Stage IV Ovarian Cancer AJCC v6 and v7 Clinical Trial
Official title:
Matched Paired Pharmacodynamics and Feasibility Study of Durvalumab in Combination With Chemotherapy in Frontline Ovarian Cancer (N-Dur)
This phase I/II trial studies how well durvalumab works when given in combination with carboplatin and paclitaxel in treating patients with stage III-IV ovarian, primary peritoneal, or fallopian tube cancer. 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. Drugs used in chemotherapy, such as carboplatin and 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 durvalumab in combination with carboplatin and paclitaxel may be a better treatment for ovarian, primary peritoneal, or fallopian tube cancer.
PRIMARY OBJECTIVES: I. To explore basal levels and effects of durvalumab in combination with chemotherapy on molecular markers in immune-related pathways, including but not limited to, deoxyribonucleic acid (DNA) copy number, mutation, and level of ribonucleic acid (RNA) and protein expression, before and after durvalumab and chemotherapy treatment in women with primary advanced high grade serous ovarian, fallopian tube, or primary peritoneal cancer. SECONDARY OBJECTIVES: I. To evaluate progression-free survival of paclitaxel and carboplatin and durvalumab in patients with advanced stage, metastatic ovarian cancer undergoing neoadjuvant chemotherapy. II. To describe the feasibility of combination therapy and maintenance durvalumab in this population. III. To evaluate the safety, tolerability and pharmacokinetics (PK) of combination and maintenance durvalumab. IV. To report overall survival. EXPLORATORY OBJECTIVES: I. To evaluate circulating lymphoid populations (subsets). II. To determine tissue programmed death-ligand 1 (PD-L1) expression and T-cell infiltration. III. To measure circulating immune-related cytokines/chemokines. IV. To capture patient reported outcomes (symptoms, quality of life, and patient utilities). OUTLINE: NEOADJUVANT CHEMOTHERAPY: Before debulking surgery, patients receive durvalumab and carboplatin intravenously (IV) over 1 hour on day 1, and paclitaxel IV over 3 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo debulking surgery. SURGERY: After 3 courses of chemotherapy, patients undergo debulking laparoscopic surgery. ADJUVANT THERAPY: Beginning after debulking surgery, patients receive carboplatin IV over 1 hour on day 1, paclitaxel IV over 3 hours on days 1, 8, and 15, and durvalumab IV over 1 hour on day 1. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive durvalumab IV over 1 hour on day 1 and 15. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days, 2, 3, 4, 6, 8, 9, 10, and 12 months, and then every 6 months thereafter. ;
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|---|---|---|---|
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