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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03530397
Registration number
NCT03530397
Ethics application status
Date submitted
28/03/2018
Date registered
21/05/2018
Titles & IDs
Public title
A Study to Evaluate MEDI5752 in Subjects With Advanced Solid Tumors
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Scientific title
A Phase 1, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability Pharmacokinetics Immunogenicity, and Antitumor Activity of MEDI5752 in Subjects With Advanced Solid Tumors.
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Secondary ID [1]
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2018-003075-35
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Secondary ID [2]
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D7980C00001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Selected Advanced Solid Tumors
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - MEDI5752
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Carboplatin
Treatment: Other - Pembrolizumab
Treatment: Drugs - Paclitaxel or Nab-Paclitaxel
Experimental: Arm A: MEDI5752 - MEDI5752
Experimental: Arm B: MEDI5752 and chemotherapy - MEDI5752, pemetrexed, carboplatin and paclitaxel.
Active comparator: Arm C: Pembrolizumab and chemotherapy - pembrolizumab, pemetrexed, and carboplatin
Treatment: Other: MEDI5752
Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation.
Treatment: Drugs: Pemetrexed
Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation
Treatment: Drugs: Carboplatin
Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation
Treatment: Other: Pembrolizumab
Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation
Treatment: Drugs: Paclitaxel or Nab-Paclitaxel
Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The number of subjects experiencing treatment related adverse events (AEs) (Dose-escalation phase)
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Assessment method [1]
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The primary endpoint is as assessed by the number of subjects experiencing adverse events (AEs) graded per NCI CTCAE v4.03
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Timepoint [1]
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From the time of informed consent through 114 days following termination of treatment with investigational product
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Primary outcome [2]
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Preliminary anti-tumor activitiy of MEDI5752 (versus pembrolizumab, where applicable) using Objective Response based on RECIST v1.1 (Dose-expansion phase)
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Assessment method [2]
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The primary endpoint of antitumor activity include Objective Response and will be based on all post baseline disease assessments that occur prior to initiation of subsequent anticancer therapy.
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Timepoint [2]
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From the first dose of study drug through the date of first documented progression, end of study, date of death, or two years after the last patient starts treatment, whichever should occur first
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Primary outcome [3]
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The number of subjects experiencing dose-limiting toxicities (DLTs) (Dose-escalation phase)
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Assessment method [3]
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The primary endpoint is as assessed by the number of subjects experiencing dose limiting toxicities (DLTs) as defined by the protocol.
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Timepoint [3]
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Up to 21 days following the first dose
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Primary outcome [4]
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The number of subjects experiencing abnormal laboratory evaluations (Dose-escalation phase)
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Assessment method [4]
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The primary endpoint is as assessed as the number of subjects experiencing changes in laboratory parameters from baseline.
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Timepoint [4]
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From the time of informed consent through 114 days following termination of treatment with investigational product
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Primary outcome [5]
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The number of subjects experiencing changes from baseline in vital signs reported as adverse events (Dose-escalation phase)
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Assessment method [5]
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The primary endpoint is as assessed by the number of subjects experiencing clinically significant changes in vital signs from baseline.
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Timepoint [5]
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From the time of informed consent through 114 days following termination of treatment with investigational product
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Primary outcome [6]
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The number of subjects experiencing abnormal electrocardiograms (ECG) reported as Adverse Events (Dose-escalation phase)
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Assessment method [6]
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The primary endpoint is as assessed by the the number of subjects experiencing clinically significant changes in ECG parameters from baseline.
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Timepoint [6]
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From the time of informed consent through 114 days following termination of treatment with investigational product
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Primary outcome [7]
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The number of subjects experiencing treatment related serious adverse events (SAEs) (Dose-escalation phase)
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Assessment method [7]
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The primary endpoint is as assessed by the number of subjects with serious adverse events (SAEs) graded per NCI CTCAE v4.03.
