Durvalumab and Tremelimumab in Combination With First-Line Chemotherapy in Advanced Solid Tumors

Sponsor
AstraZeneca
Study ID
NCT02658214
Phase
PHASE1
Status
Completed

Conditions

  • Carcinoma, Pancreatic Ductal
  • Carcinoma, Squamous Cell of Head and Neck
  • Esophageal Squamous Cell Carcinoma
  • Esophagogastric Junction Neoplasms
  • Fallopian Tube Neoplasms
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Small Cell Lung Carcinoma
  • Stomach Neoplasms
  • Triple Negative Breast Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • paclitaxel + carboplatin — DRUG
    IV infusion
  • carboplatin + etoposide — DRUG
    IV infusion
  • gemcitabine + carboplatin — DRUG
    IV infusion
  • nab-paclitaxel (paclitaxel-albumin) + carboplatin — DRUG
    IV infusion
  • oxaliplatin + 5-fluorouracil (5FU) + leucovorin (calcium folinate/folinic acid) — DRUG
    IV infusion and bolus administration
  • durvalumab — BIOLOGICAL
    IV infusion
  • tremelimumab — BIOLOGICAL
    IV infusion
  • nab-paclitaxel (paclitaxel-albumin) + gemcitabine — DRUG
    IV infusion
  • cisplatin + 5-fluorouracil (5FU) — DRUG
    IV infusion

Study Details

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.

Key Dates

Start date
Apr 28, 2016
Status verified
Aug 2020
Primary completion
Nov 14, 2019
Completion
Nov 14, 2019

Study Design

Enrollment
32 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    ovarian/peritoneal/fallopian tube cancer and squamous cell carcinoma of the head and neck (SCCHN)
  • Experimental: Cohort 2
    Small-cell lung cancer (SCLC)
  • Experimental: Cohort 3
    Triple-negative breast cancer (TNBC)
  • Experimental: Cohort 4
    Triple-negative breast cancer (TNBC)
  • Experimental: Cohort 5
    Gastric/gastro-esophageal junction (GEJ)
  • Experimental: Cohort 6
    Pancreatic ductal adenocarcinoma (PDAC)
  • Experimental: Cohort 7
    Esophageal squamous cell carcinoma (ESCC)

Primary Outcome Measure

Laboratory findings (including: clinical chemistry, hematology, and urinalysis) [ Time Frame: Throughout the study, approximately three years ]

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