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:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

<span class="go-doc-concept go-doc-intervention">Durvalumab</span> and <span class="go-doc-concept go-doc-intervention">Tremelimumab</span> in Combination With First-Line <span class="go-doc-concept go-doc-intervention">Chemotherapy</span> in Advanced Solid Tumors

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

    NCT ID: NCT02658214

    ORG ID: D419SC00001

    Trial 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

    Trial Interventions

    Drug Synonyms Arms
    paclitaxel + carboplatin Cohort 1
    carboplatin + etoposide Cohort 2
    gemcitabine + carboplatin Cohort 3
    nab-paclitaxel (paclitaxel-albumin) + carboplatin Cohort 4
    oxaliplatin + 5-fluorouracil (5FU) + leucovorin (calcium folinate/folinic acid) Cohort 5

    Trial 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.

    Detailed Description

    The study will screen approximately 100 patients in order to have a total of approximately
    80 evaluable patients in 5 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.

    Trial Arms

    Name Type Description Interventions
    Cohort 1 Experimental ovarian/peritoneal/fallopian tube cancer and squamous cell carcinoma of the head and neck (SCCHN) paclitaxel + carboplatin
    Cohort 2 Experimental Small-cell lung cancer (SCLC) carboplatin + etoposide
    Cohort 3 Experimental Triple-negative breast cancer (TNBC) gemcitabine + carboplatin
    Cohort 4 Experimental Triple-negative breast cancer (TNBC) nab-paclitaxel (paclitaxel-albumin) + carboplatin
    Cohort 5 Experimental Gastric/gastro-esophageal junction (GEJ) oxaliplatin + 5-fluorouracil (5FU) + leucovorin (calcium folinate/folinic acid)

    Eligibility Criteria

    Inclusion Criteria:

    1. Age 18 years at the time of screening

    2. Written informed consent and any locally required authorization 3. Patients with
    histologically or cytologically documented chemotherapy-naive locally advanced or
    metastatic ovarian/peritoneal/fallopian tube cancer, SCCHN, TNBC, SCLC, and gastric
    cancer/GEJ

    3. ECOG performance status of 0 or 1

    4. At least 1 lesion, not previously irradiated, that can be accurately measured at
    baseline

    5. No prior exposure to immune-mediated therapy

    6. Adequate organ and marrow function

    Exclusion Criteria:

    1. Receipt of any investigational anticancer therapy within 28 days or 5 half-lives,
    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 hepatitis B, hepatitis C, or human immunodeficiency virus
    (HIV)

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: 99 Years

    Eligible Gender: Both

    Primary Outcome Measures

    Laboratory findings (including: clinical chemistry, hematology, and urinalysis)

    Incidence of Adverse Events

    Secondary Outcome Measures

    Trial Keywords

    durvalumab, MEDI4736, tremelimumab, small-cell lung, head and neck, triple negative breast, gastric/GEJ or ovarian cancer, immuno oncology, first-line chemo