Back to resultsStudy of Durvalumab With Chemoradiotherapy for Women With Locally Advanced Cervical Cancer (CALLA) (CALLA)
Primary Purpose
Locally Advanced Cervical Cancer
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Durvalumab
Cisplatin
Carboplatin
external beam radiation therapy (EBRT) + brachytherapy
Sponsored by
About this trial
This is an interventional treatment trial for Locally Advanced Cervical Cancer focused on measuring Durvalumab, Chemoradiotherapy, Locally Advanced Cervical Cancer
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
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Durvalumab (intravenous infusion)
Placebo (matching placebo for intravenous infusion)
Arm 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
placebo + standard of care concurrent chemoradiation therapy(SoC CCRT)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
Overall Survival (Duration)
Time from the date of randomisation until death by any cause
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
Complete Response Rate
Percentage of evaluable patients with an overall visit response of Complete Response (disappearance of all target and non-target lesions)
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03830866
Brief Title
Study of Durvalumab With Chemoradiotherapy for Women With Locally Advanced Cervical Cancer (CALLA)
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
February 15, 2019 (Actual)
Primary Completion Date
January 20, 2022 (Actual)
Study Completion Date
July 3, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Cervical Cancer
Keywords
Durvalumab, Chemoradiotherapy, Locally Advanced Cervical Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
770 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Durvalumab (intravenous infusion)
Arm Type
Experimental
Arm 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
Arm Title
Placebo (matching placebo for intravenous infusion)
Arm Type
Placebo Comparator
Arm Description
placebo + standard of care concurrent chemoradiation therapy(SoC CCRT)
Intervention Type
Biological
Intervention Name(s)
Durvalumab
Intervention Description
IV infusion every 4 weeks
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Platinum based Standard of Care Chemotherapy administered concurrent with radiation therapy
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
For patients enrolled under CSP v2 and prior - platinum based Standard of Care Chemotherapy administered concurrent with radiation therapy
Intervention Type
Radiation
Intervention Name(s)
external beam radiation therapy (EBRT) + brachytherapy
Intervention Description
Radiation therapy per standard of care
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS) Based on the Investigator Assessment According to RECIST 1.1 or Histopathologic Confirmation of Local Tumour Progression
Description
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
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
Secondary Outcome Measure Information:
Title
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%
Description
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
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
Title
Overall Survival (Count)
Description
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 Frame
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
Title
Overall Survival (Duration)
Description
Time from the date of randomisation until death by any cause
Time Frame
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
Title
Objective Response Rate (ORR)
Description
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
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
Title
Complete Response Rate
Description
Percentage of evaluable patients with an overall visit response of Complete Response (disappearance of all target and non-target lesions)
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
Title
Duration of Response (DoR) in Patients With Complete Response (CR)
Description
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
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
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female: only female participants are being studied
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Urban Scheuring, M.D., Ph.D.
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Bradley Monk, M.D
Organizational Affiliation
University of Arizona, Arizona, USA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Research Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Research Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Research Site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33905
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Research Site
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Research Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Research Site
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Research Site
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Research Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44111
Country
United States
Facility Name
Research Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
Research Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Research Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Research Site
City
Spring
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Facility Name
Research Site
City
Barretos
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Research Site
City
Fortaleza
ZIP/Postal Code
60336-045
Country
Brazil
Facility Name
Research Site
City
Londrina
ZIP/Postal Code
86015-520
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90050-170
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90110-270
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
Research Site
City
Rio de Janeiro
ZIP/Postal Code
20220-410
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
01317-000
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
01509-900
Country
Brazil
Facility Name
Research Site
City
São José do Rio Preto
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Research Site
City
São Paulo
ZIP/Postal Code
03102-002
Country
Brazil
Facility Name
Research Site
City
Antofagasta
ZIP/Postal Code
1267348
Country
Chile
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
7500921
Country
Chile
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
7630370
Country
Chile
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
8380455
Country
Chile
Facility Name
Research Site
City
Temuco
ZIP/Postal Code
4810218
Country
Chile
Facility Name
Research Site
City
Temuco
ZIP/Postal Code
4810469
Country
Chile
Facility Name
Research Site
City
Viña del Mar
