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Avelumab With Chemoradiation for Stage II/III Resectable Esophageal and Gastroesophageal Cancer

NCT03490292 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2024-07-26

Study results available
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Summary

This is a 2 part Phase I/II clinical trial evaluating the safety, tolerability and efficacy of avelumab in combination with chemoradiation in patients with resectable esophageal and gastroesophageal cancer.

Part 1: This is the run-in phase of the trial. This portion will determine the safety and tolerability of avelumab in combination with chemoradiotherapy in 6 patients. The proposed combination will be considered as safe if dose limiting toxicities are observed in at most 1 patient.

Part 2: This is a Phase 2 portion of the trial, which will evaluate the efficacy of the proposed treatment regimen in patients with stage II/III resectable esophageal and gastroesophageal cancer

Conditions

Interventions

COMBINATION_PRODUCT

Avelumab combined with Chemoradiation

Co-administration of avelumab with chemoradiation in pre-operative period.

DRUG

Carboplatin

Weekly Carboplatin (AUC2) \[intravenous infusion on days 1, 8, 15, 22, \& 29\]

DRUG

Paclitaxel

Weekly paclitaxel \[intravenous infusion on days 1, 8, 15, 22, \& 29\]

RADIATION

Radiation

Radiation therapy \[23 fractions, M-F, estimated completion day 35\]

Sponsors & Collaborators

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Nataliya Uboha · University of Wisconsin, Madison

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-29
Primary Completion
2022-01-19
Completion
2023-07-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03490292 on ClinicalTrials.gov