Nivolumab and Ipilimumab and Radiation Therapy in MSS and MSI High Colorectal and Pancreatic Cancer (NCT03104439) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Nivolumab and Ipilimumab and Radiation Therapy in MSS and MSI High Colorectal and Pancreatic Cancer
United States84 participantsStarted 2017-05-10
Plain-language summary
This research study is studying a combination of drugs with radiation therapy as a possible treatment for Microsatellite Stable Colorectal Cancer, Pancreatic Cancer, or MSI High Colorectal Cancer.
The interventions involved in this study are:
* Nivolumab
* Ipilimumab
* Radiation Therapy
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Participants must have histologically or cytologically confirmed adenocarcinoma of colorectal or pancreatic origin
* Age \>18 years.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤1
* Life expectancy of greater than 3 months
* Participants must have normal organ and marrow function as defined in Table 1, all screening labs should be performed within 14 days of protocol registration.
Table 1 Adequate Organ Function Laboratory Values
System Laboratory Value
* Hematological
* Absolute neutrophil count (ANC) ≥1500 /mcL
* White blood count (WBC) ≥2000 /mcL
* Platelets ≥100,000 / mcL
* Hemoglobin ≥9 g/dL
* Renal
* Serum creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤ Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min (if using the Cockcroft-Gault formula below):
* Female CrCl = (140 - age in years) x weight in kg x 0.85 72 x serum creatinine in mg/dL
* Male CrCl = (140 - age in years) x weight in kg x 1.00 72 x serum creatinine in mg/dL
* Hepatic
* Serum total bilirubin ≤ 1.5 X ULN (upper limit of normal) (subjects with Gilbert Syndrome can have a total bilirubin \<3 mg/dL
* aspartate aminotransferase (AST) serum glutamic oxaloacetic transaminase (SGOT) and Alanine Aminotransferase ALT (SGPT) ≤ 3 X ULN OR ≤ 5 X ULN for subjects with liver metastases
* Coagulation
* International Normalized Ratio (INR) or Prothrombin Time (PT)
* …