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

Locally Advanced Cervical Cancer Clinical Trial

— CALLA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03830866
• Other study ID #: D9100C00001
• Secondary ID: 2018-002872-42
• Status: Completed
• Phase: Phase 3
• Start date: February 15, 2019
• Est. completion date: July 3, 2023

Study information

• Verified date: July 2023
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Description:

Women will be randomized in a 1:1 ratio to receive treatment with concurrent durvalumab + standard of care (SoC) or Placebo + Soc, followed by durvalumab/placebo maintenance for 24 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 770
• Est. completion date: July 3, 2023
• Est. primary completion date: January 20, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 130 Years

Eligibility

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

Related Conditions & MeSH terms

• Locally Advanced Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Biological:
• Durvalumab
IV infusion every 4 weeks

Drug:
• Cisplatin
Platinum based Standard of Care Chemotherapy administered concurrent with radiation therapy
• Carboplatin
For patients enrolled under CSP v2 and prior - platinum based Standard of Care Chemotherapy administered concurrent with radiation therapy

Radiation:
• external beam radiation therapy (EBRT) + brachytherapy
Radiation therapy per standard of care

Locations

Country	Name	City	State
Brazil	Research Site	Barretos
Brazil	Research Site	Fortaleza
Brazil	Research Site	Londrina
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Rio de Janeiro
Brazil	Research Site	São José do Rio Preto
Brazil	Research Site	Sao Paulo
Brazil	Research Site	Sao Paulo
Brazil	Research Site	Sao Paulo
Brazil	Research Site	São Paulo
Chile	Research Site	Antofagasta
Chile	Research Site	Santiago
Chile	Research Site	Santiago
Chile	Research Site	Santiago
Chile	Research Site	Temuco
Chile	Research Site	Temuco
Chile	Research Site	Viña del Mar
China	Research Site	Changchun
China	Research Site	Changsha
China	Research Site	Chengdu
China	Research Site	Chongqing
China	Research Site	Guangzhou
China	Research Site	Hangzhou
China	Research Site	Hefei
China	Research Site	Hefei
China	Research Site	Shanghai
China	Research Site	Shenyang
China	Research Site	Shenyang
China	Research Site	Tianjin
China	Research Site	Wuhan
China	Research Site	Wuhan
Hungary	Research Site	Budapest
Hungary	Research Site	Debrecen
Hungary	Research Site	Gyor
Hungary	Research Site	Kaposvár
Hungary	Research Site	Szeged
India	Research Site	Ahmedabad
India	Research Site	Gurgaon
India	Research Site	Madurai
India	Research Site	Mumbai
India	Research Site	Nagpur
India	Research Site	Nashik
India	Research Site	New Delhi
India	Research Site	Vishakhapatnam
Japan	Research Site	Fukuoka-shi
Japan	Research Site	Kagoshima-shi
Japan	Research Site	Koto-ku
Japan	Research Site	Kyoto-shi
Japan	Research Site	Nakagami-gun
Japan	Research Site	Osaka-shi
Japan	Research Site	Sapporo-shi
Japan	Research Site	Sendai-shi
Japan	Research Site	Shinjuku-ku
Japan	Research Site	Toon-shi
Japan	Research Site	Yokohama-shi
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Mexico	Research Site	Alc. Cuauhtémoc
Mexico	Research Site	Deleg. Tlalpan
Mexico	Research Site	Guadalajara
Mexico	Research Site	Guadalajara Jalisco
Mexico	Research Site	Mérida
Mexico	Research Site	San Luis Potosí
Mexico	Research Site	Veracruz
Peru	Research Site	Lima
Peru	Research Site	Lima
Peru	Research Site	Lima
Peru	Research Site	Lima
Peru	Research Site	Lima
Philippines	Research Site	Baguio City
Philippines	Research Site	Cebu
Philippines	Research Site	Iloilo
Philippines	Research Site	Makati
Philippines	Research Site	Manila
Philippines	Research Site	Quezon City
Poland	Research Site	Bialystok
Poland	Research Site	Gdansk
Poland	Research Site	Gliwice
Poland	Research Site	Lódz
Poland	Research Site	Lublin
Russian Federation	Research Site	Arkhangelsk
Russian Federation	Research Site	Chelyabinsk
Russian Federation	Research Site	Kaluga
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Novosibirsk
South Africa	Research Site	Parktown
South Africa	Research Site	Port Elizabeth
Taiwan	Research Site	Taichung
Taiwan	Research Site	Tainan City
Taiwan	Research Site	Taipei
Taiwan	Research Site	Taipei
Taiwan	Research Site	Taipei
Taiwan	Research Site	Taipei City
Taiwan	Research Site	Taoyuan City
United States	Research Site	Ann Arbor	Michigan
United States	Research Site	Augusta	Georgia
United States	Research Site	Bronx	New York
United States	Research Site	Cleveland	Ohio
United States	Research Site	Cleveland	Ohio
United States	Research Site	Cleveland	Ohio
United States	Research Site	Dallas	Texas
United States	Research Site	Dallas	Texas
United States	Research Site	Fort Myers	Florida
United States	Research Site	La Jolla	California
United States	Research Site	Lake Success	New York
United States	Research Site	Miami	Florida
United States	Research Site	Nashville	Tennessee
United States	Research Site	Orange	California
United States	Research Site	Phoenix	Arizona
United States	Research Site	Spring	Texas

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Brazil,  Chile,  China,  Hungary,  India,  Japan,  Korea, Republic of,  Mexico,  Peru,  Philippines,  Poland,  Russian Federation,  South Africa,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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%	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	Overall Survival (Count)	Number of Participants with Overall Survival (OS) where OS was defined as the time from the date of randomisation until death by any cause	Time from date of randomisation until date of death by any cause, assessed up to the data cut-off date (20th January 2022), assessed up to a maximum of 34.3 months
Secondary	Overall Survival (Duration)	Time from the date of randomisation until death by any cause	Time from date of randomisation until date of death by any cause, assessed up to the data cut-off date (20th January 2022), assessed up to a maximum of 34.3 months
Secondary	Objective Response Rate (ORR)	Percentage of evaluable patients with an Investigator-assessed visit response of complete response (CR) or partial response (PR). CR defined as disappearance of all target and non-target lesions and no new lesions. PR defined as >= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesion	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	Complete Response Rate	Percentage of evaluable patients with an overall visit response of Complete Response (disappearance of all target and non-target lesions)	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	Duration of Response (DoR) in Patients With Complete Response (CR)	Time from date of first documented CR until date of documented progression or death in the absence of progression. For patients who did not progress their DoR was their Progression-free survival censoring time	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

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