Health Condition 1: C20- Malignant neoplasm of rectum
Conditions
Interventions
Intervention1: Low-dose nivolumab 40 mg: Low-dose nivolumab 40 mg IV in 100 ml NS over 1hr (IV line with low-protein binding 0.2 or 0.22-micron in-line filter) administered intravenously every 2 weeks
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects must have histologically confirmed MSI-H locally advanced rectal cancer 2.Male or female subjects aged more than or equal to 18 years. 3.Patients who have not received any treatment for rectal cancer. 4.Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 1. 5.Subjects must have normal organ and marrow function. 6.Patients with HIV are potentially eligible, as long as they have a CD4 count more than 200, are on concurrent HAART (highly active antiretroviral therapy), and have no active AIDS-defining conditions. 7.Negative serum or urine pregnancy test at screening for women of childbearing potential. 8.Contraception. 9.Both men and women of all races and ethnic groups are eligible for this study. 10.Willing and able to comply with all study requirements, including treatment and regular follow-up assessments. 11.Ability to understand and willingness to sign a written informed consent document.
Exclusion criteria
Exclusion criteria: 1.Patients with metastases 2.Previously treated rectal cancer patients 3.Patients on other investigational agents 4.Chemotherapy within 3 weeks 5.Current use of immunosuppressants except low-dose steroids or specific short-term uses 6.Active autoimmune disease requiring immunosuppressants 7.Prior organ or stem cell transplant 8.Active infection needing systemic treatment 9.Active hepatitis B or C 10.Vaccination within 4 weeks before or during study (except inactivated vaccines) 11.Severe hypersensitivity to study drug or monoclonal antibodies 12.Significant cardiovascular disease (stroke, MI, heart failure, arrhythmia within 6 months) 13.Unresolved toxicity from prior therapy unless mild and not risky 14.Severe medical or psychiatric conditions or abnormal labs that increase study risk 15.Pregnant women excluded; effective contraception required 16.Breastfeeding not allowed during and for 1 month after treatment 17.No prior immunotherapy use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objective: To evaluate the clinical complete response (cCR) rate of low-dose nivolumab (40 mg) as neoadjuvant therapy in MSI-H locally advanced rectal cancer. cCR can be defined as no evidence of active disease as per rectal examination, sigmoidoscopy and radiological evaluationTimepoint: every 2 months upto 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Pathological complete response (pCR) rate in patients undergoing surgery. 2.Disease -free survival (PFS) in patients undergoing surgery.. 3.progression -free survival (PFS) in patients not undergoing surgery 4.Overall survival (OS) in patients undergoing surgery. 5.Safety & toxicity profile in patients undergoing surgery. 6.Quality of life (QoL) assessment in patients undergoing surgery.Timepoint: every 2 months upto 3 years | — |
Countries
India
Contacts
Public ContactDr Vikas Ostwal
Tata Memorial Hospital, Mumbai
Outcome results
None listed