NIPH Clinical Trials Search

MK-2870 in Second-line Recurrent or Metastatic Cervical Cancer

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Cervical cancer
Date of first enrollment	06/11/2024
Target sample size	60
Countries of recruitment	United States of America,Japan,Canada,Japan,Argentina,Japan,Brazil,Japan,Chile,Japan,Colombia,Japan,Mexico,Japan,Puerto Rico,Japan,Austria,Japan,Belgium,Japan,Bulgaria,Japan,Denmark,Japan,Finland,Japan,France,Japan,Germany,Japan,Greece,Japan,Ireland,Japan,Israel,Japan,Italy,Japan,Netherlands,Japan,Norway,Japan,Poland,Japan,Spain,Japan,Sweden,Japan,Switzerland,Japan,UK,Japan,Australia,Japan,Malaysia,Japan,Singapore,Japan,Refer to 7-5,Japan
Study type	Interventional
Intervention(s)	This study will have two phases: a MK-2870 safety run-in and a Phase 3 portion. Experimental Arm: MK-2870 4 mg/kg of once every 2 weeks via intravenous (IV) infusion Active Comparator Arm: TPC consisting of one of the following: -Pemetrexed (500 mg/m2, Day 1 of every 3-week cycle via IV infusion); -Tisotumab vedotin (2 mg/kg, Day 1 of every 3-week cycle via IV infusion); -Topotecan (1 mg/m2 or 1.25 mg/m2, if tolerating well, Day 1, 2, 3, 4, and 5 of every 3-week cycle via IV infusion); -Vinorelbine (30 mg/m2, Days 1 and 8 of every 3-week cycle via IV infusion); -Gemcitabine (1000 mg/m2, Days 1 and 8 of every 3-week cycle via IV infusion); -Irinotecan (100 mg/m2 or 125 mg/m2, if tolerating well, Day 1, 8, 15, and 22 of every 6-week cycle via IV infusion). Tisotumab vedotin will be used after approval in Japan. Topotecan and vinorelbine will not be used in Japan.

Outcome(s)

Primary Outcome

MK-2870 Run-in: -Objective response (OR): complete response (CR) or partial response (PR) -Adverse events (AEs) -Study intervention discontinuation due to AEs Phase 3 portion: Overall survival (OS) : The time from randomization to death due to any cause

Secondary Outcome

Phase 3 portion: -Progression-free survival (PFS) : The time from randomization to the first documented disease progression or death due to any cause, whichever occurs first -Objective response (OR): complete response (CR) or partial response (PR) -Duration of response (DOR) : For participants who demonstrate CR or PR, DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first -Adverse events (AEs) -Study intervention discontinuation due to AEs -Time to deterioration (TTD) in the EORTC QLC-C30 Global Health Status/Quality of Life (GHS/QoL) : Time from randomization to the first onset of deterioration -Change from baseline in health-related QoL outcome: -EORTC QLQ-C30 GHS/QoL -EORTC QLQ-C30 physical functioning score -EORTC QLQ-C30 role functioning score

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Female
Include criteria	1. Has histologically-confirmed diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix 2. Must have recurrent or metastatic cervical cancer that has progressed on or after treatment with 1 prior line of systemic platinum doublet chemotherapy (with or without bevacizumab) AND must have received anti-PD-1/anti-PD-L1 therapy as part of prior cervical cancer regimens 3. Has measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, as assessed by the investigator. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions 4. Is assigned female sex at birth, at least 18 years of age at the time of providing the informed consent 5. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before allocation for the MK-2870 Run-in or within 7 days before randomization for the Phase 3 portion 6. Has provided tumor tissue (most recent sample is preferred) from a core or excisional biopsy of a tumor lesion not previously irradiated 7. HIV-infected participants must have well controlled human immunodeficiency virus (HIV) on antiretroviral therapy (ART) 8. Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation (MK-2870 Run-in) or randomization (Phase 3 portion) 9. Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening 10. Has adequate organ function
Exclude criteria	1. Has Grade >=2 peripheral neuropathy 2. Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing 3. Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea) 4. Has uncontrolled, significant cardiovascular disease or cerebrovascular disease. 5. Received prior systemic anticancer therapy 6. Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids 7. Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed 8. Has histologically-confirmed diagnosis of glassy cell carcinoma variant, adenoid cystic carcinoma, adenoid basal carcinoma, neuroendocrine tumors, carcinoid, atypical carcinoid, small-carcinoma, large-cell neuroendocrine carcinoma, or undifferentiated carcinoma 9. Known additional malignancy that is progressing or has required active treatment within the past 3 years 10. Known active central nervous system (CNS) metastases and/or carcinomatous meningitis 11. Active infection requiring systemic therapy 12. HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease 13. Concurrent active Hepatitis B and active Hepatitis C virus infection 14. Severe hypersensitivity (>=Grade 3) to MK-2870 or treatment of physician's choice (TPC) and/or any of their excipients, or other biologic therapy 15. Participants who have not adequately recovered from major surgery or have ongoing surgical complications