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

August 19, 2020 updated by: AstraZeneca

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chuo-ku, Japan, 104-0045
        • Research Site
      • Kashiwa, Japan, 277-8577
        • Research Site
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Research Site
      • Seoul, Korea, Republic of, 05505
        • Research Site
      • Seoul, Korea, Republic of, 03080
        • Research Site
      • Seoul, Korea, Republic of, 135-710
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Platinum based Standard of Care Chemotherapy
Biological: durvalumab
IV infusion
Other Names:
  • MEDI4736
Biological: tremelimumab
IV infusion
Experimental: Cohort 2
Small-cell lung cancer (SCLC)
Biological: durvalumab
IV infusion
Other Names:
  • MEDI4736
Biological: tremelimumab
IV infusion
Drug: carboplatin + etoposide
IV infusion
Other Names:
  • Platinum based Standard of Care Chemotherapy
Experimental: Cohort 3
Triple-negative breast cancer (TNBC)
Biological: durvalumab
IV infusion
Other Names:
  • MEDI4736
Biological: tremelimumab
IV infusion
Drug: gemcitabine + carboplatin
IV infusion
Other Names:
  • Platinum based Standard of Care Chemotherapy
Experimental: Cohort 4
Triple-negative breast cancer (TNBC)
Biological: durvalumab
IV infusion
Other Names:
  • MEDI4736
Biological: tremelimumab
IV infusion
Drug: nab-paclitaxel (paclitaxel-albumin) + carboplatin
IV infusion
Other Names:
  • Platinum based Standard of Care Chemotherapy
Experimental: Cohort 5
Gastric/gastro-esophageal junction (GEJ)
Biological: durvalumab
IV infusion
Other Names:
  • MEDI4736
Biological: tremelimumab
IV infusion
Drug: oxaliplatin + 5-fluorouracil (5FU) + leucovorin (calcium folinate/folinic acid)
IV infusion and bolus administration
Other Names:
  • Platinum based Standard of Care Chemotherapy
Experimental: Cohort 6
Pancreatic ductal adenocarcinoma (PDAC)
Biological: durvalumab
IV infusion
Other Names:
  • MEDI4736
Biological: tremelimumab
IV infusion
Drug: nab-paclitaxel (paclitaxel-albumin) + gemcitabine
IV infusion
Other Names:
  • Standard of Care Chemotherapy
Experimental: Cohort 7
Esophageal squamous cell carcinoma (ESCC)
Biological: durvalumab
IV infusion
Other Names:
  • MEDI4736
Biological: tremelimumab
IV infusion
Drug: cisplatin + 5-fluorouracil (5FU)
IV infusion
Other Names:
  • Platinum based Standard of Care Chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Throughout the study, approximately three years
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
Throughout the study, approximately three years
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)
Throughout the study, approximately three years (for cohort 6 only)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2016

Primary Completion (Actual)

November 14, 2019

Study Completion (Actual)

November 14, 2019

Study Registration Dates

First Submitted

January 11, 2016

First Submitted That Met QC Criteria

January 14, 2016

First Posted (Estimate)

January 18, 2016

Study Record Updates

Last Update Posted (Actual)

August 20, 2020

Last Update Submitted That Met QC Criteria

August 19, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D419SC00001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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