REACTION (Radiation Enhanced Assessment of Combination Therapies in Immuno-ONcology) - Nivolumab … (NCT03610711) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
REACTION (Radiation Enhanced Assessment of Combination Therapies in Immuno-ONcology) - Nivolumab or Nivolumab in Combination With Other Immuno-oncology (IO) Agents After Targeted Systemic Radiation in Patients With Advanced Esophagogastric Cancer
United States21 participantsStarted 2019-03-06
Plain-language summary
This is a Phase 1B study assessing the safety of immune checkpoint inhibition after SBRT in patients with recurrent or metastatic gastroesophageal cancer (limited metastatic disease).
Who can participate
Age range18 Years – 99 Years
SexALL
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Inclusion Criteria:
* Men and women aged ≥ 18 years old.
* Histologically proven (squamous cell or adenocarcinoma) esophageal or gastro-esophageal junction cancer or gastric cancer (core biopsy required)
* Either a formalin fixed paraffin block or a minimum of ten 5-micron tissue section's (slides) of tumor biopsy sample must be available for biomarker evaluation.
* Recurrent disease or Stage IV disease as per American Joint Committee on Cancer (AJCC) staging 8.0 - patients who decline systemic chemotherapy in the first line metastatic setting are eligible.
* (Relatlimab arm only) LVEF assessment with documented left ventricular ejection fraction ( LVEF) \>/=50% by either echocardiogram TTE or multigated acquisition scan (MUGA) (TTE preferred test) within 6 months from first study drug administration,whichever is most recent.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* 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)
* Aspartate aminotransferase (AST) (SGOT), Alanine Aminotransferase (ALT) (SGPT), and alkaline phosphatase ≤ 2.5 times the institutional upper limit of normal
* prothrombin time (PT) such that international normalized ratio (INR) is ≤ 1.5 (or an in-rang…
What they're measuring
1
Change in the infiltrating CD8+ T cell density units after systemic treatment with radiation plus nivolumab +/- Relatlimib
Timeframe: 5 years
Trial details
NCT IDNCT03610711
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins