PD-1/CTLA-4 dual checkpoint inhibitor bispecific mAb

The key inclusion criteria are –

• Females aged at least 15 years at the time of screening
• Body weight >35 kg
• Histologically documented FIGO 2018 Stage IIIA–IVA cervical adenocarcinoma, cervical squamous carcinoma, or cervical adenosquamous carcinoma, with no evidence of metastatic disease
• Initial staging procedures performed no more than 56 days prior to the first dose of CCRT. Provision of tumor sample to assess the PD-L1 expression
• Must not have progressed following CCRT, participants with persistent disease after definitive CCRT must not be amenable to other available therapies with curative intent
• WHO/ECOG PS  of 0 or 1
• Adequate organ and bone marrow function
• Capable of providing signed informed consent

Reference:

Study NCT06079671. ClinicalTrials.gov website.

The key exclusion criteria are –

• Diagnosis of small cell (neuroendocrine) or mucinous adenocarcinoma of cervical cancer
• Evidence of metastatic disease
• Intent to administer a fertility-sparing treatment regimen
• History of organ transplant
• Active or prior documented autoimmune or inflammatory disorders
• Uncontrolled intercurrent illness
• History of another primary malignancy except for a) Malignancy treated with curative intent with no known active disease ≥2 years before the first dose of study intervention; b) Adequately treated nonmelanoma skin cancer or lentigo maligna, or carcinoma in situ without evidence of disease
• Unresolved toxicities from previous CCRT except for irreversible toxicity that is not reasonably expected to be exacerbated
• Prior history or presence of vesicovaginal, colovaginal, or rectovaginal fistula
• History of anaphylaxis to any biologic therapy or vaccine
• Current or prior use of immunosuppressive medication within 14 days before the first dose of the study intervention is excluded. The following are exceptions to this criterion: a) Intranasal, inhaled, topical steroids, or local steroid injections (eg, intraarticular injection); b) Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication or chemotherapy premedication) or a single dose for palliative purpose (eg, pain control)
• Patients who have undergone a previous hysterectomy, including a supracervical hysterectomy, or will have a hysterectomy as part of their initial cervical cancer therapy
• Any prior (besides prior cCRT) or concurrent treatment for cervical cancer
• Major surgical procedures within 4 weeks prior to the first dose of the study intervention or still recovering from prior surgery
• Exposure to immune-mediated therapy prior to the study for any indication
• Receipt of live attenuated vaccine within 30 days prior to the first dose of the study intervention
• Participants with a known allergy or hypersensitivity to the study intervention, or any excipients of the study intervention