Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-585/KEYNOTE-585)
- Conditions
- Gastric CancerGastroesophageal Junction Cancer
- Interventions
- Registration Number
- NCT03221426
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma.
The primary study hypotheses are that:
* Neoadjuvant and adjuvant pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab is superior to neoadjuvant and adjuvant placebo plus chemotherapy, followed by adjuvant placebo in terms of Event-free Survival (EFS) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), and
* Neoadjuvant pembrolizumab plus chemotherapy is superior to neoadjuvant placebo plus chemotherapy in terms of rate of Pathological Complete Response (pathCR) at the time of surgery.
With Amendment 10, upon study completion, participants will be discontinued and may be enrolled in an extension study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1007
- Has previously untreated localized gastric or GEJ adenocarcinoma as defined by T3 or greater primary lesion or the presence of any positive nodes - N+ (clinical nodes) without evidence of metastatic disease.
- Plans to proceed to surgery following pre-operative chemotherapy based on standard staging studies per local practice.
- Is willing to provide tissue from a tumor lesion at baseline and at time of surgery.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1 within 3 days prior to the first dose of study treatment.
- Has adequate organ function.
- Male participants of childbearing potential must agree to use an adequate method of contraception for the course of the study through 180 days after the last dose of chemotherapy.
- Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab, whichever is greater.
- Has life expectancy of greater than 6 months.
- Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- Has an active infection requiring systemic therapy.
- Is currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
- Has received prior therapy with an anti-programmed cell death protein-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (i.e., cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], tumor necrosis factor receptor superfamily member 4 [OX-40], necrosis factor receptor superfamily member 9 [CD137]) or has previously participated in a Merck pembrolizumab (MK-3475) clinical trial.
- Has received prior systemic anti-cancer therapy including investigational agents for the current malignancy.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 14 days prior the first dose of study treatment.
- Has a known additional malignancy that is progressing or has required active treatment within the past 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ that have undergone potentially curative therapy are not excluded.
- Has a known severe hypersensitivity (≥ Grade 3) to pembrolizumab, its active substance and/or any of its excipients, or to any of the study chemotherapy agents and/or to any of their excipients.
- Has an active autoimmune disease that has required systemic treatment in past 2 years.
- Has a known history of human immunodeficiency virus (HIV) infection.
- Has a known history of Hepatitis B or known active Hepatitis C virus infection.
- Has a known history of active tuberculosis (TB).
- Female participants who are pregnant or breastfeeding or expecting to conceive children within the projected duration of the study, starting with the screening visit through180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab, whichever is greater.
- Male participants who are expecting to father children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of chemotherapy.
- Has had an allogenic tissue/solid organ transplant.
- Has received a live vaccine within 30 days prior to the first dose of study treatment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pembrolizumab + XP/FP Pembrolizumab XP=cisplatin+capecitabine and FP=cisplatin+5-fluorouracil. Neoadjuvant: Prior to surgery, participants receive 3 cycles of pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets twice each day (BID) on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 IV infusion on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m\^2 continuous IV infusion on Days 1 to 5 of each 3-week cycle. Adjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of pembrolizumab 200 mg IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 IV infusion on Day 1 Q3W and 5FU 800 mg/m\^2 continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by pembrolizumab monotherapy 200 mg IV infusion on Day 1 Q3W for up to 11 additional cycles. Pembrolizumab + XP/FP Cisplatin XP=cisplatin+capecitabine and FP=cisplatin+5-fluorouracil. Neoadjuvant: Prior to surgery, participants receive 3 cycles of pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets twice each day (BID) on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 IV infusion on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m\^2 continuous IV infusion on Days 1 to 5 of each 3-week cycle. Adjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of pembrolizumab 200 mg IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 IV infusion on Day 1 Q3W and 5FU 800 mg/m\^2 continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by pembrolizumab monotherapy 200 mg IV infusion on Day 1 Q3W for up to 11 additional cycles. Pembrolizumab + XP/FP Capecitabine XP=cisplatin+capecitabine and FP=cisplatin+5-fluorouracil. Neoadjuvant: