Comparing 3 approaches for cancer

Inclusion

• +Patients must have histologically and/or cytologically confirmed solid tumour, that is advanced/ metastatic/recurrent or unresectable and for which no curative therapy exists.
• +Women/men of childbearing potential must have agreed to use a highly effective contraceptive method
• +Immune-related adverse eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → must have resolved to ≤ grade 1 or baselineBaselineYour starting measurements, taken before treatment begins.Read more → and patient must have completed corticosteroid therapy at least 28 days prior to registration in this current study.
• +Patients must have a life expectancy of at least 12 weeks.
• +Presence of clinically and/or radiologically documented disease. All radiology studies must be performed within 28 days prior to enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → (within 35 days if negative). Patients ideally should have measurable disease.
• +Previous Therapy
• +Two weeks;
• +5 half-lives for investigational agents;
• +Standard cycle length of standard therapies.
• +Absolute neutrophils ≥ 1.5 x 10\^9/L
• +Platelets ≥ 100 x 10\^9/L
• +Hemoglobin ≥ 90 g/L
• +Bilirubin ≤ 1.5 x ULN (upper limit of normal)
• +AST and ALT ≤ 2.5 x ULN - ≤ 5.0 x ULN (if patient has liver metastases)
• +Serum creatinine \< 1.25 x ULN or
• +Creatinine clearance ≥ 40 mL/min
• +Patient consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate.
• +Patients must be accessible for treatment and follow upFollow-upContinued check-ins after the treatment part is finished.Read more →. Patients registered on this trial must be treated and followed at the participating centre. This implies there must be reasonable geographical limits (for example: 1 ½ hour's driving distance) placed on patients being considered for this trial.
• +In accordance with CCTG policy, protocolProtocolThe detailed plan a study must follow.Read more → treatment is to begin within 2 working days of patient enrollment
• +Subjects should not donate blood while participating in this study, or for at least 90 days following the last infusion of durvalumab
• +ECOG performance status 0 or 1
• +Patients must live within Canada and have received durvalumab alone, or durvalumab in combination with tremelimumab, with or without chemotherapy/targeted therapy. Patients who have received other anti PD-1/PD-L1 agents +/- anti CTLA agents are eligible, providing full details of prior therapy, toxicity and management are available. Consult with CCTG for further details.
• +Patients must have previously discontinued immunotherapy due to an irAE.
• +Complete response, partial response or prolonged stable disease (SD ≥ 8 weeks) to initial immunotherapy. Patients that received prior adjuvant/neoadjuvant/consolidation immunotherapy are eligible providing there has been at least a 6 month treatment free interval prior to enrollment and patient has received at least one standard-of-care chemotherapy regimen in the palliative setting (discuss with CCTG if chemotherapy is not considered standard of careStandard of careThe treatment normally given for a condition outside a study.Read more → or not indicated or patient refused/not eligible as such patients are eligible).
• +Tumour material may have already been submitted to CCTG for the initial trial. If an additional formalin fixed paraffin embedded tissue block (from their primary or metastatic tumour) is available from tissue collected after immunotherapy discontinuation, patients must have provided informed consent for the release of the block. All patients must have provided informed consent for correlative studies. If patients from non-CCTG trials or commercial use are eventually enrolled, tumour material is also required if available, preferably from tissue collected after immunotherapy discontinuation.
• +Patients who received other relevant standard cancer therapies since discontinuing immunotherapy remain eligible for inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → as follows:
• +Patients may have received prior cytotoxic chemotherapy following discontinuation of immunotherapy for irAE.
• +Patients may have received other prior therapies such as tyrosine kinase inhibitors or other targeted agents, following discontinuation of immunotherapy for irAE.
• +Patients may not have received subsequent immune checkpoint inhibitors (anti-PD-(L)1 and anti-CTLA-4) following discontinuation of immunotherapy for irAE. Vaccines and oncolytic viruses are permitted.
• +Patients must have recovered from all reversible toxicity related to prior chemotherapy or systemic therapy (unless grade 1, irreversible, or considered by investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → as not clinically significant) and have adequate washoutWashout periodA gap with no treatment, so the previous one clears your system.Read more → as follows: Longest of one of the following:
• +Prior external beam radiation is permitted provided a minimum of 28 days (4 weeks) have elapsed between the last dose of radiation and date of enrollment. Exceptions may be made for low-dose, non-myelosuppressive radiotherapy after consultation with CCTG. Concurrent radiotherapy is not permitted.
• +Previous surgery is permitted provided that a minimum of 28 days (4 weeks) have elapsed between any major surgery and date of enrollment, and that wound healing has occurred.