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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02658214
Recruitment Status : Completed
First Posted : January 18, 2016
Last Update Posted : August 20, 2020
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE January 11, 2016
First Posted Date  ICMJE January 18, 2016
Last Update Posted Date August 20, 2020
Actual Study Start Date  ICMJE April 28, 2016
Actual Primary Completion Date November 14, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 13, 2017)
  • 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
  • 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
  • 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)
Original Primary Outcome Measures  ICMJE
 (submitted: January 14, 2016)
  • Laboratory findings (including: clinical chemistry, hematology, and urinalysis) [ Time Frame: Throughout the study, approximately two years ]
    To assess the safety and tolerability profile of first-line chemotherapy in combination with durvalumab + tremelimumab
  • Incidence of Adverse Events [ Time Frame: Throughout the study, approximately two years ]
    To assess incidence of Adverse Events for the safety and tolerability profile of first-line chemotherapy in combination with durvalumab and tremelimumab
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Durvalumab and Tremelimumab in Combination With First-Line Chemotherapy in Advanced Solid Tumors
Official Title  ICMJE 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.
Brief Summary 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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • 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
Intervention  ICMJE
  • Drug: paclitaxel + carboplatin
    IV infusion
    Other Name: Platinum based Standard of Care Chemotherapy
  • Drug: carboplatin + etoposide
    IV infusion
    Other Name: Platinum based Standard of Care Chemotherapy
  • Drug: gemcitabine + carboplatin
    IV infusion
    Other Name: Platinum based Standard of Care Chemotherapy
  • Drug: nab-paclitaxel (paclitaxel-albumin) + carboplatin
    IV infusion
    Other Name: Platinum based Standard of Care Chemotherapy
  • Drug: oxaliplatin + 5-fluorouracil (5FU) + leucovorin (calcium folinate/folinic acid)
    IV infusion and bolus administration
    Other Name: Platinum based Standard of Care Chemotherapy
  • Biological: durvalumab
    IV infusion
    Other Name: MEDI4736
  • Biological: tremelimumab
    IV infusion
  • Drug: nab-paclitaxel (paclitaxel-albumin) + gemcitabine
    IV infusion
    Other Name: Standard of Care Chemotherapy
  • Drug: cisplatin + 5-fluorouracil (5FU)
    IV infusion
    Other Name: Platinum based Standard of Care Chemotherapy
Study Arms  ICMJE
  • Experimental: Cohort 1
    ovarian/peritoneal/fallopian tube cancer and squamous cell carcinoma of the head and neck (SCCHN)
    Interventions:
    • Drug: paclitaxel + carboplatin
    • Biological: durvalumab
    • Biological: tremelimumab
  • Experimental: Cohort 2
    Small-cell lung cancer (SCLC)
    Interventions:
    • Drug: carboplatin + etoposide
    • Biological: durvalumab
    • Biological: tremelimumab
  • Experimental: Cohort 3
    Triple-negative breast cancer (TNBC)
    Interventions:
    • Drug: gemcitabine + carboplatin
    • Biological: durvalumab
    • Biological: tremelimumab
  • Experimental: Cohort 4
    Triple-negative breast cancer (TNBC)
    Interventions:
    • Drug: nab-paclitaxel (paclitaxel-albumin) + carboplatin
    • Biological: durvalumab
    • Biological: tremelimumab
  • Experimental: Cohort 5
    Gastric/gastro-esophageal junction (GEJ)
    Interventions:
    • Drug: oxaliplatin + 5-fluorouracil (5FU) + leucovorin (calcium folinate/folinic acid)
    • Biological: durvalumab
    • Biological: tremelimumab
  • Experimental: Cohort 6
    Pancreatic ductal adenocarcinoma (PDAC)
    Interventions:
    • Biological: durvalumab
    • Biological: tremelimumab
    • Drug: nab-paclitaxel (paclitaxel-albumin) + gemcitabine
  • Experimental: Cohort 7
    Esophageal squamous cell carcinoma (ESCC)
    Interventions:
    • Biological: durvalumab
    • Biological: tremelimumab
    • Drug: cisplatin + 5-fluorouracil (5FU)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 18, 2019)
32
Original Estimated Enrollment  ICMJE
 (submitted: January 14, 2016)
80
Actual Study Completion Date  ICMJE November 14, 2019
Actual Primary Completion Date November 14, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan,   Korea, Republic of
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT02658214
Other Study ID Numbers  ICMJE D419SC00001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account AstraZeneca
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP