Phase II Study of MEDI4736 Monotherapy or in Combinations With Tremelimumab in Metastatic Pancreatic Ductal Carcinoma

NCT02558894 | Completed Phase 2 Results FDA Drug

• 1 other identifier: D4198C00001
• Study Type: interventional
• Target: 65
• Locations: 6 countries
• Sites: 21

Brief Summary

A Phase II Open-Label, Multi-Center Study of MEDI4736 Evaluated as Single Agent or in Combination with Tremelimumab in Patients with Metastatic Pancreatic Ductal Adenocarcinoma.

Conditions

Metastatic Pancreatic Ductal Adenocarcinoma

Keywords

Pancreatic Ductal Adenocarcinoma, PDAC

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) in All Patients Using Investigator Assessments According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

  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).

  From date of first infusion until confirmed disease progression or death (up to approximately 18 months for the data analysis cut-off)

Secondary Outcomes (10)

• 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)

• Survival Status, Presented as OS Rate, at 6 Months and at 12 Months

  From date of first infusion until death (up to 6 months and 12 months)

• Best Objective Response (BoR) 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)

Study Arms (2)

MEDI4736 monotherapy

EXPERIMENTAL

MEDI4736 via IV infusion.

Drug: MEDI4736 monotherapy

tremelimumab+MEDI4736

EXPERIMENTAL

MEDI4736+tremelimumab via IV infusion.

Drug: tremelimumab+MEDI4736

Interventions

MEDI4736 monotherapy DRUG

MEDI4736 via IV infusion.

MEDI4736 monotherapy

tremelimumab+MEDI4736 DRUG

tremelimumab+MEDI4736 via IV infusion.

tremelimumab+MEDI4736

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed metastatic PDAC, no more than 1 prior chemotherapy regimen
• Eastern Cooperative Oncology Group 0 or 1
• At least 1 lesion, not previously irradiated, that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes, which must have short axis ≥15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) scan and that is suitable for accurate repeated measurements

You may not qualify if:

• Any concurrent chemotherapy, investigational product , biologic, or hormonal therapy for cancer treatment.
• History of leptomeningeal carcinomatosis
• Ascites requiring intervention
• Brain metastases or spinal cord compression.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (21)

Research Site

Tampa, Florida, 33612, United States

Location

Research Site

New York, New York, 10065, United States

Location

Research Site

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Research Site

Oshawa, Ontario, L1G 2B9, Canada

Location

Research Site

Ottawa, Ontario, K1H 8L6, Canada

Location

Research Site

Toronto, Ontario, M4N 3M5, Canada

Location

Research Site

Toronto, Ontario, M5G 2M9, Canada

Location

Research Site

Montreal, Quebec, H4A 3T2, Canada

Location

Research Site

Friedrichshafen, 88045, Germany

Location

Research Site

München, 81377, Germany

Location

Research Site

Tübingen, 72076, Germany

Location

Research Site

Amsterdam, 1105 AZ, Netherlands

Location

Research Site

Groningen, 9713 GZ, Netherlands

Location

Research Site

Nijmegen, 6525 GA, Netherlands

Location

Research Site

Seongnam-si, 463-707, South Korea

Location

Research Site

Seoul, 03080, South Korea

Location

Research Site

Seoul, 03722, South Korea

Location

Research Site

Seoul, 06591, South Korea

Location

Research Site

Seoul, 135-710, South Korea

Location

Research Site

Barcelona, 08035, Spain

Location

Research Site

Madrid, 28034, Spain

Location

Related Publications (1)

• O'Reilly EM, Oh DY, Dhani N, Renouf DJ, Lee MA, Sun W, Fisher G, Hezel A, Chang SC, Vlahovic G, Takahashi O, Yang Y, Fitts D, Philip PA. Durvalumab With or Without Tremelimumab for Patients With Metastatic Pancreatic Ductal Adenocarcinoma: A Phase 2 Randomized Clinical Trial. JAMA Oncol. 2019 Oct 1;5(10):1431-1438. doi: 10.1001/jamaoncol.2019.1588.

  PMID: 31318392 DERIVED

Related Links

• redacted csp
• Redacted SAP

MeSH Terms

Conditions

Anophthalmia with pulmonary hypoplasia

Limitations and Caveats

Study consisted of Part A Lead-in and 2 possible options for Part B: non-randomised expansion or randomised controlled trial. Criteria to open either option for Part B were not met and study was closed prematurely. Only Part A was conducted.

Results Point of Contact

• Title: Global Clinical Lead
• Organization: AstraZeneca

ClinicalTrialTransparency@astrazeneca.com

+1 301-398-0000

Study Officials

• Eileen M O'Reilly, M.D

  Memorial Sloan Kettering Cancer Center, 300 East 66th Street,New York,NY 10065

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2015
• First Posted: September 24, 2015
• Study Start: November 16, 2015
• Primary Completion: June 15, 2017
• Study Completion: June 15, 2017
• Last Updated: August 2, 2018
• Results First Posted: August 2, 2018

Record last verified: 2018-07

Locations

NL (3); DE (3); US (2); CA (6); KR (5); ES (2)