Each year, about 85,000 adolescents and young adults (AYA) between the ages of 15 and 39 are diagnosed with cancer in the United States. According to the National Cancer Institute, this represents about 4% of all new cancer diagnoses.
Depending on age and specific diagnosis, many AYA people with cancer may be treated at either a pediatric cancer center or an adult cancer center. However, often these patients don’t feel comfortable in either setting as they feel too old for settings gear toward young children, but too young in centers where most of the patients are elderly.
This population also must navigate challenges surrounding normal milestones for others their age, such as pursuing an education, establishing a career or creating a family. Additionally, financial instability and lack of insurance coverage often deter AYAs from seeking timely medical attention, further complicating their prognosis.
The Alliance for Clinical Trials in Oncology and the Alliance Foundation Trials (AFT) have several active trials specifically poised to help the AYA population as well as others open to people in the AYA demographic.
AYA Focused Trials
Alliance A232301CD : An enhanced ehealth and chat-bot enabled delivery model for clinical genetic services in community AYA cancer patients
Led by Angela Bradbury, MD, of the University of Pennsylvania Abramson Cancer Center, the AYA ACCESS study is enrolling cancer survivors to study methods to address longstanding gaps in genetic services for AYA, who often receive care in community settings with limited access to genetic specialists. Research shows that more than 10% of AYAs have familial predispositions to cancer in their DNA, yet many do not receive recommended genetic testing due to barriers such as geographic distance, lack of provider knowledge, and limited time for screening.
Alliance A041501: A phase III trial to evaluate the efficacy of the addition of inotuzumab ozogamicin (a conjugated anti-CD22 monoclonal antibody) to frontline therapy in young adults (ages 18-39 years) with newly diagnosed precursor B-Cell ALL
Led Daniel DeAngelo, MD, of the Dana-Farber Cancer Center, this phase III trial studies the side effects of inotuzumab ozogamicin and how well it works when given with frontline chemotherapy in treating patients aged 18 to 39 with newly diagnosed B acute lymphoblastic leukemia. Monoclonal antibodies, such as inotuzumab ozogamicin, may block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin with chemotherapy may work better in treating young adults with B acute lymphoblastic leukemia.
Alliance A092204: A phase II study of cabozantinib in combination with cemiplimab (cabo-cemiplimab) versus cabozantinib alone in adolescents and adults with advanced adrenocortical cancer
Bhavana Konda, MD, PhD, of The Ohio State Comprehensive Cancer Institute, leads this phase II trial open to patients aged 12 and older comparing the effect of giving cabozantinib with or without cemiplimab in patients with locally advanced adrenocortical cancer. Cabozantinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Alliance A151804: Establishment of a national biorepository to advance studies of immune-related adverse events
David Kozono, MD, PhD, of the Dana-Farber Cancer Institute, leads this trial to collect and study samples from patients who experience adverse events from immuno-oncology therapeutics. Open to children and AYA, this trial is collecting data on side effects to help researchers better understand how to predict, prevent, and treat these side effects.
Prevention Studies Open to AYA Patients
Alliance A212101 : Evaluation of provider vs. patient mediated cascade genetic testing of first-degree relatives of patients with newly diagnosed colorectal cancer
Heather Hampel, MS, CGC, of City of Hope, and Frank Sinicrope, MD, of the Mayo Clinic, lead this trial aiming to help improve how patients with colorectal cancer share information about genetic risks that can run in families. Understanding risks can help families get screening earlier, take preventive steps, and catch cancer sooner when it’s easier to treat. This study will enroll patients with colorectal cancer and their at-risk family members to compare whether it’s more effective for patients to speak directly with their family members to explain genetic risks and encourage genetic testing, or if it’s more effective for the communication to come from a healthcare provider.
Alliance A211901 : Reaching rural cancer survivors who smoke using text-based cessation interventions
Also called Project Reach, this phase III trial led by Devon Noonan, PhD, MPH, FNP-B, of Duke School of Nursing, compares the effect of text-based cessation intervention to a manual intervention to help cancer patients quit smoking cigarettes. This study is open to any cancer survivor.
Supportive Trial Open to AYA Patients
AFT A232403: Longitudinal screening for financial hardship to improve outcomes in patients with advanced cancer (PROOF)
Victoria Blinder, MD, MSc, of Memorial Sloan Kettering Cancer Center, leads this study for patients age 21 and older to determine if monthly remote digital financial hardship screening among people with advanced cancer helps improve survival outcomes. Financial hardship is a common problem affecting patients, especially AYA, often leading to poor outcomes related to financial worry, health related quality of life, symptom burden, treatment adherence and overall survival. This trial will use a screening intervention to see if patients connecting patients to financial navigation resources leads to improved health outcomes.
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The Alliance for Clinical Trials in Oncology is a national leader in advancing cancer research, uniting more than 25,000 cancer specialists at 115 main institutions and 1,400 affiliates centers across the U.S. and Canada. As part of the National Clinical Trials Network and a leading research base for the NCI Community Oncology Research Program, the Alliance conducts pioneering, practice-changing clinical trials that improve outcomes and reshape standards of care. Its work has led to multiple FDA approvals, influenced national guidelines, and produced hundreds of high-impact publications. More than 40,000 participants have taken part in Alliance studies, and its growing biospecimen repository now includes more than 1.5 million samples, collected over the past 30 years.