Testing Nivolumab with HDRBET for locally advanced rectal cancer

Exclusion

• −Known allergy or hypersensitivity to nivolumab or any of its excipients.
• −HIV-infected participants must have well-controlled HIV on antiretroviral treatment (ART), defined as:
• −Active/uncontrolled infection. Infectious screeningScreeningThe checks done before joining, to see whether a study fits.Read more → for HIV, Hepatitis B (HBV), Hepatitis C (HBC) and tuberculosis will be performed at screening:
• −Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV anti-viral therapy for at least 4 weeks; and have undetectable HBV viral load prior to starting treatment. Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention.
• −Participants with a history of HCV infection are eligible if HCV viral load is undetectable at screening. Note: Participants must have completed curative anti-viral therapy at least 4 weeks prior to start of treatment.
• −i. have a CD4+ T-cell count ≥ 0.35 x109 cells/L at the time of screening. ii. must have achieved and maintained virologic suppression defined as confirmed HIV ribonucleic acid (RNA) level below 50 or the LLOQ (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks before screening.
• −iii. must not have had any AIDS-defining opportunistic infections within the past 12 months.
• −Prior anticancer therapy for rectal cancer.
• −Contraindication to safe MRI imaging.
• −Evidence of bowel obstruction on MRI or clinical evaluation.
• −Evidence of distant metastasis.
• −Active autoimmune disease requiring systemic immunosuppressive therapy.
• −iv. must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before start of treatment and agree to continue ART throughout the study.
• −Patients with other psychiatric, social or severe or uncontrolled medical conditions that in the opinion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → may compromise their compliance with the protocolProtocolThe detailed plan a study must follow.Read more → or may represent an unacceptable risk to their safety (e.g. uncontrolled diabetes, active or uncontrolled infection, uncontrolled clinically significant cardiovascular disease).
• −Requirement for prohibited concomitant medication, as outlined in section 8.4 within 14 days prior to first brachytherapy treatment.
• −Treatment with other investigational agents (defined as not used in accordance with the approved indication) within 28 days of first neo-adjuvant treatment.
• −Patients who are pregnant or breastfeeding or WOCBP not employing an effective method of birth controlControl groupThe group a new treatment is measured against.Read more →.
• −Medical or surgical contraindications to major pelvic surgery