Nivolumab +/- Relatlimab Prior to Chemoradiation With II/III Gastro/Esophageal Cancer (NCT03044613) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Nivolumab +/- Relatlimab Prior to Chemoradiation With II/III Gastro/Esophageal Cancer
United States32 participantsStarted 2017-07-11
Plain-language summary
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 participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Men and women aged ≥ 18 years old
* Histologically proven (squamous cell or adenocarcinoma) esophageal or gastro- esophageal junction cancer (core biopsy required).
* Stage II/III disease as per AJCC staging 7.0
* Baseline imaging with FDG-PET scan and endoscopic ultrasound within 28 days prior to registration
* ECOG performance status 0-1 (see Appendix B).
* Adequate oral intake/nutritional status without the need for enteral or parenteral feeding during chemoradiation or preoperative period
* Adequate organ function as follows:
* Leukocytes ≥ 2,000/mm3
* Absolute neutrophil count (ANC) ≥ 1000/mm3
* Platelet count ≥ 100,000/mm3
* Hemoglobin ≥ 9 g/dL
* Creatinine ≤ 2.0 mg/dL
* Bilirubin (total) within normal institutional limits (except subjects with Gilbert Syndrome who must have total bilirubin \< 3.0 mg/dL)
* AST(SGOT), ALT(SGPT), and alkaline phosphatase ≤ 2.5 times the upper limit of normal
* PT such that international normalized ratio (INR) is ≤ 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin and a PTT ≤ upper limit of normal
* Adequate cardiac function as defined by: no evidence of PR prolongation or AV block on baseline electrocardiogram (ECG).
* Radiation oncology consultation within 28 days to confirm that disease can be encompassed in the radiotherapy field and that normal tissue constraints can be met.
* Subjects must have adequate lung function to permit surgical re…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Timeframe: 100 days
Trial details
NCT IDNCT03044613
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins