Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial

Summary

Participation Requirements

Description

PRIMARY OBJECTIVE: I. To determine the feasibility of implementing an individualized treatment strategy for advanced solid tumor and hematological malignancies based upon a comprehensive assessment of tumor and patient characteristics. SECONDARY OBJECTIVES: I. To describe the tolerability of impleme...

PRIMARY OBJECTIVE: I. To determine the feasibility of implementing an individualized treatment strategy for advanced solid tumor and hematological malignancies based upon a comprehensive assessment of tumor and patient characteristics. SECONDARY OBJECTIVES: I. To describe the tolerability of implementing an individualized treatment strategy, particularly by measuring unanticipated toxicity associated with the administration of different combinations of two therapeutic agents given to an individual participant. II. To assess the duration of treatment for participants receiving Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART)-PRIME Therapy #1. III. To determine overall survival of participants with advanced solid tumors and hematological malignancies. IV. To determine the time to decline in a participant's ability to perform activities of daily living. EXPLORATORY OBJECTIVES: I. To measure quality of life among enrolled participants. II. To evaluate immune-mediated tumor response among participants receiving an immunomodulatory study drug. III. To determine the rates of response and benefit to SMMART-PRIME Therapy #1, as an individualized treatment strategy for participants with advanced solid tumor and hematological malignancies. IV. To determine the progression-free and disease-free survival of participants with advanced solid tumors and hematological malignancies. OUTLINE: TUMOR BIOPSY: Patients undergo collection of tissue samples. Clinical analytics are performed on the samples and analyzed by a clinical tumor board to recommend a treatment option based on those analytics. The findings from these Clinical Study Analytics are intended to provide the basis for selection of two drugs that, when administered in combination, provide an optimal and individualized treatment approach. This may or may not include a SMMART-PRIME treatment. The decision to initiate any SMMART-PRIME Therapy ultimately resides with the treating physician in conjunction with the study participant. SMMART-PRIME TREATMENT: Patients receive a combination of 2 drugs (Drug A and Drug B, selected from interventions below). Doses will be escalated within individual patients over time. As described in detail below, escalation will occur on a monthly basis and is anticipated to occur as follows: first month -- 100% Food and Drug Administration (FDA) approved dose Drug A + 25% FDA approved dose Drug B; second month -- 100% dose Drug A + 50% dose Drug B; third month -- 100% dose Drug A + 100% dose Drug B. All dose-escalations will be reviewed and approved by an independent consultant outside of Oregon Health & Science University (OHSU). Treatment will continue for up to the end of 6 treatment cycles (cycle length is between 21-28 days) in the absence of disease progression or unacceptable toxicity. Patients whose treatment is discontinued as a result of excess toxicity or lack of efficacy may switch to a different combination of drugs. Beyond six cycles, participants will be considered off-protocol directed treatment, and will move into long term follow-up. After completion of study treatment, patients are followed for up to 5 years.

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