Trial of Neoadjuvant Durvalumab Plus Docetaxel, Oxaliplatin, S-1 Followed by Surgery and Adjuvant Durvalumab Plus S-1 Chemotherapy in Potentially Resectable MMR Proficient Gastric or Gastroesophageal Junction Adenocarcinoma

NCT04221555 | Unknown Phase 2

• 1 other identifier: AMC2001
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

Neoadjuvant durvalumab (MEDI4736) plus docetaxel, oxaliplatin, S-1 (DOS) followed by surgery and adjuvant durvalumab plus S-1 chemotherapy in potentially resectable MMR proficient (pMMR) gastric or gastroesophageal junction (GEJ) adenocarcinoma

Conditions

Resectable Gastric or Gastroesophageal Junction Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Pathologic complete regression (pCR) rate

  3 years

Secondary Outcomes (2)

• R0 resection rate

  3 years

• Disease free survival (DFS)

  3 years

Study Arms (2)

the main treatment group

EXPERIMENTAL

pMMR tumor

Drug: Docetaxel, Oxaliplatin, S-1 and Durvalumab

the exploratory group

ACTIVE COMPARATOR

dMMR tumor

Drug: Durvalumab and Tremelimumab

Interventions

Docetaxel, Oxaliplatin, S-1 and Durvalumab DRUG

1. Neoadjuvant treatment Durvalumab 1120 mg IV on day (D) 1, Docetaxel 50 mg/m2 intravenously (IV) on D1, oxaliplatin 100 mg/m2 IV on D1, S-1 40 mg/m2 bid orally on D1-14, will be administered every three weeks for three cycles. 2. Surgery 3. Adjuvant treatment After 4-6 weeks from surgery, S-1 40 mg/m2 bid orally on D1-28 plus durvalumab 1120 mg on D1 and D22 will be administered every 6 weeks for 12 months as an adjuvant treatment.

the main treatment group

Durvalumab and Tremelimumab DRUG

1. Neoadjuvant treatment Durvalumab 1500 mg IV and tremelimumab 75 mg IV on D1 will be administered every four weeks for three cycles. 2. Surgery 3. Adjuvant treatment After 4-6 weeks from surgery, durvalumab 1500 mg on D1 will be administered every 4 weeks for 12 months as an adjuvant treatment.

the exploratory group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed pathologically proven potentially resectable gastric or GEJ adenocarcinoma
• Clinical stages of T3-4N0 or T2-4N+ according to the American Joint Committee on Cancer (AJCC) 8th edition by computed tomography (CT)
• Microsatellite-instability (MSI) status determined by immunohistochemical (IHC) staining
• No peritoneal seeding identified by laparoscopy if suspected by CT
• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations
• Age \> 18 years at time of study entry
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Life expectancy of \> 12 months
• Body weight \> 30kg
• No existing neuropathy
• Adequate normal organ and marrow function as defined below:
• Haemoglobin ≥9.0 g/dL
• Absolute neutrophil count (ANC) 1.5 (or 1.0) x (\> 1500 per mm3)
• Platelet count ≥100 (or 75) x 109/L (\>75,000 per mm3)
• Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN)

You may not qualify if:

• Participation in another clinical study with an investigational product during the last 2 weeks
• Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
• Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacementtherapy) is acceptable
• Major surgical procedure within 28 days prior to the first dose of durvalumab
• Distant metastasis including M1 lymph node
• Unable to take medication orally
• Gastric outlet obstruction and/or severe gastrointestinal bleeding
• Impaired bowel absorption, including any of the following:
• Bowel obstruction
• Chronic inflammatory bowel disease
• History of extended bowel resection
• Gastric dumping syndrome
• History of allogenic organ transplantation
• Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., colitis or Crohn's disease\], diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\]). The following are exceptions to this criterion:
• Patients with vitiligo or alopecia

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Interventions

Docetaxel; Oxaliplatin; S 1 (combination); durvalumab; tremelimumab

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• Min-Hee Ryu, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min-Hee Ryu, MD, PhD

CONTACT

+82-2-3010-5935; miniryu@amc.seoul.kr

Hyung-Don Kim, MD, PhD

CONTACT

+82-2-3010-5935; kimhdmd@amc.seoul.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 9, 2020
• Study Start: May 13, 2020
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: December 29, 2023

Record last verified: 2023-12

Locations

KR (1)