Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) Trial: Adaptive Clinical Treatment (ACT)
The purpose of this clinical research study is to learn if testing samples of your cancer can be used to find specific drugs or drug combinations that can help control your disease. The safety and tolerability of the drug or drug combination will also be studied.
To participate in this study, you will need to come to the Knight Cancer Institute at Oregon Health & Science University for study visits. While participating in the study, you may undergo tests and procedures at visits including physical exams, blood draws, CT/MRI scans, and ECGs.
There are two parts of this research study. The first part is called the pre-screening part; the second is called the main part. The pre-screening part of this study is to see if we can use a portion of your cancer tissue and blood to run tests to learn more about your disease and what abnormalities are unique to your cancer. Some of these test results may help your doctor to identify and recommend drug(s) that may be directed towards these abnormalities.
The SMMART ACT study consists of several drugs or drug combinations that may be given as an experimental treatment for your cancer. If, using the results of these tests, a drug recommendation matches one or more of the experimental anti-cancer drug(s) described in the SMMART ACT study then we may be able to offer you the recommended drug or drug combination as part of this study. You will have additional tests done to see if you can receive the study drugs. You will be asked to sign an informed consent form to participate in both parts of the study.
KEY INCLUSION CRITERIA:
* Participants must have a solid tumor malignancy that is metastatic, or locally-advanced and surgically unresectable, and have progression after at least 1 line of therapy. If recurrence occurred within 6 months of adjuvant/neoadjuvant therapy (last dose), that therapy would count as 1 line of therapy. Please contact study team to confirm which diseases are currently enrolling.
* Participants must have measurable disease as defined by RECIST v1.1.
* Participants must have a tumor lesion amenable to biopsy.
* Participants must receive a treatment recommendation based on SMMART clinical analytics results from biopsy that matches one or more ACT study interventions.
* Participants must stop prior therapies for cancer, including chemotherapy, radiotherapy, or immunotherapy for at least 21 days for myelosuppressive agents or 14 days for non-myelosuppressive agents prior to initiating assigned study intervention. Some exceptions may be permitted.
* ECOG performance status ≤2 and a physician assessed life expectancy of ≥6 months.
KEY EXCLUSION CRITERIA:
* Participants cannot have more than 1 intervening cancer therapy since the pre-screening biopsy. Note: Participants who have a pre-screening biopsy while receiving a standard of care treatment will not be eligible if they receive additional lines of treatment prior to starting SMMART-ACT treatment. This treatment will count as 1 line of intervening therapy.
* Participants cannot be pregnant or breast feeding.
* Participants cannot have any condition that, in the opinion of the investigator, could jeopardize the participant’s safety or adherence to the study protocol.
* Participants must meet any additional eligibility criteria specific to their disease or any drug-specific criteria based on the study intervention recommendation. Please contact study team to confirm current disease enrollment.
18 - 100
Healthy Volunteers Needed
Duration of Participation
If you are enrolled in the study, you will receive the experimental study drug(s) based on the recommendation. The study drugs may be given by vein, by mouth or by injection. Your participation will consist of about 3 clinic visits during the first 3 months and then once a month thereafter, but may be more frequent based on the study drugs and how you are doing. You will have radiology scans every 9-12 weeks to assess how your cancer is responding to the study drugs.
You may continue to receive the experimental study drug or combination as long as your cancer does not get worse, the side effects do not become too severe, you do not withdraw consent and your doctor believes it is in your best interest.
Once you stop taking the study drug(s), you will come to the study site for a follow-up visit about 30 days after your last dose of drug(s). After the follow-up visit, the study Investigator and study team will continue to check on how you are doing, and you may need to come to the study site periodically
OHSU Knight Cancer Institute