Abstract 794TiP
Background
Despite advancements in the last 2 decades, patients(pts) with recurrent or metastatic cervical cancer (R/M CC) continue to have poor prognoses and limited treatment options.Novel therapies and targets are needed. Zimberelimab is a PD-1 monoclonal antibody and has been approved by the NMPA for the treatment of pts with R/M CC. However, the efficacy of immune checkpoint inhibitors (ICIs) mono-therapy tends to be limited. Disitamab Vedotin, a HER2-targeting antibody-drug conjugate (ADC), has demonstrated manageable safety profile and positive efficacy in HER2-expressing R/M CC. Disitamab Vedotin in combination with PD-1 immunotherapy has shown remarkable results in locally advanced or metastatic urothelial carcinoma, indicative of a synergistic effect between HER2-ADC and PD-1 immunotherapy. Stereotactic body radiotherapy (SBRT) may stimulate innate and adaptive immunity to augment immunotherapy response, which is complementary to PD-1 immunotherapy. In this study, we aim to conduct a prospective phase II trial to investigate the efficacy and safety of Disitamab Vedotin plus Zimberelimab combined with SBRT in patients with R/M CC.
Trial design
This phase II, single-arm, open-label study uses a Simon two-stage design and aimes to enroll 40 patients. Part 1 of the study will evaluate the safety and tolerability of Disitamab Vedotin plus Zimberelimab combined with SBRT.Recommended dose(RD) of Disitamab Vedotin will be confirmed. Part 2 of the study is to evaluate the anti-tumor activity of the combination. SBRT combination therapy includes 1 cycle of Disitamab Vedotin (RD,Q2W) and Zimberelimab (240mg,Q2W) on day 1 followed by SBRT on day 2. Maintenance treatment includes injection of Disitamab Vedotin(RD,Q2W) and Zimberelimab (240mg,Q2W) on day 1 of each 2-week cycle and the duration of the treatment will be up to 24 months. Patients will continue the treatment until they experience disease progression or unacceptable toxicity. Primary endpoints: objective response rate. Secondary endpoints: progression free survival, overall survival, disease control rate,during of response,time to response,time to progression.
Clinical trial identification
ChiCTR2300072129.
Editorial acknowledgement
Legal entity responsible for the study
The author.
Funding
RemeGen Co., Ltd.
Disclosure
The author has declared no conflicts of interest.
Resources from the same session
861P - Neo-TIME trial: Neoadjuvant tislelizumab combined with albumin-paclitaxel, cisplatin, and fluorouracil(APF) in patients with locally advanced oral squamous cell carcinoma (LA-OSCC)
Presenter: Wenquan Zhao
Session: Poster session 02
862P - Neoadjuvant chemo-immunotherapy using carboplatin, nab-paclitaxel, oral metronomic therapy and low dose nivolumab for “borderline resectable” oral cavity carcinoma: A prospective phase II single-arm trial (NeoLOCUS)
Presenter: Praveen Kumar Marimuthu
Session: Poster session 02
863P - Safety and efficacy of four courses of pembrolizumab combined with carboplatin and albumin-binding paclitaxel versus two courses of neoadjuvant therapy in patients with resectable head and neck squamous cell carcinoma: An optimal efficacy study (prospective, two-arm, phase II)
Presenter: Jinsong Li
Session: Poster session 02
Resources:
Abstract
866P - Neoadjuvant and adjuvant AK104 in patients with recurrent, resectable squamous cell carcinoma of the head and neck: A phase II study
Presenter: Lei Liu
Session: Poster session 02
868P - Phase II trial of ozuriftamab vedotin (BA3021), a conditionally active biologic (CAB)-ROR2-ADC, in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN)
Presenter: Winston Wong
Session: Poster session 02
869P - Results of the multicenter phase II FRAIL-IMMUNE trial evaluating the efficacy and safety of durvalumab (D) combined with weekly paclitaxel carboplatin in 1st-line in patients with recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) not eligible to cisplatin
Presenter: Jérome Fayette
Session: Poster session 02