Pembrolizumab for Gastroesophageal Junction Adenocarcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
M D Anderson Cancer Center, Houston, TXGastroesophageal Junction Adenocarcinoma+18 MorePembrolizumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This study is evaluating whether a combination of immunotherapy and chemotherapy may help treat gastroesophageal cancer.

Eligible Conditions
  • Unresectable Gastroesophageal Junction Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma
  • Clinical Stage IV Gastroesophageal Junction Adenocarcinoma
  • Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma
  • Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma
  • Locally Advanced Gastroesophageal Junction Adenocarcinoma
  • Pathologic Stage III Gastroesophageal Junction Adenocarcinoma
  • Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma
  • Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma
  • Stage IV Gastroesophageal Junction Adenocarcinoma
  • Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma
  • Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma
  • Postneoadjuvant Therapy Stage III Gastroesophageal Junction Adenocarcinoma
  • Postneoadjuvant Therapy Stage IIIA Gastroesophageal Junction Adenocarcinoma
  • Postneoadjuvant Therapy Stage IIIB Gastroesophageal Junction Adenocarcinoma
  • Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma
  • Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma
  • Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: Up to 2 years

Month 12
PFS at 12 months
Month 24
PFS at 24 months
Month 6
PFS at 6 months
Year 2
Median progression free survival (PFS)
Year 2
Overall survival (OS)
Up to 2 years
Biomarker analysis
Clinical complete response (cCR)
Tumor PD-L1 proportion
Tumor T cell infiltrate
Tumor gene expression
Tumor genetics
Day 90
Number of participants discontinuing study drug due to AEs
Number of participants experiencing adverse events (AEs)

Trial Safety

Safety Progress

1 of 3

Side Effects for

Pembrolizumab Second Course
100%Parkinsonism
100%Inappropriate antidiuretic hormone secretion
100%Urinary tract infection
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03066778) in the Pembrolizumab Second Course ARM group. Side effects include: Parkinsonism with 100%, Inappropriate antidiuretic hormone secretion with 100%, Urinary tract infection with 100%.

Trial Design

1 Treatment Group

Treatment (pembrolizumab, chemoradiotherapy)
1 of 1

Experimental Treatment

15 Total Participants · 1 Treatment Group

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 1

Treatment (pembrolizumab, chemoradiotherapy)Experimental Group · 5 Interventions: Docetaxel, Fluorouracil, Oxaliplatin, Pembrolizumab, Radiation Therapy · Intervention Types: Drug, Drug, Drug, Biological, Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel
FDA approved
Fluorouracil
FDA approved
Oxaliplatin
FDA approved
Pembrolizumab
FDA approved
Radiation Therapy
2017
Completed Phase 3
~7130

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,827 Previous Clinical Trials
1,792,653 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,163 Previous Clinical Trials
41,167,250 Total Patients Enrolled
Jaffer A AjaniPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
22 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

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Frequently Asked Questions

What medical conditions has Pembrolizumab been approved to treat?

"Pembrolizumab has been found to be effective in treating malignant neoplasms and other health issues such as unresectable melanoma, rectal carcinoma, and microsatellite instability high." - Anonymous Online Contributor

Unverified Answer

Has the FDA granted its official authorization for Pembrolizumab?

"Limited data on pembrolizumab's safety and efficacy has caused our team to assign it a rating of 1." - Anonymous Online Contributor

Unverified Answer

What is the total sample size of this research experiment?

"Affirmative. Clinicaltrials.gov indicates that the trial, which was first published on September 16th 2020, is currently seeking participants. 15 individuals must be recruited from a single clinical site." - Anonymous Online Contributor

Unverified Answer

Are there any vacancies in this trial for participants?

"Via clinicaltrials.gov, we know that this medical study is actively seeking participants. The trial was originally published on September 16th 2020 and recently edited as of October 10th 2022." - Anonymous Online Contributor

Unverified Answer

Are there any existing reports of Pembrolizumab being tested in other research projects?

"As of the present day, 1653 separate experiments are exploring Pembrolizumab's capabilities with 375 trials within Phase 3. Guangzhou, Guangdong is a particularly active location in regard to these studies; however, there exists 71618 other sites engaging in research involving Pembrolizumab." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.