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Timepoint [7]
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From the time of informed consent through 114 days following termination of treatment with investigational product
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Secondary outcome [1]
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Pharmacokinetics of MEDI5752: Cmax
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Assessment method [1]
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The endpoints for the assessment of PK of MEDI5752 include individual MEDI5752 concentrations at different time points after administration. PK parameters that may be modeled on this data include maximum observed concentration (Cmax)
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Timepoint [1]
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To be assessed at Day 1, 2, 3, 8, 15, 22, 29, 43, 64, 85, and 106 over the first 4 months of treatment and up to 114 days following end of treatment
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Secondary outcome [2]
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Pharmacokinetics of MEDI5752: AUC
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Assessment method [2]
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The endpoints for the assessment of PK of MEDI5752 include individual MEDI5752 concentrations at different time points after administration. PK parameters that may be modeled on this data include area under the concentration-time curve (AUC)
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Timepoint [2]
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To be assessed at Day 1, 2, 3, 8, 15, 22, 29, 43, 64, 85, and 106 over the first 4 months of treatment and up to 114 days following end of treatment
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Secondary outcome [3]
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Pharmacokinetics of MEDI5752: Clearance
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Assessment method [3]
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The endpoints for the assessment of PK of MEDI5752 include individual MEDI5752 concentrations at different time points after administration. PK parameters that may be modeled on this data include clearance (CL)
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Timepoint [3]
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To be assessed at Day 1, 2, 3, 8, 15, 22, 29, 43, 64, 85, and 106 over the first 4 months of treatment and up to 114 days following end of treatment
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Secondary outcome [4]
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Pharmacokinetics of MEDI5752: t 1/2
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Assessment method [4]
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The endpoints for the assessment of PK of MEDI5752 include individual MEDI5752 concentrations at different time points after administration. PK parameters that may be modeled on this data include terminal phase half life (t 1/2)
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Timepoint [4]
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To be assessed at Day 1, 2, 3, 8, 15, 22, 29, 43, 64, 85, and 106 over the first 4 months of treatment and up to 114 days following end of treatment.
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Secondary outcome [5]
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Ability of MEDI5752 to generate immune response in subjects with advanced solid tumors
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Assessment method [5]
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The endpoints for the immunogenicity of MEDI5752 include the number of subjects who develop detectable anti-drug antibodies (ADAs)
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Timepoint [5]
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To be assessed at Day 1, 8, 15, 22, 29, 43, 64, 85, and 106 over the first 4 months of treatment and up to 114 days following end of treatment.
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Secondary outcome [6]
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PD-L1 Expression in subjects with advanced solid tumors
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Assessment method [6]
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The endpoint for the PD-L1 expression will be determined by Immunohistochemistry characterization.
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Timepoint [6]
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To be assessed at baseline
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Secondary outcome [7]
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Preliminary Antitumor Activity: Duration of Response
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Assessment method [7]
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The endpoints for assessment of antitumor activity include duration of response (DoR) and is defined as the duration from the documentation of OR to the first documentation of disease progression or death due to any cause.
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Timepoint [7]
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From the date of response through the date of first documented progression, end of study, date of death, or two years after last subject starts treatment whichever should occur first
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Secondary outcome [8]
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Preliminary Antitumor Activity: Disease Control
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Assessment method [8]
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The endpoints for assessment of antitumor activity include disease control (DC) and is defined as CR, PR, or SD according to RECIST v1.1.
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Timepoint [8]
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From the first dose of study drug through the date of first documented progression, end of study, date of death, or two years after last subject starts treatment whichever should occur first
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Secondary outcome [9]
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Preliminary Antitumor Activity: Progression Free Survival
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Assessment method [9]
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The endpoints for assessment of antitumor activity include progression free survival (PFS) and is defined as the duration measured from the start of treatment with investigational product to the first documentation of disease progression or death due to any cause.
