A Study of Perioperative mFOLFOX6 Plus Pembrolizumab in Patients With Potentially Resectable Adenocarcinoma of the Gastroesophageal Junction (GEJ) and Stomach
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|ClinicalTrials.gov Identifier: NCT02943603|
Recruitment Status : Withdrawn (No participants enrolled. PI/Sponsor left UPitt. IND withdrawn & revised protocol submitted through the new institution. New study recruiting under NCT03488667.)
First Posted : October 24, 2016
Last Update Posted : July 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma Stomach Cancer||Drug: mFLOFOX6 + pembrolizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Perioperative mFOLFOX6 Chemotherapy Plus Pembrolizumab(MK-3475) Combination in Patients With Potentially Resectable Adenocarcinoma of the Gastroesophageal Junction (GEJ) and Stomach|
|Study Start Date :||January 2017|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||July 2019|
Experimental: mFOLFX6 + Pembrolizumab
Subjects will receive mFOLFOX6 every 2 weeks (on Days 1, 15, 29, 43) and Pembrolizumab every 3 weeks (on Days 1, 22, 43).
Drug: mFLOFOX6 + pembrolizumab
the combination of mFOLFOX6 + pembrolizumab is the single intervention even though the is dosed differently.
- Rate of pathological complete response [ypCR] [ Time Frame: Up to 12 weeks ]Number of participants with pathological complete response [pCR] at 12 weeks/total number of evaluable participants.
- number of adverse events related to toxicity [ Time Frame: up to 18 months for accrual + 12 months of intervention and 1 month of safety follow-up for last subject (31 months) ]
- Objective Response Rate (ORR) [ Time Frame: Up to 12 weeks ]Number of participants with response (partial response + complete response) at 12 weeks/total number of evaluable participants.
- Disease Free Survival post surgery [ Time Frame: up to 18 months for accrual + 1 month for screening and 3 months of intervention before surgery for last subject then 12 months of follow-up (34 months) ]
- Overall Survival (OS) [ Time Frame: up to 18 months for accrual + 12 months of intervention for last subject (30 months) ]
- PET response [ Time Frame: up to 18 months for accrual + 1 month for screening and 3 months of intervention for last subject (22 months) ]
- PD-L1 expression in tumor cells [ Time Frame: up to 18 months for accrual + 1 month for screening and 3 months of intervention for last subject (22 months) ]change in PD-L1 expression on the surface and in the nucleus of the tumor cells over treatment will be related to ypCR by means of logistic regression.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02943603
|United States, Pennsylvania|
|Hillman Cancer Center|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||Weijing Sun, MD||University of Pittsburgh|