Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified
Conditions
Interventions
Intervention1: Sacituzumab tirumotecan (MK-2870): Dose: 4 mg/kg IV every 2 weeks (q2w)
Intervention2: Pembrolizumab: Dose: 400 mg IV every 6 weeks (q6w)
Intervention3: Bevacizumab: Dose: 15 mg/kg I
Sponsors
Merck Sharp Dohme LLC a subsidiary of Merck and Co Inc
MSD Pharmaceuticals Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Has a histologically confirmed diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of cervix 2. Has persistent, recurrent, or newly diagnosed metastatic cervical cancer that is not amenable to curative treatment (surgery and/or radiation) 3. If infected with human immunodeficiency virus (HIV), has well controlled HIV on antiretroviral therapy 4. If positive for hepatitis B surface antigen, has received hepatitis B virus (HBV) antiviral therapy and has undetectable HBV viral load 5. If has a history of hepatitis C virus (HCV) infection, has undetectable HCV viral load 6. Has an Eastern Cooperative Oncology Group performance status of 0 or 1 7. Has tumor programmed cell death ligand 1 expression of combined positive score greater than equal to 1
Exclusion criteria
Exclusion criteria: 1. Has HIV infection with a history of Kaposis sarcoma and or Multicentric Castlemans Disease 2. Has a history of documented severe dry eye syndrome or severe Meibomian gland disease and or blepharitis or severe corneal disease that prevents or delays corneal healing 3. Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (e.g. Crohns disease or ulcerative colitis or chronic diarrhea) 4. Has uncontrolled significant cardiovascular disease or cerebrovascular disease 5. Has received prior systemic anticancer therapy other than what is specified in this protocol 6. Is currently receiving a strong inducer or inhibitor of cytochrome P450 3A4 that cannot be discontinued for the duration of treatment with sac-TMT 7. Has a diagnosis of immunodeficiency 8. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years 9. Has known active central nervous system metastases and/or carcinomatous meningitis 10. Has active autoimmune disease that has required systemic treatment in the past 2 years replacement therapy (e.g. thyroxine or insulin or physiologic corticosteroid) is allowed 11. Has a history of (noninfectious) pneumonitis or interstitial lung disease that required steroids or has current pneumonitis or interstitial lung disease 12. Has a history of stem cell or solid organ transplant 13. Has not adequately recovered from major surgery or has ongoing surgical complications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Part 1 Safety Run-in: Number of Participants Who Experience One or More Adverse Events (AEs) 2. Part 1 Safety Run-in: Number of Participants Who Discontinue Study Treatment Due to an AE 3. Part 2 Maintenance Treatment: 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) 4. Part 2 Maintenance Treatment: Overall Survival (OS) Timepoint: 1. Up to approximately 71 months 2. Up to approximately 68 months 3. Up to approximately 48 months 4. Up to approximately 60 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 2 Maintenance Treatment: Progression-free Survival 2 (PFS2) as Assessed by the Investigator PFS2 is defined as the time from randomization to the documented subsequent objective disease progression after initiation of new anticancer therapy or death due to any cause, whichever occurs first. PFS2 as assessed by the investigator will be presented.Timepoint: Up to approximately 60 month;Part 2 Maintenance Treatment: Number of Participants Who Experience One or More AEs An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study interventionTimepoint: Up to approximately 64 months;Part 2 Maintenance Treatment: Number of Participants Who Discontinue Study Treatment Due to an AE An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study interventionTimepoint: Up to approximately 61 months;Part 2 Maintenance Treatment: Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status and Quality of Life Combined Score EORTC QLQ-C30 is a questionnaire to assess the overall quality of life (QoL) of cancer patients. Participant responses to questions regarding Global Health Status (GHS How would you rate your overall health during the past week?) and QoL (How would you rate your overall quality of life during the past week?) are scored on a 7-point scale (1 = Very poor to 7 = Excellent). The combined score of GHS and QoL is computed by averaging the raw scores of the 2 questions and then applying a linear transformation to standardize the average score, so that the combined score ranges from 0 to 100. A higher score indicates a better outcome. The change from baseline in the EORTC QLQ-C30 GHS and QoL combined score will be presented.Timep | — |
Countries
Argentina, Austria, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Mexico, Philippines, Poland, Republic of Korea, South Africa, Spain, Sweden, Taiwan, Thailand, United Kingdom, United States of America
Contacts
Public ContactDr Monisha Sharma
MSD Pharmaceuticals Pvt Ltd
Outcome results
None listed