Real-world Trial of Individualized Precision Oncology
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Diego
About this trial
The goal of this clinical trial is to learn if drugs that are matched to tumor DNA mutations work to treat metastatic solid cancers in adults. The main questions it aims to answer are:
Is tumor worsening delayed for a longer period of time if patients take drugs that match DNA mutations, compared to if they take standard of care drugs?
Researchers will compare drugs matched to tumor DNA mutations to standard of care drugs to see if the matched drugs work better, and to see if tumor worsening can be delayed for longer the more DNA mutations the drugs target.
Participants will:
Take drugs matched to tumor DNA mutations or standard of care drugs based on the regular dosing schedule of the drugs.
Visit the clinic every approximately 2 months for checkups and tumor imaging.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provision of signed and dated informed consent form.
Stated willingness to comply with all study procedures and availability for the duration of the study.
Aged at least 18 years.
Metastatic or unresectable solid cancers (all) with a 2-year cancer-associated mortality of ≥ 50%, or immediate prior progression free survival < 4 months, or life expectancy between 6 and 16 months as determined at prescreening and/or enrollment due to cancer diagnosis.
Disqualifiers
Presence of very high tumor mutational burden as ≥ 20 mutations/megabase.
Presence of a microsatellite instability-high as defined by the testing laboratory.
Deficiency of mismatch repair genes: MLH1, MSH2, MSH6, or PMS2.
Molecular Tumor Board treatment recommendation is a monotherapy with an immune checkpoint inhibitor.
Trial design
Design model
Parallel
Treatments tested in this trial
Molecularly matched therapy
DrugMolecularly matched therapy, as identified by a molecular tumor board, to match molecular alterations/biomarkers found in the tumor or circulating tumor DNA.
Standard of care
DrugStandard of care therapy for the tumor type.
Treatment groups
280 Participants
are divided into 2 treatment groupsGroup A: Molecularly matched therapyExperimental treatment 1 intervention
Group B: Standard of careActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Progression free survival
Duration of time from randomization until objective tumor progression, clinical progression, treatment discontinuation due to inability to tolerate study therapy, or death from any cause.
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: