C53 Malignant neoplasm of cervix uteri Malignant neoplasm of cervix uteri
Conditions
Interventions
None listed
Sponsors
Merck Sharp & Dohme LLC., (una subsidiaria de Merck & Co. Inc.)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Has high-risk LACC 2. Has histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix 3. Has not previously received any definitive surgical, radiation, or systemic therapy for cervical cancer and is immunotherapy-naïve. Note: Previous surgical procedure for localized cervical tumor is allowed 4. Has an ECOG performance status of 0 or 1 within 7 days prior to the first dose of study intervention 5. Is female, at least 18 years of age at the time of signing the informed consent 6. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: -Is not a WOCBP OR -Is a WOCBP and using a contraceptive method that is highly effective 7. The participant (or legally acceptable representative if applicable) provides written informed consent for the study. The participant may also provide consent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research 8. Has radiographically evaluable disease, either measurable or nonmeasurable per RECIST 1.1, as assessed by the local site investigator/radiology 9. Has provided a tissue sample from a core or excisional biopsy of a tumor lesion for confirmation of adequacy by the central vendor prior to randomization. Formalin-fixed, paraffin embedded tissue blocks are preferred to slides (details pertaining to tumor tissue submission can be found in the Procedures Manual) 10. Has adequate organ function as defined in the following Table 2 (see protocol). Specimens must be collected within 7 days prior to the start of study intervention Please refer to the protocol for more information
Exclusion criteria
Exclusion criteria: 1. Has histological subtypes other than those allowed per inclusion criterion 2 (eg, sarcoma, small cell carcinoma with neuroendocrine differentiation, non-epithelial cancer) 2. Has FIGO 2014 Stage IVB disease 3. 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. 4. Has bilateral hydronephrosis, unless at least one side has been stented or resolved by positioning of nephrostomy 5. 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 6. Has received a live vaccine within 30 days prior to the first dose of study intervention.Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, BCG, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed 7. 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 8. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137). 9. Has received prior systemic anticancer therapy including investigational agents within 4 weeks prior to randomization 10. 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 11. Has any contraindication to the use of cisplatin 12. 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 the first dose of study medication 13. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years 14. Has severe hypersensitivity (=Grade 3) to pembrolizumab and/or any of its excipients 15. Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed 16. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis 17. Has an active infection requiring systemic therapy 18. Has a known history of HIV infection 19. Has a known history of Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection 20. Has a known history of active tuberculosis (TB; Bacillus tuberculosis). 21. 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 intervention administration or may interfere with the interpretation of study results, and in the judgment of t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Kaplan Meier Method NAME OF THE RESULT: Progression-free survival (PFS) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: The analysis will be conducted around 28 and 34 months after the first participant is randomized. The final analysis will be conducted around 42 months after the first participant is randomized;Kaplan Meier Method NAME OF THE RESULT: Overall survival (OS) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: The analysis will be conducted around 28 and 34 months after the first participant is randomized. The final analysis will be conducted around 42 months after the first participant is randomized | — |
Secondary
| Measure | Time frame |
|---|---|
| Kaplan Meier Method NAME OF THE RESULT: Progression-free survival (PFS) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: The analysis will be conducted around 28 and 34 months after the first participant is randomized. The final analysis will be conducted around 42 months after the first participant is randomized;Kaplan Meier Method NAME OF THE RESULT: Overall survival (OS) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: The analysis will be conducted around 28 and 34 months after the first participant is randomized. The final analysis will be conducted around 42 months after the first participant is randomized;Miettinen and Nurminen method NAME OF THE RESULT: Objective Response Rate (ORR) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: The analysis will be conducted around 28 and 34 months after the first participant is randomized. The final analysis will be conducted around 42 months after the first participant is randomized.;Kaplan Meier Method NAME OF THE RESULT: Progression-free survival (PFS) at 2 years PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: The analysis will be conducted around 28 and 34 months after the first participant is randomized. The final analysis will be conducted around 42 months after the first participant is randomized.;Kaplan Meier Method NAME OF THE RESULT: Overall survival (OS) at 3 years PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: The analysis will be conducted around 28 and 34 months after the first participant is randomized. The final analysis will be conducted around 42 months after the first participant is randomized;Miettinen and Nurminen method NAME OF THE RESULT: Proportion of adverse events (AE) and Discontinuation of study intervention due to | — |
Countries
Australia, Brazil, Canada, Chile, China, Colombia, Guatemala, Japan, Korea South, Russian Federation, Taiwan, Thailand, United States
Outcome results
None listed