Clinical trial · Interventional
Study of Durvalumab With Chemoradiotherapy for Women With Locally Advanced Cervical Cancer (CALLA)
A Phase III, Randomized, Multi-Center, Double-Blind, Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With and Following Chemoradiotherapy Compared to Chemoradiotherapy Alone for Treatment in Women With Locally Advanced Cervical Cancer
NCT03830866CI-TRIAL-00079178CALLAcompletedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Durvalumab | Biological | Durvalumab | ALIAS |
| external beam radiation therapy (EBRT) + brachytherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Durvalumab (intravenous infusion)
- description
- 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
- interventionNames
- Biological: Durvalumab
- Drug: Cisplatin
- Drug: Carboplatin
- Radiation: external beam radiation therapy (EBRT) + brachytherapy
- type
- PLACEBO_COMPARATOR
- label
- Placebo (matching placebo for intravenous infusion)
- description
- placebo + standard of care concurrent chemoradiation therapy(SoC CCRT)
- interventionNames
- Drug: Cisplatin
- Drug: Carboplatin
- Radiation: external beam radiation therapy (EBRT) + brachytherapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 130 Years
Show eligibility criteria text
Inclusion Criteria: For inclusion in the study, patients should fulfill the following criteria: 1. Female 2. Aged at least 18 years 3. Documented evidence of cervical adenocarcinoma or squamous carcinoma FIGO (2009) Stages IB2 to IIB node positive or FIGO (2009) IIIA-IVA any node 4. No prior chemotherapy or radiotherapy for cervical cancer 5. WHO/ECOG performance status of 0-1 6. 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: 1. Diagnosis of small cell (neuroendocrine) histology or mucinous adenocarcinoma cervical cancer 2. Intent to administer a fertility-sparing treatment regimen 3. Undergone a previous hysterectomy 4. 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. 5. History of allogeneic organ transplantation 6. Active or prior documented autoimmune or inflammatory disorders 7. Uncontrolled intercurrent illness 8. History of another primary malignancy and active primary immunodeficiency
References
Publications (2)
- DERIVEDMonk BJ, Toita T, Wu X, Vazquez Limon JC, Tarnawski R, Mandai M, Shapira-Frommer R, Mahantshetty U, Del Pilar Estevez-Diz M, Zhou Q, Limaye S, Godinez FJR, Oppermann Kussler C, Varga S, Valdiviezo N, Aoki D, Leiva M, Lee JY, Sulay R, Kreynina Y, Cheng WF, Rey F, Rong Y, Ke G, Wildsmith S, Lloyd A, Dry H, Tablante Nunes A, Mayadev J. Durvalumab versus placebo with chemoradiotherapy for locally advanced cervical cancer (CALLA): a randomised, double-blind, phase 3 trial. Lancet Oncol. 2023 Dec;24(12):1334-1348. doi: 10.1016/S1470-2045(23)00479-5. PMID 38039991
- DERIVEDMayadev J, Nunes AT, Li M, Marcovitz M, Lanasa MC, Monk BJ. 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. Int J Gynecol Cancer. 2020 Jul;30(7):1065-1070. doi: 10.1136/ijgc-2019-001135. Epub 2020 May 23. PMID 32447296