Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine
Dates
study started
estimated completion

Description

Summary

The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of pembrolizumab/vibostolimab co-formulation (MK-7684A) with or without other anticancer therapies in participants with selected advanced solid tumors. The primary hypothesis is that pembrolizumab/vibostolimab co-formulation is superior to pembrolizumab alone in terms of objective response rate or progression-free survival in participants with cervical cancer.

Official Title

A Multicenter, Open-label, Phase 2 Basket Study of MK-7684A, a Co-formation of Vibostolimab (MK-7684) With Pembrolizumab (MK-3475), With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors

Keywords

Uterine Cervical Neoplasms Endometrial Neoplasms Squamous Cell Carcinoma of Head and Neck Gallbladder Neoplasms Cholangiocarcinoma Esophageal Neoplasms Triple Negative Breast Neoplasms Hepatocellular Carcinoma Urinary Bladder Neoplasms Ovarian Neoplasms Stomach Neoplasms Programmed Cell Death-1 (PD1, PD-1) Programmed Death-Ligand 1 (PDL1, PD-L1) Carcinoma Neoplasms Breast Neoplasms Gemcitabine Docetaxel Bevacizumab Carboplatin Pembrolizumab Fluorouracil Capecitabine Oxaliplatin Lenvatinib Pembrolizumab/Vibostolimab Co-Formulation 5-Fluorouracil Cisplatin Paclitaxel Pembrolizumab/Vibostolimab + 5-Fluorouracil + Cisplatin Pembrolizumab/Vibostolimab Co-Formulation + Paclitaxel Pembrolizumab/Vibostolimab Co-Formulation + Gemcitabine/Cisplatin Pembrolizumab/Vibostolimab Co-Formulation+ Carboplatin/Paclitaxel/Bevacizumab Pembrolizumab/Vibostolimab Co-Formulation + Capecitabine/Oxaliplatin

Eligibility

You can join if…

Open to people ages 18 years and up

  • One of the following histologically or cytologically confirmed, advanced (locally recurrent unresectable or metastatic) solid tumors:
  • Squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix
  • Endometrial cancer
  • Head and neck squamous cell carcinoma (HNSCC)
  • Unresectable biliary adenocarcinoma (gallbladder or biliary tree [intrahepatic or extrahepatic] cholangiocarcinoma)
  • Adenocarcinoma or squamous cell carcinoma of the esophagus or advanced/metastatic Siewert type 1 adenocarcinoma of the gastroesophageal junction (GEJ).
  • Triple-negative breast cancer (TNBC)
  • Hepatocellular carcinoma (HCC)
  • Urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra
  • Ovarian cancer
  • Gastric cancer
  • Measurable disease per RECIST v1.1 as assessed by BICR or local site investigator.
  • Adequately controlled blood pressure (BP) with or without antihypertensive medications.
  • Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART).
  • Male participants must agree to follow contraceptive guidance.
  • Female participants are not pregnant or breastfeeding, not a woman of child-bearing potential (WOCBP) or is a WOCBP and agrees to follow contraceptive guidance.
  • Adequate organ function.

You CAN'T join if...

  • History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years.
  • Prior therapy with anti-programmed cell-death (PD-1), anti-PD-L1, anti-PD-L2, or anti-T-cell immunoreceptor with Ig and ITIM domains (TIGIT) agent.
  • Prior systemic anticancer therapy including investigational agents within 4 weeks before randomization/allocation.
  • Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
  • Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of study medication.
  • Active autoimmune disease that has required systemic treatment in past 2 years.
  • Active infection requiring systemic therapy.
  • Concurrent active hepatitis B and hepatitis C virus infection.
  • History of allogenic tissue/solid organ transplant.
  • Previous treatment with lenvatinib (for participants who will receive lenvatinib in their assigned treatment arm).
  • Has clinically significant cardiovascular disease within 12 months from first dose of study intervention.

Locations

  • University of California, Irvine (UCI) Health - UC Irvine Me-Chao Family Comprehensive Cancer Cente accepting new patients
    Orange California 92868 United States
  • City of Hope Comprehensive Cancer Center ( Site 1001) accepting new patients
    Duarte California 91010 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Merck Sharp & Dohme LLC
Links
Merck Oncology Clinical Trials Information
ID
NCT05007106
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 610 study participants
Last Updated