Prior to surgery, participants receive 3 cycles of pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets twice each day (BID) on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 IV infusion on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m\^2 continuous IV infusion on Days 1 to 5 of each 3-week cycle. Adjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of pembrolizumab 200 mg IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 IV infusion on Day 1 Q3W and 5FU 800 mg/m\^2 continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by pembrolizumab monotherapy 200 mg IV infusion on Day 1 Q3W for up to 11 additional cycles. Pembrolizumab + XP/FP 5-fluorouracil XP=cisplatin+capecitabine and FP=cisplatin+5-fluorouracil. Neoadjuvant: Prior to surgery, participants receive 3 cycles of pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets twice each day (BID) on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 IV infusion on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m\^2 continuous IV infusion on Days 1 to 5 of each 3-week cycle. Adjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of pembrolizumab 200 mg IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 IV infusion on Day 1 Q3W and 5FU 800 mg/m\^2 continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by pembrolizumab monotherapy 200 mg IV infusion on Day 1 Q3W for up to 11 additional cycles. Placebo + XP/FP Placebo Neoadjuvant: Prior to surgery, participants receive 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle. Adjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of placebo via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles. Placebo + XP/FP Cisplatin Neoadjuvant: Prior to surgery, participants receive 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle. Adjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of placebo via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles. Placebo + XP/FP Capecitabine Neoadjuvant: Prior to surgery, participants receive 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle. Adjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of placebo via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles. Placebo + XP/FP 5-fluorouracil Neoadjuvant: Prior to surgery, participants receive 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle. Adjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of placebo via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles. Pembrolizumab+FLOT Cohort Pembrolizumab FLOT=docetaxel+oxaliplatin+5FU+leucovorin (calcium folinate). Neoadjuvant: Prior to surgery, participants receive 3 cycles of pembrolizumab 200 mg via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m\^2 via IV infusion, oxaliplatin 85 mg/m\^2 via IV infusion, 5FU 2600 mg/m\^2 via IV infusion, and leucovorin (calcium folinate) 200 mg/m\^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations). Adjuvant: 4 to 10 weeks postsurgery, participants receive 3 cycles of pembrolizumab 200 mg via IV infusion Day 1 Q3W PLUS docetaxel 50 mg/m\^2, oxaliplatin 85 mg/m\^2, 5FU 2600 mg/m\^2, and leucovorin 200 mg/m\^2 Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations), followed by pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional cycles. Pembrolizumab+FLOT Cohort 5-fluorouracil FLOT=docetaxel+oxaliplatin+5FU+leucovorin (calcium folinate). Neoadjuvant: Prior to surgery, participants receive 3 cycles of pembrolizumab 200 mg via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m\^2 via IV infusion, oxaliplatin 85 mg/m\^2 via IV infusion, 5FU 2600 mg/m\^2 via IV infusion, and leucovorin (calcium folinate) 200 mg/m\^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations). Adjuvant: 4 to 10 weeks postsurgery, participants receive 3 cycles of pembrolizumab 200 mg via IV infusion Day 1 Q3W PLUS docetaxel 50 mg/m\^2, oxaliplatin 85 mg/m\^2, 5FU 2600 mg/m\^2, and leucovorin 200 mg/m\^2 Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations), followed by pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional cycles. Pembrolizumab+FLOT Cohort Docetaxel FLOT=docetaxel+oxaliplatin+5FU+leucovorin (calcium folinate). Neoadjuvant: Prior to surgery, participants receive 3 cycles of pembrolizumab 200 mg via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m\^2 via IV infusion, oxaliplatin 85 mg/m\^2 via IV infusion, 5FU 2600 mg/m\^2 via IV infusion, and leucovorin (calcium folinate) 200 mg/m\^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations). Adjuvant: 4 to 10 weeks postsurgery, participants receive 3 cycles of pembrolizumab 200 mg via IV infusion Day 1 Q3W PLUS docetaxel 50 mg/m\^2, oxaliplatin 85 mg/m\^2, 5FU 2600 mg/m\^2, and leucovorin 200 mg/m\^2 Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations), followed by pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional cycles. Pembrolizumab+FLOT Cohort Oxaliplatin FLOT=docetaxel+oxaliplatin+5FU+leucovorin (calcium folinate). Neoadjuvant: Prior to surgery, participants receive 3 cycles of pembrolizumab 200 mg via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m\^2 via IV infusion, oxaliplatin 85 mg/m\^2 via IV infusion, 5FU 2600 mg/m\^2 via IV infusion, and leucovorin (calcium folinate) 200 mg/m\^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations). Adjuvant: 4 to 10 weeks postsurgery, participants receive 3 cycles of pembrolizumab 200 mg via IV infusion Day 1 Q3W PLUS docetaxel 50 