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Monoclonal Antibodies

Avelumab combined with Chemoradiation for Gastroesophageal Cancer

Phase 1 & 2
Waitlist Available
Led By Nataliya Uboha
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with histologically confirmed, potentially curable squamous-cell carcinoma, adenocarcinoma, or large-cell undifferentiated carcinoma of the esophagus and gastroesopagus (Siewert type 1-3)
Locoregional disease with clinical stage of T1N1 or T2-3N0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years post-resection for all 24 subjects.
Awards & highlights

Study Summary

This trial will test if avelumab, when given with chemo and radiation, is safe and effective in treating patients with resectable esophageal and gastroesophageal cancer.

Eligible Conditions
  • Gastroesophageal Cancer
  • Esophageal Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years post-resection for all 24 subjects.
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years post-resection for all 24 subjects. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1: Dose Limiting Toxicity
Part 2: Pathological complete response rate.
Secondary outcome measures
Disease
Incidence of surgical complications
Number of Adverse Events
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Run-In PhaseExperimental Treatment4 Interventions
6 patients enrolled will receive weekly carboplatin (AUC2) and paclitaxel (50 mg/m2) [intravenous infusion on days 1, 8, 15, 22, & 29] while undergoing radiation therapy [23 fractions, M-F, estimated completion day 35]. Avelumab combined with Chemoradiation - Avelumab (10 mg/kg IV) every 2 weeks starting on the day of the last chemotherapy infusion (day 29). A total of 3 doses administered during the pre-operative period and an additional 6 doses of avelumab post-operatively. Trial enrollment will resume after at least 5 patients do not have a DLT during the DLT evaluation period or until all 6 patients are seen for post-operative evaluation. If 2 or more patients experience dose limiting toxicities associated with the proposed treatments, further accrual of the subjects will be halted and trial will be suspended. Trial may be reopened in the future with appropriate schedule and dose modifications of the proposed treatment.
Group II: Expansion CohortExperimental Treatment4 Interventions
Following a determination of safe and tolerable treatment outcome of the Run-In Phase, Part 2 of the trial will enroll 18 additional patients to evaluate activity of the proposed treatment and to obtain further safety information (carboplatin, paclitaxel, radiation & Avelumab combined with Chemoradiation).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6670
Radiation
2003
Completed Phase 3
~1020
Paclitaxel
2011
Completed Phase 4
~5380

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,176 Previous Clinical Trials
3,011,984 Total Patients Enrolled
Nataliya UbohaPrincipal InvestigatorUniversity of Wisconsin, Madison

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial presently seeking participants?

"As indicated on clinicaltrials.gov, recruitment for this trial has been suspended since March 28th 2022. Despite the fact that candidates are no longer being sought out in this study, there exist 1300 other investigations actively searching for volunteers at present."

Answered by AI

What therapeutic uses is Avelumab combined with Chemoradiation typically prescribed for?

"The combination of Avelumab and Chemoradiation is effective in treating advanced endometrial cancer, melanoma, and metastatic neoplasms."

Answered by AI

What aims is this clinical trial hoping to accomplish?

"This clinical trial aims to assess the tolerability and efficacy of a novel drug combination over 4 weeks post-resection. The primary outcome is pathological complete response rate, while secondary objectives include determining the number of participants who manage to finish their planned treatment, establishing an incidence rate for surgical complications through Wilson score method calculations and estimating R0 resection rates with 95% confidence intervals also calculated using said statistical technique."

Answered by AI

To what extent have Avelumab and Chemoradiation been tested in tandem for medical treatments?

"At the moment, 1273 clinical trials related to Avelumab combined with Chemoradiation are ongoing. Of those studies, 341 have reached Phase 3. Shanghai is home to many of these experiments; however there are 69603 global locations conducting research for this treatment."

Answered by AI

How many participants are participating in this clinical examination?

"Recruitment for this clinical trial has ended. It was first posted on May 29th 2018 and last edited on March 28 2021. If you're looking to join other studies, there are presently 27 trials recruiting patients with gastroesophageal cancer and 1273 involving Avelumab in combination with chemoradiation."

Answered by AI
~3 spots leftby Mar 2025