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OncoMatch/Clinical Trials/NCT03907475

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

Is NCT03907475 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for locally advanced malignant solid neoplasm.

Phase 2RecruitingNational Cancer Institute (NCI)NCT03907475Data as of May 2026

Treatment: Capecitabine · Carboplatin · Durvalumab · Gemcitabine Hydrochloride · Nab-paclitaxel · Paclitaxel · Pegylated Liposomal Doxorubicin HydrochlorideThis 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.

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Extracted eligibility criteria

Cancer type

Tumor Agnostic

Disease stage

Required: Stage III, IV

metastatic or locally advanced (not amenable to surgery) solid tumors

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Cannot have received: checkpoint inhibitor

Exception: patients who had prior ctla-4 inhibitor treatment and did not experience serious adverse events are eligible for all arms. patients who had prior pd-l1/pd-1 inhibitor treatment and did not experience serious adverse events are excluded from the durvalumab monotherapy arm but are eligible for the chemotherapy combinations.

Lab requirements

Blood counts

Absolute neutrophil count >= 1,000/uL; Platelets >= 100,000/uL

Kidney function

Calculated creatinine clearance > 40 mL/min by Cockcroft-Gault formula

Liver function

Total bilirubin < 1.5 x institutional upper limit of normal (Gilbert syndrome exception at PI discretion); AST/ALT <= 3 x ULN, or up to 5 x ULN if liver metastases are present

Cardiac function

Left ventricular ejection fraction greater than 50% or institutional lower limit of normal by echocardiography (ECHO) at entry (patients enrolling on Arm 3 only)

Absolute neutrophil count >= 1,000/uL (mcL). Platelets >= 100,000/uL (mcL). Total bilirubin < 1.5 x institutional upper limit of normal. AST/ALT <= 3 x ULN, or up to 5 x ULN if liver metastases are present. Calculated creatinine clearance > 40 mL/min by Cockcroft-Gault formula. Left ventricular ejection fraction greater than 50% or institutional lower limit of normal by echocardiography (ECHO) at entry (patients enrolling on Arm 3 only).

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • National Cancer Institute Developmental Therapeutics Clinic · Bethesda, Maryland

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