NCT01938612

Brief Summary

This is a phase I, open-label, multicentre study of MEDI4736 administered intravenously with a standard 3+3 dose-escalation phase to evaluate safety, tolerability, and pharmacokinetics in patients with advanced solid tumor followed by an expansion phase in patients with advanced solid tumors.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
269

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2013

Longer than P75 for phase_1

Geographic Reach
3 countries

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 10, 2013

Completed
2 days until next milestone

Study Start

First participant enrolled

September 12, 2013

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2020

Completed
Last Updated

March 12, 2021

Status Verified

March 1, 2021

Enrollment Period

4.5 years

First QC Date

September 5, 2013

Last Update Submit

March 11, 2021

Conditions

Advanced Solid Tumors

Keywords

MEDI4736Advanced solid tumorssquamous cell carcinoma of the head and Neckbiliary tract cancersquamous cell carcinoma of esophagus cancerB7-H1PD-L1

Outcome Measures

Primary Outcomes (1)

  • Number of participants experiencing dose-limiting toxicities, adverse events (AEs), serious adverse events (SAEs)

    Safety profile will be assessed through number of participants experiencing adverse events (AEs), serious adverse events (SAEs), laboratory evaluations, vital signs, and physical examinations.

    90 days after the last dose of MEDI4736

Secondary Outcomes (11)

  • Area under the concentration of MEDI4736 time curve

    Up to 90 days after the last dose of MEDI4736

  • Percentage of participants who developed detectable anti-drug antibodies (ADAs).

    Up to 6 months after the last dose of MEDI4736 or up to 1 month after the last dose of tremelimumab where applicable.

  • Objective response rate (ORR)

    From first dose of study drug until death or up to 2 years

  • Maximum tolerated dose (MTD) or optimal biological dose (OBD)

    90 days after the last dose of MEDI4736

  • Maximum concentration of MEDI4736

    Up to 90 days after the last dose of MEDI4736

  • +6 more secondary outcomes

Study Arms (5)

MEDI4736 Q2W

EXPERIMENTAL

Evaluate MEDI4736 given every 2 weeks

Drug: MEDI4736

MEDI4736 Q3W

EXPERIMENTAL

Evaluate MEDI4736 given every 3 weeks

Drug: MEDI4736

MEDI4736 Dose Expansion

EXPERIMENTAL

evaluate MEDI4736 given every 2 weeks

Drug: MEDI4736

MEDI4736 Q4W

EXPERIMENTAL

Evaluate MEDI4736 given every 4 weeks

Drug: MEDI4736

MEDI4736 combined with another drug

EXPERIMENTAL

evaluate MEDI4736 in combination with another drug given every 4 weeks

Drug: tremelimumab

Interventions

MEDI4736DRUG

MEDI4736 will be administered by IV infusion every 14, 21 or 28 days.

MEDI4736 Dose ExpansionMEDI4736 Q2WMEDI4736 Q3WMEDI4736 Q4W
tremelimumabDRUG

tremelimumab is administered by IV infusion every 4 weeks

MEDI4736 combined with another drug

Eligibility Criteria

Age20 Years - 130 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • In the dose-escalation phase: patients with advanced solid tumors refractory to standard treatment, intolerant of standard treatment, or for which no standard therapy exists.
  • In the dose-expansion phase: histologically- or cytologically-confirmed advanced or metastatic biliary tract cancer (BTC), esophagus cancer(EC) (squamous cell carcinoma) or squamous cell carcinoma of the head and neck (SCCHN). - men or women. - Eastern Cooperative Oncology Group (ECOG) status of 0 or 1. - Adequate organ and marrow function. - Subjects must have at least 1 measurable lesion. - Available archived tumor tissue sample. - Willingness to provide consent for biopsy samples.

You may not qualify if:

  • Any prior Grade ≥ 3 irAE while receiving immunotherapy - Prior exposure to any anti-PD-1 or anti-PD-L1 antibody - Active or prior documented autoimmune disease within the past 2 years - History of primary immunodeficiency - Symptomatic or untreated central nervous system (CNS) metastases requiring concurrent treatment - Women who are pregnant or lactating - Uncontrolled intercurrent illness - Known history of tuberculosis - Known to be human immunodeficiency virus (HIV) positive - Hepatitis B or C infection - Other invasive malignancy within 5 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Research Site

Beppu-shi, 874-0011, Japan

Location

Research Site

Chūōku, 104-0045, Japan

Location

Research Site

Kashiwa, 277-8577, Japan

Location

Research Site

Kitaadachi-gun, 362-0806, Japan

Location

Research Site

Kōtoku, 135-8550, Japan

Location

Research Site

Kure-shi, 737-0023, Japan

Location

Research Site

Matsuyama, 791-0280, Japan

Location

Research Site

Nagoya, 464-8681, Japan

Location

Research Site

Osaka, 541-8567, Japan

Location

Research Site

Sapporo, 003-0804, Japan

Location

Research Site

Sapporo, 060-8648, Japan

Location

Research Site

Sayama, 589-8511, Japan

Location

Research Site

Suita-shi, 565-0871, Japan

Location

Research Site

Sunto-gun, 411-8777, Japan

Location

Research Site

Takatsuki-shi, 569-8686, Japan

Location

Research Site

Yokohama, 241-8515, Japan

Location

Research Site

Seoul, 03080, South Korea

Location

Research Site

Seoul, 135-710, South Korea

Location

Research Site

Tainan, 704, Taiwan

Location

Research Site

Taipei, 10002, Taiwan

Location

Research Site

Taoyuan District, 333, Taiwan

Location

Related Publications (1)

  • Doki Y, Ueno M, Hsu CH, Oh DY, Park K, Yamamoto N, Ioka T, Hara H, Hayama M, Nii M, Komuro K, Sugimoto M, Tahara M. Tolerability and efficacy of durvalumab, either as monotherapy or in combination with tremelimumab, in patients from Asia with advanced biliary tract, esophageal, or head-and-neck cancer. Cancer Med. 2022 Jul;11(13):2550-2560. doi: 10.1002/cam4.4593. Epub 2022 May 24.

    PMID: 35611499DERIVED

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and NeckBiliary Tract Neoplasms

Interventions

durvalumabtremelimumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by SiteDigestive System NeoplasmsBiliary Tract DiseasesDigestive System Diseases

Study Officials

  • Robert Iannone, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2013

First Posted

September 10, 2013

Study Start

September 12, 2013

Primary Completion

March 1, 2018

Study Completion

November 25, 2020

Last Updated

March 12, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will share

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. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Time Frame
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.
Access Criteria
When a request has been approved AstraZeneca will provide access to the deidentified 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.
More information

Locations

TW(3)JP(16)KR(2)