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MEDI4736

Phase 1

Solid Tumors | Small molecule | Oncology |Incyte Corporation|Last Updated: Jan 13, 2022

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment176

FDA Designations

No designations recorded

Clinical trial landscape

MEDI4736 · 1 trial · 4 indications

Phase 1 1
NCT02318277A Study of Epacadostat (INCB024360) in Combination With Durvalumab (MEDI4736) in Subjects With Selected Advanced Solid Tumors (ECHO-203)Solid Tumors
COMPLETED176 Analytics
PHASE1COMPLETED
A Study of Epacadostat (INCB024360) in Combination With Durvalumab (MEDI4736) in Subjects With Selected Advanced Solid Tumors (ECHO-203)
Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Phase 1 : Number of Treatment-Emergent Adverse Events (TEAE)
Duration of study treatment and up to 90 days after the last dose [approximately 3 years]

Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment

Phase 2: Objective Response Rate (ORR) as Determined by Radiographic Disease Assessments Per Modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured every 8 weeks for duration of study treatment [approximately 12 months]

ORR was defined as the percentage of participants having a complete response (CR) or partial response (PR) as determined by investigator assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Secondary Endpoints

Phase 1: Objective Response Rate (ORR) as Determined by Radiographic Disease Assessments Per Modified RECIST v1.1
Measured every 8 weeks for duration of study treatment [approximately 6 months]
Phase 2: Number of Treatment-Emergent Adverse Events
Continuously for duration of study treatment and up to 90 days after the last dose [approximately 3 years]
Phase 1 and 2: Durability of Response as Measured by the Time From the Earliest Date of Disease Response Until Earliest Date of Disease Progression
Measured every 8 weeks for duration of active study treatment [approximately 24 months]
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MEDI4736 + INCB024360EXPERIMENTALMEDI4736 at selected dose levels every 2 weeks + INCB024360 25 mg BID as starting dose, followed by dose escalations until MTD or PAD is identified

Interventions

NameTypeDescription
MEDI4736DRUGMEDI4736 administered intravenously (IV) every two weeks (q2w)
INCB024360DRUGINCB024360: Oral daily dosing
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: * Male or female subjects, age 18 years or older * Histologically or cytologically confirmed diagnosis of selected locally advanced or metastatic solid tumors * Must have failed at least 1 prior treatment regimen for locally advanced or metastatic disease or be intolerant to tre...

Countries:United States
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumors")

Frequently asked questions about MEDI4736

What is MEDI4736 used for?

MEDI4736, also known as durvalumab, is an investigational drug being studied for the treatment of solid tumors, including head and neck cancer, lung cancer, and urothelial cancer. It is being evaluated in combination with epacadostat in patients with selected advanced solid tumors.

Who makes MEDI4736?

MEDI4736 is being developed by Incyte Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol INCY. The drug is being studied in combination with epacadostat for the treatment of advanced solid tumors.

What phase is MEDI4736 in?

MEDI4736 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study evaluating MEDI4736 in combination with epacadostat has been completed.

What clinical trials is MEDI4736 in?

MEDI4736 was studied in a Phase 1 clinical trial with the identifier NCT02318277, titled 'A Study of Epacadostat (INCB024360) in Combination With Durvalumab (MEDI4736) in Subjects With Selected Advanced Solid Tumors (ECHO-203)'. The trial enrolled 176 participants and has been completed.

Is MEDI4736 the same as durvalumab?

Yes, MEDI4736 is also known as durvalumab. In clinical trials, it is referred to by both names, with the study title using 'Durvalumab (MEDI4736)' to identify the drug.