Durvalumab in Combination With Chemotherapy in Treating Patients With Advanced Solid Tumors, (DURVA+ Study)

Summary

Participation Requirements

Description

PRIMARY OBJECTIVE: I. To determine the safety of adding MEDI4736 (durvalumab) to standard chemotherapy regimens. SECONDARY OBJECTIVES: I. Determine the changes that occur in the immune microenvironment in response to chemotherapy and assess how these changes alter the pharmacodynamic effects of a ch...

PRIMARY OBJECTIVE: I. To determine the safety of adding MEDI4736 (durvalumab) to standard chemotherapy regimens. SECONDARY OBJECTIVES: I. Determine the changes that occur in the immune microenvironment in response to chemotherapy and assess how these changes alter the pharmacodynamic effects of a checkpoint inhibitor. II. Investigate whether the response to immunotherapy correlates with patients' genetic aberrations and/or the activation status of tumor-infiltrating and circulating T cells. III. Explore the relationship between immune status of the tumor and overall tumor mutational load. IV. Assess preliminary antitumor activity of the MEDI4736 (durvalumab) and chemotherapy combinations. OUTLINE: Patients are assigned to 1 of 7 arms. ARM I: Patients receive durvalumab intravenously (IV) over 60 minutes on days 1 and 15 of cycles 1 and 2 and day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and durvalumab IV over 60 minutes on days 8 and 22 of cycles 1 and 2 and day 8 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. ARM III: Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 and durvalumab IV over 60 minutes on days 8 and 22 of cycles 1 and 2 and day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. ARM IV: Patients receive capecitabine orally (PO) twice daily (BID) on days 1-14, and durvalumab IV over 60 minutes on days 8 of cycle 1, day 8 and 15 of cycle 2, day 8 of cycles 3, and day 1 of subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM V: Patients receive carboplatin IV over 30-60 minutes on day 1 and durvalumab IV over 60 minutes on day 8 of cycle 1, days 8 and 15 of cycle 2, day 8 of cycles 3, and day 1 of subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM VI: Patients receive paclitaxel IV over 60 minutes on day 1 and durvalumab IV over 60 minutes on day 8 of cycle 1, days 8 and 15 of cycle 2, day 8 of cycles 3, and day 1 of subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM VII: Patients receive nab-paclitaxel IV over 30 minutes on day 1 and durvalumab IV over 60 minutes on day 8 of cycle 1, days 8 and 15 of cycle 2, day 8 of cycles 3, and day 1 of subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up monthly for 3 months.

Tracking Information