Status: New
| Name & address of the Laboratory/Organization | Tata Memorial Centre | |
| Website address | https://tmc.gov.in | |
| Affiliated to which Department/Ministry | Department Of Atomic Energy (DAE) | |
| CSR Registration Number | CSR00001287 | |
| Registration under 12A | INS/12128 Provisional approval no.- AAATT3620RE20214 | |
| Registration under 80G | DIT(E)/ITO(Tech)/80G/2010-11 Provisional approval no.- AAATT3620RF20241 | |
| Name of the CSR Nodal | Dr Heena Shaikh | |
| Contact information of CSR Nodal | Phone- +91-22 -68735000 Extn: 5483, hshaikh@actrec.gov.in | |
| Principal Investigator | Dr.Vikas Ostwal, hshaikh@actrec.gov.in | |
| Co- Principal Investigator (Co-PI) | ||
| Objective on the basis of need | In this study, we will evaluate the prolongation of life in an additional 20 % of patients at one year when they receive immunotherapy in a low dose (40 mg) as compared to chemotherapy alone, specifically when MSI marker is high on the tumor biopsy |
| Executive summary of the proposed project (In 250 words) | It is a single-arm, prospective, phase 2 study. Patients diagnosed with MSI markers high on the tumor tissue will be screened and recruited to this study. All subjects will be treated for 1 year or till the progression of the disease or development of intolerable side effects. In the first stage, 20 patients will be added to the study and if 7 or more patients have their tumor controlled at 1 year, the study will proceed to the second stage to recruit an additional 27 patients for a total of 52 including 5 patients attrition. All patients will undergo axial imaging of the thorax, abdomen, and pelvis before the enrolment and at 2 monthly intervals thereafter to check the response. Blood samples will be collected at different time points namely at baseline (Day 0), 3 months, 6 months and 12 months of follow-up for ctDNA analysis. |
| Technology Readiness Level (If not a new project but an advancement of existing know how) | The smallest quantity of a Nivolumab Vial available is 40 mg. In accordance with the above literature proposing benefit of using a dose as low as 20 mg is equally beneficial, we would like to explore the efficacy of a flat dose of 40 mg in patients with dMMR mCRC, which has never been evaluated in this cohort. The studies have evaluated standard doses and they cost more than 50 lakh rupees for the entire treatment duration. If this study turns positive, it will transform the lives of an additional 20% patient towards potentially curative situation. |
| Outomes or Deliverables | The cost of Nivolumab at the standard dose is around 2,30,000 INR per dose, which is beyond the affording capacity of most. Such treatment for 1 to 2 years, would cost 50,00,000 to 100,00,000 Rupees. Unpublished data from Tata Memorial Centre revealed that <2% of our patients can afford it. Hence, there is an urgent unmet need to develop an alternative regimen. We are giving single agent Nivolumab and hence 40 mg is considered to be a reasonable dose, and the smallest quantity of a Nivolumab Vial available is 40 mg which will be cost-effective, with which 1-2 years of therapy would cost 10,00,000 – 20,00,000 Rupees if proven effective in this study. |
| Project aligned with which most relevant UN SDGs | Goal 3 - Good Health & Well-Being |
| Duration (In years) | 4 years |
| Expected Impact | 1. Cost reduction 2. Prolonging life in 20 % additional patient compared to chemotherapy al |
| Implementation model (self- implemented/ outsourced partnership) | The study has been initiated and till date we have enrolled 20 patients in the study out of 52 patients. The study is implemented at Tata Memorial Hospital, Mumbai. The cost of protocol specific investigations and study treatment is covered through study account. The patients are contacted regularly telephonically for toxicity assessment. |
| Total Budget (Recurring +Non-Recurring Expenses) | Rs 5,33,64,000/- |