Weill Cornell Medicine, in collaboration with the Moffitt Cancer Center in Tampa, Florida and the Universidade de São Paulo in Brazil, has been awarded a five-year, $8.3 million grant from the National Cancer Institute to investigate ways to prevent human papillomavirus (HPV)-related cancers in people living with human immunodeficiency virus (HIV) infection.
Together, investigators at these three institutions comprise the “Multinational Partnership to Prevent HPV-Associated Cancer in People Living with HIV: Brazil, Mexico, Puerto Rico,” or PHAC-BMPR, which is part of the National Cancer Institute’s U.S.-Latin American-Caribbean Clinical Trials Network (ULACNet). ULACNet brings United States institutions together with their counterparts in low- and middle-income countries in Latin America and the Caribbean—where there are large populations of people with HIV/AIDS and HPV-related cancers—to conduct multidisciplinary clinical trials.
The grant will fund work designing and implementing three clinical trials at the University of São Paulo, University of Puerto Rico and the Mexico National Institute of Public Health that focus on two forms of cancer that are associated with HPV, which is a sexually transmitted infection. The first, oropharyngeal cancer, forms in the tissues of the oropharynx, located at the back of the mouth behind the oral cavity. The second is cervical cancer, which occurs in cells of the cervix. Both cancers are caused by HPV infections, with rates of those cancers significantly higher among people living with HIV. New solutions for the prevention, screening and treatment challenges faced by these populations are urgently needed.
“What we learn and discover through this collaboration will be very beneficial for the Latin American and Caribbean populations that we’re studying, but it will also translate to a much broader area,” said co-principal investigator Dr. Timothy Wilkin, an associate professor of medicine in the Division of Infectious Diseases at Weill Cornell Medicine and infectious disease specialist at NewYork-Presbyterian/Weill Cornell Medical Center. Dr. Wilkin will work with co-PIs Dr. Anna Giuliano, the founding director of the Cancer for Immunization and Research in Cancer at the Moffitt Cancer Center, and Dr. Luisa Villa, an associate professor in the Department of Radiology and Oncology in the School of Medicine at the Universidade de São Paulo.
In the United States, HPV is thought to cause 70 percent of oropharyngeal cancers for which there are no proven prevention modalities. The first clinical trial will evaluate whether an existing HPV vaccine best known by the brand name Gardasil-9 can prevent oral HPV infections in men living with HIV. The investigators hope this study will lead to a new use for the vaccine for oropharyngeal cancer. “This trial has the ability to help far more people than just the men who participate in the study,” Dr. Giuliano said. “We are hoping this will open a larger conversation on vaccination strategies in the participating countries.”
The second clinical trial will focus on rapid “point-of-care” screening tests that occur at the time and place of patient care, to help detect cervical premalignant lesions. “In Latin America and many other countries, there are no organized screenings, just opportunistic screenings. As a result, cervical cancer incidence continues to be high, especially among women with HIV because their immune systems are suppressed,” Dr. Villa said. “I believe these point-of-care screening tests, which can be administered and interpreted in the clinic, will help us find those women who are at increased risk to develop cervical disease.”
The third clinical trial will evaluate the effectiveness of a novel therapeutic HPV vaccine for treating pre-malignant lesions of the cervix. Currently, these lesions are treated with surgical procedures. “Cervical cancer is the leading cause of cancer death in women living with HIV in Latin American and Caribbean countries, despite being preventable with proper screening and vaccination,” said Dr. Wilkin. “The results of our clinical trials could help form new methods and interventions that can decrease the incidence cervical cancer in these countries, and around the globe.”