Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2025-12-24 @ 3:04 PM
NCT ID:
NCT04632459
Brief 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.
Detailed Description:
Goal : To estimate efficacy and safety of combination therapy of Ramucirumab and Pembrolizumab in patients with metastatic gastric or GEJ adenocarcinoma
Planned Sample Size : A maximum of 35 patients will be recruited to this single-arm phase II trial. In this single-arm phase II trial, 33 people were calculated using Simon's two-stage design and a total of 35 patients will be recruited to account for a 5% dropout rate.
The sample size is calculated by use of a two-stage minimax Simon's design to control the type I error at 2.5 % for null hypothesis that, for arm, the true response was 15 % or below and to have 90 % of power if the true response was 40 % or higher. 19 evaluable patients are to be treated in the first stage. If 3 or fewer response are observed in the first stage, the arm will be stopped. If at least 4 responses are observed in the first stage, 14 additional evaluable patients are to be entered onto the second stage. At the final analysis, the null hypothesis will be rejected if at least 9 responses are observed in 33 evaluable patients. RR is reported with its exact 95% CI.
Durationof Study: About 2 years from approval from the regulatory authority
Study:
NCT04632459
Study Brief:
Protocol Section:
NCT04632459