KEY TAKEAWAYS
- The phase III CALLA trial (NCT03830866) will evaluate the efficacy and safety of durvalumab in conjunction with and after concurrent chemoradiotherapy in advanced cervical cancer.
- The primary endpoint is PFS, as evaluated by the investigator in accordance with Response Evaluation Criteria in Solid Tumors.
- The clinical trial aims to recruit adult patients who have not received immunotherapy before and have been diagnosed with cervical adenocarcinoma.
- The enrollment of patients is in process globally with an estimated completion date of April 2024.
The recommended treatment for locally advanced cervical cancer is concurrent chemoradiotherapy. The administration of chemoradiotherapy with programmed cell death-1/programmed cell death-ligand 1 pathway blockade may foster a heightened immunogenic milieu by augmenting phagocytosis, cellular demise, and antigen presentation, thereby resulting in elevated immune-mediated tumor surveillance.
The CALLA clinical trial has been formulated to evaluate the effectiveness and safety of durvalumab, a programmed cell death-ligand 1 blocking antibody, combined with concurrent chemoradiotherapy and as a follow-up treatment, compared to concurrent chemoradiotherapy alone. The trial is intended for women diagnosed with locally advanced cervical cancer. The administration of Durvalumab in conjunction with and after concurrent chemoradiotherapy is expected to enhance the progression-free survival of patients diagnosed with cervical cancer at International Federation of Gynecology and Obstetrics (FIGO) 2009 stage IB2 to IVA, in comparison to those who receive concurrent chemoradiotherapy alone.
The CALLA study is a phase III clinical trial that is randomized, multicenter, international, double-blind, and placebo-controlled. The subjects will be randomly assigned in a 1:1 ratio to obtain either durvalumab (1500 mg administered intravenously) or placebo at 4-week intervals for 24 cycles. All patients will undergo external beam radiotherapy with either cisplatin (40 mg/m2) IV or carboplatin (area under curve 2) IV every week for 5 weeks. This will be followed by image-guided brachytherapy. The clinical trial aims to recruit adult patients who have not received immunotherapy before and have been diagnosed with cervical adenocarcinoma, cervical squamous, or adenosquamous carcinoma according to the FIGO 2009 staging system. The study will include patients with stages IB2 to IIB who have positive lymph nodes and those with stage IIIA to IVA with any node stage. The patients included in the study have no history of definitive surgical, radiation, or systemic therapy for cervical cancer.
The principal objective is the assessment of progression-free survival, as evaluated by the investigator in accordance with Response Evaluation Criteria in Solid Tumors v1.1, with histopathological confirmation of local tumor progression or mortality. A total of 714 individuals will be randomly assigned in a 1:1 ratio. They will be administered either durvalumab with concurrent chemoradiotherapy or a placebo in combination with concurrent chemoradiotherapy.
Source: https://ijgc.bmj.com/content/early/2020/05/21/ijgc-2019-001135
Clinical Trail: https://clinicaltrials.gov/ct2/show/NCT03830866
Mayadev J, Nunes AT, Li M, et al. CALLA: Efficacy and safety of concurrent and adjuvant durvalumab with chemoradiotherapy versus chemoradiotherapy alone in women with locally advanced cervical cancer: a phase III, randomized, double-blind, multicenter studyInternational Journal of Gynecologic Cancer Published Online First: 23 May 2020. doi: 10.1136/ijgc-2019-001135
