Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2026-01-21 @ 4:36 PM
Study NCT ID:
NCT04632459
Status:
UNKNOWN
Last Update Posted:
2022-03-11
First Post:
2020-09-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pembrolizumab Plus Ramucirumab in Metastatic Gastric Cancer
Sponsor:
Samsung Medical Center
Organization:
Study Overview
Official Title:
Phase II Study of Pembrolizumab Plus Ramucirumab in Metastatic Gastric or GEJ Adenocarcinoma as Salvage Treatment
Status:
UNKNOWN
Status Verified Date:
2022-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: