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NCT Number: NCT02000947

A Phase 1b Study of MEDI4736 in Combination With Tremelimumab in Subjects With Advanced Non-small Cell Lung Cancer

The purpose of this study is to determine if MEDI4736 will be adequately tolerated in combination with tremelimumab in subjects with advanced non-small cell lung cancer (NSCLC).

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Key information

Conditions

NSCLC Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Non-small Cell Lung Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–101 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Darlinghurst, Australia

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About this study

This is a multicenter, open-label, dose-escalation, and dose expansion study of MEDI4736 in combination with tremelimumab to evaluate the safety, tolerability, pharmacokinetic (PK), immunogenicity, and antitumor activity of MEDI4736 in combination with tremelimumab in adult subjects with advanced NSCLC.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years
  • Advanced non-small cell lung cancer
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Adequate organ and marrow function

Exclusion criteria

  • Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment
  • Current or prior use of immunosuppressive medication within 14 days before the first dose of study drugs
  • Active or prior documented autoimmune disease within the last 2 years.

Treatment and study plan

MEDI4736

Drug

MEDI4736 is an anti-PD-L1 monoclonal antibody (MAb).

Tremelimumab

Drug

Tremelimumab is an anti-CTLA4 monoclonal antibody (mAb).

Primary outcomes

  1. Number of subjects reporting adverse events

    Time frame: Screening through 90 days after the last dose of study medication

    The number of subjects reporting adverse events (AEs) and number (percentage) of subjects reporting serious adverse events (SAEs) as graded by CTCAE Version 4.03

  2. Objective response

    Time frame: At least 24 weeks as compared to baseline

    Best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as defined as the best response among all overall responses recorded from the start of treatment until progression, or the last evaluable disease assessment in the absence of progressive disease (PD) prior to the initiation of subsequent anti-cancer therapy, or discontinuation from the study, whichever occurs first.

  3. Number of subjects experiencing dose-limiting toxicities (DLTs)

    Time frame: Depending upon the cohort, the DLT evaluation period is from the 1st dose of study medication until (1) the 3rd dose of MEDI4736 and tremelimumab (2) the 2nd dose of MEDI4736 and tremelimumab or (3) the 3rd dose of MEDI4736 and 2nd dose of tremelimumab

    The maximum tolerated dose (MTD), which is the highest dose within a cohort where no more than 1 out of 6 subjects experience DLTs or the highest protocol-defined dose for each agent in the absence of exceeding the MTD, will be evaluated using the following safety assessments: adverse events, serious advents, laboratory evaluations, vital signs, physical examinations, and electrocardiogram (ECG) results. Measurements will be aggregated to determine whether a subject has experienced a DLT as assessed by the investigator.

Secondary outcomes

  1. Immunogenicity of tremelimumab in combination with MEDI4736

    Time frame: During treatment through study completion, about 2 years

    Immunogenicity of MEDI4736 and tremelimumab will include the number and percentage of subjects who develop detectable anti-drug antibodies (ADAs).

  2. Antitumor activity of tremelimumab in combination with MEDI4736

    Time frame: During treatment through study completion, about 2 years

    Antitumor activity will include objective response (OR) and disease control (DC) based on RECIST Version 1.1, duration of response (DoR), progression-free survival (PFS), and overall survival (OS).

  3. Pharmacokinetic parameters

    Time frame: During treatment through study completion, about 2 years

    Assessment of PK of MEDI4736 and tremelimumab will include individual MEDI4736 and tremelimumab concentrations in serum, and PK parameters including peak concentration (Cmax), area under the concentration-time curve (AUC), clearance (CL), and half-life (t½).

  4. Number of subjects reporting adverse events

    Time frame: Screening through 90 days after the last dose of study medication

    The number of subjects reporting adverse events (AEs) and number (percentage) of subjects reporting serious adverse events (SAEs) as graded by CTCAE Version 4.03

Other outcomes

  1. Biomarkers

    Time frame: During treatment through study completion, about 2 years

    To evaluate biomarkers that may correlate with clinical activity of MEDI4736 in combination with tremelimumab

Sponsors and collaborators

Lead sponsor

MedImmune LLC

Industry

Registry information

Official study title

A Phase 1b Open-label Study to Evaluate the Safety and Tolerability of MEDI4736 in Combination With Tremelimumab in Subjects With Advanced Non-small Cell Lung Cancer

Acronym: D4190C00006

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Dec 4, 2013
Registry last updated
Oct 31, 2019

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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