Molecularly Matched Therapy for Cancer
(STRIPe Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether drugs tailored to specific DNA mutations in tumors can better treat adults with metastatic solid cancers compared to standard treatments. The goal is to determine if these personalized drugs can slow tumor progression for a longer period. Participants will receive either molecularly matched therapy (personalized treatment) or regular care, with clinic visits every two months for checkups and scans. This trial may suit individuals whose cancer has spread, have had up to two previous treatments, and possess a tumor with specific DNA changes recommended for treatment by a Molecular Tumor Board. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to benefit from cutting-edge personalized therapies.
Do I need to stop my current medications to join the trial?
Yes, you will need to stop taking any prior antibody therapy for at least 3 half-lives and other anti-tumor agents for at least 5 half-lives, or a total of 3 weeks from the last day of treatment, whichever is shortest.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that treatments tailored to specific DNA changes in a tumor are generally well-tolerated by patients. For instance, a study with patients in the late stages of cancer found that this personalized approach could be safely managed. Another study reported that 210 patients who received at least one FDA-approved drug as part of their customized treatment experienced manageable side effects. These findings suggest that this type of therapy has a promising safety record in human studies, making it a potential option for those considering joining clinical trials.12345
Why do researchers think this study treatment might be promising?
Unlike the standard of care treatments that generally apply a one-size-fits-all approach, molecularly matched therapy is tailored to the specific molecular profile of a patient's tumor. This personalized treatment targets the unique genetic mutations driving the cancer, potentially leading to more effective outcomes. Researchers are excited about this approach because it promises to increase precision in targeting cancer cells while minimizing damage to healthy cells, potentially reducing side effects compared to conventional therapies.
What evidence suggests that this trial's treatments could be effective for metastatic solid cancers?
Research shows that treatments specifically matched to the DNA changes in a tumor can effectively treat advanced solid cancers. In this trial, participants will receive either molecularly matched therapy based on their tumor's molecular profile or standard care treatment. Studies have found that patients receiving these personalized treatments often experience better results. For example, one study found that patients on matched therapy had a longer period before their treatment stopped working, about 3.9 months, compared to 2.4 months for those on standard treatments. Another study showed that personalizing treatments based on the tumor's DNA profile improved overall survival. These findings suggest that targeting specific DNA changes in tumors can slow cancer progression more effectively than standard treatments.36789
Who Is on the Research Team?
Jason K. Sicklick, MD
Principal Investigator
University of California, San Diego
Are You a Good Fit for This Trial?
Adults with metastatic or unresectable solid cancers, who have had up to two prior cancer treatments and a life expectancy of 6-16 months. They must have tumors with specific DNA mutations that can be targeted by drugs recommended by a Molecular Tumor Board, based on recent tumor imaging and molecular profiling.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive drugs matched to tumor DNA mutations or standard of care drugs based on the regular dosing schedule
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Molecularly matched therapy
Trial Overview
The trial is testing if using drugs tailored to match patients' tumor DNA mutations is more effective in delaying cancer progression than standard cancer care. Patients will receive either the matched therapy or standard treatment and undergo regular checkups and tumor imaging every two months.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Molecularly matched therapy based on tumor's molecular profile.
Standard of care treatment.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Diego
Lead Sponsor
Citations
Systematic review and meta-analysis of molecular tumor ...
Of these, 20.8% (2,532 patients) received MTB-recommended therapies, with 178 outcome measures reported, achieving a median overall survival (OS) ...
Genomic actionability and matched targeted therapy in a ...
However, the data reveal a particularly high efficiency in trial matching for lung cancer, which accounted for 10.3% of the total patient ...
Molecular Profiling to Match Individually Dosed, ...
Better outcome correlated with how well treatments matched molecular alterations, but not the number of drugs or starting doses.
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targetedonc.com
targetedonc.com/view/impact-study-shows-benefit-of-matched-targeted-therapies-for-hardtotreat-cancersIMPACT Study Shows Benefit of Matched ...
According to findings of the IMPACT study discussed at the 2018 ASCO Annual Meeting, overall survival was improved with personalized therapy ...
Measuring the Value of Matched Therapy
In the study, patients who were matched with a targeted therapy experienced a mean TTF of 3.9 months, compared to 2.4 months for patients who ...
Patient Outcomes in End-Stage Cancer - The MetAction ...
Here, we employed it to identify molecularly matched therapy and recorded outcome in end-stage cancer (2016-2019).
patient outcomes in end-stage cancer – the MetAction study
The TARGET study in theUnited Kingdom analyzed patients'circulating tumor DNA astemplate for molecularly matched therapy and resulted in ORRof 36% for treated ...
N-of-1 Tailored Combination Therapy Matched to the ...
Overall, 210 evaluable of 456 consented patients received ≥1 drug approved by FDA (mostly off label) after NGS. Median number of pathogenic ...
Molecularly matched therapy in the context of sensitivity ...
Here, we employed it to identify molecularly matched therapy and recorded outcome in end-stage cancer (2016–2019).
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