Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2025-12-24 @ 4:52 PM
NCT ID:
NCT04551950
Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria for participants enrolling into Cohort 1:
* Study participants had documented persistent, recurrent, or metastatic squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix
* Study participants had not been treated with systemic chemotherapy and were not amenable to curative treatment
* Prior radiation with or without radio-sensitizing chemotherapy was allowed
* Inclusion Criteria for participants enrolling into Cohort 2:
* Participants had documented evidence of cervical adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma International Federation of Gynecology and Obstetrics (FIGO) 2018 Stages 1B2 to 4A
* Participants had not received prior chemotherapy or radiotherapy for cervical cancer
* Inclusion Criteria for all participants:
* Archival tumor tissue sample or newly obtained core or excisional biopsy was required
* Participants who had Eastern Cooperative Oncology Group (ECOG) Performance status (PS) of 0 to 1 were eligible
* Participants had a life expectancy greater than or equal to 12 weeks
* Participants had adequate hematological, hepatic, renal, and coagulation function as defined in the protocol
* Participants with known Human immunodeficiency virus (HIV) infections were eligible if the criteria described in the protocol were met
* Participants with Hepatitis B virus (HBV) and/or Hepatitis C virus (HCV) infections were eligible if the criteria described in the protocol were met
* Other protocol defined inclusion criteria could apply
Exclusion Criteria:
* Exclusion Criteria for All Participants were:
* Participants with active central nervous system (CNS) metastases causing clinical symptoms or metastases that required therapeutic intervention were excluded. Participants with a history of treated CNS metastases (by surgery or radiation therapy) were not eligible unless they had fully recovered from treatment, demonstrated no progression for at least 4 weeks, and were not using steroids for at least 7 days prior to the start of study intervention
* Participants that received any organ transplantation, including allogeneic stem-cell transplantation, but with the exception of transplants that did not require immuno-suppression
* Participants with significant acute or chronic infections
* Participants with active autoimmune disease that might have deteriorated when receiving an immuno-stimulatory agent
* Participants with clinically significant cardiovascular/cerebrovascular disease including: a cerebral vascular accident/stroke, myocardial infarction, unstable angina, congestive heart failure, or serious cardiac arrhythmia
* Participants with a history of bleeding diathesis or recent major bleeding events
* Participant that had received prior cancer treatment with any other immunotherapy or checkpoint inhibitors or any other immune-modulating monoclonal antibody (mAb)
* Exclusion Criteria for Participants in Cohort 1A related to use of bevacizumab were:
* Participants with inadequately controlled hypertension
* Prior history of hypertensive crisis or hypertensive encephalopathy
* Participants with significant vascular disease within 6 months prior to Screening
* Participants with a history of hemoptysis within 1 month prior to Screening
* Current use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes
* Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to the first dose of bevacizumab
* Participants with a history of abdominal or trache-oesophageal fistula or gastrointestinal (GI) perforation within 6 months prior to Screening
* Participants with clinical signs of GI obstruction or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding
* Participants with evidence of abdominal free air not explained by paracentesis or recent surgical procedure
* Participants with serious, non-healing wound, active ulcer, or untreated bone fracture
* Participants with proteinuria
* Other protocol defined exclusion criteria could apply
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04551950
Study Brief:
Protocol Section:
NCT04551950