About this trial
The main idea of this study is that a low protein diet may alter the environment surrounding the tumor, enhancing the body's immune response leading to greater anticancer effects of treatment. This study intends to use a low-protein diet as a tool to enhance the immune response generated by immune check point inhibitor treatments.
Eligibility criteria
Qualifiers
Histologically documented solid tumor malignancies which is amenable for immunotherapy treatment with immune checkpoint inhibitors (i.e. PD1, PD-L1, CTLA inhibitors) as single agents or in combination.
Metastatic disease as evidenced by soft tissue and/or bony metastases on baseline bone scan and/or computed tomography (CT) scan of the chest, abdomen, and pelvis
Life expectancy of at least 6 months
Adults ≥ 18 years of age
Disqualifiers
• Eastern Cooperative Oncology Group (ECOG) performance status 2 or higher
Systemic corticosteroids; however, use of inhaled, intranasal, and topical steroids is acceptable.
High dose calcitriol [1,25(OH)2VitD] (i.e., > 7.0 μg/week)
A requirement for systemic immunosuppressive therapy for any reason
Trial design
Treatments tested in this trial
- Diet