Nivolumab +/- Relatlimab Prior to Chemoradiation With II/III Gastro/Esophageal Cancer (NCT03044613)
🩺 Plain-English Summary (8th-Grade Level)
Anti-PD-1 (nivolumab) or Anti-PD1/Anti LAG-3- (relaltimab) administration in the pre-operative setting with chemoradiation will be safe and feasible in patients with resectable distal esophageal/gastroesophageal junction cancer and will change cellular and molecular characteristics of the tumor microenvironment that will improve survival.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (26 items) and avoid the listed exclusions (28 items).
Location: Johns Hopkins University — Baltimore, Maryland
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Patient has active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- Esophageal tumors that are located in the mid esophagus or higher i.e. not involving distal esophagus or GE junction.
- Tumors whose proximal end are higher that the level of the carina
- Biopsy proven involvement of supraclavicular lymph nodes
- Tumors must not extend 5cm or more into the stomach
- Patient has a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first dose. Inhaled or topical steroids and adrenal replacement steroid doses are permitted in the absence of active autoimmune disease.
- Subjects with previous malignancies (except non-melanoma skin cancers, in situ bladder, gastric, breast, colon or cervical cancers/dysplasia) are excluded unless a complete remission was achieved at least 1 years prior to study entry and no additional therapy (other than adjuvant hormonal therapy for breast cancer) is required or anticipated to be required during the study period.
- Subjects with brain metastasis are excluded from this study and all patients should have brain imaging (either MRI brain or CT brain with contrast) prior to enrollment.
- Subjects with a history of interstitial lung disease.
- Active systemic infection requiring therapy, positive tests for Hepatitis B surface antigen or Hepatitis C ribonucleic acid (RNA).
- Known positive history or positive test for Human Immunodeficiency Virus or Acquired ImmunoDeficiency Syndrome (AIDS).
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (3 Sites)
- Johns Hopkins University — Baltimore, Maryland
- Alleghany Health Network — Pittsburgh, Pennsylvania
- Baylor University/ Charles A. Sammons Cancer Center — Dallas, Texas
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.