Testing the Addition of Durvalumab to Chemotherapy Before Surgery for Patients with High-Grade Upper Urinary Tract Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04628767

Provider View

This clinical trial is exploring whether adding the immunotherapy drug durvalumab to chemotherapy before surgery can improve treatment outcomes for patients with high-grade upper urinary tract cancer.

Patient Parameters

Program Overview

This study is investigating if combining the immunotherapy drug durvalumab with chemotherapy before surgery is more effective than chemotherapy alone in treating upper urinary tract cancer. Durvalumab may help the immune system attack cancer cells, while chemotherapy drugs work to stop cancer cells from growing and spreading. The goal is to see if this combination can shrink tumors more effectively before surgery.

Description

The main goal of this study is to compare how well patients with upper tract urothelial cancer do when treated with chemotherapy alone versus chemotherapy combined with durvalumab before surgery. The study will look at how long patients remain free of cancer events and how many have no cancer left at the time of surgery.

Secondary goals include assessing overall survival, disease-free survival, and cancer-specific survival. The study will also evaluate kidney function after treatment and surgery, as well as the safety and tolerability of the treatments.

Patients eligible for cisplatin will be randomly assigned to one of two groups:

  • Arm A: Patients receive durvalumab and chemotherapy drugs (methotrexate, vinblastine, doxorubicin, and cisplatin) every 14 days for up to 4 cycles, followed by surgery if the cancer has not spread.
  • Arm B: Patients receive the same chemotherapy drugs without durvalumab every 14 days for up to 4 cycles, followed by surgery if the cancer has not spread.

Patients not eligible for cisplatin will be assigned to:

  • Arm C: Patients receive durvalumab and gemcitabine every 21 days for up to 4 cycles, followed by surgery if the cancer has not spread.

Throughout the study, patients will have tissue biopsies, blood samples, and imaging tests like CT or MRI scans. After treatment, patients will be followed up regularly for up to 5 years.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must understand and agree to sign a consent form. Patients with decision-making difficulties can participate if they have a legal representative.
  • Must have a diagnosis of high-grade upper tract urothelial carcinoma confirmed by biopsy within the last 12 weeks.
  • Must have adequate blood cell counts and organ function based on specific lab tests.
  • HIV-positive patients can participate if their viral load is undetectable and they meet other health criteria.
  • Patients with hepatitis B or C must have undetectable viral loads if on treatment.
  • Must have a body weight over 30 kg and a life expectancy of at least 12 weeks.
  • Must have a creatinine clearance over 15 ml/min.
  • Patients will be assigned to treatment groups based on their ability to receive cisplatin, determined by kidney function and other health factors.

Exclusion Criteria

  • Must not have small cell/neuroendocrine carcinoma.
  • Must not be pregnant or breastfeeding.
  • Must not have evidence of cancer spread or enlarged lymph nodes on imaging.
  • Must not have another active cancer within the last two years, except for certain non-threatening cancers.
  • Must not have uncontrolled illnesses, such as active infections or severe heart disease.
  • Must not have received certain prior cancer treatments, like extensive radiation or anthracycline therapy.
  • Must not have a history of autoimmune diseases requiring immunosuppressive therapy.
  • Must not have used immunosuppressive medication recently, with some exceptions.
  • Must not have received a live vaccine recently.
  • Must not have had major surgery recently, except for minor procedures like cystoscopy.

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