Gastroesophageal Junction Adenocarcinoma Clinical Trial
Official title:
A Pilot Study of Pembrolizumab Monotherapy in Patients With Previously Treated Advanced Gastroesophageal Adenocarcinoma
This early phase I trial studies how well pembrolizumab works in treating patients with gastroesophageal adenocarcinoma that has spread to other places or cannot be removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
PRIMARY OBJECTIVES: I. To estimate the overall response rate (ORR) of intravenous administration of pembrolizumab by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 in adult subjects with advanced (unresectable and/or metastatic) and previously treated gastroesophageal adenocarcinoma. SECONDARY OBJECTIVES: I. To evaluate the duration of response (DOR), disease control rate (DCR), time to progression (TTP), progression-free survival (PFS), and overall survival (OS) using RECIST 1.1 and immune-related (ir)RECIST criteria. II. To perform exploratory biomarkers to study the correlation between immunological and molecular changes in tumor tissues and peripheral blood with clinical outcomes (DOR, DCR, TTP, PFS, and OS) using RECIST 1.1, and irRECIST rate of adverse events. III. To determine the safety and tolerability of intravenous administration of pembrolizumab or pembrolizumab plus ramucirumab in adult subjects with advanced (unresectable and/or metastatic) and previously treated gastroesophageal adenocarcinoma. EXPLORATORY OBJECTIVES: I. To explore the association between PD-L1 expression by immunohistochemistry, shed PD-L1 levels, somatic gene expression profiling and antitumor efficacy of pembrolizumab based on RECIST 1.1 imaging criteria as well as overall survival. II. To explore the relationship between genomic variation and response to the treatment administered. III. Tissue and blood immune monitoring will be conducted through our immune platform group as detailed per the biomarker section based on 3 biopsies done at the following time points: 1) pre-treatment, 2) 6 weeks after therapy, and 3) and an optional biopsy upon progression. OUTLINE: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 12 weeks thereafter. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03175224 -
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
|
Phase 2 | |
| Completed |
NCT02128243 -
Trial of S-1 Maintenance Therapy in Metastatic Esophagogastric Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT05008783 -
A Study of AK104 in the First-line Treatment of Locally Advanced Unresectable or Metastatic G/GEJ Adenocarcinoma
|
Phase 3 | |
| Recruiting |
NCT04140526 -
Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03421288 -
Study of Atezolizumab + FLOT vs. FLOT Alone in Patients With GC/GEJ and High Immune Responsiveness
|
Phase 2 | |
| Completed |
NCT03196232 -
Epacadostat and Pembrolizumab in Treating Patients With Metastatic or Unresectable Gastroesophageal Junction or Gastric Cancer
|
Phase 2 | |
| Terminated |
NCT03511222 -
Vorolanib (X-82) Combined With Checkpoint Inhibitors in Patients With Solid Tumors
|
Phase 1 | |
| Completed |
NCT02891447 -
Heated Mitomycin and Cisplatin During Surgery in Treating Patients With Stomach or Gastroesophageal Cancer
|
Phase 2 | |
| Completed |
NCT02864381 -
Study to Evaluate the Efficacy and Safety of Andecaliximab Combined With Nivolumab Versus Nivolumab Alone in Adults With Unresectable or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma
|
Phase 2 | |
| Terminated |
NCT04032704 -
A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors
|
Phase 2 | |
| Active, not recruiting |
NCT03615326 -
Pembrolizumab/Placebo Plus Trastuzumab Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-811/KEYNOTE-811)
|
Phase 3 | |
| Completed |
NCT02830594 -
Pembrolizumab and Palliative Radiation Therapy in Treating Patients With Metastatic Esophagus, Stomach, or Gastroesophageal Junction Cancer
|
Phase 2 | |
| Completed |
NCT02539225 -
A Study of Ramucirumab in Participants With Gastric or Gastroesophageal Junction Adenocarcinoma
|
Phase 2 | |
| Recruiting |
NCT06038578 -
A Study of TRK-950 When Used in Combination With Ramucirumab and Paclitaxel in Patients With Gastric Cancer
|
Phase 2 | |
| Recruiting |
NCT04581473 -
Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CT041 Autologous CAR T-cell Injection
|
Phase 1/Phase 2 | |
| Completed |
NCT00515411 -
Study of Modified Docetaxel, Cisplatin, and Fluorouracil (mDCF) in Unresectable or Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma
|
Phase 2 | |
| Recruiting |
NCT06206278 -
Evaluation of Infigratinib in Patients With Locally Advanced or Metastatic Gastric Cancer or GEJ Adenocarcinoma
|
Phase 2 | |
| Recruiting |
NCT05902988 -
A Phase I/II Study of VLS-1488 in Subjects With Advanced Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT02514551 -
A Study of Ramucirumab (LY3009806) in Combination With Paclitaxel in Participants With Gastric Cancer
|
Phase 2 |