Personalized cancer treatment based on genomic analysis

Personalized OncoGenomics (POG) Program of British Columbia: Connecting Cancer Genomics to Cancer Care

This study is testing whether personalized cancer treatments based on each patient's unique genetic makeup can improve outcomes for people with advanced cancers.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 5000 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: British Columbia Cancer Agency (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Vancouver, British Columbia)
• Trial ID: NCT02155621 on ClinicalTrials.gov

What this trial studies

This program focuses on the genomic analysis of metastatic and advanced cancers to identify unique genetic drivers of each patient's cancer. By utilizing full genome sequencing, the study aims to match these genetic profiles with targeted therapies that may inhibit the identified pathways. The approach recognizes the complexity and variability of cancer behavior, allowing for personalized treatment strategies based on individual molecular signatures. The program builds on a successful pilot project that demonstrated the feasibility of this personalized approach in a clinical setting.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with measurable metastatic or advanced cancer who are fit for a therapeutic clinical trial.

Not a fit: Patients who do not have adequate archival tissue or cannot undergo a biopsy may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could lead to more effective and tailored cancer treatments for patients with advanced and metastatic cancers.

How similar studies have performed: Previous studies have shown success in using genomic profiling to guide targeted therapies in specific cancer subgroups, indicating a promising approach.

Eligibility criteria

Inclusion criteria:

1. Patients must agree to allow their archival specimens to be used and possibly completely depleted for these analyses.
2. Willing and able to have a study-specific biopsy or resection of the tumour or metastatic site OR if there is adequate archival material available, either fresh frozen or FFPE (if specimen is thought to be adequate) that is taken after the most recent chemo or radiation. Ideally this sample should have been collected within 16 weeks of the date of consent. If archival tissue is not adequate and if a biopsy is not feasible or deemed medically safe by the investigators the patient would become ineligible.
3. Patients must understand and agree to provide a blood test (or other sample of normal DNA) for germline genomic analysis.
4. ECOG PS 0 or 1.
5. Age \>/= 18 years.
6. Estimated life expectancy \>/= 6 months and high likelihood of being clinically fit for a therapeutic clinical trial in 3-6 months.
7. Measurable disease with RECIST v1.1 (or updated version).
8. Adequate organ function.
9. Patients must clearly understand that this data may be used to help guide treatment recommendations, including the avoidance of some therapeutic agents or the suggestion to use standard cytotoxic chemotherapy agents.
10. Willingness to have their de-identified genomic and clinical data shared with national and international research collaborators and data sharing platforms (as detailed in the consent form).
11. Willingness to be contacted for future studies based on the data that is generated by participation in POG; included in this is the anticipation that patient would be fit or a candidate for clinical trials.

Exclusion criteria:

1. Unable or unwilling to consent to the above tissue and blood requirements.
2. Significant medical condition that in the opinion of the treating or consenting oncologist and/or the POG central office review team renders the subject not suitable for participation. This includes the likelihood that a subject would be suitable for a clinical trial within 12 weeks after POG biopsy.
3. Unwilling or unable to provide treatment and outcome follow up information to the BC Cancer or affiliated investigators.
4. Unwilling to receive medically actionable findings (germline and/or somatic).

Where this trial is running

Vancouver, British Columbia

• BC Cancer Agency — Vancouver, British Columbia, Canada (Recruiting)

Study contacts

• Principal investigator: Janessa J Laskin, MD — British Columbia Cancer Agency
• Study coordinator: Janessa J Laskin, MD

Conditions Metastatic Cancers; Advanced Cancers; Cancers That Cannot be Treated With Curative Intent; cancer genomics; precision medicine; metastatic cancer; clinical decision-making