A Phase 3 Randomized, Active-Controlled, Open-Label, Multicenter Study To Compare The Efficacy And Safety Of Mk-2870 Monotherapy Versus Treatment Of Physician's Choice As Second-Line Treatment For Participants With Recurrent Or Metastatic Cervical Cancer
Posted Date: Jun 25, 2025
- Investigator: Amanda Jackson
- Specialties: Gynecologic Oncology, Gynecology
- Type of Study: Drug
This study will have two phases: a sacituzumab tirumotecan safety run-in and a Phase 3 portion. The safety run-in phase will be used to evaluate the efficacy and safety of sacituzumab tirumotecan at the dose for evaluation in the Phase 3 portion. The purpose of this study is to compare the efficacy and safety of sacituzumab tirumotecan versus treatment of physician's choice as second-line treatment for participants with recurrent or metastatic cervical cancer in the Phase 3 portion. The primary study hypotheses are that, in the Phase 3 portion, sacituzumab tirumotecan results in a superior overall survival compared to TPC in participants with high trophoblast cell surface antigen 2 (TROP2) expression level and in all participants.
Criteria:
Inclusion Criteria: Has Histologically-Confirmed Diagnosis Of Squamous Cell Carcinoma, Adenosquamous Carcinoma, Or Adenocarcinoma Of The Cervix 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 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 Is Assigned Female Sex At Birth, At Least 18 Years Of Age At The Time Of Providing The Informed Consent Has Ecog Performance Status Of 0 Or 1 Within 7 Days Before Allocation For The Sacituzumab Tirumotecan Run-In Or Within 7 Days Before Randomization For The Phase 3 Portion Has Provided Tumor Tissue (Most Recent Sample Is Preferred) From A Core Or Excisional Biopsy Of A Tumor Lesion Not Previously Irradiated Hiv-Infected Participants Must Have Well Controlled Human Immunodeficiency Virus (Hiv) On Antiretroviral Therapy (Art) 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 (Sacituzumab Tirumotecan Run-In) Or Randomization (Phase 3 Portion) Participants With History Of Hepatitis C Virus (Hcv) Infection Are Eligible If Hcv Viral Load Is Undetectable At Screening Has Adequate Organ Function Exclusion Criteria: Has Grade =2 Peripheral Neuropathy Has History Of Documented Severe Dry Eye Syndrome, Severe Meibomian Gland Disease And/Or Blepharitis, Or Severe Corneal Disease That Prevents/Delays Corneal Healing Has Active Inflammatory Bowel Disease Requiring Immunosuppressive Medication Or Previous History Of Inflammatory Bowel Disease (Eg, Crohn's Disease, Ulcerative Colitis, Or Chronic Diarrhea) Has Uncontrolled, Significant Cardiovascular Disease Or Cerebrovascular Disease. Received Prior Systemic Anticancer Therapy Received Prior Radiotherapy Within 2 Weeks Of Start Of Study Intervention, Or Has Radiation-Related Toxicities, Requiring Corticosteroids Received A Live Or Live-Attenuated Vaccine Within 30 Days Before The First Dose Of Study Intervention. Administration Of Killed Vaccines Is Allowed Has Histological Subtypes Of Cervical Cancer Other Than Squamous Cell Carcinoma, Adenocarcinoma, Or Adenosquamous Carcinoma (Eg, Carcinosarcoma) Or Nonepithelial Cancer (Eg, Sarcoma, Neuroendocrine Tumors) Known Additional Malignancy That Is Progressing Or Has Required Active Treatment Within The Past 3 Years Known Active Central Nervous System (Cns) Metastases And/Or Carcinomatous Meningitis Active Infection Requiring Systemic Therapy Hiv-Infected Participants With A History Of Kaposi's Sarcoma And/Or Multicentric Castleman's Disease Concurrent Active Hepatitis B And Active Hepatitis C Virus Infection Severe Hypersensitivity (=Grade 3) To Sacituzumab Tirumotecan Or Treatment Of Physician's Choice (Tpc) And/Or Any Of Their Excipients, Or Other Biologic Therapy Participants Who Have Not Adequately Recovered From Major Surgery Or Have Ongoing Surgical Complications Has A History Of (Noninfectious) Pneumonitis/Ild That Required Steroids Or Has Current Pneumonitis/Ild
Keywords:
Uterine Neoplasms, Genital Neoplasms, Female, Urogenital Neoplasms
For More Information:
Jill Brennan
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cancer@uchealth.com