Avelumab With Chemoradiation for Stage II/III Resectable Esophageal and Gastroesophageal Cancer (NCT03490292) | Clinical Trial Compass
CompletedPhase 1/2
Avelumab With Chemoradiation for Stage II/III Resectable Esophageal and Gastroesophageal Cancer
United States22 participantsStarted 2018-05-29
Plain-language 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
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients with histologically confirmed, potentially curable squamous-cell carcinoma, adenocarcinoma, or large-cell undifferentiated carcinoma of the esophagus and gastroesophagus (Siewert type 1-3)
✓. Locoregional disease with clinical stage of T1N1 or T2-3N0-2
✓. No clinical evidence of metastatic spread. Staging should include endoscopic ultrasound and positron emission tomography/computed tomography (PET/CT) as recommended by National Comprehensive Cancer Network (NCCN) guidelines. PET/CT should be performed within 3 weeks of signing informed consent
✓. Age 18 years or older
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
✓. Subjects must be deemed to be potential surgical candidates by an evaluating surgeon
✓. Adequate organ function:
✓. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
Exclusion criteria
✕
What they're measuring
1
Number of Participants With Dose Limiting Toxicity
Timeframe: Up to 4 weeks post-resection (up to approximately 4 months on study) of all Run-In Phase participants
2
Number of Participants With Pathological Complete Response
Timeframe: Post-resection (80-100 days) pathology review for all participants (up to approximately 4 months on study)
✕. Other active malignancy within the last 3 years (except for non-melanoma skin cancer, a non-invasive/in situ cancer, or indolent non metastatic Gleason 6 prostate cancer)
✕. Subjects with an active or known autoimmune disease. Subjects with type I diabetes mellitus, hypo- or hyperthyroidism only requiring hormone replacement/suppression, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic immunosuppressive treatment are eligible
✕. Current use of immunosuppressive medication, except for the following:
✕. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection)
✕. systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent
✕. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)