The Subject Expert Committee (Oncology) of the Central Drugs Standard Control Organisation (CDSCO) has recommended granting permission to conduct a Phase IV clinical trial of dostarlimab in adult patients in India with primary advanced or recurrent endometrial cancer. The recommendation was made during the SEC (Oncology) meeting held on August 5, 2026, at CDSCO Headquarters, New Delhi.
GSK Pharma India presented the Phase IV clinical trial protocol titled “Phase 4, open label, single-arm, interventional, multicenter study to evaluate the safety of dostarlimab in adult patients in India with primary advanced or recurrent endometrial cancer” (Study 309169). The application was submitted under Protocol No. 309169 dated March 2, 2026, for dostarlimab concentrate for solution for infusion 500 mg/10 mL (50 mg/mL).
After detailed deliberation, the committee recommended granting permission to conduct the Phase IV clinical trial as per the protocol presented by the company, subject to specific conditions. The committee stipulated that all Principal Investigators (PIs) must be Medical Oncologists. It also directed that day-care facilities should not be used as clinical trial sites and that the participating clinical trial sites should be geographically distributed.
In addition, the committee recommended that post-trial access to the study drug should be provided to participating subjects until disease progression. These conditions will apply to the conduct of the Phase IV study as recommended by the SEC (Oncology).
The recommendation relates to the evaluation of the safety of dostarlimab in adult patients with primary advanced or recurrent endometrial cancer in the Indian population. The final regulatory action will be subject to the applicable CDSCO requirements and permissions.
