| NCT ID | NCT04243720 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Health Network, Toronto |
| Condition | Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2020-08-26 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2020-08-26 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a prospective research study which will include patients who have progressed on immunotherapy as their most recent line of therapy. This study aims to characterize whether patients who fail to respond to immunotherapy versus patients who respond initially but after a period of time progress demonstrate different genomic, transcriptomic, epigenetic, immunophenotyping profiles. Patients will have a one-time fresh tumor biopsy. Serial blood samples (total amount of blood drawn may not exceed the lesser of 50 mL or 3 mL/kg in an 8 week period), archival tissue (if available) and one stool sample will be collected.
Eligibility Criteria
Inclusion Criteria: * Patients with a histological or cytological diagnosis of solid malignancies, with at least one tumor lesion amenable to core needle biopsy and consent to such a procedure. * Patients must have progressed on immunotherapy (defined as anti-PD1/PD-L1 antibodies given as monotherapy or as part of a combination therapy) as their most recent line of therapy. Patients will be classified into two groups: 1) those who benefitted from immunotherapy with either complete response (CR), partial response (PR) or prolonged stable disease (SD) lasting at least 6 months with subsequent progression or who had disease progression after at least 12 weeks from the last dose of immunotherapy in the adjuvant setting (i.e. acquired resistance), 2) those whose disease is primary refractory to immunotherapy with disease progression at their first on-treatment imaging, those who benefitted from immunotherapy with stable disease (SD) but progressed in \<6 months or those that had progressive disease earlier than 12 weeks from the last dose of immunotherapy in the adjuvant setting. * Patients must be of good performance status, ECOG 0-1, for subsequent anticancer therapy, with either standard treatment or within the context of a clinical trial. * Patients must be ≥ 18 years old. * Patients must have provided voluntary written informed consent. Exclusion Criteria: * Any condition that could interfere with a patient's ability to provide informed consent such as dementia or severe cognitive impairment. * Any contraindication to undergoing venipuncture. * Any condition that, in the opinion of the Investigator, would interfere with patient safety, or evaluation of the collected specimens and interpretation of study results.
Contact & Investigator
Lillian Siu, MD
PRINCIPAL INVESTIGATOR
Princess Margaret Cancer Centre
Frequently Asked Questions
Who can join the NCT04243720 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04243720 currently recruiting?
Yes, NCT04243720 is actively recruiting participants. Contact the research team at celeste.yu@uhn.ca for enrollment information.
Where is the NCT04243720 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT04243720 clinical trial?
NCT04243720 is sponsored by University Health Network, Toronto. The principal investigator is Lillian Siu, MD at Princess Margaret Cancer Centre. The trial plans to enroll 100 participants.
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