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New treatment option for Cancer
Official title A Phase II Study of Durvalumab Treatment - Substudy A: In Patients Who Discontinued Prior Checkpoint Therapy Due to Immune Related Toxicity - Substudy B: For Continued Treatment (+/- Tremelimumab) of Patients Previously Enrolled to Completed CCTG Studies
ClinicalTrials.gov ID: NCT03847649
What this study is testing
What is Durvalumab?
Durvalumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- I238A: The purpose of this study is to find out what effects being treated with durvalumab has on cancer. The researchers doing this study also want to evaluate if prednisone (a type of steroid), when given together with durvalumab, can reduce any side effects.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Substudy A:
- Patients must have histologically and/or cytologically confirmed solid tumour, that is advanced/ metastatic/recurrent or unresectable and for which...
- Patients must live within Canada and have received durvalumab alone, or durvalumab in combination with tremelimumab, with or without...
- Patients must have previously discontinued immunotherapy due to an irAE.
- Immune-related adverse events must have resolved to ≤ grade 1 or baseline and patient must have completed corticosteroid therapy at least 28 days...
You likely can't join if
- In general, patients with prior grade 4 non-hematological, non-endocrine immune-related adverse events are not eligible.
- History of primary immunodeficiency, history of allogenic organ transplant that requires therapeutic immunosuppression and the use of...
- Live attenuated vaccination administered within 30 days prior to enrollment or within 30 days of receiving durvalumab.
- History of hypersensitivity to durvalumab or any excipient.
- Any immune-related adverse event that required biologic agents such as infliximab, or mycophenolate motefil to manage.
- Documented progressive disease (PD) while on initial immunotherapy. Exception: patients who had iUPD but continued on immunotherapy, and did not have...
See the full eligibility criteria
Who can join
- Substudy A:
- Patients must have histologically and/or cytologically confirmed solid tumour, that is advanced/ metastatic/recurrent or unresectable and for which no curative therapy exists.
- 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...
- Patients must have previously discontinued immunotherapy due to an irAE.
- Immune-related adverse events must have resolved to ≤ grade 1 or baseline and patient must have completed corticosteroid therapy at least 28 days prior to registration in this current study.
- 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...
- Patients must have a life expectancy of at least 12 weeks.
- 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...
- Presence of clinically and/or radiologically documented disease. All radiology studies must be performed within 28 days prior to enrollment (within 35 days if negative). Patients ideally should have measurable disease.
- ECOG performance status 0 or 1
- Previous Therapy
- Patients who received other relevant standard cancer therapies since discontinuing immunotherapy remain eligible for inclusion 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 investigator as not clinically significant) and have adequate...
- Two weeks;
- 5 half-lives for investigational agents;
- Standard cycle length of standard therapies.
- 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...
- 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.
- 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 consent 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...
- Patients must be accessible for treatment and follow up. Patients registered on this trial must be treated and followed at the participating centre. This implies there must be reasonable geographical limits (for...
- In accordance with CCTG policy, protocol treatment is to begin within 2 working days of patient enrollment
- Women/men of childbearing potential must have agreed to use a highly effective contraceptive method
- people should not donate blood while participating in this study, or for at least 90 days following the last infusion of durvalumab
What rules you out
- In general, patients with prior grade 4 non-hematological, non-endocrine immune-related adverse events are not eligible.
- History of primary immunodeficiency, history of allogenic organ transplant that requires therapeutic immunosuppression and the use of immunosuppressive agents within 28 days of enrollment.
- Live attenuated vaccination administered within 30 days prior to enrollment or within 30 days of receiving durvalumab.
- History of hypersensitivity to durvalumab or any excipient.
- Any immune-related adverse event that required biologic agents such as infliximab, or mycophenolate motefil to manage.
- Documented progressive disease (PD) while on initial immunotherapy. Exception: patients who had iUPD but continued on immunotherapy, and did not have documented iCPD within 8 weeks of discontinuing immunotherapy
- Patients who have experienced untreated and/or uncontrolled cardiovascular conditions and/or have symptomatic cardiac dysfunction (unstable angina, congestive heart failure, myocardial infarction within the previous...
- Concurrent treatment with other investigational drugs or anti-cancer therapy.
- Patients with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol (including corticosteroid administration), or would put the patient at risk. This includes...
- History of significant neurologic or psychiatric disorder which would impair the ability to obtain consent or limit compliance with study requirements.
- Active infection requiring systemic therapy; (including any patient known to have active hepatitis B, hepatitis C or human immunodeficiency virus (HIV) or tuberculosis or any infection requiring systemic therapy).
- Active peptic ulcer disease or gastritis.
- Untreated symptomatic brain metastases or brain metastases in whom radiation or surgery is indicated.
- Patients with diabetes mellitus are eligible but must be clinically stable on therapy (if applicable) and investigator and patient should be aware of the potential risk of immune mediated pancreatic toxicity and B cell...
- Pregnant or lactating women Substudy B: Inclusion Criteria
- Patients must be currently enrolled and receiving active treatment on a treatment arm containing durvalumab +/- tremelimumab with or without maintenance pemetrexed with no contraindications to continue receiving their...
- For BR.34 ONLY: patients who have disease progression (iUPD) on durvalumab may receive one dose of tremelimumab (75 mg) along with their next durvalumab infusion as long as all the following criteria are met:
- Patient is clinically stable
- According to the judgement of the treating physician, the patient had clinical benefit while receiving tremelimumab in the induction phase on BR.34
- ECOG performance status of 0 or 1
- Laboratory values meet the criteria below: 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 (if liver metastases...
The study team makes the final eligibility decision.
Where it's taking place
- Edmonton, Alberta, Canada
- Kelowna, British Columbia, Canada
- Vancouver, British Columbia, Canada
- Saint John, New Brunswick, Canada
- Hamilton, Ontario, Canada
- Kitchener, Ontario, Canada
- Ottawa, Ontario, Canada
- Toronto, Ontario, Canada
- Windsor, Ontario, Canada
- Montreal, Quebec, Canada
- Saskatoon, Saskatchewan, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edmonton, Alberta, Canada; Kelowna, British Columbia, Canada; Vancouver, British Columbia, Canada; Saint John, New Brunswick, Canada; Hamilton, Ontario, Canada; Kitchener, Ontario, Canada and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.