Study of Chemoradiotherapy With or Without Pembrolizumab (MK-3475) For The Treatment of Locally Advanced Cervical Cancer (MK-3475-A18/KEYNOTE-A18/ENGOT-cx11)

STATUS

Recruiting
days left to enroll

80
participants needed

980
sponsor

Merck Sharp & Dohme Corp.

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Updated on 19 February 2024

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cancer

pembrolizumab

squamous cell carcinoma

adenocarcinoma

external beam radiotherapy

chemoradiotherapy

carcinoma

systemic therapy

brachytherapy

adenosquamous carcinoma

cervical carcinoma

external beam radiation therapy

excisional biopsy

concurrent radiochemotherapy

cervical cancer

cisplatin

adenosquamous cell carcinoma of the cervix

cervix neoplasms

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.

Details

Condition	Cervical Cancer, Cervical Cancer, Uterine Cancer, Uterine Cancer
Age	18-100 years
Treatment	Pembrolizumab, Cisplatin, Placebo for pembrolizumab, External Beam Radiotherapy (EBRT), Brachytherapy
Clinical Study Identifier	NCT04221945
Sponsor	Merck Sharp & Dohme Corp.
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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 and is immunotherapy-nave
	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
	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 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 within 7 days prior to the start of study treatment
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
	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 such as bacterial or viral vaccines, 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 that required steroids or has current pneumonitis
	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 known history of active tuberculosis (TB; Bacillus tuberculosis)
	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
	Is pregnant or breastfeeding or expecting to conceive children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of pembrolizumab or placebo and 180 days following the end of chemoradiotherapy
	Has had an allogenic tissue/solid organ transplant

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adenosquamous cell carcinoma of the cervix

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Study Definition

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Study of Chemoradiotherapy With or Without Pembrolizumab (MK-3475) For The Treatment of Locally Advanced Cervical Cancer (MK-3475-A18/KEYNOTE-A18/ENGOT-cx11)