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Advanced MalignancyPhase 1NCT02978482

A Phase 1/2 Study of Durvalumab(MEDI4736) and Tremelimumab in Chinese Patients With Advanced Malignancies

A Phase 1 study testing durvalumab and tremelimumab + durvalumab in people with Advanced Malignancy, run by AstraZeneca at 2 sites in China.

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

A Phase 1/2 Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of Durvalumab (MEDI4736) in combination with tremelimumab in Chinese Patients with Advanced Malignancies Read more about this study

Who is it for?
Ages 18 to 130 years
Conditions the study is for
Advanced Malignancy
What is being tested?
durvalumab and tremelimumab + durvalumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
2 sitesChina
Study dates
1 Dec 2016to 26 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 18 to 130 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provision of informed consent prior to any study specific procedures
  • Male or female, aged at least 18 years
  • For Phase 1 PK cohort:
  • Patients with histologically or cytologically confirmed advanced and/or metastatic solid tumors other than HCC refractory or intolerable to existing standard of treatment
  • For Phase 2 cohort:
  • For nasopharyngeal carcinoma:
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  • Patients with histologically or cytologically confirmed nasopharyngeal carcinoma must have locally advanced or metastatic disease progressed on or after at least 1 chemotherapy regimen with or without radiotherapy.
  • ONLY FOR PHASE 2 PORTION: mandatory tumor sample
  • No prior exposure to immune-mediated therapy including, but not limited to, other anti CTLA-4, anti-PD-1, anti-PD-L1, and anti-programmed cell death ligand 2 (anti-PD-L2) antibodies, excluding therapeutic anticancer vaccines.
  • Life expectancy ≥12 weeks at Day 1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • At least 1 lesion that can be accurately measured at baseline, and that is suitable for repeated measurements as per RECIST 1.1 guidelines.
  • Adequate organ and marrow function
  • Hemoglobin ≥9 g/dL Absolute neutrophil count ≥1.0 × 109 /L Platelet count ≥75 × 109/L Total serum bilirubin ≤1.5×upper limit of normal (ULN) ALT and AST ≤2.5×ULN; for patients with hepatic metastases, ALT and AST ≤5×ULN Calculated creatinine clearance >40 mL/min as determined by Cockcroft-Gault (using actual body weight), or by measured 24-hour urine collection for determination of creatinine clearance.
  • Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients.

Who cannot join

  • Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (eg, hormone replacement therapy) is acceptable. Note: Local treatment of isolated lesions for palliative intent is acceptable (eg, local surgery or radiotherapy).
  • Receipt of last dose of an approved (marketed) anticancer therapy (chemotherapy, targeted therapy, biologic therapy, mAbs, etc) within 21 days prior to the first dose of study treatment. If sufficient washout time has not occurred due to the schedule or PK properties of an agent, a longer washout period will be required, as agreed upon by AstraZeneca and the Investigator.
  • Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug.
  • Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.
  • History of allogenic organ transplantation
  • Any unresolved toxicity National Cancer Institute (NCI) CTCAE Version 4.03 Grade ≥2 from previous anticancer therapy
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  • Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], celiac disease, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis], Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc).
  • Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent
  • History of another primary malignancy
  • History of leptomeningeal carcinomatosis
  • Brain metastases or spinal cord compression unless asymptomatic or treated and stable off steroids and anti-convulsants for at least 14 days prior to study treatment.
  • QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated.
  • History of active primary immunodeficiency
  • Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus .
  • Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab (MEDI4736) or tremelimumab.
  • Receipt of live, attenuated vaccine within 30 days prior to the first dose of IP.
  • Female patients who are pregnant or breast-feeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 180 days after the last dose of durvalumab (MEDI4736) plus tremelimumab combination therapy or 90 days after the last dose of durvalumab (MEDI4736) monotherapy.
  • Known allergy or hypersensitivity to IP or any IP excipient, or to other humanized mAbs
  • Prior randomisation or treatment in a previous durvalumab (MEDI4736) and/or tremelimumab clinical study regardless of treatment arm assignment
  • NSCLC patients have history of interstitial lung disease