mg/m\^2, oxaliplatin 85 mg/m\^2, 5FU 2600 mg/m\^2, and leucovorin 200 mg/m\^2 Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations), followed by pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional cycles. Pembrolizumab+FLOT Cohort Leucovorin FLOT=docetaxel+oxaliplatin+5FU+leucovorin (calcium folinate). Neoadjuvant: Prior to surgery, participants receive 3 cycles of pembrolizumab 200 mg via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m\^2 via IV infusion, oxaliplatin 85 mg/m\^2 via IV infusion, 5FU 2600 mg/m\^2 via IV infusion, and leucovorin (calcium folinate) 200 mg/m\^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations). Adjuvant: 4 to 10 weeks postsurgery, participants receive 3 cycles of pembrolizumab 200 mg via IV infusion Day 1 Q3W PLUS docetaxel 50 mg/m\^2, oxaliplatin 85 mg/m\^2, 5FU 2600 mg/m\^2, and leucovorin 200 mg/m\^2 Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations), followed by pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional cycles. Placebo+FLOT Cohort Placebo Neoadjuvant: Prior to surgery, participants receive 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m\^2 via IV infusion, oxaliplatin 85 mg/m\^2 via IV infusion, 5FU 2600 mg/m\^2 via IV infusion, and leucovorin 200 mg/m\^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations). Adjuvant: 4 to 10 weeks postsurgery, participants receive 3 cycles of placebo via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m\^2 via IV infusion, oxaliplatin 85 mg/m\^2 via IV infusion, 5FU 2600 mg/m\^2 via IV infusion, and leucovorin 200 mg/m\^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations), followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles. Placebo+FLOT Cohort 5-fluorouracil Neoadjuvant: Prior to surgery, participants receive 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m\^2 via IV infusion, oxaliplatin 85 mg/m\^2 via IV infusion, 5FU 2600 mg/m\^2 via IV infusion, and leucovorin 200 mg/m\^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations). Adjuvant: 4 to 10 weeks postsurgery, participants receive 3 cycles of placebo via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m\^2 via IV infusion, oxaliplatin 85 mg/m\^2 via IV infusion, 5FU 2600 mg/m\^2 via IV infusion, and leucovorin 200 mg/m\^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations), followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles. Placebo+FLOT Cohort Docetaxel Neoadjuvant: Prior to surgery, participants receive 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m\^2 via IV infusion, oxaliplatin 85 mg/m\^2 via IV infusion, 5FU 2600 mg/m\^2 via IV infusion, and leucovorin 200 mg/m\^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations). Adjuvant: 4 to 10 weeks postsurgery, participants receive 3 cycles of placebo via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m\^2 via IV infusion, oxaliplatin 85 mg/m\^2 via IV infusion, 5FU 2600 mg/m\^2 via IV infusion, and leucovorin 200 mg/m\^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations), followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles. Placebo+FLOT Cohort Oxaliplatin Neoadjuvant: Prior to surgery, participants receive 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m\^2 via IV infusion, oxaliplatin 85 mg/m\^2 via IV infusion, 5FU 2600 mg/m\^2 via IV infusion, and leucovorin 200 mg/m\^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations). Adjuvant: 4 to 10 weeks postsurgery, participants receive 3 cycles of placebo via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m\^2 via IV infusion, oxaliplatin 85 mg/m\^2 via IV infusion, 5FU 2600 mg/m\^2 via IV infusion, and leucovorin 200 mg/m\^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations), followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles. Placebo+FLOT Cohort Leucovorin Neoadjuvant: Prior to surgery, participants receive 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m\^2 via IV infusion, oxaliplatin 85 mg/m\^2 via IV infusion, 5FU 2600 mg/m\^2 via IV infusion, and leucovorin 200 mg/m\^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations). Adjuvant: 4 to 10 weeks postsurgery, participants receive 3 cycles of placebo via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m\^2 via IV infusion, oxaliplatin 85 mg/m\^2 via IV infusion, 5FU 2600 mg/m\^2 via IV infusion, and leucovorin 200 mg/m\^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations), followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles.
- Primary Outcome Measures
Name Time Method Event-free Survival (EFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms Up to approximately 75 months EFS is based on RECIST 1.1 as assessed by the investigator and is defined as the time from randomization to the first of the following events: radiographic disease progression per RECIST 1.1; local or distant recurrence as assessed by computer tomography (CT) scan or biopsy if indicated (for participants who are disease free after surgery); clinical progression as evidenced by peritoneal carcinomatosis confirmed by preoperative laparoscopy or laparotomy (for participants who are confirmed to be free of peritoneal involvement by laparoscopy at screening); or death due to any cause. A second primary malignancy, or radiographic progressive disease (PD) during the neoadjuvant phase that does not preclude successful surgery (i.e., disease free after surgery), are not considered EFS events.
