Study on Pemetrexed and Avelumab for Treating Patients with MTAP-Deficient Metastatic Urothelial Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT03744793

Provider View

This clinical trial is testing a combination of two drugs, pemetrexed and avelumab, to see if they can effectively treat urothelial cancer that has spread and lacks a specific enzyme called MTAP. The study aims to find out if this combination can stop cancer growth and improve patient outcomes.

Patient Parameters

Program Overview

This study is exploring how well the drugs pemetrexed and avelumab work together to treat urothelial cancer that has spread to other parts of the body and is missing an enzyme called MTAP. Pemetrexed may help stop cancer cells from growing by blocking certain enzymes, while avelumab, an immunotherapy drug, may help the immune system attack cancer cells. The goal is to see if this combination is more effective in treating this type of cancer.

Description

The main goal of this study is to see how well patients with MTAP-deficient metastatic urothelial cancer respond to treatment with pemetrexed and avelumab. Researchers will also look at how long patients live without the cancer getting worse and their overall survival rates. Additionally, the study will explore how these drugs affect the immune system and the environment around the tumor.

Patients will receive pemetrexed through an IV on the first day of each cycle. Starting from the second cycle, they will also receive avelumab through an IV. Each treatment cycle lasts 21 days, and patients will continue treatment as long as it is effective and side effects are manageable. After finishing the treatment, patients will have follow-up visits at 30 and 120 days, and then every three months for two years.

Eligibility Criteria

Inclusion Criteria

  • Must have confirmed MTAP-deficient metastatic urothelial cancer.
  • Can be considered for second or third line of therapy after previous treatments.
  • Must have measurable disease by specific criteria, with tumors large enough for biopsy.
  • Must have a performance status score of 2 or less, indicating they are able to carry out daily activities.
  • Must have certain blood test results within specified limits, including liver and kidney function.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception.
  • Men must agree to use effective contraception and refrain from donating sperm during and after treatment.
  • Must be able to stop taking certain anti-inflammatory drugs around the time of pemetrexed treatment.
  • Must be able to take specific vitamins and medications as part of the treatment protocol.
  • Mild autoimmune conditions are allowed if well-controlled.

Exclusion Criteria

  • Cannot have cancer that has spread to the brain or central nervous system unless treated and stable.
  • Cannot have had another cancer within the last two years, except for certain skin or prostate cancers.
  • Cannot be pregnant or breastfeeding.
  • Cannot have uncontrolled fluid buildup in the body that cannot be managed.
  • Cannot have certain autoimmune diseases or require high doses of steroids or other immune-suppressing drugs.
  • Cannot have a history of organ transplantation.
  • Cannot have received certain vaccines recently.
  • Cannot have active hepatitis or HIV.
  • Cannot have uncontrolled illnesses, including heart or lung diseases.
  • Cannot have severe side effects from previous treatments that have not resolved.
  • Cannot have major surgery recently or be recovering from surgery.
  • Cannot be on dialysis.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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