GC 2nd Line Durvalumab(MEDI4736)/Tremelimumab Plus Paclitaxel Study

Sponsor
Asan Medical Center
Study ID
NCT03751761
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Metastatic Gastric Cancer

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • durvalumab, tremelimumab, paclitaxel — DRUG
    Durvalumab, 1500 mg Q4W for 12 months Tremelimumab 75 mg Q4W for up to 4 doses/cycles Paclitaxel iv D1, D8, D15 Q4W (from 60mg/m2 to 80mg/m2)

Study Details

To evaluate safety and response rate of durvalumab/tremelimumab in combination with paclitaxel in patients with metastatic gastric cancers who fail a first-line chemotherapy

Key Dates

Start date
Jun 11, 2018
Status verified
Feb 2024
Primary completion
Aug 30, 2023
Completion
Aug 30, 2023

Study Design

Enrollment
58 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: durvalumab, tremelimumab, paclitaxel

Primary Outcome Measure

Safety based on NCI-CTCAE v4.03 [ Time Frame: at least 4 weeks ]

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