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MEDI4736 monotherapy

Phase 2

Metastatic Pancreatic Ductal Adenocarcinoma | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Aug 2, 2018

Target and mechanism

ModalitySmall molecule

Also known as MEDI4736, MEDI4736 (Durvalumab)

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment65

FDA Designations

No designations recorded

Clinical trial landscape

MEDI4736 monotherapy · 1 trial · 1 indication

Phase 2 1
NCT02558894Phase II Study of MEDI4736 Monotherapy or in Combinations With Tremelimumab in Metastatic Pancreatic Ductal CarcinomaMetastatic Pancreatic Ductal Adenocarcinoma
COMPLETED65 Analytics
PHASE2COMPLETED
Phase II Study of MEDI4736 Monotherapy or in Combinations With Tremelimumab in Metastatic Pancreatic Ductal Carcinoma
Metastatic Pancreatic Ductal AdenocarcinomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Objective Response Rate (ORR) in All Patients Using Investigator Assessments According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
From date of first infusion until confirmed disease progression or death (up to approximately 18 months for the data analysis cut-off)

ORR was defined as the percentage of patients with at least one visit response of confirmed complete response (CR) or partial response (PR). CR was defined as disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have had reduction in short axis to \<10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of TLs, taking as reference the baseline sum of diameters. A confirmed response meant that a response of CR/PR was recorded at 1 visit and confirmed by repeat imaging, preferably at the next regularly scheduled imaging visit and not less than 4 weeks after the visit when response was first observed with no evidence of progression between the initial and CR/PR confirmation visits. Results are reported as percentage of patients with a confirmed response and percentage of patients with confirmed or unconfirmed responses (i.e., including single visit responses).

Secondary Endpoints

Progression-free Survival (PFS) Using Investigator Assessments According to RECIST 1.1
From date of first infusion until confirmed disease progression or death (up to approximately 18 months for the data analysis cut-off)
PFS Rate at 3 Months and at 6 Months
From date of first infusion until confirmed disease progression or death (up to 3 months and 6 months)
Overall Survival (OS)
From date of first infusion until death (up to approximately 18 months for the data analysis cut-off)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MEDI4736 monotherapyEXPERIMENTALMEDI4736 via IV infusion.
tremelimumab+MEDI4736EXPERIMENTALMEDI4736+tremelimumab via IV infusion.

Interventions

NameTypeDescription
MEDI4736 monotherapyDRUGMEDI4736 via IV infusion.
tremelimumab+MEDI4736DRUGtremelimumab+MEDI4736 via IV infusion.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: - 1. Histologically or cytologically confirmed metastatic PDAC, no more than 1 prior chemotherapy regimen 2. Eastern Cooperative Oncology Group 0 or 1 3. At least 1 lesion, not previously irradiated, that can be accurately measured at baseline as ≥10 mm in the longest diameter (...

Countries:United StatesCanadaGermanyNetherlandsSouth KoreaSpain
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Frequently asked questions about MEDI4736 monotherapy

What is MEDI4736 used for?

MEDI4736, also known as durvalumab, is an investigational monoclonal antibody being studied for the treatment of several cancers, including non-small cell lung cancer, urothelial cancer, breast cancer, and recurrent or metastatic squamous cell carcinoma of the head and neck. It is currently in Phase 3 clinical development.

Who makes MEDI4736?

MEDI4736 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker symbol AZN. The drug is an investigational monoclonal antibody in Phase 3 clinical trials for oncology indications.

What phase is MEDI4736 in?

MEDI4736 is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials for the treatment of various cancers, including non-small cell lung cancer and head and neck cancer.

What clinical trials is MEDI4736 in?

MEDI4736 has been studied in several clinical trials, including NCT02352948, a Phase 3 study in non-small cell lung cancer with 597 participants, and NCT02369874, a Phase 3 study in head and neck cancer with 736 participants. Both trials have been completed.

Is MEDI4736 the same as durvalumab?

Yes, MEDI4736 is also known as durvalumab. The drug is being developed by AstraZeneca PLC under the ticker AZN and is currently in Phase 3 clinical trials for multiple oncology indications, including non-small cell lung cancer and urothelial cancer.