Phase II Study of AK104 for Recurrent Neuroendocrine Cervical Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT05063916

Provider View

This clinical trial is testing the effectiveness and safety of a new drug, AK104, for adults with recurrent or metastatic high-grade neuroendocrine cervical cancer that has returned after previous treatment.

Patient Parameters

Program Overview

The study aims to find out if AK104 can help control cervical cancer that has come back or spread after initial treatments. Researchers will look at how long patients can go without the cancer getting worse, how well the drug works overall, and how safe it is for patients to use. They will also check if certain DNA markers can predict how well the treatment works.

Description

This study is focused on patients with high-grade neuroendocrine cervical cancer that has returned or spread after treatment. The main goal is to see if the drug AK104 can help keep the cancer from progressing for at least six months. Researchers will also evaluate how long the cancer stays under control, the overall response to the drug, and any side effects. Additionally, they will investigate if certain DNA markers can indicate how well the treatment is working.

Participants must be adults who have had no more than two previous treatments for their cancer and are not eligible for surgery or radiation. They need to have measurable cancer lesions and be in good general health. Women of childbearing potential must use contraception and have a negative pregnancy test before starting the study.

The study excludes those currently in another clinical trial, with other types of cervical cancer, or with active infections like HIV or hepatitis. It also excludes those with certain autoimmune diseases, recent heart issues, or unresolved side effects from previous cancer treatments. Participants should not have had recent major surgery or received certain medications or vaccines before starting the study.

Eligibility Criteria

Inclusion Criteria

  • Must be able to provide written consent.
  • Age 18 or older.
  • Confirmed diagnosis of recurrent or metastatic high-grade neuroendocrine cervical cancer.
  • Cancer must have progressed after previous platinum-based chemotherapy.
  • No more than two prior treatments for recurrent or metastatic cancer.
  • Not eligible for surgery or radiation.
  • Measurable cancer lesions.
  • Good overall health with an ECOG score of 0 or 1.
  • Adequate blood, kidney, and liver function.
  • Women of childbearing potential must use contraception and have a negative pregnancy test.
  • Willing to follow study procedures and attend scheduled visits.

Exclusion Criteria

  • Currently in another clinical trial.
  • Other types of cervical cancer.
  • Active cancer within the last two years, except for certain skin cancers.
  • Brain metastases unless treated and stable.
  • Significant kidney issues not resolved by medical procedures.
  • Active infections requiring treatment.
  • Positive for HIV or active hepatitis B or C.
  • Certain autoimmune diseases unless well-controlled.
  • Recent heart or lung issues.
  • Unresolved side effects from previous cancer treatments.
  • Severe allergies to similar drugs.
  • Recent major surgery or certain treatments.
  • Use of immunosuppressive medications recently.
  • Recent live vaccines.
  • Previous exposure to certain experimental cancer treatments.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.