The Immune Effects of Fermented Wheat Germ Nutritional Supplementation in Patients With Advanced Solid Tumor Cancers Being Treated With Standard of Care Checkpoint Inhibitors

Must have received: checkpoint inhibitor — standard-of-care

solid tumor malignancies deemed appropriate to receive standard-of-care checkpoint inhibitor (CPi)-based therapy

Cannot have received: allogeneic bone marrow transplantation

Prior allogeneic bone marrow transplantation

Cannot have received: solid organ transplantation

Prior...solid organ transplantation

Cannot have received: chemotherapy

Exception: allowed if completed >= 2 weeks prior to cycle 1 day 1 (6 weeks for nitrosoureas or mitomycin C)

Chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to cycle 1 day 1

Cannot have received: radiotherapy

Exception: allowed if completed >= 2 weeks prior to cycle 1 day 1 (6 weeks for nitrosoureas or mitomycin C)

Chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to cycle 1 day 1

Cannot have received: herbal therapy intended as anticancer therapy

Exception: must be discontinued for at least 1 week prior to enrollment

Herbal therapy intended as anticancer therapy must be discontinued for at least 1 week prior to enrollment

Cannot have received: investigational agent

Treatment with any other investigational agent within 3 weeks

Cannot have received: systemic immunostimulatory agents (interferon-alpha, interleukin-2)

Exception: allowed if completed >= 6 weeks prior

Treatment with systemic immunostimulatory agents (for example, interferon [IFN]-alpha or interleukin [IL]-2) within 6 weeks prior

Cannot have received: immunosuppressive medications (corticosteroid, cyclophosphamide, azathioprine, methotrexate, thalidomide, calcineurin inhibitors, anti-TNF agents)

Exception: intranasal, inhaled, topical or local steroid injections; steroids as premedication for hypersensitivity reactions; systemic corticosteroid at physiologic doses not to exceed 10 mg/day of prednisone or equivalent; acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea); inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for orthostatic hypotension or adrenocortical insufficiency

Current or prior use of immunosuppressive medications (for example, corticosteroid, cyclophosphamide, azathioprine, methotrexate, thalidomide, calcineurin inhibitors, and anti-tumor necrosis factor [anti-TNF] agents) within 14 days prior to first dose of FWG

Cannot have received: bisphosphonate therapy for hypercalcemia

Exception: use for bone metastasis or osteoporosis is allowed

Patients taking bisphosphonate therapy for hypercalcemia. Use of bisphosphonate therapy for other reasons (e.g., bone metastasis or osteoporosis) is allowed

Cannot have received: live, attenuated vaccine

Administration of a live, attenuated vaccine within 4 weeks before cycle 1, day 1 or anticipation that such a live, attenuated vaccine will be required during the study and up to 5 months after the last dose of FWG

Cannot have received: live, attenuated influenza vaccine

Must not have received live, attenuated influenza vaccine within 4 weeks prior to cycle 1, day 1 or at any time during the study

Cannot have received: fermented wheat germ

Currently taking FWG

Cannot have received: checkpoint inhibitor

Exception: prior intolerance only

Prior intolerance to checkpoint inhibitor (CPi)-based therapies