Pathological Complete Response (pathCR) Rate - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms Up to approximately 9 weeks following completion of neoadjuvant treatment (up to Study Week 18) PathCR rate is defined as the percentage of participants having a pathCR based on central review. pathCR is defined as no invasive disease within an entirely submitted and evaluated gross lesion, and histologically negative nodes. The percentage of participants having pathCR is presented for the Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms.
Overall Survival (OS) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms Up to approximately 75 months OS is defined as the time from randomization to death due to any cause. OS is presented for the Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms.
Number of Participants Who Experience One or More Adverse Events (AEs) - Pembrolizumab+FLOT and Placebo+FLOT Cohorts Up to approximately 70 months An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience at least one AE is presented for the Pembrolizumab+FLOT and Placebo+FLOT Cohorts.
Number of Participants Who Discontinue Study Treatment Due to an AE - Pembrolizumab+FLOT and Placebo+FLOT Cohorts Up to approximately 17 months An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinued study treatment due to an AE is presented for the Pembrolizumab+FLOT and Placebo+FLOT Cohorts.
- Secondary Outcome Measures
Name Time Method Number of Participants Who Experience One or More Adverse Events (AEs) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms Separately and in Combination With the Pembrolizumab+FLOT and Placebo+FLOT Cohorts Up to approximately 75 months An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience at least one AE will be presented for the Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms separately and in combination with the Pembrolizumab+FLOT and Placebo+FLOT Cohorts.
Number of Participants Who Discontinue Study Treatment Due to an AE - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms Separately and in Combination With the Pembrolizumab+FLOT and Placebo+FLOT Cohorts Up to approximately 18 months An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be presented the Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms separately and in combination with the Pembrolizumab+FLOT and Placebo+FLOT Cohorts.
Disease-free Survival (DFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms Up to approximately 75 months DFS is defined as the time from post-surgery baseline scan until the first occurrence of local or distant recurrence or death from any cause and is based on RECIST 1.1 as assessed by the investigator.
Overall Survival (OS) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms in Combination With the Pembrolizumab+FLOT and Placebo+FLOT Cohorts Up to approximately 75 months OS is defined as the time from randomization to death due to any cause. OS is presented for the Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms in combination with the Pembrolizumab+FLOT and Placebo+FLOT Cohorts.
Event-free Survival (EFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms in Combination With the Pembrolizumab+FLOT and Placebo+FLOT Cohorts Up to approximately 75 months EFS is based on RECIST 1.1 as assessed by the investigator and is defined as the time from randomization to the first of the following events: radiographic disease progression per RECIST 1.1; local or distant recurrence as assessed by CT scan or biopsy if indicated (for participants who are disease free after surgery); clinical progression as evidenced by peritoneal carcinomatosis confirmed by preoperative laparoscopy or laparotomy (for participants who are confirmed to be free of peritoneal involvement by laparoscopy at screening); or death due to any cause. A second primary malignancy, or radiographic progressive disease (PD) during the neoadjuvant phase that does not preclude successful surgery (i.e., disease free after surgery), are not considered EFS events.
