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

Official 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

Basic Trial Information

Phase Type Age Sponsor Protocol IDs Status
Phase 1/Phase 2 Interventional 18 - 99 Years MedImmune LLC D4190C00006
2015-003715-38
NCT02000947
Ongoing but not enrolling patients

Study Design:


Principal Investigator

Professor of Medicine
Chair, Data and Safety Monitoring Committee
Bonnie J. and Anthony Addario Endowed Chair in Thoracic Oncology
UCSF Helen Diller Family Comprehensive Cancer Center

Clinical Research Coordinator

UCSF Helen Diller Family Comprehensive Cancer Center
415) 353-9712 Phone
(415) 353-9721 Fax

Trial Summary

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).

Eligibility

Inclusion Criteria:

     1. Age ≥ 18 years
     2. Advanced non-small cell lung cancer
     3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
     4. Adequate organ and marrow function
Exclusion Criteria:

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

Detailed Description

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.

Important

Final eligibility is determined by the health professionals conducting the trial and the protocol approved by the Committee on Human Resources (CHR) at the University of California, San Francisco (UCSF). The Patient Consent Form for this trial is available upon request. For more information about this trial, please see the full posting at ClinicalTrials.gov.

Information about this trial was obtained from the NIH Clinical Trials website, http://clinicaltrials.gov on 1/26/2017. UCSF specific information including the PI (Principal Investigator), trial enrollment status, and UCSF Study ID, supplement the ClinicalTrials.gov study posting.
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