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

Inclusion Criteria:

• Histologically or cytologically confirmed non small cell lung carcinoma (NSCLC),renal cell carcinoma (RCC), melanoma, colorectal carcinoma (CRC) and triple-negativebreast cancer (TNBC) solid tumor malignancies deemed appropriate to receivestandard-of-care checkpoint inhibitor (CPi)-based therapy

• Age >= 18 years of age at time of consent

• Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)

• Life expectancy of greater than 6 months

• Women of child-bearing potential must agree to use adequate contraception (hormonalor barrier method of birth control; abstinence) for the duration of studyparticipation (including dosing interruptions) and for 5 months (150 days) after thelast dose of study agent. Women must agree to refrain from egg donation during thistimeframe

• Male subjects must agree to employ an effective method of birth control startingdose from cycle 1 day 1, including dosing interruptions through 90 days afterreceipt of the last dose of fermented wheat germ (FWG). Male subjects must agree torefrain from sperm donation while taking FWG during study treatment for at least 90days after the last dose of FWG

• Ability to understand and the willingness to sign a written informed consentdocument

• Must be able to swallow study treatment

Exclusion Criteria:

• Prior allogeneic bone marrow transplantation or solid organ transplantation

• Chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycinC) prior to cycle 1 day 1. However, the following therapies are allowed: *Hormone-replacement therapy or oral contraceptives * Herbal therapy intended asanticancer therapy must be discontinued for at least 1 week prior to enrollment)

• Any subject who have not recovered to at least grade 2 from adverse events (otherthan alopecia) due to agents administered more than 2 weeks earlier. Treatment withany other investigational agent within 3 weeks

• Currently taking FWG

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

• 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 doseof FWG. The following are exceptions to this criterion: * Intranasal, inhaled,topical or local steroid injections (e.g., intra-articular injection); steroids aspremedication for hypersensitivity reactions; systemic corticosteroid at physiologicdoses not to exceed 10 mg/day of prednisone or equivalent may be enrolled * Patientswho have received acute, low dose, systemic immunosuppressant medications (e.g., aone-time dose of dexamethasone for nausea) may be enrolled * The use of inhaledcorticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients withorthostatic hypotension or adrenocortical insufficiency is allowed

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

• Known history of allergic reactions or sensitivity attributed to compounds ofsimilar chemical or biologic composition to the study agent (e.g., gluten)

• Active or prior documented autoimmune or inflammatory disorders (includinginflammatory bowel disease [e.g., colitis, Crohn's disease], diverticulitis with theexception of a prior episode that has resolved or diverticulosis, celiac disease,irritable bowel disease, or other serious gastrointestinal chronic conditionsassociated with diarrhea; systemic lupus erythematosus; Wegener's syndrome [granulomatosis with polyangiitis]; myasthenia gravis; Graves' disease; rheumatoidarthritis; hypophysitis; uveitis; etc.) within the past 3 years prior to the startof treatment. The following are exceptions to this criterion: subjects with vitiligoor alopecia; subjects with hypothyroidism (e.g., following Hashimoto syndrome)stable on hormone replacement; or subjects with psoriasis not requiring systemictreatment

• History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced),organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizingpneumonia, etc.), or evidence of active pneumonitis on screening chest computedtomography (CT) scan.History of radiation pneumonitis in the radiation field (fibrosis) is permitted * Patients with a history of autoimmune hypothyroidism on astable dose of thyroid replacement hormone are eligible * Patients with controlledtype 1 diabetes mellitus on a stable insulin regimen are eligible

• Patients with known active tuberculosis

• Major surgical procedure within 28 days prior to cycle 1, day 1 or anticipation ofneed for a major surgical procedure during the study

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

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

• Uncontrolled intercurrent illness including, but not limited to, ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris, cardiacarrhythmia, or psychiatric illness/social situations that would interfere withpatient safety or limit compliance with study requirements

• Female subjects who are pregnant or breast-feeding

• Any condition that would prohibit the understanding or rendering of informed consentin the opinion of the investigator

• Prior intolerance to checkpoint inhibitor (CPi)-based therapies

• Any medical condition that in the opinion of the investigator would interfere withthe patient's safety or compliance while on trial