A Phase 1 interventional study of MEDI0562 and Tremelimumab in Select Advanced Solid Tumors, sponsored by MedImmune LLC. Completed at 12 sites in 3 countries. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2019-08-26.
Sponsored by MedImmune LLC · Phase 1, Interventional, and Treatment
The purpose of this study is to evaluate MEDI0562 in combination with immune therapeutic agents in adult subjects with select advanced solid tumors.
This is a Phase 1 multicenter, open-label study to evaluate the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and antitumor activity of MEDI0562 in combination with immune therapeutic agents in adult subjects with select advanced solid tumors.
9,359 studies on the registry are indexed under Neoplasms; 2,486 are open to participants now.
This study's enrollment of 58 is above the median of 50 across 7,250 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →MedImmune LLC is the lead sponsor of 265 studies on the registry; none are open to participants now.
Of its 50 completed or terminated interventional studies of FDA-regulated products, 28 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects must meet all of the following criteria:
At the time of Day 1 of the study, subjects with CNS metastases must have been treated and must be asymptomatic and meet the following:
Exclusion Criteria:
Any of the following would exclude the subject from participation in the study:
MEDI0562 and durvalumab
Biological: MEDI0562 · Biological: Durvalumab
MEDI0562 and tremelimumab
Biological: MEDI0562 · Biological: Tremelimumab
Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease (PD), or development of other reason for treatment discontinuation.
Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease (PD), or development of other reason for treatment discontinuation.
Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease (PD), or development of other reason for treatment discontinuation.
Safety as defined by the presence of adverse events (AE), serious adverse events (SAE), and dose limiting toxicities (DLT).
The primary endpoint is safety as assessed by presence of adverse event (AE), serious adverse event (SAE), and dose limiting toxicity (DLT).
Time frame: From time of informed consent through 12 weeks after ending treatment with investigational product
Preliminary Antitumor Activity:Best Overall Response
The endpoints for assessment of antitumor activity include Best Overall Response (BOR) and will be based on all post-baseline disease assessments that occur prior to the initiation of subsequent anticancer therapy
Time frame: At approximately 3 time points through Day 113.
Pharmacokinetics of MEDI0562/durvalumab or MEDI0562/tremelimumab: Cmax
The endpoints for assessment of PK of MEDI0562 and durvalumab or tremelimumab include individual MEDI0562, durvalumab, and tremelimumab concentrations at different time points after administration. PK parameters that may be modeled on these data include, but are not limited to, maximum observed concentration (Cmax).
Time frame: To be assessed at approximately 12 clinic visits through Day 113
Immunogenicity
The endpoints for assessment of immunogenicity of MEDI0562, durvalumab, and tremelimumab include the number and percentage of subjects who develop detectable anti drug antibodies (ADAs).
Time frame: At approximately 8 time points through Day 113.
Pharmacodynamic Activity
The endpoints for assessment of pharmacodynamic activity include induction of proliferation markers in various lymphocyte populations and assessment of tumor-infiltrating lymphocytes (TILs) in tumor biopsy specimens.
Time frame: At approximately 12 time points through Day 113.
Preliminary Antitumor Activity: Disease Control
The endpoints for assessment of antitumor activity include disease control and is defined as CR, PR, or SD according to RECIST v1.1
Time frame: At approximately 3 time points through Day 113.
Preliminary Antitumor Activity: Duration of Response
The endpoints for assessment of antitumor activity include duration of response (DoR) and is defined as the duration from the first documentation of OR to the first documentation of disease progression or death due to any cause.
Time frame: At approximately 3 time points through Day 113.
Preliminary Antitumor Activity: Progression-free Survival
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
Time frame: At approximately 3 time points through Day 113.
Preliminary Antitumor Activity: Overall Survival
The endpoints for assessment of antitumor activity include overall survival (OS) and is defined as the time from the start of treatment with Investigational Product until death due to any cause.
Time frame: At approximately 3 time points through Day 113.
Pharmacokinetics of MEDI0562/durvalumab or MEDI0562/tremelimumab: AUC
The endpoints for assessment of PK of MEDI0562 and durvalumab or tremelimumab include individual MEDI0562, durvalumab, and tremelimumab concentrations at different time points after administration. PK parameters that may be modeled on these data include area under the concentration-time curve (AUC).
Time frame: To be assessed at approximately 12 clinic visits through Day 113
Pharmacokinetics of MEDI0562/durvalumab or MEDI0562/tremelimumab: Clearance
The endpoints for assessment of PK of MEDI0562 and durvalumab or tremelimumab include individual MEDI0562, durvalumab, and tremelimumab concentrations at different time points after administration. PK parameters that may be modeled on these data include clearance (CL).
Time frame: To be assessed at approximately 12 clinic visits through Day 113
Pharmacokinetics of MEDI0562/durvalumab or MEDI0562/tremelimumab: t½
The endpoints for assessment of PK of MEDI0562 and durvalumab or tremelimumab include individual MEDI0562, durvalumab, and tremelimumab concentrations at different time points after administration. PK parameters that may be modeled on these data include terminal phase half-life (t½).
Time frame: To be assessed at approximately 12 clinic visits through Day 113
Preliminary Antitumor Activity: Objective Response
The endpoints for assessment of antitumor activity include objective response (OR) and is defined as confirmed CR or confirmed PR based on RECIST v1.1
Time frame: At approximately 3 time points through Day 113.
Preliminary Antitumor Activity: Time to Response
The endpoints for assessment of Time to Response TTR and is defined as the time of first treatment to a subsequently confirmed CR or confirmed PR based on RECIST v1.1
Time frame: At approximately 3 time points through Day 113.
Preliminary Antitumor Activity: Percent Change from Baseline
The endpoints for assessment percent change from baseline in target lesion sum of diameters will be calculated at each adequate post baseline disease assessment with recorded measurement for all target lesions defined at baseline.
Time frame: At approximately 3 time points through Day 113.
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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