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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04221945




Registration number
NCT04221945
Ethics application status
Date submitted
23/12/2019
Date registered
9/01/2020
Date last updated
26/11/2024

Titles & IDs
Public title
Study of Chemoradiotherapy With or Without Pembrolizumab (MK-3475) For The Treatment of Locally Advanced Cervical Cancer (MK-3475-A18/KEYNOTE-A18/ENGOT-cx11/GOG-3047)
Scientific title
A Randomized, Phase 3, Double-Blind Study of Chemoradiotherapy With or Without Pembrolizumab for the Treatment of High-risk, Locally Advanced Cervical Cancer (KEYNOTE-A18/ENGOT-cx11/GOG-3047)
Secondary ID [1] 0 0
MK-3475-A18
Secondary ID [2] 0 0
3475-A18
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Uterine Cervical Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Cervical (cervix)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Pembrolizumab
Treatment: Drugs - Placebo for pembrolizumab
Treatment: Drugs - Cisplatin
Treatment: Other - External Beam Radiotherapy (EBRT)
Treatment: Other - Brachytherapy

Experimental: chemoradiotherapy + pembrolizumab - Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by pembrolizumab 400 mg IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of pembrolizumab, participants receive concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m\^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays).

Experimental: chemoradiotherapy + placebo for pembrolizumab - Participants receive placebo for pembrolizumab IV on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by placebo IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of placebo, participants receive concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m\^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays).


Treatment: Other: Pembrolizumab
IV infusion

Treatment: Drugs: Placebo for pembrolizumab
IV infusion

Treatment: Drugs: Cisplatin
IV infusion

Treatment: Other: External Beam Radiotherapy (EBRT)
Given as a total radiotherapy dose of 80 Gy for volume-directed and 75 Gy for point-directed

Treatment: Other: Brachytherapy
Given as a total radiotherapy dose of 80 Gy for volume-directed and 75 Gy for point-directed
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by the Investigator
Timepoint [1] 0 0
Up to approximately 38 months
Primary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Up to approximately 46 months
Secondary outcome [1] 0 0
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
Timepoint [1] 0 0
Up to approximately 38 months
Secondary outcome [2] 0 0
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) at Month 24 as Assessed by the Investigator
Timepoint [2] 0 0
Up to approximately 38 months
Secondary outcome [3] 0 0
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) at Month 24 as Assessed by Blinded Independent Central Review (BICR)
Timepoint [3] 0 0
Up to approximately 38 months
Secondary outcome [4] 0 0
Overall Survival (OS) at Month 36
Timepoint [4] 0 0
Up to approximately 46 months
Secondary outcome [5] 0 0
Complete Response (CR) Rate Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) at Week 12 as Assessed by the Investigator
Timepoint [5] 0 0
Up to approximately 38 months
Secondary outcome [6] 0 0
Complete Response (CR) Rate Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) at Week 12 as Assessed by Blinded Independent Central Review (BICR)
Timepoint [6] 0 0
Up to approximately 38 months
Secondary outcome [7] 0 0
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by the Investigator
Timepoint [7] 0 0
Up to approximately 46 months
Secondary outcome [8] 0 0
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
Timepoint [8] 0 0
Up to approximately 46 months
Secondary outcome [9] 0 0
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Participants as Assessed by the Investigator
Timepoint [9] 0 0
Up to approximately 38 months
Secondary outcome [10] 0 0
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Participants as Assessed by Blinded Independent Central Review (BICR)
Timepoint [10] 0 0
Up to approximately 38 months
Secondary outcome [11] 0 0
Overall Survival (OS) in Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Participants as Assessed by the Investigator
Timepoint [11] 0 0
Up to approximately 46 months
Secondary outcome [12] 0 0
Overall Survival (OS) in Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Participants as Assessed by Blinded Independent Central Review (BICR)
Timepoint [12] 0 0
Up to approximately 46 months
Secondary outcome [13] 0 0
Progression-Free Survival (PFS) After Next-Line Treatment (PFS 2) Following Discontinuation of Study Treatment
Timepoint [13] 0 0
Up to approximately 46 months
Secondary outcome [14] 0 0
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status Score
Timepoint [14] 0 0
Baseline and up to approximately 46 months
Secondary outcome [15] 0 0
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Function Score
Timepoint [15] 0 0
Baseline and up to approximately 46 months
Secondary outcome [16] 0 0
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Symptom Specific Scale for Cervical Cancer (EORTC QLQ-CX24) Score
Timepoint [16] 0 0
Baseline and up to approximately 46 months
Secondary outcome [17] 0 0
Number of Participants Who Experience One or More Adverse Events (AEs)
Timepoint [17] 0 0
Up to approximately 46 months
Secondary outcome [18] 0 0
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Timepoint [18] 0 0
Up to approximately 46 months

