Perioperative Chemo and Pembrolizumab in Gastric Cancer
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|ClinicalTrials.gov Identifier: NCT02918162|
Recruitment Status : Recruiting
First Posted : September 28, 2016
Last Update Posted : December 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer Adenocarcinoma of the Gastroesophageal Junction||Drug: Pembrolizumab Drug: Standard of care chemotherapy regimen||Phase 2|
Gastric cancer is one of the most common cancers worldwide. Surgical resection is the primary treatment for gastric cancer but most patients present with locally advanced disease and recurrence is common after surgery. Many patients (35%) will have early recurrence within 6-9 months of surgery indicating the need for more aggressive upfront therapy in these subjects. In addition, the majority of patients will ultimately have recurrence and 5 year survival rates are 35-40% despite aggressive therapy.
The ability to combine immunotherapy with pembrolizumab gives the potential to increase therapeutic options while continuing standard of care chemotherapy. The particular use of maintenance therapy may delay or eliminate the growth of residual micrometastatic disease and lead to durable disease control. Additionally, this study provides the foundation for substantial correlative work to define tumor and patient characteristics that may predict for response to pembrolizumab in gastric cancer.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Chemotherapy and Immune Checkpoint Blockade With Pembrolizumab in the Perioperative and Maintenance Treatment of Locoregional Gastric or GE Junction Adenocarcinoma.|
|Actual Study Start Date :||January 25, 2017|
|Estimated Primary Completion Date :||June 30, 2019|
|Estimated Study Completion Date :||June 30, 2020|
All study subjects will receive standard of care chemotherapy regimen for 3 cycles prior to and 3 cycles following surgery in combination with Pembrolizumab with an additional cycle of Pembrolizumab (4 total) in the pre-operative period. Additionally subjects will complete 12 months of maintenance Pembrolizumab (14 additional doses to complete 17 post-operative cycles) following completion of post-operative chemotherapy.
Standard of care combination chemotherapy regimen has a 21-day cycle.
Pembrolizumab dosed IV at 200mg every 21 days per cycle.
Drug: Standard of care chemotherapy regimen
Standard regimen containing at least a platinum and Fluorouracil (5-FU) agent (per National Comprehensive Cancer Network guidelines) - such as Doublet or Triplet chemotherapy with capecitabine, oxaliplatin, and epirubicin (optional) (21 day cycle). Epirubicin can be excluded at the discretion of the treating physician.
Oxaliplatin dosed IV at 130 mg/m2 every 21 days per cycle. Capecitabine dosed orally at 625mg/m2 twice a day daily.
Other Name: Investigator's choice of of standard regimen
- 24 month Disease Free Survival (DFS) Rate [ Time Frame: At 24 months ]Proportion of subjects who are alive without evidence of disease (either initial progression or recurrence) 24 months after Cycle 1 Day 1 treatment administration.
- Pathologic Complete Response (pCR) Rate [ Time Frame: Up to 34 months ]Proportion of subjects with absence of viable tumor on surgical resection specimen as determined by local pathology review.
- Overall Survival (OS) [ Time Frame: Up to 5 years ]Time from Cycle 1 Day 1 treatment administration to death due to any cause.
- Overall Response Rate (ORR) [ Time Frame: Up to 34 months ]Proportion of subjects with initial RECIST 1.1 measurable disease who have complete response (CR) or partial response (PR) at any time.
- Disease Free Survival (DFS) [ Time Frame: Up to 5 years ]Time from Cycle 1 Day 1 treatment administration to the first documented event of: disease progression, disease recurrence following surgery (preferably biopsy proven), or death - whichever occurs first.
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): NCT02918162
|Contact: Dan Otapfirstname.lastname@example.org|
|United States, New York|
|Weill Cornell Medical College/ NewYork-Presbyterian||Not yet recruiting|
|New York, New York, United States, 10021|
|Contact: Manish Shah, MD email@example.com|
|Principal Investigator: Manish Shah, MD|
|Columbia University Medical Center||Recruiting|
|New York, New York, United States, 10032|
|Contact: Paul Oberstein, MD 646-317-6085 firstname.lastname@example.org|
|Principal Investigator: Paul Oberstein, MD|
|Principal Investigator:||Paul E Oberstein, MD||Columbia University|