AstraZeneca gets a CDSCO panel Nod To study Rilvegostomig
New Delhi: The drug major AstraZeneca has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the trial of the Rilvegostomig (AZD2936) concentrate for solution for infusion to assess the efficacy and tolerability of rilvegostomig compared to placebo in combination with investigator's choice of chemotherapy in participants with Biliary Tract Cancer after surgical resection with curative intent.
However, this approval is subject to the condition that they should include a surgical oncologist in the study team to confirm the criteria of surgical resectability.
This came after the drug major AstraZeneca presented the Phase III Clinical Study Protocol no. D7025C00001.
The above clinical study is a Phase III, randomized, double-blind, placebo-controlled, multicenter, global study to assess the efficacy and tolerability of rilvegostomig compared to placebo in combination with investigator's choice of chemotherapy (capecitabine, S-1(tegafur/ gimeracil/ oteracil) or gemcitabine/cisplatin) as adjuvant treatment in participants with Biliary Tract Cancer after resection with curative intent.
This study will be conducted in patients with Biliary Tract Cancer who are at risk of recurrence after resection with curative intent.
AZD2936 is a monovalent, bispecific, humanized IgG1 antibody that specifically binds to human TIGIT and PD-1 with high affinity and enhances T cell activity within preclinical models.
