Molecular Profiling for Biliary Tract Cancer

(COMPASS-B-MUHC Trial)

Overseen By George Zogopoulos, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Must be taking: Gemcitabine-based regimens

Disqualifiers: Brain metastases, Uncontrolled illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 years

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Biliary tract cancer (BTC) accounts for \<1% of all cancers, but remains a highly fatal malignancy. Surgical resection is the only hope for cure, but most patients present with advanced disease when curative-intent surgery is not possible. The therapeutic options for patients with advanced disease are limited, primarily to chemotherapeutic regimens, which are based on empiric evidence without the use of biomarkers. These current treatment strategies have been largely ineffective in controlling the disease, resulting in poor survival outcomes of less than 1 year. An understanding of the molecular characteristics of biliary tract cancer may enable stratification of patients into therapies that target specific molecular alterations with greater efficacies and improved clinical outcomes. This study aims to investigate the feasibility and clinical utility of prospective molecular profiling of advanced biliary tract cancer. The primary endpoint of this study is to demonstrate the feasibility of returning whole genome sequencing results within 8 weeks of tumour biopsy for second-line treatment consideration (n=30 patients). In parallel, tumour whole transcriptome sequencing will be performed to identify actionable molecular alterations (e.g., fusion transcripts). Once the primary endpoint is met, the study will be expanded. Current funding allows expansion to 40 patients in total.

Are You a Good Fit for This Trial?

This trial is for adults with advanced biliary tract cancer that can't be removed by surgery. They must have a measurable tumor, understand and sign consent, have an ECOG status ≤1 (which means they are able to walk and capable of all self-care), expect to live more than 90 days, and have normal organ/marrow function. They should've had gemcitabine-based treatment first without success.

Inclusion Criteria

I am receiving or will receive gemcitabine as my first treatment.

Ability to understand and willing to sign a written informed consent document

I have a tumor that can be measured and another that can be biopsied.

Exclusion Criteria

Any other condition that would contraindicate the patient's participation due to safety concerns or compliance with clinical study procedures

I have cancer that has spread to my brain.

I have not received chemotherapy or other cancer treatments in the advanced stage.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Molecular Profiling

Tumour biopsy is performed for whole genome and transcriptome sequencing to identify actionable molecular alterations

8 weeks

Treatment

Chemo-naive patients receive first-line gemcitabine-based chemotherapy or an investigational drug

4 years

Follow-up

Participants are monitored for disease control, progression-free survival, and overall survival

4 years

What Are the Treatments Tested in This Trial?

Interventions

• Tumour and germline molecular profiling

Trial Overview The study tests the process of molecular profiling on tumors from patients with advanced biliary tract cancer. It aims to return whole genome sequencing results within 8 weeks after biopsy for second-line treatment consideration. The goal is to find specific molecular changes in the cancer that could lead to more effective treatments.

How Is the Trial Designed?

Group I: Individuals with advanced biliary tract cancer Experimental Treatment 1 Intervention

Following a tumour biopsy for molecular profiling, chemo-naive patients with advanced biliary tract cancer will receive first-line gemcitabine-based chemotherapy or an investigational drug on a participating clinical trial.

Who Is Running the Clinical Trial?

McGill University Health Centre/Research Institute of the McGill University Health Centre

Lead Sponsor

Trials

476

Recruited

170,000+

Cancer Research Society

Collaborator

Trials

8

Recruited

5,400+

Cancer Research Society

Collaborator

Trials

6

Recruited

650+