Durvalumab and Tremelimumab in Treating Participants With Recurrent or Refractory Ovarian, Primar… (NCT03026062) | Clinical Trial Compass
CompletedPhase 2
Durvalumab and Tremelimumab in Treating Participants With Recurrent or Refractory Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
United States100 participantsStarted 2017-05-18
Plain-language summary
This phase II trial studies how well durvalumab and tremelimumab work in treating participants with ovarian, primary peritoneal, or fallopian tube cancer that has come back or does not respond to treatment. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether give durvalumab and tremelimumab in combination or sequential administration works better in treating participants with ovarian, primary peritoneal, or fallopian tube cancer.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Written informed consent and any locally-required authorization (e.g., HIPAA in the USA, EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
✓. Age \>/= 18 years at time of study entry.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
✓. Adequate normal organ and marrow function as defined by: Hemoglobin \>/= 9.0 g/dL (transfusion is allowed to correct anemia); Absolute neutrophil count (ANC) \>/= 1.5 x 10\^9/L (\> 1500 per mm\^3); Platelet count \>/= 100 x 10\^9/L (\>100,000 per mm\^3); Serum bilirubin \</= 1.5 x institutional upper limit of normal (ULN) unless diagnosed with Gilbert's syndrome; AST and ALT \</= 2.5 x ULN unless liver metastases are present, in which case it must be \</= 5x ULN; Serum creatinine CL \>40 mL/min by the Cockcroft-Gault formula ( Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance: Creatinine CL (mL/min) = \[Weight (kg) x (140 - Age) x 0.85\]/\[72 x serum creatinine (mg/dL)\].
✓. Subjects must either be of non-reproductive potential (i.e., post-menopausal by history: \>/= 60 years old and no menses for \>/= 1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry.
✓. Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including biopsies and follow up.
✓. Histology (reviewed at MDACC) showing recurrent high grade epithelial ovarian, peritoneal, or fallopian tube cancer of clear cell histology or mixed carcinoma with a clear cell component. In addition, subjects for the molecularly defined expansion cohort will also include patients with recurrent uterine serous carcinoma (who have received at least one prior line of platinum-based chemotherapy), and must have somatic mutations testing (performed by MD Anderson or a CLIA certified test offered by a commercial vendor such as Foundation One or Caris) that demonstrates a nonsynonymous PPP2R1A mutation (other protein phosphatase 2A or related pathway mutations/alterations may be eligible if approved by the PI). Synonymous mutations and variants of uncertain significance do not qualify.
✓. Platinum resistant or refractory disease as defined by progression of disease on a platinum-containing regimen or recurrence of disease within 180 days of previous platinum treatment (not applicable to the uterine serous carcinoma molecularly defined expansion cohort, however, subjects with uterine serous must have received at least one prior line of platinum-based therapy).
Exclusion criteria
✕. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
✕. Previous enrollment or randomization in the present study.
✕. Participation in another clinical study with an investigational product administered during the last 28 days.
✕. Any previous treatment with adoptive T cells therapy, a PD1 or PDL1 inhibitor, including Durvalumab or any anti-CTLA4 therapy, including Tremelimumab.
✕. History of another primary malignancy except for: malignancy treated with curative intent and with no known active disease \>/= 5 years before the first dose of study drug and of low potential risk for recurrence; adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; or adequately treated carcinoma in situ without evidence of disease, e.g., cervical cancer in situ.
✕. Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) \</= 28 days prior to the first dose of study drug (\</= 21 days prior to the first dose of study drug for subjects who have received prior TKIs \[e.g., erlotinib, gefitinib and crizotinib\] and \</= 6 weeks for nitrosourea, mitomycin C, or bevacizumab). (If sufficient wash-out time has not occurred due to the schedule or PK properties of an agent, a longer wash-out period may be required.)
✕. Mean QT interval corrected for heart rate (QTc) \>/= 470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia's Correction.
✕. Current or prior use of immunosuppressive medication within 28 days before the first dose of Durvalumab OR Tremelimumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid. Steroid premedication for the prevention of radiologic contrast hypersensitivity is allowed.