dispensary, Orenburg, , Russian Federation
Russian Scientific Center For Radiology and Surgical Technologies, Pesochny, Saint Petersburg, , Russian Federation
Magnetic resonance and computer tomography, Pyatigorsk, , Russian Federation
NS HI "Road Clinical Hospital of JSC "Russian Railways"", Saint Petersburg, , Russian Federation
North-West Medical Center, Saint-Petersburg, , Russian Federation
Road clinical clinic of JSC "RZD", Saint-Petersburg, , Russian Federation
Private Healthcare Institution "Clinical Hospital "RZD-Medicine" of St. Petersburg, Saint-Petersburg, , Russian Federation
Medical University REAVIZ, Samara, , Russian Federation
Medical University REAVIZ, Samara, , Russian Federation
LLC Medical Center "Magnit", St. Petersburg, , Russian Federation
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Limited Liability Company "MedX-ray International Group", Pliuty Village, Obuhiv District, KIEV Region, Ukraine
Asklepion Medical Center, Khodosivka, Kyivska Oblast, Ukraine
Municipal non-profit enterprise of Sumy Regional Council Sumy Regional Clinical Oncology Dispensary, Sumy, Sumska Oblast, Ukraine
"Medeya Sumy" LLC, Sumy, SUMY Region, Ukraine
Communal Non-profit Enterprise City Clinical Hospital #4 of Dnipro City Council, Dnipro, , Ukraine
LLC "AR DI PI Ukraine", Dnipro, , Ukraine
Llc "Mdc Expert", Dnipro, , Ukraine
Municipal Non-profit Enterprise "SubCarpathian Clinical Oncological Centre of Ivano-Frankivsk RC", Ivano-Frankivsk, , Ukraine
Private Enterprise of Private Manufacturing Company "Acinus", Medical and Diagnostic Center, Kirovohrad, , Ukraine
Private Enterprise of Private Manufacturing Company "Acinus", Medical and Diagnostic Center, Kropyvnytskyi, , Ukraine
Medical centre "Verum" Limited Liability Company, Kyiv, , Ukraine
Vita Сom LLC, Kyiv, , Ukraine
SI "Romodanov Neurosurgery Institute National Academy of Medical Sciences of Ukraine", Kyiv, , Ukraine
The State Institution "Romodanov Neurosurgery Institute,, Kyiv, , Ukraine
Llc Medical Centre, Odesa, , Ukraine
Municipal Non-profit Enterprise Odesa Regional Clinical Hospital of Odesa Regional Council, Odesa, , Ukraine
Llc Lidermed, Odesa, , Ukraine
Municipal Non Profit enterprise of Sumy Regional Council "Sumy Regional Clinical Oncology Center", Sumy, , Ukraine
Municipal Non Profit enterprise of Sumy Regional Council "Sumy Regional Clinical Oncology Center", Sumy, , Ukraine
Llc Medical Center Diamed, Uzhgorod, , Ukraine
MNPE Central City Clinical Hospital of Uzhhorod City Council, Uzhgorod, , Ukraine
Мunicipal non-profit enterprise "Zhytomyr Regional Oncology Dispensary" of Zhytomyr Regional Cou, Zhytomyr, , Ukraine
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR