Durvalumab and Tremelimumab in Combination With First-Line Chemotherapy in Advanced Solid Tumors
NCT ID: NCT02658214
Last Updated: 2020-08-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
32 participants
INTERVENTIONAL
2016-04-28
2019-11-14
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1
ovarian/peritoneal/fallopian tube cancer and squamous cell carcinoma of the head and neck (SCCHN)
paclitaxel + carboplatin
IV infusion
durvalumab
IV infusion
tremelimumab
IV infusion
Cohort 2
Small-cell lung cancer (SCLC)
carboplatin + etoposide
IV infusion
durvalumab
IV infusion
tremelimumab
IV infusion
Cohort 3
Triple-negative breast cancer (TNBC)
gemcitabine + carboplatin
IV infusion
durvalumab
IV infusion
tremelimumab
IV infusion
Cohort 4
Triple-negative breast cancer (TNBC)
nab-paclitaxel (paclitaxel-albumin) + carboplatin
IV infusion
durvalumab
IV infusion
tremelimumab
IV infusion
Cohort 5
Gastric/gastro-esophageal junction (GEJ)
oxaliplatin + 5-fluorouracil (5FU) + leucovorin (calcium folinate/folinic acid)
IV infusion and bolus administration
durvalumab
IV infusion
tremelimumab
IV infusion
Cohort 6
Pancreatic ductal adenocarcinoma (PDAC)
durvalumab
IV infusion
tremelimumab
IV infusion
nab-paclitaxel (paclitaxel-albumin) + gemcitabine
IV infusion
Cohort 7
Esophageal squamous cell carcinoma (ESCC)
durvalumab
IV infusion
tremelimumab
IV infusion
cisplatin + 5-fluorouracil (5FU)
IV infusion
Interventions
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paclitaxel + carboplatin
IV infusion
carboplatin + etoposide
IV infusion
gemcitabine + carboplatin
IV infusion
nab-paclitaxel (paclitaxel-albumin) + carboplatin
IV infusion
oxaliplatin + 5-fluorouracil (5FU) + leucovorin (calcium folinate/folinic acid)
IV infusion and bolus administration
durvalumab
IV infusion
tremelimumab
IV infusion
nab-paclitaxel (paclitaxel-albumin) + gemcitabine
IV infusion
cisplatin + 5-fluorouracil (5FU)
IV infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
99 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Chūōku, , Japan
Research Site
Kashiwa, , Japan
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Countries
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References
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Lee DH, Kim HR, Keam B, Kato K, Kuboki Y, Gao H, Yovine A, Robbins SH, Ahn MJ. Safety and tolerability of first-line durvalumab with tremelimumab and chemotherapy in esophageal squamous cell carcinoma. Cancer Med. 2023 Aug;12(15):16066-16075. doi: 10.1002/cam4.6260. Epub 2023 Jul 25.
Related Links
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Results of this clinical trial are available on www.astrazenecaclinicaltrials.com
Other Identifiers
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D419SC00001
Identifier Type: -
Identifier Source: org_study_id
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