Recurrent Ovarian Carcinoma Clinical Trial
Official title:
Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) Trial: Adaptive Clinical Treatment (ACT)
SMMART-ACT is a feasibility pilot study to determine if testing samples from a participant's cancer using a precision medicine approach can be used to identify specific drugs or drug combinations that can help control their disease. The safety and tolerability of the drug or drug combination is also to be studied. Another purpose is for researchers to study tumor cells to try to learn why some people respond to a certain therapy and others do not, and why some cancer drugs stop working. The study population will include participants with advanced breast, ovarian, prostate, or pancreatic malignancies, or sarcomas.
PRIMARY OBJECTIVE: I. Feasibility of utilizing a SMMART-ACT Tumor Board to select personalized advanced cancer treatment plans based on a pre-determined set of drug agents with recommended phase 2 doses (RP2Ds). SECONDARY OBJECTIVES: I. Safety and tolerability of assigned ACT intervention per cancer type; II. Preliminary indications of efficacy based on disease-specific responses; and. III. Estimated survival benefit per cancer type. EXPLORATORY OBJECTIVES: I. Durability of a response compared to the most recent therapy on which progression occurred. II. Changes in ability to conduct activities of daily living (ADL). III. Changes in quality of life (QOL). IV. Feasibility of SMMART centric assessments of ongoing responses to treatment to identify mechanisms of therapy induced change, per investigator discretion. Such mechanisms may include, but will not be limited to, the following: IVa. Changes in tumor and tumor ecosystem biology; IVb. Response and resistance to therapy. OUTLINE: PRE-SCREENING: Participants undergo a screening biopsy and blood collection for review and assessment of their tumor, utilizing one or more of the SMMART-Clinical Analytics Platform (SMMART-CAP) assays. The clinical assays may be used to provide an optimal and individualized treatment approach which may or may not include a SMMART-ACT treatment regimen. SMMART-ACT TREATMENT: Prior to enrollment, participants must receive a treatment recommendation, via a SMMART-ACT Tumor Board, that consists of one or more of the pre-defined SMMART-ACT treatment regimen options. Participants are considered enrolled in SMMART-ACT if they receive a targeted SMMART-ACT treatment regimen, which may be administered in monotherapy or in combination with other targeted agents or immunotherapies, chemotherapies, or radiation. A combination treatment plan may include a two-week monotherapy lead-in, followed by a combination treatment regimen. Regardless of overall recommended treatment plan details, each SMMART-ACT study intervention must have an established RP2D that was determined in a prior clinical trial. All participants are required to undergo an On-Treatment Biopsy after two weeks on the first dose of study drug(s), and before starting Cycle 2, regardless of whether the participant is on a monotherapy, monotherapy-induction or combination regimen. Participants will continue to receive the study agent(s) after their On-Treatment Biopsy according to the biopsy results and the results of ongoing safety and clinical assessments. Treatment cycles repeat every 21 to 28 days in the absence of disease progression or unacceptable toxicity. Cycles are determined based on the study agent(s). Upon disease progression, participants are given the option to undergo an additional repeat biopsy. Participants completing study treatment due to disease progression are followed every 3 months for 1 year, then every 6 months for 5 years. Participants completing study treatment without disease progression are followed every 6-12 weeks for up to 5 years or until disease progression, start of a new therapy, withdrawal from the study, or death, whichever occurs first. ;
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