Large NCI-Funded Phase 3 Trial Tests Probiotic CBM588 With Immunotherapy in Advanced Kidney Cancer

A kidney cancer patient at University Hospitals Seidman Cancer Center in Cleveland will become the first participant in the first late-phase trial testing probiotics to amplify cancer treatment in the coming days. The multicenter study is testing CBM588, a strain of Clostridium butyricum, in nearly 700 people with advanced renal cell carcinoma who will swallow capsules along with immunotherapy.

The trial is funded by the National Cancer Institute.

Dr. ” The study follows a City of Hope study that found CBM588 improved outcomes in people with renal cell carcinoma who received immune-based treatment. Dr. Sumanta Pal led the City of Hope research and is a co-investigator on the new trial.

Dr. Marcel van den Brink was named president of City of Hope Cancer Center in Duarte in 2023. US Health and Human Services Secretary Robert F. Kennedy Jr. attended a research symposium at the center last month.

US National Institutes of Health Director Dr. ” A recent publication by the American Society of Clinical Oncology lists nearly 100 recent or ongoing studies testing ways to manipulate the gut microbiome to treat cancer. Dr.

Sumanta Pal began interest in the microbiome over a decade ago after talking with Dr. Paul Frankel, a biostatistician at City of Hope. Dr. Arielle Elkrief is co-director of the CHUM Microbiome Centre at the Montreal Cancer Institute.

After an intensive educational campaign launched in 2019 at CHUM, the proportion of lung cancer patients receiving antibiotics in the 30 days prior to starting immunotherapy fell from 20% to 5%. Dr. Marcel van den Brink and colleagues analyzed fecal samples from more than 1,300 people who received donor hematopoietic cell transplants and found dysbiosis was directly linked to likelihood of death.

Dysbiosis is also tied to lower survival rates in patients receiving their own hematopoietic cell transplants. A seminal 2021 paper by researchers at the University of Texas MD Anderson Cancer Center showed that for every 5-gram increase in fiber intake, the risk of cancer progression or death fell 30% in melanoma patients on treatment.

The surface area of the human intestine is about 20 times larger than the area covered by our skin.

The human intestine holds about a third of all the body’s T-cells and B-cells. City of Hope developed a new inpatient menu that includes fresh organic options such as beet salad topped with chicken. Kimberly Shipman, 60, was four weeks post-transplant for acute lymphocytic leukemia at City of Hope and ate an organic beet salad.

New patients at City of Hope meet with a nutritionist within three days of admission. Patients are told fruits and vegetables are fine as long as they are washed, but sprouts, blue cheese, and sushi are not recommended. Dr.

Robert Jenq was at MD Anderson when the 2021 fiber paper was published and is now director of the Microbiome Program at City of Hope. Certain gut bacteria metabolize fiber into short-chain fatty acids that improve T-cell survival and function, prevent harmful bacteria, nourish the colon lining, and suppress inflammation. Dr.

Jenny Paredes is a microbiologist in the van den Brink lab and is launching a trial providing dietary coaching, high-fiber meals, and tracking every bite eaten by hematopoietic cell transplant recipients for 100 days. Dr. Armin Rashidi is a hematologist and associate professor at the Fred Hutchinson Cancer Center.

He analyzed data from a study of 157 patients undergoing hematopoietic cell transplants who received either fecal microbiota transplants from screened healthy donors or a placebo. An earlier study by his team found that fecal microbiota transplants corrected dysbiosis but did not change the risk of infection.

Elkrief and colleagues at the CHUM Microbiome Centre combined immunotherapy with fecal transplants from healthy volunteers and doubled the number of lung cancer patients who responded to treatment; similar results were seen against melanoma.

The study was published in the journal Nature Medicine. At least 40 cancer trials testing versions of fecal microbiota transplants have been launched in the past few years. Ferring Pharma’s Rebyota is the first product to receive US Food and Drug Administration approval for fecal microbiota transplant and is designed to treat C.

Diff infection. Seres Pharmaceuticals has received an FDA fast-track designation to develop a product meant to reduce infections and graft-versus-host disease in hematopoietic cell transplant patients. Dr.

Marcel van den Brink has a financial stake in Seres Pharmaceuticals. Kanvas Biosciences is developing two synthetic fecal transplant products: one with 145 bacterial species modeled on a super-donor from MD Anderson and another with around 50 species from healthy donors with no overlap. Dr.

Matthew Cheng is CEO and co-founder of Kanvas Biosciences. In the 1990s, about a quarter of allogeneic hematopoietic cell transplant patients died from infections and other complications including graft-versus-host disease. CBM588 is already a popular dietary supplement in Japan sold over the counter for gastrointestinal complaints.

Poultry and livestock producers limit cleaning of litter when chickens are healthy and use probiotics or prebiotics such as inulin to boost Bifidobacteria. Expanded use of probiotics and prebiotics in agriculture coincided with new federal rules limiting unchecked antibiotic use. Heavy antibiotic use is independently associated with poor outcomes in cancer patients.

At CHUM Microbiome Centre, patients are not given antibiotics unless a bacterial infection is confirmed except in rare cases, and broad-spectrum antibiotics are avoided. Many leading cancer centers including City of Hope have developed a cautious approach to antibiotics.

For 20 years, hematopoietic cell transplant recipients were warned to avoid fresh fruits and vegetables and encouraged to consume high-calorie simple-sugar drinks.

City of Hope now runs a quarterly food pantry and has planted a garden where patients and staff can obtain fresh vegetables.