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Monoclonal Antibodies

Monotherapy with Balstilimab (BAL) for Cervical Cancer

Phase 3
Waitlist Available
Research Sponsored by Agenus Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the beginning of each cycle (each cycle is 21 days) through 90-day safety follow-up visit (3 months after last dose of bal)
Awards & highlights

Study Summary

This study is evaluating whether a drug called Balstilimab can improve the survival of people with cervical cancer.

Eligible Conditions
  • Cancer
  • Cervical Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the beginning of each cycle (each cycle is 21 days) through 90-day safety follow-up visit (3 months after last dose of bal)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at the beginning of each cycle (each cycle is 21 days) through 90-day safety follow-up visit (3 months after last dose of bal) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall survival in all patients randomized to BAL vs Investigator's Choice chemotherapy
Overall survival in patients with PD-L1 positive tumors randomized to BAL vs Investigator's Choice chemotherapy
Secondary outcome measures
Objective response rate (ORR) to BAL and to IC chemotherapy in all patients' tumors
Objective response rate (ORR) to BAL and to IC chemotherapy in patients with PD-L1 positive tumors
Progression-free survival in all patients randomized to BAL vs Investigator's Choice chemotherapy
+1 more
Other outcome measures
Frequency, severity, and duration of treatment-emergent adverse events (TEAEs) and laboratory abnormalities using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0
To evaluate the PK of BAL - area under the drug concentration-time curve
Dimercaprol
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Monotherapy with Balstilimab (BAL)Experimental Treatment1 Intervention
300 mg IV once every 3 weeks for up to 24 months
Group II: Monotherapy with Investigator Choice (IC) Chemotherapy per Institutional guidelinesActive Control5 Interventions
Topotecan: 1 or 1.25 mg/m^2 IV on Days 1 to 5, every 21 days or Vinorelbine: 30 mg/m^2 IV on Days 1 and 8, every 21 days or Gemcitabine: 1000 mg/m^2 IV on Days 1 and 8, every 21 days or Irinotecan: 100 or 125 mg/m^2 IV weekly for 28 days, every 42 days or Pemetrexed: 500 mg/m^2 IV on Day 1, every 21 days

Find a Location

Who is running the clinical trial?

European Network of Gynaecological Oncological Trial Groups (ENGOT)OTHER
37 Previous Clinical Trials
17,549 Total Patients Enrolled
Agenus Inc.Lead Sponsor
52 Previous Clinical Trials
4,789 Total Patients Enrolled
Medical DirectorStudy DirectorAgenus Inc.
2,800 Previous Clinical Trials
8,070,200 Total Patients Enrolled
~0 spots leftby Jun 2025
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