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Advanced Solid TumorsPhase 1NCT01938612

A Phase I, Open-Label, Multicentre Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MEDI4736 in Patients With Advanced Solid Tumours

A Phase 1 study testing MEDI4736 and tremelimumab in people with Advanced Solid Tumors, run by AstraZeneca at 21 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 130 years
Conditions the study is for
Advanced Solid Tumors
What is being tested?
MEDI4736 and tremelimumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
269 participants
Where
21 sitesin 3 countries
Study dates
12 Sep 2013to 25 Nov 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 130 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

21 sites in 3 countries.

21 sites in 3 countries

Japan16 sites

  • Research Site

    Beppu-shi, 874-0011

  • Research Site

    Chūōku, 104-0045

  • Research Site

    Kashiwa, 277-8577

  • Research Site

    Kitaadachi-gun, 362-0806

  • Research Site

    Kōtoku, 135-8550

  • Research Site

    Kure-shi, 737-0023

  • Research Site

    Matsuyama, 791-0280

  • Research Site

    Nagoya, 464-8681

  • Research Site

    Osaka, 541-8567

  • Research Site

    Sapporo, 003-0804

  • Research Site

    Sapporo, 060-8648

  • Research Site

    Sayama, 589-8511

  • Research Site

    Suita-shi, 565-0871

  • Research Site

    Sunto-gun, 411-8777

  • Research Site

    Takatsuki-shi, 569-8686

  • Research Site

    Yokohama, 241-8515

Other trials in Japan

Taiwan3 sites

  • Research Site

    Tainan, 704

  • Research Site

    Taipei, 10002

  • Research Site

    Taoyuan, 333

Other trials in Taiwan

South Korea2 sites

  • Research Site

    Seoul, 03080

  • Research Site

    Seoul, 135-710

Other trials in South Korea

About this study

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.

Being tested
MEDI4736, tremelimumab
Keywords
MEDI4736, Advanced solid tumors, squamous cell carcinoma of the head and Neck, biliary tract cancer, squamous cell carcinoma of esophagus cancer, B7-H1, PD-L1
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Biliary Tract Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MEDI4736Drug

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

  • tremelimumabDrug

    tremelimumab is administered by IV infusion every 4 weeks

Study groups in NCT01938612
Study groupRoleWhat they receive
MEDI4736 Q2WExperimentalEvaluate MEDI4736 given every 2 weeks
Receives: Drug: MEDI4736
MEDI4736 Q3WExperimentalEvaluate MEDI4736 given every 3 weeks
Receives: Drug: MEDI4736
MEDI4736 Dose ExpansionExperimentalevaluate MEDI4736 given every 2 weeks
Receives: Drug: MEDI4736
MEDI4736 Q4WExperimentalEvaluate MEDI4736 given every 4 weeks
Receives: Drug: MEDI4736
MEDI4736 combined with another drugExperimentalevaluate MEDI4736 in combination with another drug given every 4 weeks
Receives: Drug: tremelimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 90 days after the last dose of MEDI4736

Secondary outcomes (11)

  1. Area under the concentration of MEDI4736 time curve

    If data allow, noncompartmental PK parameter (AUC) will be estimated.

    Measured: Up to 90 days after the last dose of MEDI4736

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

    The immunogenic potential of MEDI4736 or tremelimumab will be assessed by summarizing the number percentage of subjects who develop detectable anti-drug antibodies (ADAs).

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

  3. Objective response rate (ORR)

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

  4. Maximum tolerated dose (MTD) or optimal biological dose (OBD)

    maximum tolerated dose (MTD) or optimal biological dose (OBD) of MEDI4736, if possible

    Measured: 90 days after the last dose of MEDI4736

  5. Maximum concentration of MEDI4736

    If data allow, noncompartmental PK parameter (Cmax) will be estimated.

    Measured: Up to 90 days after the last dose of MEDI4736

  6. Clearance

    If data allow, noncompartmental PK parameter (CL) will be estimated.

    Measured: Up to 90 days after the last dose of MEDI4736

  7. half-life after administration of MEDI4736

    If data allow, noncompartmental PK parameter (t½) will be estimated.

    Measured: Up to 90 days after the last dose of MEDI4736

  8. Disease control rate (DCR)

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

  9. Duration of response (DoR)

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

  10. Progression-free survival (PFS)

    Alive and progression free at 6 months (APF6) and 12 months (APF12) will be obtained using the Kaplan-Meier plot of PFS.

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

  11. Overall survival (OS)

    The proportion of patients alive at 12 months will be obtained from the Kaplan-Meier plot of OS.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2013 (estimated)
  2. Study start12 Sep 2013
  3. Primary completion1 Mar 2018
  4. Study completion25 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
269 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01938612
Sponsor's protocol ID
D4190C00002
Status last verified
Mar 2021
First submitted
5 Sep 2013
Last updated
12 Mar 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 35611499

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MEDI4736 and tremelimumab in people with Advanced Solid Tumors, run by AstraZeneca at 21 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Japan, Taiwan, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants experiencing dose-limiting toxicities, adverse events (AEs), serious adverse events (SAEs) (time frame: 90 days after the last dose of MEDI4736). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01938612, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2021.

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