Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT03907475

Durvalumab in Combination With Chemotherapy in Treating Patients With Advanced Solid Tumors, DURVA+ Trial

Led by National Cancer Institute (NCI) · Updated on 2026-05-13

115

Participants Needed

1

Research Sites

358 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This phase II trial studies the side effects of durvalumab when given together with chemotherapy in treating patients with solid tumors that have spread to other places in the body (advanced). Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as gemcitabine hydrochloride, pegylated liposomal doxorubicin hydrochloride, capecitabine, carboplatin, paclitaxel, and nab-paclitaxel work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with durvalumab may improve how immune cells respond and attack tumor cells.

CONDITIONS

Official Title

Durvalumab in Combination With Chemotherapy in Treating Patients With Advanced Solid Tumors, DURVA+ Trial

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients must have metastatic or locally advanced solid tumors not suitable for surgery and progressed after at least one standard treatment or have no standard treatments.
  • Tumor must be suitable for biopsy and patient willing to undergo biopsy.
  • Patients must have measurable disease with at least one lesion measurable by standard imaging.
  • Patients with bone metastases or receiving certain bone treatments are eligible.
  • Age 18 years or older.
  • ECOG performance status of 0, 1, or 2.
  • Absolute neutrophil count of at least 1,000/uL.
  • Platelet count of at least 100,000/uL.
  • Total bilirubin less than 1.5 times the upper limit of normal (exceptions for Gilbert syndrome).
  • AST/ALT less than 3 times upper limit or up to 5 times if liver metastases present.
  • Creatinine clearance above 40 mL/min.
  • Completed prior systemic therapy or surgery at least 3 weeks prior, with recovery from toxicity.
  • Radiation therapy or radiofrequency ablation completed at least 1 week before treatment.
  • No recent immunostimulatory agent use within 3 weeks.
  • Body weight over 30 kg.
  • HIV-positive patients meeting specific viral load and CD4 count criteria and not on prophylactic therapy.
  • Agreement to use effective contraception during and for 6 months after study.
  • Agreement to stop breastfeeding during and for 6 months after study.
  • Willingness not to donate blood during study and for 90 days after.
  • Left ventricular ejection fraction above 50% (for Arm 3).
  • Ability and willingness to provide informed consent.
Not Eligible

You will not qualify if you...

  • Patients who had serious adverse events from prior checkpoint inhibitor therapy are excluded.
  • Patients with pancreatic, prostate, or certain colorectal cancers may not receive durvalumab alone.
  • Pregnant or breastfeeding women.
  • Receiving other investigational agents currently.
  • History of autoimmune or inflammatory disorders, with some exceptions.
  • History or evidence of active lung inflammation or tuberculosis.
  • Use of immunosuppressive medications within 14 days before starting treatment, with specified exceptions.
  • Vaccinated with live vaccines within 30 days before or after durvalumab treatment.
  • History of seizures unless stable and controlled.
  • Use of warfarin is exclusionary for Arm 4.
  • Uncontrolled illnesses that could affect study compliance or safety.
  • History of severe infusion or allergic reactions to monoclonal antibodies.
  • History of primary immunodeficiency or organ transplant.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

National Cancer Institute Developmental Therapeutics Clinic

Bethesda, Maryland, United States, 20892

Actively Recruiting

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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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