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Timepoint [9]
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From the first dose of study drug through the date of first documented progression, end of study, date of death, or two years after last subject starts treatment whichever should occur first
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Secondary outcome [10]
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Preliminary Antitumor Activity: Overall Survival
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Assessment method [10]
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The endpoints for assessment of antitumor activity include overall survival (OS) and is defined as the duration measured from the start of treatment with investigational product until death due to any cause.
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Timepoint [10]
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From the first dose of study drug through the end of study, or date of death, or two years after last subject starts treatment whichever should occur first
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Secondary outcome [11]
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The number of subjects experiencing treatment related adverse events (AEs) (Dose-expansion phase)
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Assessment method [11]
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The secondary endpoint is as assessed by the number of subjects experiencing adverse events (AEs) graded per NCI CTCAE v4.03
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Timepoint [11]
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From the time of informed consent through 114 days following termination of treatment with investigational product
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Secondary outcome [12]
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The number of subjects experiencing abnormal laboratory evaluations (Dose-expansion phase)
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Assessment method [12]
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The secondary endpoint is as assessed by the number of subjects experiencing changes in laboratory parameters from baseline.
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Timepoint [12]
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From the time of informed consent through 114 days following termination of treatment with investigational product
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Secondary outcome [13]
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The number of subjects experiencing Changes from baseline in vital signs reported as adverse events (Dose-expansion phase)
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Assessment method [13]
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The secondary endpoint is as assessed by the number of subjects experiencing clinically significant changes in vital signs from baseline.
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Timepoint [13]
0
0
From the time of informed consent through 114 days following termination of treatment with investigational product
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Secondary outcome [14]
0
0
The number of subjects experiencing abnormal ECGs reported as adverse events (Dose-expansion phase)
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Assessment method [14]
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The secondary endpoint is as assessed by the number of subjects experiencing clinically significant changes in ECG parameters from baseline.
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Timepoint [14]
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0
From the time of informed consent through 14 days following termination of treatment with investigational product
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Secondary outcome [15]
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0
The number of subjects experiencing treatment related serious adverse events (SAEs) (Dose-expansion phase)
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Assessment method [15]
0
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The secondary endpoint is as assessed by the number of subjects with serious adverse events (SAEs) graded per NCI CTCAE v4.03
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Timepoint [15]
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From the time of informed consent through 114 days following termination of treatment with investigational product
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Eligibility
Key inclusion criteria
Inclusion Criteria
1. Age = 18 years at the time of screening
2. World Health Organization/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
3. Life expectancy = 12 weeks
4. Histologically or cytologically-confirmed advanced solid tumors
5. Subjects who have received prior anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapy or any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment may be eligible to enter the study following a washout period as applicable
6. Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception
7. Nonsterilized males who are sexually active with a female partner of childbearing potential must use a male condom with spermicide where locally available from Day 1 and for 90 days after the final dose of investigational product. Males receiving pemetrexed or carboplatin must use contraception during study treatment and up to 6 months thereafter.
8. Subjects must have at least one measurable lesion
9. Adequate organ and marrow function
10. Written informed consent and any locally required authorization
11. Subjects must provide tumor material as applicable
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Minimum age
18
Years
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Maximum age
120
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion Criteria
1. Involvement in the planning and/or conduct of the study (applies to both MedImmune staff and/or staff at the study site)
2. Concurrent enrollment in another clinical study, unless it is an observational clinical study or the follow-up period of an interventional study
3. For subjects who have received prior anti-PD-1, anti-PD-L1, or anti-CTLA-4:
1. Subjects must not have received anti-PD-1, anti-PD-L1, anti-CTLA-4 or any other immunotherapy or immune-oncology (IO) agent within 21 days of commencing treatment with investigational product.
2. Subject must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.
3. All AEs while receiving prior immunotherapy must have completely resolved or resolved to Grade 1 prior to screening for this study.
4. Current or prior use of immunosuppressive medication within 14 days before the first dose of investigational product is excluded.