Trial Locations
- Locations (171)
Fox Chase Cancer Center ( Site 0006)
🇺🇸Philadelphia, Pennsylvania, United States
Cross Cancer Institute ( Site 0033)
🇨🇦Edmonton, Alberta, Canada
Jewish General Hospital ( Site 0034)
🇨🇦Montreal, Quebec, Canada
Institut Paoli Calmettes ( Site 0472)
🇫🇷Marseille, Bouches-du-Rhone, France
Sunnybrook Research Institute ( Site 0032)
🇨🇦Toronto, Ontario, Canada
UZ Gent ( Site 0486)
🇧🇪Gent, Oost-Vlaanderen, Belgium
AZ Groeninge ( Site 0481)
🇧🇪Kortrijk, West-Vlaanderen, Belgium
CHU Hopital Saint Antoine ( Site 0471)
🇫🇷Paris, France
Instituto do Cancer do Ceara ( Site 0311)
🇧🇷Fortaleza, Ceara, Brazil
Instituto Nacional Do Cancer Jose Alencar Gomes Da Silva ( Site 0307)
🇧🇷Rio de Janeiro, Brazil
CHU de Liege ( Site 0482)
🇧🇪Liège, Liege, Belgium
CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0035)
🇨🇦Sherbrooke, Quebec, Canada
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0430)
🇮🇹Milano, Lombardia, Italy
Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 0429)
🇮🇹Modena, Italy
Soroka University M.C ( Site 0385)
🇮🇱Beer Sheva, HaDarom, Israel
Hopital Prive Jean Mermoz ( Site 0462)
🇫🇷Lyon, Auvergne, France
Rambam Health Care Campus ( Site 0381)
🇮🇱Haifa, Israel
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0305)
🇧🇷Sao Paulo, Brazil
Grand Hopital de Charleroi ( Site 0478)
🇧🇪Charleroi, Hainaut, Belgium
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0040)
🇨🇦Montreal, Quebec, Canada
CHU de Quebec - Hotel-Dieu de Quebec ( Site 0042)
🇨🇦Quebec, Canada
Haematologisch-Onkologische Praxis Eppendorf Facharztzentrum Eppendorf - Hope ( Site 0454)
🇩🇪Hamburg, Germany
CHU Brest - Institut de Cancerologie et d Hematologie ( Site 0474)
🇫🇷Brest, Finistere, France
Moncton Hospital - Horizon Health Network ( Site 0038)
🇨🇦Moncton, New Brunswick, Canada
Hospital de Base de Sao Jose de Rio Preto ( Site 0304)
🇧🇷Sao Jose Rio Preto, Sao Paulo, Brazil
Meir medical center ( Site 0386)
🇮🇱Kfar Saba, HaMerkaz, Israel
Kobe University Hospital ( Site 0188)
🇯🇵Kobe, Hyogo, Japan
Rabin-Medical Center ( Site 0384)
🇮🇱Petah Tikva, Israel
Centro Medico Integral De Cancerología (CEMIC) ( Site 0260)
🇬🇹Quetzaltenango, Guatemala
Universitaetsklinikum Carl Gustav Carus der TU Dresden ( Site 0448)
🇩🇪Dresden, Sachsen, Germany
Hadassah Medical Center. Ein Kerem ( Site 0383)
🇮🇱Jerusalem, Israel
Sourasky Medical Center. ( Site 0382)
🇮🇱Tel-Aviv, Tell Abib, Israel
Sheba Medical center ( Site 0387)
🇮🇱Ramat Gan, Israel
Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 0354)
🇵🇱Bielsko-Biala, Slaskie, Poland
City Clinical Hosp.4 of DCC ( Site 0325)
🇺🇦Dnipro, Dnipropetrovska Oblast, Ukraine
Seconda Universita Napoli ( Site 0436)
🇮🇹Napoli, Italy
City clinical oncological dispensary ( Site 0336)
🇷🇺Sankt-Petersburg, Sankt-Peterburg, Russian Federation
Chang Gung Medical Foundation. Linkou ( Site 0064)
🇨🇳Taoyuan, Taiwan
Kaluga Regional Clinical Oncology Center ( Site 0345)
🇷🇺Kaluga, Kaluzskaja Oblast, Russian Federation
National Medical and Surgical Center n.a. N.I.Pirogov ( Site 0338)
🇷🇺Moscow, Moskva, Russian Federation
National Cancer Centre Singapore ( Site 0097)
🇸🇬Singapore, Central Singapore, Singapore
SBHI Leningrad Regional Clinical Hospital ( Site 0496)
🇷🇺Saint Petersburg, Leningradskaya Oblast, Russian Federation
Gifu University Hospital ( Site 0166)
🇯🇵Gifu, Japan
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0344)
