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A Phase 1/2 Study to Evaluate MEDI4736

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by MedImmune LLC
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT01693562
First received: September 14, 2012
Last updated: September 26, 2014
Last verified: September 2014

September 14, 2012
September 26, 2014
August 2012
November 2015   (final data collection date for primary outcome measure)
  • Number of participants experiencing dose-limiting toxicities, adverse events (AEs), serious adverse events (SAEs). [ Time Frame: 90 days after the last dose of MEDI4736 ] [ Designated as safety issue: Yes ]

    MTD or OBD will be determined by the number of participants experiencing dose-limiting toxicities.

    Safety profile will be assessed through number of participants experiencing adverse events (AEs), serious adverse events (SAEs), laboratory evaluations, vital signs, and physical examinations.

  • Anti-tumor efficacy (dose expansion subjects) [ Time Frame: Until end of study ] [ Designated as safety issue: No ]
    Evaluate the objective response rate in subjects with non-squamous NSCLC who have received 2 or more prior lines of therapy and subjects with squamous NSCLC who have received 1 prior lines of therapy and 2 or more prior lines of therapy
Same as current
Complete list of historical versions of study NCT01693562 on ClinicalTrials.gov Archive Site
  • Area under the concentration time curve, maximum concentration, clearance, half-life after administration of MEDI4736. [ Time Frame: Up to 90 days after the last dose of MEDI4736 ] [ Designated as safety issue: No ]
    If data allow, noncompartmental PK parameters (AUC, Cmax, CL, t½) will be estimated.
  • Number and percentage of subjects who develop detectable anti-drug antibodies (ADAs). [ Time Frame: Up to 6 months after the last dose of MEDI4736. ] [ Designated as safety issue: Yes ]
    The immunogenic potential of MEDI4736 will be assessed by summarizing the number and percentage of subjects who develop detectable anti-drug antibodies (ADAs).
  • Objective response rate (ORR) [ Time Frame: Until end of study ] [ Designated as safety issue: No ]
    The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR
  • Disease control rate (DCR) [ Time Frame: Until end of study ] [ Designated as safety issue: No ]

    The DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for

    ≥ 12 weeks)

  • Duration of response (DR) [ Time Frame: Until end of study ] [ Designated as safety issue: No ]
    Duration of response will be defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.
  • Progression-free survival (PFS) [ Time Frame: Until end of study ] [ Designated as safety issue: No ]
    Progression-free survival is the time interval from the start of treatment with MEDI4736 until the documentation of confirmed immune-related disease progression or death due to any cause, whichever occurs first.
  • Overall survival (OS) [ Time Frame: From first dose of study drug until death or up to 2 years ] [ Designated as safety issue: No ]
    Overall survival will be determined as the time from the start of treatment with MEDI4736 until death.
  • Area under the concentration time curve, maximum concentration, clearance, half-life after administration of MEDI4736. [ Time Frame: Up to 90 days after the last dose of MEDI4736 ] [ Designated as safety issue: No ]
    If data allow, noncompartmental PK parameters (AUC, Cmax, CL, t½) will be estimated.
  • Number and percentage of subjects who develop detectable anti-drug antibodies (ADAs). [ Time Frame: Up to 6 months after the last dose of MEDI4736. ] [ Designated as safety issue: Yes ]
    The immunogenic potential of MEDI4736 will be assessed by summarizing the number and percentage of subjects who develop detectable anti-drug antibodies (ADAs).
  • Immune-related objective response rate (ORR) [ Time Frame: 84 days ] [ Designated as safety issue: No ]
  • Immune-related disease control rate (DCR) [ Time Frame: 84 days ] [ Designated as safety issue: No ]
  • Immune-related duration of response (DR) [ Time Frame: From first documented response up to 2 years ] [ Designated as safety issue: No ]
  • Immune-related progression-free survival (PFS) [ Time Frame: From documented response up to 2 years ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: From first dose of study drug until death or up to 2 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Phase 1/2 Study to Evaluate MEDI4736
A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI4736 in Subjects With Advanced Solid Tumors

This is a multicenter, open-label, first-time-in-human study with a standard 3+3 dose-escalation phase in subjects with advanced solid tumors followed by an expansion phase in patients with advanced solid tumors.

A dose-escalation and dose-expansion study of MEDI4736 (a monoclonal antibody that targets programmed cell death-1 ligand 1 (PD-L1)) will evaluate the safety, tolerability, PK, IM, and antitumor activity of MEDI4637 in adult patients with solid tumors.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Solid Tumors
Drug: MEDI4736
MEDI4736 will be administered by IV infusion every 14 or 21 days.
  • Experimental: MEDI4736 Q2W
    Evaluate MEDI4736 given every 2 weeks
    Intervention: Drug: MEDI4736
  • Experimental: MEDI4736 Q3W
    Evaluate MEDI4736 given every 3 weeks
    Intervention: Drug: MEDI4736
  • Experimental: MEDI4736 Dose Expansion
    At least 16 different types of solid tumors will be evaluated in the expansion phase
    Intervention: Drug: MEDI4736
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
950
March 2016
November 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

Age 18 or older. In the dose-escalation phase: histologically- or cytologically- confirmed advanced solid tumor that is refractory to standard therapy and for which no standard therapy exists.

  • In the dose-expansion phase: histologically- or cytologically- confirmed advanced solid tumor where if an approved first-line therapy is available, subjects must have failed, be intolerant to, be ineligible for, or have refused treatment.
  • Eastern Cooperative Oncology Group (ECOG) status of 0 or 1.
  • Adequate organ and marrow function.
  • Subjects must have at least 1 measurable lesion.
  • Available archived tumor tissue sample.
  • Willingness to provide consent for biopsy samples (dose-expansion only)

Exclusion Criteria:

  • Any prior Grade ≥ 3 irAE while receiving immunotherapy
  • Prior exposure to any anti-PD-1 or anti-PD-L1 antibody
  • Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment.
  • Active or prior documented autoimmune disease within the past 2 years
  • History of primary immunodeficiency
  • History of organ transplant that requires use of immunosuppressives
  • Symptomatic or untreated central nervous system (CNS) metastases requiring concurrent treatment
  • Other invasive malignancy within 2 years
  • Women who are pregnant or lactating
  • Uncontrolled intercurrent illness
  • Known history of tuberculosis
  • Known to be human immunodeficiency virus (HIV) positive
  • Known to be Hepatitis B or C positive (excpet HCC patients)
Both
18 Years and older
No
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 ClinicalTrialEnquiries@Medimmune.com
United States,   Belgium,   Canada,   France,   Germany,   Italy,   Korea, Republic of,   United Kingdom
 
NCT01693562
CD-ON-MEDI4736-1108
No
MedImmune LLC
MedImmune LLC
Not Provided
Study Director: Dominic Lai, MD MedImmune LLC
MedImmune LLC
September 2014

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