Eligibility
Key inclusion criteria
* Has high-risk locally advanced cervical cancer (LACC): The International Federation of Gynecology and Obstetrics (FIGO) 2014 Stage IB2-IIB (with node-positive disease) or FIGO 2014 Stages III-IVA
* Has histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix
* Has not previously received any definitive surgical, radiation, or systemic therapy for cervical cancer, including investigational agents, and is immunotherapy-naïve
* Female participants must not be pregnant or breastfeeding and agree to use highly effective contraception during the treatment period and for at least 120 days after the last dose of pembrolizumab or placebo and 180 days following the end of chemoradiotherapy and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period.
* Female participants must abstain from breastfeeding during the study intervention period and for at least 120 days after the last dose of pembrolizumab or placebo and 180 days following the end of chemoradiotherapy
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to the first dose of study treatment
* Has provided a tissue sample from a core incisional or excisional biopsy of a tumor lesion
* Has radiographically evaluable disease, either measurable or non-measurable per RECIST 1.1, as assessed by the local site investigator/radiology
* Has adequate organ function within 7 days prior to the start of study treatment.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has excluded subtypes of LACC
* Has FIGO 2014 Stage IVB disease
* Has undergone a previous hysterectomy defined as removal of the entire uterus or will have a hysterectomy as part of their initial cervical cancer therapy
* Has bilateral hydronephrosis, unless at least one side has been stented or resolved by positioning of nephrostomy or considered mild and not clinically significant in the opinion of the investigator
* Has anatomy or tumor geometry or any other reason or contraindication that cannot be treated with intracavitary brachytherapy or a combination of intracavitary and interstitial brachytherapy
* Has received a live vaccine within 30 days prior to the first dose of study treatment
* Has received treatment with systemic immunostimulatory agents, colony stimulating factors, interferons, interleukins and vaccine combinations within 6 weeks or 5 half-lives of the drug, whichever is shorter, prior to Cycle 1, Day 1
* Has received prior therapy with an anti-programmed cell death receptor 1 (PD-1), anti-programmed cell death receptor ligand 1 (PD-L1), or anti-programmed cell death receptor ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137)
* Has received prior systemic anticancer therapy including investigational agents within 4 weeks prior to randomization
* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to randomization
* Has any contraindication to the use of cisplatin
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
* Has severe hypersensitivity to pembrolizumab and/or any of its excipients
* Has an active autoimmune disease that has required systemic treatment in past 2 years
* Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* Has an active infection requiring systemic therapy
* Has a known history of Human Immunodeficiency Virus (HIV) infection
* Has a known history of Hepatitis B or known active Hepatitis C virus infection
* Has a history or current evidence of any condition, therapy, lab abnormality, or other circumstance that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results, and in the judgment of the investigator or Sponsor, would make the participant inappropriate for entry into this study
* Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
* Has had an allogenic tissue/solid organ transplant
* Has evidence of metastatic disease per RECIST 1.1 including lymph nodes above the first lumbar vertebra (L1) cephalad body, in the inguinal region

