Status: Open
Activation Date: 2019JUN07
Phase: II
Description: A Phase II Study of Durvalumab 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
Eligibility: Must live in Canada & received durvalumab +/- tremelimumab, with or without chemo/targeted therapy. Patients who received other PD-1/PD-L1 agents +/- anti-CTLA agents may be eligible, contact CCTG. Had a G3 irAEs that required study drug discontinuation per protocol, selected G4 irAEs, & prolonged G1-2 irAEs where physician/patient wanted to discontinue therapy due to poor tolerability. irAE must have resolved to <= grade 1 or baseline. Completed steroid therapy & have documented CR, PR, or prolonged SD to initial IO therapy. Prior adjuvant/neoadjuvant/consolidation IO is eligible provided a >= 6 mo. treatment free interval prior to enrollment and >= 1 standard of care chemo in the palliative setting (discuss with CCTG if chemo is not SOC or indicated or patient refusal/not eligible). Ineligible if prior G4 non-hematological, non-endocrine irAE, or if required biologic agents to manage irAE, had PD as best response to initial IO, or symptomatic or uncontrolled brain mets.
Objective: Primary: To determine the safety and toxicity profile of rechallenging with durvalumab in patients who previously discontinued immunotherapy due to irAE. Secondary: To determine the objective response rate (RECIST 1.1 and iRECIST); To evaluate the efficacy of corticosteroids in preventing recurrent or new grade 2 or higher irAEs. Tertiary: To explore PFS and iPFS on rechallenge with durvalumab after progression on initial immunotherapy; To explore blood-based and stool-based biomarkers for irAEs; PD-L1 expression.
Participation: Limited to invited centres
Lay Description: The purpose of this study is to determine if patients who discontinued immunotherapy due to severe side effects related to treatment can be safely retreated with durvalumab and to investigate whether prophylactic steroid use can prevent or reduce new or recurrent side effects. This study will also examine response, progression free survival and explore the relationship between certain biomarkers and outcomes of treatment.
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Hide Tissue Samples
Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
IND | I238 | Open Trial | 3 | 7 | 10 |
(Core size is 0.6 mm)
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Fluid SamplesDisease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
IND | I238 | Open Trial | 0 | 0 |
Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
IND | I238 | Open Trial | 0 | 0 | 0 | 0 | 7 | 7 | 0 | 0 |