This Study is a Phase II Study of AZD6738 in Combination With Durvalumab in Patients With Solid Tumor (Cohort A (N=30): GC Who Have Failed Secondary Chemotherapy Treatments Regimen; Cohort B (B=30): Melanoma Patients Who Have Failed to IO)

Summary

Participation Requirements

Description

Target subject population There will be two cohorts for this study: Cohort A: Patients with refractory gastric cancer who have failed secondary chemotherapy treatments for advanced disease will be enrolled. Patients must have imaging confirmed progression on previous chemotherapy for gastric cancer ...

Target subject population There will be two cohorts for this study: Cohort A: Patients with refractory gastric cancer who have failed secondary chemotherapy treatments for advanced disease will be enrolled. Patients must have imaging confirmed progression on previous chemotherapy for gastric cancer treatment with at least one measurable lesion per modified RECIST 1.1. GC patients must not have received previous therapy with immune checkpoint inhibitors. Prior exposure to AZD6738 is not allowed. Cohort B: Patients with metastatic melanoma patients who have failed prior anti-PD(L)1 will be enrolled. Anti-PD(L)1 therapy should be the immediate prior regimen before study entry. Duration of treatment Patients will continue to receive treatment with AZD6738 and durvalumab provided that the treatment is tolerable and there is evidence of clinical benefit (as judged by the investigator) and secure supply of medication. Upon confirmation of objective disease progression, or treatment disconiutation criteria are met, both durvalumab and AZD6738 must be discontinued. Patients may continue with AZD6738/durvalumab beyond objective disease progression (determined by RECIST 1.1) at the discretion of the investigator if they are clinically benefiting from the treatment and they do not meet any other discontinuation criteria. If either durvalumab and/or AZD6738 are deemed intolerable (as judged by the investigator) so that discontinuation of either agent is deemed in the patient's best interest despite dose interruptions, dose modification and initiation of supportive treatments, both durvalumab and AZD6738 must be discontinued and the patient withdrawn from the study. Pateints are not permitted to continue either AZD6738 or durvalumab as monotherapy. There is no maximum duration of treatment with AZD6738 and durvalumab.

Tracking Information