Study on Anti-PD-1 Alone or with Anti-CTLA-4 for Second-Line Treatment in Cervical Cancer

Sponsor: Agenus Inc.

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT03894215

Provider View

This clinical trial is testing two different treatments for advanced cervical cancer that has returned or worsened after initial chemotherapy. One group will receive a drug called AGEN2034 with a placebo, and the other group will receive AGEN2034 with another drug called AGEN1884. The study aims to see how effective and safe these treatments are.

Patient Parameters

Program Overview

This study is exploring two treatment options for patients with advanced cervical cancer that has come back or progressed after first-line platinum-based chemotherapy. Participants will either receive AGEN2034 with a placebo or AGEN2034 combined with AGEN1884. The goal is to evaluate the effectiveness and safety of each treatment option compared to historical data. The study will last up to 24 months or until the cancer progresses, side effects become unacceptable, or other criteria for stopping are met. Participants, doctors, and researchers will not know which treatment each participant is receiving to ensure unbiased results. An independent committee will monitor safety and effectiveness, and a separate group will assess tumor responses.

Description

This clinical trial involves two groups of patients with advanced cervical cancer. One group will receive a drug called AGEN2034 along with a placebo, while the other group will receive AGEN2034 combined with another drug, AGEN1884. The study will last for up to 24 months, or until the cancer progresses, side effects become too severe, or other stopping criteria are met. The purpose is to evaluate the safety and effectiveness of these treatments compared to historical data. Participants, doctors, and researchers will not know which treatment each participant is receiving to ensure unbiased results. An independent committee will monitor safety and effectiveness, and a separate group will assess tumor responses.

Eligibility Criteria

Inclusion Criteria

  • Agree to participate and provide written consent.
  • Be 18 years or older.
  • Have a confirmed diagnosis of certain types of cervical cancer that is advanced, spread, or cannot be removed by surgery.
  • Cancer must have returned after initial platinum-based treatment.
  • Have measurable disease on scans.
  • Have a life expectancy of at least 3 months and be in good general health.
  • Have adequate organ function based on specific blood tests.
  • No history of another primary cancer, except for certain treated cancers.
  • Provide a recent tumor tissue sample.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for 120 days after the last treatment.
  • Willing to comply with study requirements.

Exclusion Criteria

  • Currently participating in another study or have recently received other investigational treatments.
  • Have received certain treatments too close to the start of the study.
  • Have had previous treatments targeting specific immune checkpoints.
  • Have ongoing severe side effects from previous treatments.
  • Require other cancer treatments during the study.
  • Have severe allergies to similar drugs.
  • Have active brain tumors or metastases.
  • Have a history of autoimmune diseases requiring treatment in the past 2 years.
  • Have had a tissue or organ transplant.
  • Have lung diseases requiring steroids.
  • Have active infections needing IV treatment.
  • Have a history of HIV, active hepatitis B or C, or tuberculosis.
  • Have significant heart disease or recent heart events.
  • Have conditions that could interfere with the study.
  • Have psychiatric or substance abuse issues affecting participation.
  • Are pregnant, breastfeeding, or planning to become pregnant during the study.

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