Clinical Trial 24369

• Overview

  Study Title:

  A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab With or Without Bevacizumab Compared With Standard of Care as First-line Maintenance Treatment for Participants With Persistent, Recurrent, or Newly Diagnosed Metastatic Cervical Cancer With PD-L1 CPS Greater Than or Equal to 1 (TroFuse-036/GOG-3123/ENGOT-cx22)

  Summary:

  The goals of this study are to learn: About the safety of sac-TMT with pembrolizumab and bevacizumab, and if people tolerate them when given together, and If people who receive sac-TMT and pembrolizumab, with or without bevacizumab, live longer overall or without their cancer getting worse as compared to those who receive standard treatment

  Objective:

  Primary Objectives: - Part 1 (Safety Run-in): *To evaluate the safety and tolerability of maintenance treatment with sac-TMT plus pembrolizumab with bevacizumab - Part 2 Maintenance: *To compare maintenance treatment with sac-TMT plus pembrolizumab, with or without bevacizumab to SoC with respect to PFS per RECIST 1.1 as assessed by BICR. - Part 2 Maintenance: *To compare maintenance treatment with sac-TMT plus pembrolizumab, with or without bevacizumab to SoC with respect to OS. Secondary Objectives: - Part 2 Maintenance: *To evaluate maintenance treatment with sac-TMT plus pembrolizumab, with or without bevacizumab versus SoC with respect to PFS2 as assessed by the physician investigator. - Part 2 Maintenance: *To evaluate safety and tolerability of maintenance treatment with sac-TMT plus pembrolizumab, with or without bevacizumab. - Part 2 Maintenance: *To evaluate maintenance treatment with sac-TMT plus pembrolizumab, with or without bevacizumab versus SoC with respect to HRQoL outcome.

• Treatments

  Therapies:

  Antibody-Drug Conjugate; Chemotheraphy; Chemotherapy (NOS); Immunotherapy

  Medications:

  Avastin (Bevacizumab); Bevacizumab (); Paraplatin (carboplatin); Pembrolizumab (Keytruda); Taxol (paclitaxel); carboplatin (); cisplatin (); paclitaxel (); sac-TMT ()

• Inclusion Criteria

  Main Inclusion Criteria:
  • Has a histologically confirmed diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of cervix
  • Has persistent, recurrent, or newly diagnosed metastatic (International Federation of Gynecology and Obstetrics [FIGO]-2028 Stage IVB) cervical cancer that is not amenable to curative treatment (surgery and/or radiation)
  • If infected with human immunodeficiency virus (HIV), has well controlled HIV on antiretroviral therapy
  • If positive for hepatitis B surface antigen, has received hepatitis B virus (HBV) antiviral therapy and has undetectable HBV viral load
  • If has a history of hepatitis C virus (HCV) infection, has undetectable HCV viral load
  • Has an Eastern Cooperative Oncology Group performance status of 0 or 1
  • Has tumor programmed cell death ligand 1 expression of combined positive score ≥1
  • Other criteria apply

• Exclusion Criteria

  Main Exclusion Criteria:
  • Has HIV infection with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • Has a 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
  • Has received prior systemic anticancer therapy other than what is specified in this protocol
  • Is currently receiving a strong inducer/inhibitor of cytochrome P450 3A4 that cannot be discontinued for the duration of treatment with sac-TMT
  • Has a diagnosis of immunodeficiency
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
  • Has known active central nervous system metastases and/or carcinomatous meningitis
  • Has active autoimmune disease that has required systemic treatment in the past 2 years; replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed
  • Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/ILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments
  • Has a history of stem cell/solid organ transplant
  • Has not adequately recovered from major surgery or has ongoing surgical complications
  • Other exclusions may apply

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