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/05/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
17/01/2026
Actual
Sample size
Target
980
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Westmead Hospital ( Site 0973) - Westmead
Recruitment hospital [2] 0 0
Royal Brisbane and Women s Hospital ( Site 0972) - Herston
Recruitment hospital [3] 0 0
Monash Health-Monash Medical Centre ( Site 0970) - Clayton
Recruitment hospital [4] 0 0
Peter MacCallum Cancer Centre ( Site 0971) - Melbourne
Recruitment hospital [5] 0 0
St John of God Subiaco Hospital ( Site 0969) - Subiaco
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3000 - Melbourne
Recruitment postcode(s) [5] 0 0
6008 - Subiaco
Recruitment outside Australia
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United States of America
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Indiana
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Louisiana
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Cork
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Milano
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Piemonte
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Roma
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Italy
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Bologna
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Lecce
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Napoli
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Torino
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Aichi
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Chiba
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Ehime
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Fukuoka
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Hokkaido
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Iwate
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Japan
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Okinawa
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Japan
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Saitama
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Tokyo
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Kagoshima
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Japan
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Osaka
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Korea, Republic of
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Kyonggi-do
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Korea, Republic of
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Seoul
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Korea, Republic of
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Taegu-Kwangyokshi
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Norway
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Hordaland
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Norway
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Oslo
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Peru
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Ariqipa
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Peru
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La Libertad
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Peru
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Lima
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Russian Federation
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Chelyabinskaya Oblast
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Russian Federation
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Krasnoyarskiy Kray
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Russian Federation
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Moskva
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Russian Federation
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Sankt-Peterburg
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Russian Federation
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Yaroslavskaya Oblast
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Spain
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Barcelona
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Spain
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La Coruna
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Spain
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Madrid
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Spain
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Jaen
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Spain
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Zaragoza
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Sweden
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Stockholms Lan
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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Thailand
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Khon Kaen
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Thailand
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Krung Thep Maha Nakhon
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Thailand
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Songkhla
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Thailand
State/province [118] 0 0
Chiang Mai
Country [119] 0 0
Turkey
State/province [119] 0 0
Istanbul
Country [120] 0 0
Turkey
State/province [120] 0 0
Adana
Country [121] 0 0
Turkey
State/province [121] 0 0
Ankara
Country [122] 0 0
Ukraine
State/province [122] 0 0
Kharkivska Oblast
Country [123] 0 0
Ukraine
State/province [123] 0 0
Lvivska Oblast
Country [124] 0 0
United Kingdom
State/province [124] 0 0
England
Country [125] 0 0
United Kingdom
State/province [125] 0 0
London, City Of
Country [126] 0 0
United Kingdom
State/province [126] 0 0
Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
GOG Foundation
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus concurrent chemoradiotherapy compared to placebo plus concurrent chemoradiotherapy in participants with locally advanced cervical cancer.

The primary hypotheses are that pembrolizumab plus concurrent chemoradiotherapy is superior to placebo plus concurrent chemoradiotherapy with respect to progression-free survival and overall survival.

Once the study objectives have been met or the study has ended, participants will be discontinued from this study and will be enrolled in an extension study to continue protocol-defined assessments and treatment.
Trial website
https://clinicaltrials.gov/study/NCT04221945
Trial related presentations / publications
Lorusso D, Xiang Y, Hasegawa K, Scambia G, Leiva M, Ramos-Elias P, Acevedo A, Sukhin V, Cloven N, Pereira de Santana Gomes AJ, Contreras Mejia F, Reiss A, Ayhan A, Lee JY, Saevets V, Zagouri F, Gilbert L, Sehouli J, Tharavichitkul E, Lindemann K, Lazzari R, Chang CL, Lampe R, Zhu H, Oaknin A, Christiaens M, Polterauer S, Usami T, Li K, Yamada K, Toker S, Keefe SM, Pignata S, Duska LR; ENGOT-cx11/GOG-3047/KEYNOTE-A18 investigators. Pembrolizumab or placebo with chemoradiotherapy followed by pembrolizumab or placebo for newly diagnosed, high-risk, locally advanced cervical cancer (ENGOT-cx11/GOG-3047/KEYNOTE-A18): a randomised, double-blind, phase 3 clinical trial. Lancet. 2024 Apr 6;403(10434):1341-1350. doi: 10.1016/S0140-6736(24)00317-9. Epub 2024 Mar 20.
Lorusso D, Xiang Y, Hasegawa K, Scambia G, Leiva M, Ramos-Elias P, Acevedo A, Cvek J, Randall L, Pereira de Santana Gomes AJ, Contreras Mejia F, Helpman L, Akilli H, Lee JY, Saevets V, Zagouri F, Gilbert L, Sehouli J, Tharavichitkul E, Lindemann K, Colombo N, Chang CL, Bednarikova M, Zhu H, Oaknin A, Christiaens M, Petru E, Usami T, Liu P, Yamada K, Toker S, Keefe SM, Pignata S, Duska LR; ENGOT-cx11/GOG-3047/KEYNOTE-A18 investigators. Pembrolizumab or placebo with chemoradiotherapy followed by pembrolizumab or placebo for newly diagnosed, high-risk, locally advanced cervical cancer (ENGOT-cx11/GOG-3047/KEYNOTE-A18): overall survival results from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2024 Oct 5;404(10460):1321-1332. doi: 10.1016/S0140-6736(24)01808-7. Epub 2024 Sep 14. Erratum In: Lancet. 2024 Nov 2;404(10464):1730. doi: 10.1016/S0140-6736(24)02371-7.
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Merck Sharp & Dohme LLC
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Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04221945