Study on Durvalumab Combined with Chemotherapy for Treating Advanced Solid Tumors (DURVA+ Study)

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03907475

Provider View

This clinical trial is exploring the safety and effects of combining the immunotherapy drug durvalumab with chemotherapy to treat advanced solid tumors that have spread. The study aims to see if this combination can help the immune system better attack cancer cells.

Patient Parameters

Program Overview

This phase II study is testing how safe and effective durvalumab, an immunotherapy drug, is when used with chemotherapy in patients with advanced solid tumors. Durvalumab may help the immune system target cancer cells, while chemotherapy works to stop cancer cells from growing and spreading. The study will assess if combining these treatments can improve the immune response against tumors.

Description

Primary Objective:

  • To determine if adding durvalumab to standard chemotherapy is safe for patients.

Secondary Objectives:

  • To study changes in the immune system when chemotherapy is given and how these changes affect the action of durvalumab.
  • To see if the response to treatment is linked to patients' genetic factors or the activity of certain immune cells.
  • To explore the relationship between the immune status of the tumor and the overall genetic changes in the tumor.
  • To assess the initial effectiveness of the durvalumab and chemotherapy combination.

Exploratory Objective:

  • To see if changes in cell-free DNA in the blood are linked to how well patients respond to the treatment.

Study Design:

Patients are divided into 7 groups, each receiving different combinations of durvalumab and chemotherapy. Treatment cycles repeat every 21 or 28 days, depending on the group, as long as the disease does not progress or cause unacceptable side effects. Patients will undergo regular CT scans, tissue biopsies, and blood tests throughout the study.

After completing the study treatment, patients will have monthly follow-ups for 3 months.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 and older with advanced solid tumors that have spread and have not responded to standard treatments.
  • Tumors must be measurable by scans.
  • Patients must be willing to undergo a tumor biopsy.
  • Good overall health with specific blood counts and organ function within normal limits.
  • HIV-positive patients can participate if their viral load is undetectable and they meet other health criteria.
  • Women of childbearing potential and men must agree to use effective contraception during the study and for 6 months after.
  • Patients must be able to understand and sign a consent form.

Exclusion Criteria

  • Patients who had serious side effects from previous checkpoint inhibitor treatments.
  • Patients with certain types of cancer where durvalumab alone is not effective.
  • Pregnant or breastfeeding women.
  • Patients with active autoimmune or inflammatory disorders, except for certain stable conditions.
  • Patients using immunosuppressive medications recently.
  • Patients with a history of severe allergic reactions to similar treatments.
  • Patients with uncontrolled illnesses or infections that could interfere with the study.

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