Study of Durvalumab With Chemoradiotherapy for Women With Locally Advanced Cervical Cancer (CALLA)
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
2 other identifiers
interventional
770
15 countries
117
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2019
Typical duration for phase_3
117 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2018
CompletedFirst Posted
Study publicly available on registry
February 5, 2019
CompletedStudy Start
First participant enrolled
February 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2022
CompletedResults Posted
Study results publicly available
March 6, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 3, 2023
CompletedJuly 26, 2024
June 1, 2024
2.9 years
December 4, 2018
January 13, 2023
June 28, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free Survival (PFS) Based on the Investigator Assessment According to RECIST 1.1 or Histopathologic Confirmation of Local Tumour Progression
PFS defined as time from date of randomisation until date of tumour progression or death by any cause, regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression
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
Secondary Outcomes (6)
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%
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
Overall Survival (Count)
Time from date of randomisation until date of death by any cause, assessed up to the data cut-off date (3rd July 2023), assessed up to a maximum of 51.7 months
Overall Survival (Duration)
Time from date of randomisation until date of death by any cause, assessed up to the data cut-off date (3rd July 2023), assessed up to a maximum of 51.7 months
Objective Response Rate (ORR)
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
Complete Response Rate
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
- +1 more secondary outcomes
Study Arms (2)
Durvalumab (intravenous infusion)
EXPERIMENTALdurvalumab + 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 (matching placebo for intravenous infusion)
PLACEBO COMPARATORplacebo + standard of care concurrent chemoradiation therapy(SoC CCRT)
Interventions
Platinum based Standard of Care Chemotherapy administered concurrent with radiation therapy
For patients enrolled under CSP v2 and prior - platinum based Standard of Care Chemotherapy administered concurrent with radiation therapy
Radiation therapy per standard of care
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (117)
Research Site
Phoenix, Arizona, 85016, United States
Research Site
La Jolla, California, 92093, United States
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Orange, California, 92868, United States
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Fort Myers, Florida, 33905, United States
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Miami, Florida, 33136, United States
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Augusta, Georgia, 30912, United States
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Ann Arbor, Michigan, 48109, United States
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Lake Success, New York, 11042, United States
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The Bronx, New York, 10461, United States
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Cleveland, Ohio, 44111, United States
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Cleveland, Ohio, 44124, United States
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Cleveland, Ohio, 44195, United States
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Nashville, Tennessee, 37203, United States
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Dallas, Texas, 75235, United States
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Dallas, Texas, 75390, United States
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Spring, Texas, 77380, United States
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Barretos, 14784-400, Brazil
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Fortaleza, 60336-045, Brazil
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Londrina, 86015-520, Brazil
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Porto Alegre, 90050-170, Brazil
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Porto Alegre, 90110-270, Brazil
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Porto Alegre, 90610-000, Brazil
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Porto Alegre, 91350-200, Brazil
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Rio de Janeiro, 20220-410, Brazil
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São José do Rio Preto, 15090-000, Brazil
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São Paulo, 01246-000, Brazil
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São Paulo, 01317-000, Brazil
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São Paulo, 01509-900, Brazil
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São Paulo, 03102-002, Brazil
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Antofagasta, 1267348, Chile
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Santiago, 7500921, Chile
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Santiago, 7630370, Chile
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Santiago, 8380455, Chile
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Temuco, 4810218, Chile
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Temuco, 4810469, Chile
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Viña del Mar, 2540488, Chile
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Changchun, 130021, China
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Changsha, 410013, China
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Chengdu, 610041, China
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Chongqing, 400030, China
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Guangzhou, 510000, China
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Hangzhou, 310022, China
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Hefei, 230001, China
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Hefei, 230031, China
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Shanghai, 200032, China
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Shenyang, 100003, China
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Shenyang, 110016, China
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Tianjin, 300052, China
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Wuhan, 430022, China
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Wuhan, 430079, China
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Budapest, 1122, Hungary
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Debrecen, 4032, Hungary
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Győr, 9024, Hungary
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Kaposvár, 7400, Hungary
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Szeged, 6725, Hungary
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Ahmedabad, 380015, India
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Gūrgaon, 122001, India
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Madurai, 625107, India
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Mumbai, 400012, India
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Nagpur, 440026, India
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Nashik, 422002, India
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New Delhi, 110063, India
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Visakhapatnam, 530017, India
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Fukuoka, 811-1395, Japan
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Kagoshima, 890-8520, Japan
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Kōtoku, 135-8550, Japan
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Kyoto, 606-8507, Japan
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Nakagami-gun, 903-0215, Japan
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Osaka, 541-8567, Japan
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Sapporo, 003-0804, Japan
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Sendai, 980-8574, Japan
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Shinjuku-ku, 160-8582, Japan
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Toon-shi, 791-0204, Japan
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Yokohama, 236-0004, Japan
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Alc. Cuauhtémoc, 06700, Mexico
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Deleg. Tlalpan, 14080, Mexico
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Guadalajara, 44680, Mexico
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Guadalajara Jalisco, 44280, Mexico
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Mérida, 97134, Mexico
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San Luis Potosí City, 78250, Mexico
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Veracruz, 91900, Mexico
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Lima, L27, Peru
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Lima, LIMA 27, Peru
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Lima, LIMA 31, Peru
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Lima, LIMA 34, Peru
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Lima, LIMA 41, Peru
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Baguio City, 2600, Philippines
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Cebu, 6000, Philippines
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Iloilo City, 5000, Philippines
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Makati, 1229, Philippines
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Manila, 1015, Philippines
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Quezon City, 1112, Philippines
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Bialystok, 15-027, Poland
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Gdansk, 80-214, Poland
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Gliwice, 44-101, Poland
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Lodz, 90-513, Poland
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Lublin, 20-090, Poland
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Arkhangelsk, 163045, Russia
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Chelyabinsk, 454087, Russia
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Kaluga, 248007, Russia
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Moscow, 115533, Russia
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Moscow, 117997, Russia
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Moscow, 125367, Russia
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Novosibirsk, 630055, Russia
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Parktown, 2193, South Africa
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Port Elizabeth, 6045, South Africa
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Seoul, 03722, South Korea
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Seoul, 05505, South Korea
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Seoul, 06351, South Korea
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Seoul, 08826, South Korea
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Taichung, 40705, Taiwan
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Tainan, 704, Taiwan
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Taipei, 10002, Taiwan
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Taipei, 10449, Taiwan
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Taipei, 11217, Taiwan
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Taipei, 11490, Taiwan
Research Site
Taoyuan, 333, Taiwan
Related Publications (2)
Monk 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: 38039991DERIVEDMayadev 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: 32447296DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca Clinical Study Information Center
Study Officials
- STUDY DIRECTOR
Urban Scheuring, M.D., Ph.D.
AstraZeneca
- PRINCIPAL INVESTIGATOR
Bradley Monk, M.D
University of Arizona, Arizona, USA
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2018
First Posted
February 5, 2019
Study Start
February 15, 2019
Primary Completion
January 20, 2022
Study Completion
July 3, 2023
Last Updated
July 26, 2024
Results First Posted
March 6, 2023
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.