Actively Recruiting
Durvalumab Combined With Chemotherapy for Advanced Solid Tumors Evaluating Safety and Immune Effects
Led by National Cancer Institute (NCI) ยท Updated on 2026-05-13
115
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and immune effects of durvalumab combined with chemotherapy in patients with advanced solid tumors that have spread to other parts of the body. This phase II trial aims to understand how durvalumab, an immunotherapy drug, works with different chemotherapy treatments and how genetic and immune factors affect the response. The study also explores changes in tumor DNA and immune environment as they relate to treatment outcomes. Participants are assigned to one of seven treatment groups receiving durvalumab alone or with various chemotherapy drugs including gemcitabine, pegylated liposomal doxorubicin, capecitabine, carboplatin, paclitaxel, or nab-paclitaxel. Treatments are given intravenously or orally on specific schedules repeating every 21 or 28 days, depending on the group. Imaging scans, biopsies, and blood samples are collected before and during treatment to monitor effects and tumor response. During the trial, participants undergo regular CT scans and, for some, echocardiography at screening. Tumor biopsies and blood sample collections are done at screening and throughout the study to assess immune and genetic changes. After completing the treatment cycles, patients are followed monthly for three months to track safety and outcomes. The main measure is the occurrence of side effects during the early treatment cycles, with ongoing monitoring for disease progression or toxicity.
CONDITIONS
Brief Title
Durvalumab in Combination With Chemotherapy in Treating Patients With Advanced Solid Tumors, DURVA+ Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years or older with metastatic or locally advanced solid tumors not suitable for surgery and progressed after at least one standard therapy or no standard treatment exists
- Tumor must be suitable for biopsy and patient willing to undergo biopsy
- Measurable disease with at least one lesion that can be accurately measured
- Patients with bone metastases or hypercalcemia on certain treatments are eligible
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Adequate blood counts and liver function within specified limits
- Completed prior systemic therapy or major surgery at least 3 weeks before enrollment, with recovery from toxicity
- Body weight over 30 kg
- HIV-positive patients may participate if stable on antiretroviral therapy with undetectable viral loads and adequate CD4 counts
- Agreement to use effective contraception during and for 6 months after study participation
- Willingness to avoid breastfeeding during and 6 months after treatment
- Willingness not to donate blood during study and for 90 days after last dose
- Left ventricular ejection fraction greater than 50% for patients enrolling on Arm 3
- Ability to understand and sign informed consent
You will not qualify if you...
- Prior checkpoint inhibitor therapy causing serious adverse events
- Certain cancer types not eligible for durvalumab alone but may receive combination therapy
- Pregnant or breastfeeding women
- Receiving other investigational agents or trials with ongoing study treatment
- Active or prior autoimmune or inflammatory disorders with some exceptions
- History of certain lung diseases or active pneumonitis or tuberculosis
- Use of immunosuppressive medications within 14 days before durvalumab except certain steroids
- Vaccination with live vaccines within 30 days before or after durvalumab treatment
- History of seizures unless stable and on medication
- Use of warfarin in certain study arms
- Uncontrolled illnesses such as severe infections, heart failure, or liver disease
- History of severe infusion reactions to monoclonal antibodies with some exceptions
- History of primary immunodeficiency
- History of allogeneic organ transplant
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21- or 28-day cycles until disease progression or unacceptable toxicity
Participants receive durvalumab combined with chemotherapy according to their assigned arm. Treatment cycles repeat every 21 or 28 days depending on the chemotherapy regimen, continuing until disease progression or unacceptable toxicity occurs. Participants undergo CT scans throughout the treatment period and provide tissue biopsy and blood samples during treatment.
Multiple visits per cycle with infusions on specified days, including imaging and sample collections throughout treatment
Duration - 3 months
After completing study treatment, participants are followed monthly for safety and health status monitoring.
Monthly visits for 3 months
Trial Site Locations
Total: 1 location
1
National Cancer Institute Developmental Therapeutics Clinic
Bethesda, Maryland, United States, 20892
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
7
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