Clinical trial NCT02658214: Durvalumab and Tremelimumab in Combination With First-Line Chemotherapy in Advanced Solid Tumors
Official title: A Phase Ib Study to Evaluate the Safety and Tolerability of Durvalumab and Tremelimumab in Combination With First-Line Chemotherapy in Patients With Advanced Solid Tumors.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Small Cell Lung Carcinoma
Carcinoma, Squamous Cell of Head and Neck
Stomach Neoplasms
Triple Negative Breast Neoplasms
Ovarian Neoplasms
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Esophagogastric Junction Neoplasms
Carcinoma, Pancreatic Ductal
Esophageal Squamous Cell Carcinoma
Keywords: durvalumab, tremelimumab, metastatic, solid tumors, immuno-oncology, first-line chemotherapy, esophageal, pancreatic
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2016-01-18
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 7 cohorts of first-line chemotherapy regimens combined with durvalumab + tremelimumab.

This study will evaluate the safety and tolerability of durvalumab (MEDI4736) + tremelimumab in combination with first line chemotherapy regimens in patients with locally advanced or metastatic solid tumors: ovarian/peritoneal/fallopian tube cancer, squamous cell carcinoma of the head and neck (SCCHN), triple negative breast cancer (TNBC), small cell lung carcinoma (SCLC), and gastric/gastro-esophageal junction (GEJ) cancer, pancreatic ductal adenocarcinoma (PDAC) and esophageal squamous cell carcinoma (ESCC).

Eligibility criteria: Inclusion Criteria:

1. ≥18 years
2. Written informed consent
3. 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.
4. ECOG performance status of 0 or 1
5. Patients must be considered suitable candidates for, and able to receive, first line chemotherapy for metastatic disease
6. At least 1 lesion, not previously irradiated, that can be accurately measured at baseline
7. No prior exposure to immune-mediated therapy
8. Adequate organ and marrow function as defined below

Exclusion Criteria:

1. Receipt of any investigational anticancer therapy within 28 days or 5 halflives, whichever is longer, prior to the first dose of study treatment
2. 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
3. Any unresolved Grade ≥2 toxicity from previous anticancer therapy
4. Active or prior documented autoimmune or inflammatory disorders
5. 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
6. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms 20. Active tuberculosis
7. Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)

Primary outcomes:
measure: Laboratory findings (including: clinical chemistry, hematology, and urinalysis)
timeFrame: Throughout the study, approximately three years
measure: Incidence of Adverse Events
timeFrame: Throughout the study, approximately three years
measure: Tumor assessment based on RECIST 1.1 (for cohort 6 only)
timeFrame: Throughout the study, approximately three years (for cohort 6 only)
Secondary outcomes:
Other outcomes:
Locations:
city: Chuo-ku
country: Japan
facility: Research Site
city: Kashiwa
country: Japan
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
Study officials:
References: