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 range18 Years
SexALL
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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…
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