Spots Global Cancer Trial Database for A Study of TAK-981 Given With Pembrolizumab in Participants With Select Advanced or Metastatic Solid Tumors
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Trial Identification
Brief Title: A Study of TAK-981 Given With Pembrolizumab in Participants With Select Advanced or Metastatic Solid Tumors
Official Title: A Phase 1b/2 Study of TAK-981 Plus Pembrolizumab to Evaluate the Safety, Tolerability, and Antitumor Activity of the Combination in Patients With Select Advanced or Metastatic Solid Tumors
Study ID: NCT04381650
Conditions
Study Description
Brief Summary: TAK-981 is being tested in combination with pembrolizumab to treat participants who have select advanced or metastatic solid tumors. The study aims are to evaluate the safety, tolerability, and preliminary efficacy of TAK-981 in combination with pembrolizumab. Participants will be on this combination treatment for 21-day cycles. They will continue with this treatment for up to 24 months or until participants meet any discontinuation criteria.
Detailed Description: The drug being tested in this study is called TAK-981. TAK-981 is being tested to treat people who have select advanced or metastatic solid tumors. The study will include a dose escalation phase and a dose expansion phase. The study will enroll approximately 231 participants, approximately 32 participants in the dose escalation phase 1 and approximately 76 to 199 participants in the 8 cohorts of dose expansion phase 2. Participants will receive escalating doses of TAK-981 and fixed dose of pembrolizumab until recommended phase 2 dose (RP2D) is determined: • Dose Escalation: TAK-981 + Pembrolizumab (Fixed Dose) Once Phase 2 doses are identified, participants of select advanced or metastatic solid tumors will receive TAK-981 in below defined cohorts in the expansion phase 2: * Dose Expansion Phase: Cohort A: Non-squamous Non-small Cell Lung Cancer (NSCLC) * Dose Expansion Phase: Cohort B: Cervical Cancer * Dose Expansion Phase: Cohort C: Microsatellite Stable Colorectal Cancer (MSS-CRC) * Dose Expansion Phase: Cohort D: Cutaneous Melanoma * Dose Expansion Phase: Cohort E: Squamous NSCLC * Dose Expansion Phase: Cohort F: Checkpoint Inhibitors (CPI) Refractory Squamous or Nonsquamous NSCLC This multi-center trial will be conducted worldwide. The overall time to participate in this study is 60 months. Participants will make multiple visits to the clinic, and progression-free survival follow-up for maximum up to 12 months after last dose of study drug.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
HonorHealth, Scottsdale, Arizona, United States
University of California Irvine Medical Center, Orange, California, United States
Stanford Cancer Institute (SCI), Stanford, California, United States
Yale Cancer Center, New Haven, Connecticut, United States
Georgia Cancer Center at Augusta University, Augusta, Georgia, United States
The Center for Cancer and Blood Disorders - PPDS, Bethesda, Maryland, United States
Morristown Medical Center, Morristown, New Jersey, United States
Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Montefiore Einstein Cancer Center - BRANY - PPDS, Bronx, New York, United States
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
University of Oklahoma Peggy and Charles Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
Providence Cancer Institute, Franz Clinic, Portland, Oregon, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
START South Texas Accelerated Research Therapeutics, San Antonio, Texas, United States
University of Virginia Health System, Charlottesville, Virginia, United States
Virginia Cancer Specialists (Fairfax) - USOR, Fairfax, Virginia, United States
Instituto de Oncologia Do Parana, Curitiba, Parana, Brazil
ONCOSITE Centro de Pesquisa Clinica Em Oncologia, Ijui, Rio Grande Do Sul, Brazil
Hospital de Clinicas de Porto Alegre (HCPA) - PPDS, Porto Alegre, Rio Grande Do Sul, Brazil
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS), Porto Alegre, Rio Grande Do Sul, Brazil
Fundacao Pio XII Hospital de Cancer de Barretos, Barretos, Sao Paulo, Brazil
Hospital de Base Da Faculdade de Medicina de Sao Jose Do Rio Preto, Sao Jose Do Rio Preto, Sao Paulo, Brazil
Cetus Hospital Dia Oncologia, Belo Horizonte, , Brazil
INCA Instituto Nacional de Cancer, Rio De Janeiro, , Brazil
Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira, Rio de Janeiro, , Brazil
Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, Hubei, China
The First Affiliated Hospital, Zhejiang University School of Medicine - PPDS, Hangzhou, Zhejiang, China
Klinicki bolnicki centar Zagreb, Zagreb, Grad Zagreb, Croatia
Clinical Hospital Centre Osijek, Osijek, , Croatia
General Hospital Pula, Pula, , Croatia
University Hospital Centre Split, Split, , Croatia
National Cancer Center East, Kashiwa-Shi, Tiba, Japan
National Cancer Center Hospital, Chuo-Ku, Tokyo, Japan
The Cancer Institute Hospital of Japanese Foundation For Cancer Research, Chuo-Ku, Tokyo, Japan
Pauls Stradins Clinical University Hospital, Riga, , Latvia
Riga East Clinical University Hospital Latvian Oncology Center, Riga, , Latvia
Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Kaunas, Kauno Apskritis, Lithuania
Hospital of Lithuanian University of Health Sciences Kauno klinikos, Kaunas, Kauno Apskritis, Lithuania
National Cancer Institute, Vilnius, Vilniaus Apskritis, Lithuania
Centrum Terapii Wspolczesnej, Lodz, Lodzkie, Poland
Uniwersyteckie Centrum Kliniczne-Ul. Smoluchowskiego 17, Gdansk, Pomorskie, Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy, Bydgoszcz, , Poland
Instytut Medyczny Santa Familia Sp. z o. o., Lodz, , Poland
Specjalistyczna Praktyka Lekarska Slawomir Mandziuk, Lublin, , Poland
Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie, Olsztyn, , Poland
Med-Polonia Sp. z o.o., Poznan, , Poland
Kantonsspital Muensterlingen, Munsterlingen, Thurgau (de), Switzerland
Kantonsspital Winterthur, Winterthur, Zurich (de), Switzerland
Universitaetsspital Bern - Inselspital, Bern, , Switzerland
Contact Details
Name: Study Director
Affiliation: Takeda
Role: STUDY_DIRECTOR
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