Table 1

Key inclusion and exclusion criteria

Inclusion criteriaExclusion criteria
Women aged ≥18 years*, body weight >30 kgDiagnosis of small cell (neuroendocrine) histology or mucinous adenocarcinoma cervical cancer
Histologically confirmed cervical adenocarcinoma, cervical squamous carcinoma, or cervical adenosquamous carcinoma with:
  • FIGO (2009) stages IB2–IIB N positive (N≥1) or FIGO (2009) stages IIIA–IVA with any N stage (N≥0)

  • Nodal staging may be either surgical or by imaging (CT or MRI) with pathological lymph node size defined by a short-axis diameter* of ≥10 mm (axial plane)

  • No evidence of metastatic disease (M0)

Intent to administer a fertility-sparing treatment regimen
WHO/ECOG PS of 0 or one at enrollment and randomizationPrior hysterectomy (including supracervical hysterectomy) and patients who intend to have a hysterectomy as part of their initial cervical cancer therapy
≥1 lesion that qualifies as a RECIST v1.1 tumor lesions, not previously irradiated, at baseline assessed (by CT scan or MRI) within 28 days before randomizationEvidence of metastatic disease per RECIST v1.1, including lymph nodes ≥15 mm (short axis) above the L1 cephalad body or outside the planned radiation field
No prior chemotherapy or radiotherapy for cervical cancer and immunotherapy naïveHistory of another primary malignancy, active primary immunodeficiency, or allogeneic organ transplantation
Sustainability and fitness for concurrent chemoradiotherapy as determined by the investigatorActive or prior documented autoimmune or inflammatory disorders
Uncontrolled inter-current illness
Prior chemotherapy or radiation therapy for the management of cervical cancer
Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment
  • *For female patients aged <20 years and enrolled in Japan, written informed consent should be obtained from the patient and her legally acceptable representative.

  • CT, computed tomography; ECOG, Eastern Cooperative Oncology Group; FIGO, International Federation of Gynecology and Obstetrics; IP, intra-peritoneal; M, metastasis; MRI, magnetic resonance imaging; N, node; PS, performance status; RECIST, Response Evaluation Criteria in Solid Tumors; WHO, World Health Organization.