Description:
This is a Global Study of Neoadjuvant-Adjuvant Durvalumab or Placebo and FLOT Chemotherapy
Followed by Adjuvant Durvalumab or Placebo in Patients with Resectable Gastric and
Gastroesophageal Cancer (GC/GEJC) (MATTERHORN).
Title
- Brief Title: Assessing Durvalumab and FLOT Chemotherapy in Resectable Gastric and Gastroesophageal Junction Cancer
- Official Title: A Randomized, Double-blind, Placebo-controlled, Phase III Study of Neoadjuvant-Adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Patients With Resectable Gastric and Gastroesophageal Junction Cancer (GC/GEJC)
Clinical Trial IDs
- ORG STUDY ID:
D910GC00001
- SECONDARY ID:
2019-001555-40
- NCT ID:
NCT04592913
Conditions
- Gastrointestinal Neoplasms
- Esophagogastric Junction
Interventions
| Drug | Synonyms | Arms |
|---|
| Durvalumab | | Arm A |
| FLOT chemotherapy | | Arm A |
Purpose
This is a Global Study of Neoadjuvant-Adjuvant Durvalumab or Placebo and FLOT Chemotherapy
Followed by Adjuvant Durvalumab or Placebo in Patients with Resectable Gastric and
Gastroesophageal Cancer (GC/GEJC) (MATTERHORN).
Detailed Description
This study investigates treatment of durvalumab or placebo therapy combined with FLOT
chemotherapy (flurouroacil + leucovorin + oxaliplatin + docetaxel) given before surgery
(neoadjuvant) and durvalumab or placebo therapy combined with FLOT chemotherapy after surgery
(adjuvant), will work and be safe for the treatment of resectable (removable by surgery)
gastric or gastroesophageal cancer, and also to better understand the studied disease and
associated health problems.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Arm B | Placebo Comparator | placebo product and FLOT chemotherapy | |
| Arm A | Experimental | Durvalumab and FLOT chemotherapy | - Durvalumab
- FLOT chemotherapy
|
Eligibility Criteria
Key Inclusion Criteria:
- Patients with histologically documented gastric or gastroesophageal junction
adenocarcinoma with resectable disease (Stage II or higher per AJCC 8th edition).
- Patients must undergo radical surgery.
- No prior anti-cancer therapy for the current malignancy.
- World Health Organization (WHO)/ECOG performance status of 0 or 1 at enrollment.
- Adequate organ and marrow function.
- Availability of tumor sample prior to study entry.
- Must have a life expectancy of at least 24 weeks.
Key Exclusion Criteria:
- Patients with peritoneal dissemination or distant metastasis.
- Patients with adenosquamous cell carcinoma, squamous cell carcinoma, or GI stromal
tumor.
- Current or prior use of immunosuppressive medication within 14 days before the first
dose of durvalumab.
- Contra-indication to any of the study drugs.
- History of allogeneic organ transplantation.
| Maximum Eligible Age: | 200 Years |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Event-free survival (EFS) |
| Time Frame: | Up to 5 years |
| Safety Issue: | |
| Description: | EFS is the time from date of randomization until the date of disease progression or death. |
Secondary Outcome Measures
| Measure: | To compare Arm A relative to Arm B on overall survival (OS) |
| Time Frame: | Up to 5 years |
| Safety Issue: | |
| Description: | Overall survival is length of time from randomization until the date of death due to any cause. |
| Measure: | To compare Arm A relative to Arm B on pathological complete response (pCR) rate |
| Time Frame: | Up to 5 years |
| Safety Issue: | |
| Description: | pCR rate is the proportion of patients who have no residual viable tumor in the resected specimens. |
Details
| Phase: | Phase 3 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | AstraZeneca |
Last Updated
August 4, 2021
