Durvalumab and Tremelimumab in Combination With First-Line Chemotherapy in Advanced Solid Tumors (NCT02658214) | Clinical Trial Compass
CompletedPhase 1
Durvalumab and Tremelimumab in Combination With First-Line Chemotherapy in Advanced Solid Tumors
Japan, South Korea32 participantsStarted 2016-04-28
Plain-language summary
Durvalumab and Tremelimumab in combination with first-line chemotherapy in the following indications: Ovarian/peritoneal/fallopian tube cancer, SCCHN, TNBC, SCLC and gastric/GEJ cancer, PDAC, ESCC.
Who can participate
Age range18 Years – 99 Years
SexALL
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Inclusion criteria
✓. ≥18 years
✓. Written informed consent
✓. Patients with histologically or cytologically documented chemotherapy-naïve locally advanced unresectable or metastatic ovarian/peritoneal/fallopian tube cancer, SCCHN, TNBC, SCLC, gastric cancer/GEJ, PDAC and ESCC.
✓. ECOG performance status of 0 or 1
✓. Patients must be considered suitable candidates for, and able to receive, first line chemotherapy for metastatic disease
✓. At least 1 lesion, not previously irradiated, that can be accurately measured at baseline
✓. No prior exposure to immune-mediated therapy
✓. Adequate organ and marrow function as defined below
Exclusion criteria
✕. Receipt of any investigational anticancer therapy within 28 days or 5 halflives, whichever is longer, prior to the first dose of study treatment
✕. Brain metastases or spinal cord compression unless asymptomatic or treated and stable off steroids and anti-convulsants for at least 1 month prior to study treatment
✕. Any unresolved Grade ≥2 toxicity from previous anticancer therapy
✕. Active or prior documented autoimmune or inflammatory disorders
What they're measuring
1
Laboratory findings (including: clinical chemistry, hematology, and urinalysis)
Timeframe: Throughout the study, approximately three years
2
Incidence of Adverse Events
Timeframe: Throughout the study, approximately three years
3
Tumor assessment based on RECIST 1.1 (for cohort 6 only)
Timeframe: Throughout the study, approximately three years (for cohort 6 only)
. Uncontrolled intercurrent illness, including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs from study drugs, or compromise the ability of the patient to give written informed consent
✕. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms 20. Active tuberculosis
✕. Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)