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This phase III trial compares pembrolizumab with radiation therapy to pembrolizumab without radiation therapy (standard therapy) given after pembrolizumab plus chemotherapy for the treatment of patients with squamous cell carcinoma of the head and neck that has spread from where it first started (primary site) to other places in the body (metastatic). Pembrolizumab is a type of immunotherapy that stimulates the body's immune system to fight cancer cells. Pembrolizumab targets and blocks a protein called PD-1 on the surface of certain immune cells called T-cells. Blocking PD-1 triggers the T-cells to find and kill cancer cells. Radiation therapy uses high-powered rays to kill cancer cells. Giving radiation with pembrolizumab may be more effective at treating patients with metastatic head and neck cancer than the standard therapy of giving pembrolizumab alone.

Drug shows safety, efficacy for precancerous stomach lesions

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An early-stage clinical trial, supported by the Department of Defense, has demonstrated that the targeted cancer drug trametinib shows potential as an interventional therapy to reprogram precancerous gastric lesions, potentially preventing them from becoming malignant, and that it can be administered safely.

The results of the Phase 1 trial involving 15 patients, which were published recently in Gastroenterology, were pleasantly surprising, said James Goldenring, MD, PhD, professor of Surgery and of Cell and Developmental Biology at Vanderbilt University Medical Center.

The primary goal of this trial was to evaluate whether a low-dose, limited duration treatment of two weeks with trametinib would be safe for patients at risk for developing a second cancer after having undergone resection of a Stage 1 gastric cancer. The drug also showed promise that it could be the first therapeutic intervention against precancerous lesions in the stomach.

Endoscopies revealed that trametinib reversed metaplasia, which is an abnormal change of cells into ones that are non-native to the tissue and can progress to dysplasia, an irreversible change in cell development that can lead to cancer. While the 15 patients in the study had no evidence of recurrent cancer, they did have extensive metaplasia when they entered the study.

“I was pleasantly surprised at how much benefit we could see in the endoscopies after one month and one year; it really was pretty remarkable,” said Goldenring, the Paul W. Sanger Professor of Experimental Surgery.

The reversal of the metaplasia could be viewed in endoscopic images and was confirmed with biopsies.

“I think that’s almost more compelling than anything else in this study,” Goldenring said. “I honestly did not expect endoscopies to be that different, but they were.”

However, he noted that follow-up clinical trials with more participants are needed to further validate the drug’s efficacy. The only significant side effect among the participants was one patient with a mild increase in blood pressure after trametinib treatment that returned to normal after the patient stopped taking the drug.

The patients in the study were recruited from Japan, where the clinical trial was led by Sachiyo Nomura, MD, PhD, in collaboration with Goldenring. Trametinib is an inhibitor of the MEK signaling pathway. MEK, an abbreviation for the mitogen-activated extracellular signal-regulated kinase pathway, plays an integral role in the development of stomach cancer.

The study was supported by a $2.5 million Department of Defense Translational Team Science Award, which is also supporting another clinical trial in the United States with similar aims. The U.S. clinical trial will evaluate the effectiveness of pyrvinium, an existing medicine that has been used for the past 70 years to treat pinworms in children, for a new purpose — reversing metaplasia of stomach cells and killing dysplastic precancerous cells. Pyrvinium also blocks the MEK pathway.

While stomach cancer is one of the three leading causes of cancer-related deaths worldwide, its incidence is lower is the U.S. Nevertheless, it does occur more frequently among minority ethnic groups, and incidence has been rising among young women. DOD support for clinical trials reflects the increased incidence of stomach cancer in minority groups, which make up a higher percentage of the U.S. armed services than of the general population. In the U.S., most stomach cancers are diagnosed at late stages when they are more difficult to treat.

Goldenring said he hopes the MEK inhibitor study will spur more research into therapeutic interventions for people with precancerous lesions who are at high risk for cancer.

