Phase 2 Study of Pemetrexed, Etrumadenant, and Zimberelimab for Previously Treated Advanced Urothelial Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05335941

Provider View

This clinical trial is testing a new combination of drugs for patients with advanced urothelial cancer that has a specific genetic deficiency (MTAP-deficient) and who have already received immunotherapy. The study is being conducted at the University of Texas MD Anderson Cancer Center.

Patient Parameters

Program Overview

The study aims to evaluate the safety and effectiveness of a three-drug combination treatment for patients with advanced urothelial cancer that is MTAP-deficient and has been previously treated with immune checkpoint inhibitors. This trial is open to patients who are receiving a second line of treatment or beyond for their cancer.

Description

The main goals of this study are to assess how safe and tolerable the combination of Pemetrexed, Etrumadenant, and Zimberelimab is for patients, and to see how well it works in treating advanced urothelial cancer. Researchers will also explore how the treatment affects the cancer environment, including immune cells around the tumor. Additionally, the study will look at the survival rates of patients receiving this treatment.

Participants must meet certain criteria to join the study, including having a confirmed diagnosis of MTAP-deficient urothelial cancer and having been previously treated with specific immunotherapy drugs. The study will involve regular monitoring and assessments to ensure the treatment is safe and effective for participants.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of MTAP-deficient metastatic urothelial cancer.
  • Eligible for second line of therapy or beyond, after previous treatment with immune checkpoint inhibitors.
  • Have measurable disease by standard criteria, with tumors large enough for biopsy.
  • Have a performance status score of 2 or less, indicating ability to carry out daily activities.
  • Have adequate liver, kidney, and bone marrow function as determined by specific blood tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study.
  • Must be able to interrupt certain medications and take specific vitamins as required by the study protocol.
  • Prior treatment with anti-PD-1/PD-L1 therapy is required.

Exclusion Criteria

  • Have a heart condition with a prolonged QT interval.
  • Have taken certain medications that interact with the study drugs within a specified time before the study.
  • Have gastrointestinal issues that prevent taking oral medications.
  • Have had severe allergic reactions to similar drugs.
  • Have untreated or unstable brain metastases.
  • Have another active cancer or have been cancer-free for less than 2 years, except for certain non-threatening cancers.
  • Are pregnant or breastfeeding.
  • Have uncontrolled fluid buildup in the body.
  • Have active inflammatory bowel disease or certain autoimmune disorders.
  • Require high doses of steroids or other immunosuppressive medications.
  • Have a history of primary immunodeficiency or organ transplantation.
  • Have received live vaccines recently.
  • Test positive for active hepatitis or HIV.
  • Have uncontrolled illnesses or psychiatric conditions that affect study participation.
  • Have had major surgery recently or are still recovering.
  • Are on dialysis.
  • Had to stop previous checkpoint therapy due to severe side effects.
  • Have had prior antifolate therapy for cancer treatment.

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