5. Receipt of live attenuated vaccine within 30 days prior to the first dose of investigational product.
6. Active or prior documented autoimmune or inflammatory disorders
7. History of active primary immunodeficiency:
8. History of organ transplant
9. Known allergy or reaction to any component of the planned study treatment.
10. Untreated CNS metastatic disease, leptomeningeal disease, or cord compression
11. Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v4.03 Grade 0 or 1, or to levels dictated in the inclusion/exclusion criteria
12. Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of Investigational Product or still recovering from prior surgery
13. Female subjects who are pregnant or breastfeeding, as well as male or female subjects of reproductive potential who are not willing to employ one highly effective method of birth control
14. Uncontrolled intercurrent illness, that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the subject to give written informed consent.
15. Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of the subject's safety or study results
16. Judgment by the investigator that the subject is unsuitable to participate in the study and the subject is unlikely to comply with study procedures, restrictions, and requirements.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
24/04/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/12/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
401
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Melbourne
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Recruitment hospital [2]
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Research Site - Randwick
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Recruitment postcode(s) [1]
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3000 - Melbourne
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Recruitment postcode(s) [2]
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3004 - Melbourne
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Recruitment postcode(s) [3]
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2031 - Randwick
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Michigan
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Country [2]
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0
United States of America
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State/province [2]
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New York
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Country [3]
0
0
United States of America
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State/province [3]
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North Carolina
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Country [4]
0
0
United States of America
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State/province [4]
0
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Rhode Island
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Country [5]
0
0
United States of America
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State/province [5]
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Tennessee
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Virginia
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Country [7]
0
0
France
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State/province [7]
0
0
Bordeaux Cedex
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Country [8]
0
0
France
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State/province [8]
0
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Lyon
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Country [9]
0
0
France
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State/province [9]
0
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Villejuif Cedex
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Country [10]
0
0
Italy
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State/province [10]
0
0
Meldola
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Country [11]
0
0
Italy
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State/province [11]
0
0
Napoli
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Country [12]
0
0
Italy
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State/province [12]
0
0
Ravenna
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Country [13]
0
0
Italy
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State/province [13]
0
0
Roma
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Country [14]
0
0
Korea, Republic of
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State/province [14]
0
0
Cheongju-si
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Country [15]
0
0
Korea, Republic of
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State/province [15]
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0
Gyeonggi-do
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Country [16]
0
0
Korea, Republic of
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State/province [16]
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0
Incheon
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Country [17]
0
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Korea, Republic of
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State/province [17]
0
0
Seoul
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Country [18]
0
0
Netherlands
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State/province [18]
0
0
Amsterdam
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Country [19]
0
0
Portugal
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State/province [19]
0
0
Lisboa
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Country [20]
0
0
Portugal
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State/province [20]
0
0
Porto
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Country [21]
0
0
Spain
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State/province [21]
0
0
A Coruna
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Country [22]
0
0
Spain
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State/province [22]
0
0
Barcelona
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Country [23]
0
0
Spain
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State/province [23]
0
0
Majadahonda
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Country [24]
0
0
Spain
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State/province [24]
0
0
Malaga
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Country [25]
0
0
Spain
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State/province [25]
0
0
Pamplona
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Country [26]
0
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Spain
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State/province [26]
0
0
Valencia
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Country [27]
0
0
Taiwan
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State/province [27]
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0
Taichung
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Country [28]
0
0
Taiwan
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State/province [28]
0
0
Tainan
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Country [29]
0
0
Taiwan
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State/province [29]
0
0
Taipei
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
MedImmune LLC
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate MEDI5752 and carboplatin and pemetrexed or paclitaxel or nab-paclitaxel in adult subjects with advanced solid tumors, when administered as a single agent or combined with chemotherapy.
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Trial website
https://clinicaltrials.gov/study/NCT03530397
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Deepa Subramaniam, MD, MSc
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Address
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AstraZeneca
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Country
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Phone
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Fax
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0
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Email
0
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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Available to whom?
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03530397