Study of Durvalumab With Chemoradiotherapy for Women With Locally Advanced Cervical Cancer (CALLA)

Conditions

• Locally Advanced Cervical Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 130 Years

Healthy Volunteers

Not accepted

Interventions

• Durvalumab — BIOLOGICAL
  IV infusion every 4 weeks
• Cisplatin — DRUG
  Platinum based Standard of Care Chemotherapy administered concurrent with radiation therapy
• Carboplatin — DRUG
  For patients enrolled under CSP v2 and prior - platinum based Standard of Care Chemotherapy administered concurrent with radiation therapy
• external beam radiation therapy (EBRT) + brachytherapy — RADIATION
  Radiation therapy per standard of care

Study Details

This is a randomized, multi-center, double-blind, placebo-controlled, global, Phase III study to determine the efficacy and safety of durvalumab + Chemoradiotherapy versus Chemoradiotherapy alone as treatment in Women With Locally Advanced Cervical Cancer

Key Dates

Start date

Feb 15, 2019

Status verified

Jun 2024

Primary completion

Jan 20, 2022

Completion

Jul 3, 2023

Study Design

Enrollment

770 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Durvalumab (intravenous infusion)
  durvalumab + standard of care concurrent chemoradiation therapy(SoC CCRT) followed by durvalumab monotherapy up to 24 months or until PD from the date of randomization
• Placebo Comparator: Placebo (matching placebo for intravenous infusion)
  placebo + standard of care concurrent chemoradiation therapy(SoC CCRT)

Primary Outcome Measure

Progression-free Survival (PFS) Based on the Investigator Assessment According to RECIST 1.1 or Histopathologic Confirmation of Local Tumour Progression [ Time Frame: Tumor assessments start 20 weeks after randomisation then every 12 weeks up to 164 weeks, then every 24 weeks until date of RECIST1.1 defined radiological progression. Assessed up to date of DCO (20-Jan-2022) to a maximum of 32.6 months ]

Locations (16)

Find similar trials in Phoenix, AZ

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