🇷🇺Saint Petersburg, Sankt-Peterburg, Russian Federation
National Taiwan University Hospital ( Site 0063)
🇨🇳Taipei, Taiwan
SPZOZ WSS nr 3 w Rybniku ( Site 0357)
🇵🇱Rybnik, Slaskie, Poland
National Cancer Institute of the MoH of Ukraine ( Site 0319)
🇺🇦Kyiv, Kyivska Oblast, Ukraine
Koo Foundation Sun Yat-Sen Cancer Center ( Site 0066)
🇨🇳Taipei, Taiwan
Royal Marsden NHS Foundation Trust ( Site 0400)
🇬🇧Sutton, Surrey, United Kingdom
Blokhin National Medical Oncology ( Site 0494)
🇷🇺Moscow, Moskva, Russian Federation
Imperial College Healthcare NHS Trust ( Site 0402)
🇬🇧London, London, City Of, United Kingdom
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0361)
🇵🇱Gliwice, Slaskie, Poland
National University Hospital ( Site 0095)
🇸🇬Singapore, Central Singapore, Singapore
Taipei Medical University Shuang Ho Hospital ( Site 0068)
🇨🇳New Taipei, Taiwan
Communal non profit enterprise Regional Clinical Oncology Center ( Site 0591)
🇺🇦Kharkiv, Kharkivska Oblast, Ukraine
Kyiv City Clinical Oncology Center ( Site 0590)
🇺🇦Kyiv, Kyivska Oblast, Ukraine
Oncocare Cancer Centre ( Site 0096)
🇸🇬Singapore, Central Singapore, Singapore
University Hospitals Bristol NHS Foundation Trust ( Site 0407)
🇬🇧Bristol, Bristol, City Of, United Kingdom
Ninewells Hospital and Medical School ( Site 0406)
🇬🇧Dundee, Dundee City, United Kingdom
MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council ( Site 0589)
🇺🇦Kryviy Rih, Dnipropetrovska Oblast, Ukraine
Royal Free London NHS Foundation Trust ( Site 0403)
🇬🇧London, London, City Of, United Kingdom
Northwestern University - Robert H. Lurie Comprehensive Cancer Center ( Site 0018)
🇺🇸Chicago, Illinois, United States
The University of Chicago Medical Center ( Site 0004)
🇺🇸Chicago, Illinois, United States
CHU UCL Namur Site de Godinne ( Site 0485)
🇧🇪Yvoir, Namur, Belgium
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0308)
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Zhejiang Cancer Hospital ( Site 0231)
🇨🇳Hangzhou, Zhejiang, China
Beijing Cancer Hospital ( Site 0221)
🇨🇳Beijing, Beijing, China
Sir Run Run Shaw Hospital ( Site 0233)
🇨🇳Hangzhou, Zhejiang, China
Institut du Cancer de Montpellier ( Site 0473)
🇫🇷Montpellier, Herault, France
The Royal Marsden Foundation Trust ( Site 0405)
🇬🇧London, London, City Of, United Kingdom
The Christie NHS Foundation Trust ( Site 0397)
🇬🇧Manchester, United Kingdom
Chiba Cancer Center ( Site 0180)
🇯🇵Chiba, Japan
Kyungpook National University Chilgok Hospital ( Site 0089)
🇰🇷Daegu, Taegu-Kwangyokshi, Korea, Republic of
Korea University Anam Hospital ( Site 0084)
🇰🇷Seoul, Korea, Republic of
Leningrad Regional Oncology Center ( Site 0335)
🇷🇺Saint-Petersburg, Sankt-Peterburg, Russian Federation
Institut Mutualiste Montsouris ( Site 0463)
🇫🇷Paris, France
Osaka General Medical Center ( Site 0159)
🇯🇵Osaka, Japan
Georgetown University ( Site 0015)
🇺🇸Washington, District of Columbia, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0019)
🇺🇸New York, New York, United States
Memorial Sloan Kettering ( Site 0024)
🇺🇸New York, New York, United States
University of Rochester ( Site 0011)
🇺🇸Rochester, New York, United States
Weill Cornell Medical Center ( Site 0023)
🇺🇸New York, New York, United States
Hopital Erasme ULB ( Site 0484)
🇧🇪Brussels, Bruxelles-Capitale, Region De, Belgium
Roswell Park Cancer Institute ( Site 0001)
🇺🇸Buffalo, New York, United States
