A Phase II Study of Pembrolizumab Immunotherapy with Lenvatinib in Women with Advanced Uterine Carcinosarcoma

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Full Title

A Phase II Trial of Pembrolizumab plus Lenvatinib for the Treatment of Patients with Advanced Uterine Carcinosarcoma

Purpose

The purpose of this study is to assess the safety and effectiveness of combining the drugs lenvatinib and pembrolizumab to treat advanced uterine carcinosarcoma. Pembrolizumab is a form of immunotherapy. It boosts the power of the immune system to find and kill cancer cells. Lenvatinib works by blocking certain proteins that help cancer cells grow and develop blood vessels.

Both drugs are used in combination to treat endometrial cancer; their use in uterine carcinosarcoma is considered investigational. Lenvatinib is taken orally (by mouth) and pembrolizumab is given intravenously (by vein).

Eligibility

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

  • Participants must have advanced uterine carcinosarcoma that came back or continued to grow despite treatment that included a platinum-based chemotherapy regimen.
  • Patients may have received up to three prior lines of systemic therapy. At least 3 weeks must pass between the completion of previous treatment and receipt of the study therapy.
  • 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 women age 18 and older.

For more information about this study and to ask about eligibility, please contact the office of Dr. Vicky Makker at 646-888-4224.

Protocol

21-273

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators