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NCT Number: NCT02658214

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

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.

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Key information

Conditions

Small Cell Lung Carcinoma Abdominal Neoplasms Adenocarcinoma Adnexal Diseases Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Ductal Carcinoma, Pancreatic Ductal Carcinoma, Squamous Cell Carcinoma, Squamous Cell of Head and Neck Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Diseases Esophageal Neoplasms Esophageal Squamous Cell Carcinoma Esophagogastric Junction Neoplasms Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Head and Neck Neoplasms Lung Diseases Lung Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Neoplastic Processes Ovarian Diseases Ovarian Neoplasms Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Peritoneal Diseases Peritoneal Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Squamous Cell Carcinoma of Head and Neck Stomach Diseases Stomach Neoplasms Thoracic Neoplasms Triple Negative Breast Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Chūōku, Japan

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Paclitaxel + Carboplatin

Drug

IV infusion

Other names: Platinum based Standard of Care Chemotherapy

Carboplatin + Etoposide

Drug

IV infusion

Other names: Platinum based Standard of Care Chemotherapy

Gemcitabine + carboplatin

Drug

IV infusion

Other names: Platinum based Standard of Care Chemotherapy

nab-paclitaxel (paclitaxel-albumin) + carboplatin

Drug

IV infusion

Other names: Platinum based Standard of Care Chemotherapy

oxaliplatin + 5-fluorouracil (5FU) + leucovorin (calcium folinate/folinic acid)

Drug

IV infusion and bolus administration

Other names: Platinum based Standard of Care Chemotherapy

Durvalumab

Biological

IV infusion

Other names: MEDI4736

Tremelimumab

Biological

IV infusion

nab-paclitaxel (paclitaxel-albumin) + gemcitabine

Drug

IV infusion

Other names: Standard of Care Chemotherapy

cisplatin + 5-fluorouracil (5FU)

Drug

IV infusion

Other names: Platinum based Standard of Care Chemotherapy

Primary outcomes

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

    Time frame: Throughout the study, approximately three years

    To assess the safety and tolerability profile of first-line chemotherapy in combination with durvalumab + tremelimumab

  2. Incidence of Adverse Events

    Time frame: Throughout the study, approximately three years

    To assess incidence of Adverse Events for the safety and tolerability profile of first-line chemotherapy in combination with durvalumab and tremelimumab

  3. Tumor assessment based on RECIST 1.1 (for cohort 6 only)

    Time frame: Throughout the study, approximately three years (for cohort 6 only)

    To estimate the objective response rate (ORR) of durvalumab + tremelimumab + chemotherapy (for cohort 6 only)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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.

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jan 18, 2016
Registry last updated
Aug 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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