Hospital Israelita Albert Einstein ( Site 0309)
🇧🇷Sao Paulo, Brazil
City of Hope ( Site 0005)
🇺🇸Duarte, California, United States
CISSS de la Monteregie-Centre ( Site 0039)
🇨🇦Greenfield Park, Quebec, Canada
CHU Reims - Hopital Robert Debre ( Site 0465)
🇫🇷Reims, Champagne-Ardenne, France
Aichi Cancer Center Hospital ( Site 0165)
🇯🇵Nagoya, Aichi, Japan
Temple University Hospital ( Site 0026)
🇺🇸Philadelphia, Pennsylvania, United States
Virginia Cancer Specialists, PC ( Site 0010)
🇺🇸Fairfax, Virginia, United States
Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0301)
🇧🇷Barretos, Sao Paulo, Brazil
CHU Poitiers - Pole Regional de Cancerologie ( Site 0467)
🇫🇷Poitiers, Vienne, France
Klinikum Esslingen GmbH ( Site 0453)
🇩🇪Esslingen, Baden-Wurttemberg, Germany
Kliniken Essen Mitte Gmbh Evang. Huyssens Stiftung ( Site 0445)
🇩🇪Essen, Nordrhein-Westfalen, Germany
Medizinische Hochschule Hannover ( Site 0449)
🇩🇪Hannover, Niedersachsen, Germany
Medizinische klinilk und Poliklinik Johannes Gutenberg Univ ( Site 0455)
🇩🇪Mainz, Rheinland-Pfalz, Germany
Klinikum der Universitaet in Muenchen ( Site 0446)
🇩🇪Muenchen, Bayern, Germany
Universitaetsklinikum Freiburg ( Site 0450)
🇩🇪Freiburg, Baden-Wurttemberg, Germany
IRCCS Istituto Oncologico Veneto ( Site 0431)
🇮🇹Padova, Abruzzo, Italy
A.O.U. Santa Maria della Misericordia di Udine ( Site 0434)
🇮🇹Udine, Italy
IRCCS Policlinico San Donato ( Site 0433)
🇮🇹San Donato Milanese, Milano, Italy
Istituto Clinico Humanitas Research Hospital ( Site 0432)
🇮🇹Rozzano, Milano, Italy
National Cancer Center Hospital East ( Site 0178)
🇯🇵Kashiwa, Chiba, Japan
National Hospital Organization Shikoku Cancer Center ( Site 0186)
🇯🇵Matsuyama, Ehime, Japan
Hyogo Cancer Center ( Site 0182)
🇯🇵Akashi, Hyogo, Japan
Hokkaido University Hospital ( Site 0160)
🇯🇵Sapporo, Hokkaido, Japan
Iwate Medical University Hospital ( Site 0184)
🇯🇵Shiwa-gun, Iwate, Japan
Ibaraki Prefectural Central Hospital ( Site 0177)
🇯🇵Kasama, Ibaraki, Japan
Kobe City Medical Center General Hospital ( Site 0181)
🇯🇵Kobe, Hyogo, Japan
Kansai Medical University Hospital ( Site 0190)
🇯🇵Hirakata, Osaka, Japan
Kanagawa Cancer Center ( Site 0167)
🇯🇵Yokohama, Kanagawa, Japan
St. Marianna University School of Medicine Hospital ( Site 0187)
🇯🇵Kawasaki, Kanagawa, Japan
Saitama Cancer Center ( Site 0170)
🇯🇵Kitaadachi-gun, Saitama, Japan
Osaka Medical College Hospital ( Site 0168)
🇯🇵Takatsuki, Osaka, Japan
Osaka University Hospital ( Site 0162)
🇯🇵Suita, Osaka, Japan
Shizuoka Cancer Center Hospital and Research Institute ( Site 0176)
🇯🇵Sunto-gun, Shizuoka, Japan
Kyushu University Hospital ( Site 0173)
🇯🇵Fukuoka, Japan
National Hospital Organization Kyushu Cancer Center ( Site 0172)
🇯🇵Fukuoka, Japan
Osaka International Cancer Institute ( Site 0161)
🇯🇵Osaka, Japan
Hiroshima City Hiroshima Citizens Hospital ( Site 0171)
🇯🇵Hiroshima, Japan
Kochi Health Sciences Center ( Site 0189)
🇯🇵Kochi, Japan
Niigata Cancer Center Hospital ( Site 0169)
🇯🇵Niigata, Japan
Kumamoto University Hospital ( Site 0164)
🇯🇵Kumamoto, Japan
The Cancer Institute Hospital of JFCR ( Site 0185)
🇯🇵Tokyo, Japan
Tokyo Metropolitan Komagome Hospital ( Site 0183)
🇯🇵Tokyo, Japan
Chonnam National University Hwasun Hospital ( Site 0083)
🇰🇷Hwasun Gun, Jeonranamdo, Korea, Republic of
National Cancer Center Hospital ( Site 0179)
🇯🇵Tokyo, Japan
Toyama Prefectural Central Hospital ( Site 0163)
🇯🇵Toyama, Japan
