Phase 3
Completed N=770
Study of Durvalumab With Chemoradiotherapy for Women With Locally Advanced Cervical Cancer (CALLA)
Locally Advanced Cervical Cancer
Source: ClinicalTrials.gov NCT03830866 ↗
Enrolled (actual)
770
Serious AEs
26.4%
Results posted
Mar 2023
Primary outcomePrimary: Progression-free Survival (PFS) Based on the Investigator Assessment According to RECIST 1.1 or Histopathologic Confirmation of Local Tumour Progression — NA; NA Months — p=0.174
◆ Published Evidence
Highly cited
200citations · ~67 / year
Durvalumab versus placebo with chemoradiotherapy for locally advanced cervical cancer (CALLA): a randomised, double-blind, phase 3 trial.
Summary
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
Linked Publications (2)
-
Durvalumab versus placebo with chemoradiotherapy for locally advanced cervical cancer (CALLA): a randomised, double-blind, phase 3 trial.
-
CALLA: Efficacy and safety of concurrent and adjuvant durvalumab with chemoradiotherapy versus chemoradiotherapy alone in women with locally advanced cervical cancer: a phase III, randomized, double-blind, multicenter study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS) Based on the Investigator Assessment According to RECIST 1.1 or Histopathologic Confirmation of Local Tumour Progression |
NA; NA | 0.174 |
| SECONDARY Progression-free Survival (PFS) Based on the Investigator Assessment According to RECIST 1.1 or Histopathologic Confirmation of Local Tumour Progression, PD-L1 Expression >= 1% |
NA; NA | 0.203 |
| SECONDARY Overall Survival (Count) |
91; 112; 294; 273 | — |
| SECONDARY Overall Survival (Duration) |
NA; NA | 0.091 |
| SECONDARY Objective Response Rate (ORR) |
82.6; 80.5 | 0.465 |
| SECONDARY Complete Response Rate |
42.9; 40.3 | 0.469 |
| SECONDARY Duration of Response (DoR) in Patients With Complete Response (CR) |
NA; NA | — |
Eligibility Criteria
Inclusion Criteria
For inclusion in the study, patients should fulfill the following criteria:
- Female
- Aged at least 18 years
- Documented evidence of cervical adenocarcinoma or squamous carcinoma FIGO (2009) Stages IB2 to IIB node positive or FIGO (2009) IIIA-IVA any node
- No prior chemotherapy or radiotherapy for cervical cancer
- WHO/ECOG performance status of 0-1
- At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 Target Lesion at baseline.
Exclusion Criteria
Patients should not enter the study if any of the following exclusion criteria are fulfilled:
- Diagnosis of small cell (neuroendocrine) histology or mucinous adenocarcinoma cervical cancer
- Intent to administer a fertility-sparing treatment regimen
- Undergone a previous hysterectomy
- Evidence of metastatic disease per RECIST 1.1 including lymph nodes ≥15 mm (short axis) above the L1 cephalad body, in the inguinal region or outside the planned radiation field.
- History of allogeneic organ transplantation
- Active or prior documented autoimmune or inflammatory disorders
- Uncontrolled intercurrent illness
- History of another primary malignancy and active primary immunodeficiency
Data sourced from ClinicalTrials.gov (NCT03830866) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.