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Research Site

    Changchun, 130000

  • Research Site

    Changchun, 130012

Other trials in China

About this study

Official title: A Phase 1/2 Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of Durvalumab (MEDI4736) in Combination With Tremelimumab in Chinese Patients With Advanced Malignancies

A Phase 1/2 Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of Durvalumab (MEDI4736) in combination with tremelimumab in Chinese Patients with Advanced Malignancies

Being tested
durvalumab, tremelimumab + durvalumab

What participants receive

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

  • durvalumabDrug

    durvalumab (MEDI4736) 20mg/kg via IV infusion every 4 weeks until confirmed disease progression or unacceptable toxicity

  • tremelimumab + durvalumabDrug

    20 mg/kg durvalumab (MEDI4736) via IV infusion q4w and 1 mg/kg tremelimumab via IV infusion q4w for up to 4 doses/cycles, and then continue 20 mg/kg durvalumab (MEDI4736) q4w starting on Week 16 for up to confirmed disease progression

Study groups in NCT02978482
Study groupRoleWhat they receive
durvalumabExperimentaldurvalumab alone
Receives: Drug: durvalumab
durvalumab+tremelimumabExperimentaldurvalumab plus tremelimumab
Receives: Drug: tremelimumab + durvalumab

What is being measured

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

  1. Maximum plasma concentration (Cmax)

    Only for phase 1 portion of the study

    Measured: approximately 6 months after the last evaluable patient in Phase 1 portion is first dosed

  2. Trough plasma concentration (Ctrough)

    Only for phase 1 portion of the study

    Measured: approximately 6 months after the last evaluable patient is first dosed in phase 1 portion

  3. Area under the plasma drug concentration-time curve from time zero to Day 28 post-dose (AUC 0-28)

    Only for phase 1 portion of the study

    Measured: approximately 6 months after the last evaluable patient is first dosed in phase 1 portion

  4. Adverse event

    Measured: Approximately 12 months after the last evaluable patient from Ph 1 is 1st dosed or the last patient has withdrawn from study or the study discontinued by Sponsor

  5. Objective response rate (ORR)

    Only for phase 2 portion of the study (Phase 2 part withdrawn without initiation)

    Measured: Approximately 12 months after the last evaluable patient is dosed, or the last patient has withdrawn from the study or the study is discontinued by the sponsor.

Secondary outcomes (4)

  1. Anti-drug antibody (ADA)

    Measured: approximately 12 months after the last evaluable patient is first dosed, or the last patient has withdrawn from the study, or the study is discontinued by the Sponsor

  2. Anti-drug antibody neutralizing antibodies (ADA nAB)

    Measured: approximately 12 months after the last evaluable patient is first dosed, or the last patient has withdrawn from the study, or the study is discontinued by the Sponsor

  3. Complete response/Partial response/Stable disease/Progressive disease

    Only for phase 1 portion of the study

    Measured: approximately 6 months after the last evaluable patient is first dosed in phase 1 portion

  4. Overall survival (OS)

    Only for phase 2 portion of the study (Phase 2 part withdrawn without initiation)

    Measured: approximately 12 months after the last evaluable patient is first dosed, or the last patient has withdrawn from the study, or the study is discontinued by the Sponsor

Timeline

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

  1. First posted1 Dec 2016 (estimated)
  2. Study start1 Dec 2016
  3. Primary completion28 Jan 2018
  4. Study completion26 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
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02978482
Sponsor's protocol ID
D419AC00006
Status last verified
Aug 2021
First submitted
8 Nov 2016
Last updated
18 Aug 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing durvalumab and tremelimumab + durvalumab in people with Advanced Malignancy, run by AstraZeneca at 2 sites in China.

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 15 inclusion and 20 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 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. 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?

Maximum plasma concentration (Cmax) (time frame: approximately 6 months after the last evaluable patient in Phase 1 portion is first dosed). The study lists 5 primary outcomes in all. 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 NCT02978482.

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 18 Aug 2021.

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