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A decision was made to terminate the study due to expected timelines associated with start-up, participant enrollment, ethics committee approval and data availability from the study.
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| Name | Class |
|---|---|
| PPD Development, LP | INDUSTRY |
The purpose of this study is to describe the effectiveness and use of nivolumab after surgery in participants with early stage (Stage II/III) Esophageal Cancer/Gastroesophageal Junction Cancer (EC/GEJC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 |
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| Measure | Description | Time Frame |
|---|---|---|
| Disease-free Survival (DFS) | Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first |
| Measure | Description | Time Frame |
|---|---|---|
| DFS in Subgroups of Interest | Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first | |
| DFS Rates in Subgroups of Interest | From baseline up to 42 months | |
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Inclusion criteria:
Exclusion criteria:
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The study population will consist of participants from the United States and Germany with early stage (Stage II/III) EC/GEJC who received adjuvant nivolumab after resection.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233-1711 | United States | ||
| Pacific Central Coast Health Centers - San Luis Obispo Oncology and Hematology Health Center |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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| Overall Survival (OS) |
| Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first |
| OS Rates | From baseline up to 42 months |
| Progression-free Survival (PFS) | Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first |
| PFS Rates | From baseline up to 42 months |
| Distant Metastasis-free Survival (DMFS) | Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first |
| DMFS Rates | From baseline up to 42 months |
| Treatment Patterns of Adjuvant Nivolumab | From baseline up to 42 months |
| Treatment Patterns of Subsequent Therapy | From baseline up to 42 months |
| Post-recurrence Survival | Up to Month 42, death, lost to follow-up, or study withdrawal, whichever occurs first |
| Time To Next Treatment | From baseline up to 42 months |
| OS for Participants That Received Subsequent Nivolumab Treatment | Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first |
| OS Rates for Participants That Received Subsequent Nivolumab Treatment | From baseline up to 42 months |
| PFS for Participants That Received Subsequent Nivolumab Treatment | Up to 42 months, death, lost to follow-up, or study withdrawal, whichever occurs first |
| PFS Rates for Participants That Received Subsequent Nivolumab Treatment | From baseline up to 42 months |
| Overall Response Rate for Participants That Received Subsequent Nivolumab Treatment | From baseline up to 42 months |
| Time to Disease Recurrence | From baseline up to 42 months |
| Type of Disease Recurrence | From baseline up to 42 months |
| Participant Sociodemographics | From baseline up to 42 months |
| Number of Participants with Adverse Events | From baseline up to 42 months |
| Number of Participants with Serious Adverse Events Related to Nivolumab Treatment | From baseline up to 42 months |
| Disease stage at initial diagnosis | Esophageal Cancer/Gastroesophageal Junction Cancer (EC/GEJC) stage (i.e., I, II or III) and stage using Tumor, node, and metastasis (TNM) system | From baseline up to 42 months |
| Eastern Cooperative Oncology Group (ECOG) performance status | 0: Fully active, able to carry on all pre-disease performance without restriction
| From baseline up to 42 months |
| Tumor location at initial diagnosis | EC (upper, middle, lower area of the esophagus) or GEJC (Siewert type I, II or III, if available) | From baseline up to 42 months |
| Tumor histology at initial diagnosis | Squamous Cell Carcinoma (SSC) or adenocarcinoma | From baseline up to 42 months |
| Pathologic lymph node status | ypN0, ypN1, ypN2, ypN3, unknown | From baseline up to 42 months |
| Pathologic tumor status | ypT0, ypT1, ypT2, ypT3, ypT4, unknown | From baseline up to 42 months |
| Tumor cell PD-L1 expression (≥1% vs. <1% vs. indeterminate/non-evaluable) | Tumor cell PD-L1 expression levels and cells assessed. This will be used to group PD-L1 expression into ≥1%, <1%, or Indeterminate/non-evaluable and to derive the combined positive score (CPS) score which is defined as PD-L1 positive tumor cells + PD-L1 positive mononuclear inflammatory cells)/Total tumor cells) × 100 | From baseline up to 42 months |
| Type of recurrence | local/regional vs. distant | From baseline up to 42 months |
| Serum levels of nuclear protein Ki67 | From baseline up to 42 months |
| Number of participants with metastasis | From baseline up to 42 months |
| Sites of metastases | Lung, brain, liver, peritoneum, bone, lymph nodes, other | From baseline up to 42 months |
| Comorbidities | Diagnosis date and name of diagnosis, grouped using the National Cancer Institute (NCI) Comorbidity Index. | From baseline up to 42 months |
| Concomitant treatments | Type of treatment or therapies receive in parallel of nivolumab treatment and details (e.g., medications, radiotherapy, chemotherapy, systemic therapy, or surgical treatment) | From baseline up to 42 months |
| Concurrent medical conditions | From baseline up to 42 months |
| Prior treatments for EC/GEJC | Type of therapies received prior to initiation of nivolumab treatment (e.g., radiotherapy, chemotherapy, targeted therapy, systemic treatment, platinum-based therapy) and details (if applicable, e.g., regimens, dosing | From baseline up to 42 months |
| Participant Treatment History | From baseline up to 42 months |
| San Luis Obispo |
| California |
| 93401-7970 |
| United States |
| Mission Cancer Center | Santa Maria | California | 93454-5909 | United States |
| Saint Alphonsus Regional Medical Center | Boise | Idaho | 83706-1309 | United States |
| UPMC Hillman Cancer Center | Westwood | Kansas | 66205-2005 | United States |
| University Of Louisville | Louisville | Kentucky | 40202 | United States |
| Weill Cornell Medical College | New York | New York | 10065-6007 | United States |
| Local Institution - 0009 | Dallas | Texas | 75390-7208 | United States |
| William Beaumont Army Medical Center | Fort Bliss | Texas | 79906-5327 | United States |
| The University Of Texas | Houston | Texas | 77030-4000 | United States |
| Baylor Scott and White Health | Temple | Texas | 76508-0001 | United States |
| Universitätsklinikum Tübingen | Tübingen | Baden-Wurttemberg | 72076 | Germany |
| Klinikum Munchen-Bogenhausen | München | Bavaria | 81925 | Germany |
| Klinikum Kassel | Kassel | Hesse | 34125 | Germany |
| Onkologische Schwerpunktpraxis Dres. Ingo Zander und Eyck von der Heyde | Hanover | Lower Saxony | 30169 | Germany |
| Alexianer, Maria-Hilf-Krankenhaus | Essen | North Rhine-Westphalia | 45136 | Germany |
| Oncologianova GmbH | Recklinghausen | North Rhine-Westphalia | 45657 | Germany |
| Local Institution - 0006 | Mainz | Rhineland-Palatinate | 55131 | Germany |
| Universitätsklinikum Bonn | Bonn | Saarland | 53127 | Germany |
| Local Institution - 0033 | Homburg | Saarland | 66424 | Germany |
| CaritasKlinikum Saarbruecken. | Saarbrücken | Saarland | 66113 | Germany |
| Klinikum Chemnitz Ggmbh | Chemnitz | Saxony | 9113 | Germany |
| BAG Freiberg-Richter, Jacobash, Illmer, Wolf | Dresden | Saxony | 1307 | Germany |
| Universitätsklinik Magdeburg | Magdeburg | Saxony-Anhalt | 39120 | Germany |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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