Clinical Trials /

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

NCT02658214

Description:

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.

Related Conditions:
  • Adenocarcinoma of the Gastroesophageal Junction
  • Breast Carcinoma
  • Fallopian Tube Carcinoma
  • Gastric Carcinoma
  • Head and Neck Squamous Cell Carcinoma
  • Ovarian Carcinoma
  • Primary Peritoneal Carcinoma
  • Small Cell Lung Carcinoma
Recruiting Status:

Completed

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: 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.

Clinical Trial IDs

  • ORG STUDY ID: D419SC00001
  • NCT ID: NCT02658214

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

Interventions

DrugSynonymsArms
paclitaxel + carboplatinPlatinum based Standard of Care ChemotherapyCohort 1
carboplatin + etoposidePlatinum based Standard of Care ChemotherapyCohort 2
gemcitabine + carboplatinPlatinum based Standard of Care ChemotherapyCohort 3
nab-paclitaxel (paclitaxel-albumin) + carboplatinPlatinum based Standard of Care ChemotherapyCohort 4
oxaliplatin + 5-fluorouracil (5FU) + leucovorin (calcium folinate/folinic acid)Platinum based Standard of Care ChemotherapyCohort 5
durvalumabMEDI4736Cohort 1
tremelimumabCohort 1
nab-paclitaxel (paclitaxel-albumin) + gemcitabineStandard of Care ChemotherapyCohort 6
cisplatin + 5-fluorouracil (5FU)Platinum based Standard of Care ChemotherapyCohort 7

Purpose

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).
    

Trial Arms

NameTypeDescriptionInterventions
Cohort 1Experimentalovarian/peritoneal/fallopian tube cancer and squamous cell carcinoma of the head and neck (SCCHN)
  • paclitaxel + carboplatin
  • durvalumab
  • tremelimumab
Cohort 2ExperimentalSmall-cell lung cancer (SCLC)
  • carboplatin + etoposide
  • durvalumab
  • tremelimumab
Cohort 3ExperimentalTriple-negative breast cancer (TNBC)
  • gemcitabine + carboplatin
  • durvalumab
  • tremelimumab
Cohort 4ExperimentalTriple-negative breast cancer (TNBC)
  • nab-paclitaxel (paclitaxel-albumin) + carboplatin
  • durvalumab
  • tremelimumab
Cohort 5ExperimentalGastric/gastro-esophageal junction (GEJ)
  • oxaliplatin + 5-fluorouracil (5FU) + leucovorin (calcium folinate/folinic acid)
  • durvalumab
  • tremelimumab
Cohort 6ExperimentalPancreatic ductal adenocarcinoma (PDAC)
  • durvalumab
  • tremelimumab
  • nab-paclitaxel (paclitaxel-albumin) + gemcitabine
Cohort 7ExperimentalEsophageal squamous cell carcinoma (ESCC)
  • durvalumab
  • tremelimumab
  • cisplatin + 5-fluorouracil (5FU)

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)
      
Maximum Eligible Age:99 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Laboratory findings (including: clinical chemistry, hematology, and urinalysis)
Time Frame:Throughout the study, approximately three years
Safety Issue:
Description:To assess the safety and tolerability profile of first-line chemotherapy in combination with durvalumab + tremelimumab

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:AstraZeneca

Trial Keywords

  • durvalumab, tremelimumab, metastatic, solid tumors, immuno-oncology, first-line chemotherapy, esophageal, pancreatic

Last Updated

August 20, 2020