“I’m hoping that this is a direction that multiple researchers might take in the future to really change the dynamics of how we’re going to intervene so that people don’t develop cancer,” he said. “That’s a different mindset than we’ve had previously.”

Eunyoung Choi, PhD, associate professor of Surgery and of Cell and Developmental Biology, is a co-principal investigator of the pyrvinium study along with Katherine Garman, MD, associate professor of Medicine at Duke University. Choi is also a co-author of the study published in Gastroenterology.

Goldenring is supported by grants from the Department of Defense, a Department of Veterans Affairs Merit Review Award, and the National Institutes of Health (R01DK101332 and R01CA272687. Choi is supported by grants from the National Institutes of Health (R37CA244970 and R01CA272687), the Department of Defense, the American Association for Cancer Research, and an American Gastroenterological Association Robert & Sally Funderburg Research Award.

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This phase I/II trial studies the side effects and best dose of temozolomide and M1774 and how well they works in treating patients with cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and may have spread to nearby tissue, lymph nodes, or distant parts of the body (advanced). Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill tumor cells and slow down or stop tumor growth. M1774 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Adding M1774 to temozolomide may shrink or stabilize cancer for longer than temozolomide alone.
This phase II trial tests whether loncastuximab tesirine works to shrink tumors in patients with marginal zone lymphoma (MZL), a type of immune cell cancer, that has come back (relapsed) or become unresponsive to one or more treatments (refractory). Loncastuximab tesirine is composed of an antibody, called loncastuximab linked to a chemotherapy drug called tesirine. Loncastuximab attaches to specific proteins in the cancer cell and delivers tesirine only to the cancer cells because of this antibody. Ultimately this results in cancer cell death only without exposing normal cells to the tesirine.

The real MVP: Fitness challenge raises funds in honor of 4-year-old cancer patient

When 4-year-old Monroe Peterson was diagnosed with cancer, her family was determined to not only rally around her in support but also wanted to make a difference for other patients and families going through a similar experience.

To honor her journey, in November 2024 Monroe’s father, fitness expert and celebrity trainer Gunnar Peterson, started the MVP Challenge on his app, Common Ground, to raise awareness and funds for pediatric cancer efforts at Monroe Carell Jr. Children’s Hospital at Vanderbilt.

The MVP Challenge, named for Monroe Vivian Peterson, included four weeks of guided workouts, question and answer sessions with Gunnar, and an opportunity to win special prizes. The fitness challenge raised funds to support pediatric cancer research, training and care at Monroe Carell.

“For months, Monroe has faced this battle with more grit, determination and positivity than I’ve ever seen,” said Peterson. “She hasn’t backed down; she doesn’t quit; and she moves forward with a smile on her face every day. To honor her strength, we launched the MVP Challenge as a way to come together as a community, push ourselves and raise funds to support children’s cancer treatment and research.”

Monroe Peterson with her mother, Jessica, left, and Debra Friedman, MD, MS.
Monroe Peterson with her mother, Jessica, left, and Debra Friedman, MD, MS.

Monroe was diagnosed with acute myeloid leukemia and completed two rounds of chemotherapy. She received two bone marrow transplants, one from each of her older brothers, and she is now in remission.

During her treatment, Monroe’s family says that she brought positivity, joy and levity to those around her and earned the nickname MVP. Many family members, friends and community members came together in support of the challenge to make it a success.

“We are blown away by the incredible success of the MVP Challenge and know that it would not have been possible without the advocacy, outreach and community engagement work of Gunnar, Jess and the whole Peterson family,” said Debra Friedman, MD, MS, director of the Division of Pediatric Hematology and Oncology at Monroe Carell, deputy director of Vanderbilt-Ingram Cancer Center, and holder of the E. Bronson Ingram Chair in Pediatric Oncology. “This challenge was a wonderful way to honor Monroe’s journey and tenacious spirit.”

Funds raised from the MVP Challenge will support Monroe Carell’s vision to advance personalized pediatric, adolescent and young adult cancer care in the region, specifically leukemia and stem cell research.

