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NCT03395847
Pembrolizumab in Treating Patients With Metastatic or Unresectable Gastroesophageal Adenocarcinoma
EARLY_PHASE1 trial testing Pembrolizumab in Advanced Gastroesophageal Junction Adenocarcinoma in 9 participants. Completed in 27 January 2023.
27 January 2023
Quick facts
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 9 |
| Start date | 9 February 2018 |
| Primary completion | 27 January 2023 |
| Estimated completion | 27 January 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Pembrolizumab (pembrolizumab) — full drug profile →
Conditions studied
- Advanced Gastroesophageal Junction Adenocarcinoma — all drugs for Advanced Gastroesophageal Junction Adenocarcinoma →
- Clinical Stage III Esophageal Adenocarcinoma AJCC v8 — all drugs for Clinical Stage III Esophageal Adenocarcinoma AJCC v8 →
- Clinical Stage III Gastric Cancer AJCC v8 — all drugs for Clinical Stage III Gastric Cancer AJCC v8 →
- Clinical Stage IV Esophageal Adenocarcinoma AJCC v8 — all drugs for Clinical Stage IV Esophageal Adenocarcinoma AJCC v8 →
Sponsor
M.D. Anderson Cancer Center — full company profile →
Who can join
18 and older, any sex, with Advanced Gastroesophageal Junction Adenocarcinoma or Clinical Stage III Esophageal Adenocarcinoma AJCC v8. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Tumor vessel normalization and immunotherapy in gastric cancer.
Yu X, He S, Shen J, Huang Q, et al · · 2022 · cited 6× · PMID 35872968 · DOI 10.1177/17588359221110176 -
Prognostic and predictive factors in advanced upper gastrointestinal cancer treated with immune checkpoint inhibitors: a systematic review and meta-analysis of the current evidence.
Wang P, Chen P, Yang W, Yang W, et al · · 2024 · PMID 39385078 · DOI 10.1186/s12885-024-12998-w
Verify or expand the search:
- PubMed search for NCT03395847
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Advanced Gastroesophageal Junction Adenocarcinoma
Currently open trials in the same condition.
- NCT06028737 — Total Neoadjuvant FLOT Chemotherapy in Locally Advanced Gastric and Gastroesophageal Junction Cancer · Phase 2, PHASE3 · recruiting
- NCT06203600 — Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial · Phase 2, PHASE3 · recruiting
- NCT06642857 — Multi-omics Based Prediction of Treatment Response to Immunotherapy Combined with Chemotherapy in Advanced Gastric/Gastr · recruiting
- NCT05733000 — CPI-613 (Devimistat) in Combination With Hydroxychloroquine and 5-fluorouracil or Gemcitabine in Treating Patients With · Phase 2 · recruiting
- NCT05677490 — mFOLFIRINOX Versus mFOLFOX With or Without Nivolumab for the Treatment of Advanced, Unresectable, or Metastatic HER2 Neg · Phase 3 · recruiting
Other M.D. Anderson Cancer Center trials
Trials by the same sponsor.
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- NCT07137481 — Phase II Study of CD5 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Che · Phase 2 · not yet recruiting
- NCT07162480 — Phase II Trial of Puxitatug Samrotecan (AZD8205) in Advanced, Recurrent or Metastatic (R/M) Aggressive Adenoid Cystic Ca · Phase 2 · not yet recruiting
- NCT07076498 — Engineered HSV-1 M032 for the Treatment of Children and Adults With Newly Diagnosed Diffuse Midline Glioma After Standar · Phase 1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03395847 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
- Last refreshed: 18 November 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03395847.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing