A Phase II Study of MK-7684A Immunotherapy with or without Other Anticancer Therapies in People with Solid Tumors

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Full Title

A Multicenter, Open-label, Phase 2 Basket Study of MK-7684A, a Co-formation of Vibstolimab (MK-7684) with Pembrolizumab (MK-3475), With or Without Other Anticancer Therapies in Participants with Selected Solid Tumors (KEYVIBE-005)

Purpose

MK-7684A is an investigational immunotherapy made up of the drugs MK-7684 and pembrolizumab. Immunotherapy works by boosting the power of the immune system to find and kill cancer cells.

The purpose of this study is to assess the safety and effectiveness of MK-7684A alone and with other anticancer therapies in people with cervical, endometrial, or esophageal cancer. There are three study groups:

  • Patients with cervical cancer will receive MK-7684A alone or pembrolizumab alone.
  • Participants with endometrial cancer will receive MK-7684A alone or in combination with lenvatinib.
  • People with esophageal cancer will receive MK-7684A in combination with 5-fluorouracil and cisplatin.

The medications in this study are given intravenously, except for lenvatinib, which is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have cervical or endometrial cancer that has returned or continued to grow despite prior treatment, or newly diagnosed inoperable esophageal cancer that has not yet been treated with chemotherapy.
  • Patients may not have previously received immunotherapy with a drug such as pembrolizumab (“anti-PD-1/PD-L1 therapies”).
  • The serious side effects of prior treatments should go away before the study treatment is given.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

For more information and to ask about eligibility for this study, please contact the office of Dr.  Robin Guo at 646-888-6950.

Protocol

21-522

Phase

II

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators