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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02658214
Recruitment Status : Recruiting
First Posted : January 18, 2016
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
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 Drug: paclitaxel + carboplatin Drug: carboplatin + etoposide Drug: gemcitabine + carboplatin Drug: nab-paclitaxel (paclitaxel-albumin) + carboplatin Drug: oxaliplatin + 5-fluorouracil (5FU) + leucovorin (calcium folinate/folinic acid) Biological: durvalumab Biological: tremelimumab Drug: nab-paclitaxel (paclitaxel-albumin) + gemcitabine Drug: cisplatin + 5-fluorouracil (5FU) Phase 1

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : April 28, 2016
Estimated Primary Completion Date : June 28, 2019
Estimated Study Completion Date : June 28, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Durvalumab
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Cohort 1
ovarian/peritoneal/fallopian tube cancer and squamous cell carcinoma of the head and neck (SCCHN)
Drug: paclitaxel + carboplatin
IV infusion
Other Name: Platinum based Standard of Care Chemotherapy
Biological: durvalumab
IV infusion
Other Name: MEDI4736
Biological: tremelimumab
IV infusion
Experimental: Cohort 2
Small-cell lung cancer (SCLC)
Drug: carboplatin + etoposide
IV infusion
Other Name: Platinum based Standard of Care Chemotherapy
Biological: durvalumab
IV infusion
Other Name: MEDI4736
Biological: tremelimumab
IV infusion
Experimental: Cohort 3
Triple-negative breast cancer (TNBC)
Drug: gemcitabine + carboplatin
IV infusion
Other Name: Platinum based Standard of Care Chemotherapy
Biological: durvalumab
IV infusion
Other Name: MEDI4736
Biological: tremelimumab
IV infusion
Experimental: Cohort 4
Triple-negative breast cancer (TNBC)
Drug: nab-paclitaxel (paclitaxel-albumin) + carboplatin
IV infusion
Other Name: Platinum based Standard of Care Chemotherapy
Biological: durvalumab
IV infusion
Other Name: MEDI4736
Biological: tremelimumab
IV infusion
Experimental: Cohort 5
Gastric/gastro-esophageal junction (GEJ)
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
Experimental: Cohort 6
Pancreatic ductal adenocarcinoma (PDAC)
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
Experimental: Cohort 7
Esophageal squamous cell carcinoma (ESCC)
Biological: durvalumab
IV infusion
Other Name: MEDI4736
Biological: tremelimumab
IV infusion
Drug: cisplatin + 5-fluorouracil (5FU)
IV infusion
Other Name: Platinum based Standard of Care Chemotherapy


Outcome Measures

Primary Outcome Measures :
  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)


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02658214


Contacts
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com
Contact: AstraZeneca Cancer Study Locator Service 1-877-400-4656 AstraZeneca@emergingmed.com

Locations
United States, Georgia
Research Site Withdrawn
Augusta, Georgia, United States, 30912
United States, Pennsylvania
Research Site Withdrawn
Pittsburgh, Pennsylvania, United States, 15232
Japan
Research Site Recruiting
Chuo-ku, Japan, 104-0045
Research Site Recruiting
Kashiwa, Japan, 277-8577
Korea, Republic of
Research Site Recruiting
Seoul, Korea, Republic of, 03080
Research Site Recruiting
Seoul, Korea, Republic of, 03722
Research Site Recruiting
Seoul, Korea, Republic of, 05505
Research Site Recruiting
Seoul, Korea, Republic of, 06351
Sponsors and Collaborators
AstraZeneca
More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02658214     History of Changes
Other Study ID Numbers: D419SC00001
First Posted: January 18, 2016    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by AstraZeneca:
durvalumab, tremelimumab, metastatic, solid tumors, immuno-oncology, first-line chemotherapy, esophageal, pancreatic

Additional relevant MeSH terms:
Carcinoma
Neoplasms
Carcinoma, Squamous Cell
Breast Neoplasms
Lung Neoplasms
Esophageal Neoplasms
Ovarian Neoplasms
Stomach Neoplasms
Small Cell Lung Carcinoma
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Head and Neck Neoplasms
Carcinoma, Pancreatic Ductal
Triple Negative Breast Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Endocrine Gland Neoplasms