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A Global Study of Volrustomig (MEDI5752) for Participants With Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma Following Definitive Concurrent Chemoradiotherapy

The main purpose of this study is to assess the efficacy and safety of volrustomig compared to observation in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not progressed after receiving definitive concurrent chemoradiotherapy (cCRT).

ALTE2131 Triptorelin and Protection of Ovarian Reserve in Adolescents and Young Adults with Cancer an NCORP Phase 3 Study

A Randomized Phase III Study of BRAF-Targeted Therapy vs Cabozantinib in RAI-Refractory Differentiated Thyroid Cancer with BRAF V600Em

Study shows sharp increase in appendix cancer for Generation X and millennials 

Cases of appendiceal cancer tripled for Americans born between 1976 to 1984 and quadrupled for those born between 1981 to 1989, according to a study published June 9 in the Annals of Internal Medicine. 

The study compared chronological data in five-year intervals from the National Cancer Institute’s Surveillance, Epidemiology and End Results (SEER) Program, using 1941 to 1949 as the baseline. The lead author, Andreana Holowatyj, PhD, MSCI, assistant professor of Medicine at Vanderbilt University Medical Center and Vanderbilt-Ingram Cancer Center, said the findings reveal the need for increased awareness about appendiceal cancer from both clinicians and the public as well as more research to determine the reasons for the sharp spike in incidence.  

Andreana Holowatyj, PhD, MSCI

“When you take these alarming rates that we are seeing for appendiceal cancer across generations, together with the fact that 1 in every 3 patients diagnosed with appendiceal cancer is diagnosed under the age of 50, these point to a timely need for everyone to be aware of the signs and symptoms of appendix cancer.

“Albeit cancer of the appendix is rare, it is important for individuals who have these symptoms to see a health care professional. Ruling out the possibility of an appendix cancer diagnosis, or diagnosing it early, is important for this cancer as we continue to learn what factors may be contributing to this worrisome trend,” Holowatyj said.

Symptoms may include abdominal pain, bloating, changes in bowel habits, and loss of appetite. 

Appendiceal cancer is a rare cancer with about 3,000 new cases diagnosed every year in the United States, according to prior studies, but Holowatyj and colleagues took a closer look at statistics by combing through the SEER database. 

“As incidence rates in younger generations are often indicative of future disease burden, these results support the need for histology-specific investigations of appendiceal adenocarcinoma, as well as increased education and awareness of appendiceal adenocarcinomas among health care providers and the public,” the study stated. 

Appendiceal cancer has had no standardized screening guidelines, risk factors or tumor classifications — a lack of clinical evidence that has resulted in late diagnosis and poor prognosis. Up to 1 of every 2 patients is diagnosed with distant metastatic disease, and five-year survival rates vary between 10% and 63%.  

Earlier this year, Holowatyj and a team of experts identified six key research priority areas to deliver a fundamental understanding of appendiceal tumors and to improve treatments and outcomes for patients.  

The recommendations published Feb. 20 in Nature Reviews Cancer are the result of a concerted focus by the Appendix Cancer Pseudomyxoma Peritonei (ACPMP) Research Foundation to better understand the disease that afflicts an estimated 3,000 new patients across all age groups each year. 

The recommendations arose from the inaugural ACPMP Research Foundation Scientific Think Tank, sponsored by ACPMP and chaired by Holowatyj at Vanderbilt-Ingram Cancer Center in December 2023. 

The current study in the Annals of Internal Medicine received support from ACPMP and the National Institutes of Health (grants K12HD043483 and P50CA236733). 

Other authors on the study are Mary Kay Washington, MD, PhD, professor of Pathology, Microbiology and Immunology at VUMC, Richard Goldberg, MD, of the West Virginia University School of Medicine, and Caitlin Murphy, PhD, MPH, of the UT Health Houston School of Public Health. 

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