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Spots Global Cancer Trial Database for Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)

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Trial Identification

Brief Title: Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)

Official Title: A Phase 2 Study of ALX148 in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)

Study ID: NCT04675294

Study Description

Brief Summary: A Phase 2 Study of evorpacept (ALX148) in Combination With pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma.

Detailed Description: This is a open-label, randomized phase 2 multi-center study of the anti-tumor efficacy of evorpacept (ALX148) + pembrolizumab and of pembrolizumab alone in patients with metastatic or unresectable, recurrent HNSCC that is PD-L1 positive (CPS ≥1 by an FDA-approved test) and who have not yet been treated for their advanced disease. The study comprises an initial safety lead-in cohort followed by a randomized portion.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Hoag Hospital, Irvine, California, United States

University of California San Diego, La Jolla, California, United States

H. Lee Moffitt Cancer Center, Tampa, Florida, United States

Northwest Georgia Oncology Centers, Marietta, Georgia, United States

Rush University Medical Center, Chicago, Illinois, United States

Blessing Cancer Center, Quincy, Illinois, United States

University of Maryland Medical System, Baltimore, Maryland, United States

University of Maryland, Baltimore, Maryland, United States

Massachusetts General Hospital, Boston, Massachusetts, United States

Rutgers Cancer Institute of New Jersey, Newark, New Jersey, United States

Memorial Sloan-Kettering Cancer Center, Long Island City, New York, United States

The Ohio State University, Columbus, Ohio, United States

Oregon Health & Science University, Portland, Oregon, United States

Vanderbilt - Ingram Cancer Center, Nashville, Tennessee, United States

Houston Methodist Cancer Center, Houston, Texas, United States

St. Vincent's, Sydney, New South Wales, Australia

Royal Brisbane and Womens Hospital, Brisbane, Queensland, Australia

Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

Sir Charles Gairdner Hospital, Perth, Western Australia, Australia

Cliniques Universitaires Saint-Luc, Brussels, , Belgium

AZ Groeninge, Kortrijk, , Belgium

UZ Leuven, Leuven, , Belgium

Hamilton Health Sciences - Juravinski Cancer Centre, Hamilton, Ontario, Canada

LHSC - Victoria Hospital, London, Ontario, Canada

Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada

Princess Margaret Cancer Centre, Toronto, Ontario, Canada

Chungbuk National University Hospital, Cheongju, , Korea, Republic of

Yeungnam University Medical Center, Daegu, , Korea, Republic of

Chungnam National University Hospital, Daejeon, , Korea, Republic of

CHA University of Bundang, Gyeonggi-do, , Korea, Republic of

Gachon University - Gil Medical Center, Incheon, , Korea, Republic of

Seoul National University Bundang Hospital, Seongnam, , Korea, Republic of

Korea University Medical Center (KUMC) - Korea University Anam Hospital, Seoul, , Korea, Republic of

Seoul National University Hospital, Seoul, , Korea, Republic of

The Catholic University of Korea - Eunpyeong St. Mary's Hospital, Seoul, , Korea, Republic of

Samsung Medical Center, Seoul, , Korea, Republic of

SNU Boramae Medical Center, Seoul, , Korea, Republic of

Severance Hospital Yonsei University, Seoul, , Korea, Republic of

Catholic University of Korea, St. Vincent's Hospital Suwon, Suwon, , Korea, Republic of

Yonsei University - Wonju Severance Christian Hospital, Wŏnju, , Korea, Republic of

VUMC Goederenontvangst, Amsterdam, , Netherlands

Universitair Medisch Centrum Groningen, Groningen, , Netherlands

National University Cancer Institute, Singapore, , Singapore

National Cancer Centre Singapore, Singapore, , Singapore

Hospital Universitari Dexeus, Barcelona, , Spain

Institud Catala d´Oncologia, Barcelona, , Spain

Hospital Universitario La Paz, Madrid, , Spain

HM Sanchinarro, Madrid, , Spain

Hospital Severo Ochoa, Madrid, , Spain

Hospital Regional Universitario de Malaga, Málaga, , Spain

Hospital Universitario de Navarra, Pamplona, , Spain

Royal Marsden NHS Foundation Trust, London, , United Kingdom

Royal Marsden NHS Foundation Trust, Sutton, , United Kingdom

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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