Balstilimab Versus Investigator Choice Chemotherapy in Patients With Recurrent Cervical Cancer (BRAVA)

Part of paid clinical trials in Albuquerque, New Mexico.

Sponsor
Agenus Inc.
Study ID
NCT04943627
Phase
PHASE3
Status
Withdrawn

Conditions

  • Advanced Cancer
  • Metastatic Cervical Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Balstilimab (BAL) — DRUG
    Anti-PD-1 Monoclonal antibody
  • Topotecan — DRUG
    Chemotherapy
  • Vinorelbine — DRUG
    Chemotherapy
  • Gemcitabine — DRUG
    Chemotherapy
  • Irinotecan — DRUG
    Chemotherapy
  • Pemetrexed — DRUG
    Chemotherapy

Study Details

This Phase 3 trial is an open-label, randomized study with single-agent Balstilimab (BAL) or Investigator Choice (IC) chemotherapy (single-agent gemcitabine, irinotecan, pemetrexed, vinorelbine, or topotecan) in patients with recurrent, persistent, or metastatic cervical cancer who have progressed after receiving platinum based chemotherapy.

Key Dates

Start date
Aug 2, 2021
Status verified
Oct 2022
Primary completion
Oct 22, 2021
Completion
Oct 22, 2021

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Monotherapy with Balstilimab (BAL)
    300 mg IV once every 3 weeks for up to 24 months
  • Active Comparator: Monotherapy with Investigator Choice (IC) Chemotherapy per Institutional guidelines
    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

Primary Outcome Measure

Overall survival in patients with PD-L1 positive tumors randomized to BAL vs Investigator's Choice chemotherapy [ Time Frame: time until observing 234 OS events but no later than 36 months after enrollment of the last patient ]

Locations (1)

FacilityCityStateZIPSite coordinators
Optimum Research (Southwest Women's Oncology Center)AlbuquerqueNew Mexico87109-

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By research site
Optimum Research (Southwest Women's Oncology Center)· Albuquerque, NM

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