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Pembrolizumab Plus Ramucirumab in Metastatic Gastric Cancer

NCT04632459 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2022-03-11

No results posted yet for this study

Summary

1. Objective 1) Primary Objective: To estimate preliminary overall response rate (ORR) of combination therapy of Ramucirumab and Pembrolizumab in patients with metastatic gastric or GEJ adenocarcinoma 2)Secondary Objectives: To assess secondary measures of clinical efficacy

* Best Overall Response Rate: BORR
* Disease Control Rate: DCR
* Progression-Free Survival:PFS
* Overall Survival: OS
* Duration of Overall Response: DOR \& maximal tumor shrinkage
2. Subjects : Patients with metastatic gastric or GEJ adenocarcinoma
3. Study design(Dosage \& Treatment) Patients will continue to receive study treatment, until they demonstrate objective disease progression (determined by modified RECIST 1.1) or until they meet any other discontinuation criteria.

* Ramucirumab 8mg/kg on q2W
* Pembrolizumab 200mg on q3W (pembrolizumab first followed by ramucirumab when concurrently administered on the same day)
* If ramucirumab had to be stopped due to intolerable toxicity, pembrolizumab will be continued until unacceptable toxicity, disease progression or upto 35 cycles.

Conditions

Interventions

DRUG

pembrolizumab plus ramucirumab

Patients will continue to receive study treatment, until they demonstrate objective disease progression (determined by modified RECIST 1.1) or until they meet any other discontinuation criteria. * Ramucirumab 8mg/kg on q2W * Pembrolizumab 200mg on q3W (pembrolizumab first followed by ramucirumab when concurrently administered on the same day) * If ramucirumab had to be stopped due to intolerable toxicity, pembrolizumab will be continued until unacceptable toxicity, disease progression or upto 35 cycles.

Sponsors & Collaborators

  • Samsung Medical Center

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-16
Primary Completion
2022-12-01
Completion
2022-12-01

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

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 NCT04632459 on ClinicalTrials.gov