ZIP/Postal Code
2540488
Country
Chile
Facility Name
Research Site
City
Changchun
ZIP/Postal Code
130021
Country
China
Facility Name
Research Site
City
Changsha
ZIP/Postal Code
410013
Country
China
Facility Name
Research Site
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
Research Site
City
Chongqing
ZIP/Postal Code
400030
Country
China
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510000
Country
China
Facility Name
Research Site
City
Hangzhou
ZIP/Postal Code
310022
Country
China
Facility Name
Research Site
City
Hefei
ZIP/Postal Code
230001
Country
China
Facility Name
Research Site
City
Hefei
ZIP/Postal Code
230031
Country
China
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Research Site
City
Shenyang
ZIP/Postal Code
100003
Country
China
Facility Name
Research Site
City
Shenyang
ZIP/Postal Code
110016
Country
China
Facility Name
Research Site
City
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Research Site
City
Wuhan
ZIP/Postal Code
430022
Country
China
Facility Name
Research Site
City
Wuhan
ZIP/Postal Code
430079
Country
China
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Research Site
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Research Site
City
Győr
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Research Site
City
Kaposvár
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Research Site
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Research Site
City
Ahmedabad
ZIP/Postal Code
380015
Country
India
Facility Name
Research Site
City
Gurgaon
ZIP/Postal Code
122001
Country
India
Facility Name
Research Site
City
Madurai
ZIP/Postal Code
625107
Country
India
Facility Name
Research Site
City
Mumbai
ZIP/Postal Code
400012
Country
India
Facility Name
Research Site
City
Nagpur
ZIP/Postal Code
440026
Country
India
Facility Name
Research Site
City
Nashik
ZIP/Postal Code
422002
Country
India
Facility Name
Research Site
City
New Delhi
ZIP/Postal Code
110063
Country
India
Facility Name
Research Site
City
Vishakhapatnam
ZIP/Postal Code
530017
Country
India
Facility Name
Research Site
City
Fukuoka-shi
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Research Site
City
Kagoshima-shi
ZIP/Postal Code
890-8520
Country
Japan
Facility Name
Research Site
City
Koto-ku
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Research Site
City
Kyoto-shi
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
Research Site
City
Nakagami-gun
ZIP/Postal Code
903-0215
Country
Japan
Facility Name
Research Site
City
Osaka-shi
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
Research Site
City
Sapporo-shi
ZIP/Postal Code
003-0804
Country
Japan
Facility Name
Research Site
City
Sendai-shi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Research Site
City
Shinjuku-ku
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Research Site
City
Toon-shi
ZIP/Postal Code
791-0295
Country
Japan
Facility Name
Research Site
City
Yokohama-shi
ZIP/Postal Code
236-0004
Country
Japan
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
08826
Country
Korea, Republic of
Facility Name
Research Site
City
Alc. Cuauhtémoc
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Research Site
City
Deleg. Tlalpan
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Research Site
City
Guadalajara Jalisco
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Research Site
City
Guadalajara
ZIP/Postal Code
44680
Country
Mexico
Facility Name
Research Site
City
Mérida
ZIP/Postal Code
97134
Country
Mexico
Facility Name
Research Site
City
San Luis Potosí
ZIP/Postal Code
78250
Country
Mexico
Facility Name
Research Site
City
Veracruz
ZIP/Postal Code
91900
Country
Mexico
Facility Name
Research Site
City
Lima
ZIP/Postal Code
L27
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 27
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 31
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 34
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 41
Country
Peru
Facility Name
Research Site
City
Baguio City
ZIP/Postal Code
2600
Country
Philippines
Facility Name
Research Site
City
Cebu
ZIP/Postal Code
6000
Country
Philippines
Facility Name
Research Site
City
Iloilo
ZIP/Postal Code
5000
Country
Philippines
Facility Name
Research Site
City
Makati
ZIP/Postal Code
1229
Country
Philippines
Facility Name
Research Site
City
Manila
ZIP/Postal Code
1015
Country
Philippines
Facility Name
Research Site
City
Quezon City
ZIP/Postal Code
1112
Country
Philippines
Facility Name
Research Site
City
Bialystok
ZIP/Postal Code
15-027
Country
Poland
Facility Name
Research Site
City
Gdańsk
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Research Site
City
Gliwice
ZIP/Postal Code
44-101
Country
Poland
Facility Name
Research Site
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
Research Site
City
Łódź
ZIP/Postal Code
90-513
Country
Poland
Facility Name
Research Site
City
Arkhangelsk
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
Research Site
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
Research Site
City
Kaluga
ZIP/Postal Code
248007
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
115533
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
125367
Country
Russian Federation
Facility Name
Research Site
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation
Facility Name
Research Site
City
Parktown
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Research Site
City
Port Elizabeth
ZIP/Postal Code
6045
Country
South Africa
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Research Site
City
Tainan City
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Research Site
City
Taipei City
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
10449
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
11490
Country
Taiwan
Facility Name
Research Site
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home
Citations:
PubMed Identifier
32447296
Citation
Mayadev 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.
Results Reference
derived
Links:
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D9100C00001&attachmentIdentifier=456f5a65-1160-4292-a679-7ae588fa79b9&fileName=D9100C00001_Protocol_v4_Redacted_PDFA.pdf&versionIdentifier=
Description
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URL
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Description
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URL
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Description
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Learn more about this trial
Study of Durvalumab With Chemoradiotherapy for Women With Locally Advanced Cervical Cancer (CALLA)
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