MedTrace Logo

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)

NCT03780608 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2022-06-15

No results posted yet for this study

Summary

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). Patients will receive AZD6738 plus durvalumab combination regimen.

AZD6738 will be administered at 240 mg twice daily on days 1 to 7 in Cycle 0 (lead-in period) and therafter at 240 mg BD on days 22 to 28 in a 28-day cycle. Durvalumab will be administered at 1500 mg every 4 weeks from cycle 1 day 1.

Tumour evaluation using modified RECIST 1.1 will be conducted at screening (within 28 days prior to first dose) and every 8 weeks relative to the date of first dose, up to week 40, then every 12 weeks until objective disease progression (within a window of +/- 7 days of the scheduled date).

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 modified 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modification and initiation of supportive treatments, both durvalumab and AZD6738 must be discontinued and the patient withdrawn from the study. Patients are not permitted to continue either AZD6738 or durvalumab as monotherapy. There is no maximum duration of treatment with AZD6738 and durvalumab.

The imaging modalities used for modified RECIST 1.1 assessment will be CT or MRI scans of chest,abdomen and pelvis. modified RECIST 1.1 scans will be analysed by the investigator on site.

Patients will also be requested to provide tumour samples from the primary or metastatic tumours pre-study and on progression. Sample provision is mandatory, subject to aspecific consent, and will aid understanding of resistance mechanisms. However, if biopsy site is not feasible, the protocol will allow waiving the rebiopsy procedure.

Conditions

  • Gastric Adenocarcinoma
  • Malignant Melanoma

Interventions

DRUG

AZD6738

AZD6738 will be administered at 240 mg twice daily on days 1 to 7 in Cycle 0 (lead-in period) and therafter at 240 mg BD on days 22 to 28 in a 28-day cycle.

DRUG

Durvalumab

. Durvalumab will be administered at 1500 mg every 4 weeks from cycle 1 day 1.

Sponsors & Collaborators

  • Samsung Medical Center

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-30
Primary Completion
2022-12-01
Completion
2023-12-01

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03780608 on ClinicalTrials.gov