Seoul National University Bundang Hospital ( Site 0085)
🇰🇷Seongnam-si, Kyonggi-do, Korea, Republic of
Asan Medical Center ( Site 0082)
🇰🇷Seoul, Korea, Republic of
SMG-SNU BORAMAE Medical Center ( Site 0086)
🇰🇷Seoul, Korea, Republic of
Gachon University Gil Medical Center ( Site 0087)
🇰🇷Incheon, Korea, Republic of
Severance Hospital Yonsei University Health System ( Site 0081)
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital -SNUH- ( Site 0080)
🇰🇷Seoul, Korea, Republic of
Nacionalinis Vezio Institutas ( Site 0569)
🇱🇹Vilnius, Lithuania
Gangnam Severance Hospital ( Site 0088)
🇰🇷Seoul, Korea, Republic of
LSMUL Kauno Klinikos ( Site 0570)
🇱🇹Kaunas, Lithuania
Hospital Kuala Lumpur ( Site 0146)
🇲🇾Kuala Lumpur, Malaysia
St. Luke s Medical Center ( Site 0622)
🇵🇭Quezon City, National Capital Region, Philippines
Wojewodzki Szpital Specjalistyczny we Wroclawiu ( Site 0358)
🇵🇱Wroclaw, Dolnoslaskie, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie ( Site 0351)
🇵🇱Lublin, Lubelskie, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0349)
🇵🇱Warszawa, Mazowieckie, Poland
Szpital Uniwersytecki w Krakowie ( Site 0352)
🇵🇱Krakow, Malopolskie, Poland
Riga East Clinical University Hospital ( Site 0550)
🇱🇻Riga, Latvia
Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 0353)
🇵🇱Koscierzyna, Pomorskie, Poland
Tomsk Scientific Research Institute of Oncology ( Site 0337)
🇷🇺Tomsk, Tomskaya Oblast, Russian Federation
CEPON - Centro de Pesquisas Oncologicas ( Site 0302)
🇧🇷Florianopolis, Santa Catarina, Brazil
SA Pohja-Eesti Regionaalhaigla ( Site 0526)
🇪🇪Tallinn, Harjumaa, Estonia
Centre Eugene Marquis ( Site 0466)
🇫🇷Rennes, Ille-et-Vilaine, France
Vilniaus Universiteto Ligonine Santaros Klinikos ( Site 0568)
🇱🇹Vilnius, Lithuania
Mackay Memorial Hospital ( Site 0065)
🇨🇳Taipei, Taiwan
Instituto Clinico del Sur. ICOS ( Site 0290)
🇨🇱Temuco, Araucania, Chile
Hospital Regional Rancagua Libertador Bernardo O Higgins ( Site 0299)
🇨🇱Rancagua, Lbtdr Gen Bernardo O Higgins, Chile
Hospital Clinico Universidad de Chile ( Site 0287)
🇨🇱Santiago, Region M. De Santiago, Chile
CHU Toulouse - Hopital Rangueil ( Site 0470)
🇫🇷Toulouse, Haute-Garonne, France
Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0469)
🇫🇷Saint Herblain, Loire-Atlantique, France
Integra Cancer Institute ( Site 0262)
🇬🇹Guatemala, Guatemala
Grupo Medico Angeles ( Site 0261)
🇬🇹Guatemala, Guatemala
CHRU Lille - Hopital Claude Huriez ( Site 0461)
🇫🇷Lille, Nord, France
University Malaya Medical Centre ( Site 0143)
🇲🇾Kuala Lumpur, Malaysia
National Cheng Kung University Hospital ( Site 0067)
🇨🇳Tainan, Taiwan
Fundacion Arturo Lopez Perez FALP ( Site 0286)
🇨🇱Santiago, Region M. De Santiago, Chile
Pontificia Universidad Catolica de Chile ( Site 0285)
🇨🇱Santiago, Region M. De Santiago, Chile
Mazowiecki Szpital Onkologiczny ( Site 0363)
🇵🇱Wieliszew, Mazowieckie, Poland
Institut Jules Bordet ( Site 0480)
🇧🇪Brussels, Bruxelles-Capitale, Region De, Belgium
UCL Saint Luc ( Site 0479)
🇧🇪Bruxelles, Bruxelles-Capitale, Region De, Belgium
UZ Leuven ( Site 0483)
🇧🇪Leuven, Vlaams-Brabant, Belgium
Yale Cancer Center ( Site 0016)
🇺🇸New Haven, Connecticut, United States
University of Utah, Huntsman Cancer Institute ( Site 0012)
🇺🇸Salt Lake City, Utah, United States
Ivano-Frankivsk Regional Oncology Clinical Dispensary ( Site 0321)
🇺🇦Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine