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Part A and B: Advanced Solid MalignanciesPhase 1NCT02141347

Ph1 to Assess Safety, Tolerability of Tremelimumab/ Tremelimumab+MEDI4736 in Japanese Solid Malignancies/ Mesothelioma

A Phase 1 study testing Tremelimumab and MEDI4736 in people with Part A and B: Advanced Solid Malignancies and Part C: Malignant Mesothelioma, run by AstraZeneca at 11 sites in Japan.

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 I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, PK and Preliminary Anti-tumor Activity when given as a monotherapy of Tremelimumab or Tremelimumab in combination with MEDI4736 in Japanese Patients with Advanced Solid Malignancies, and when given as a monotherapy of tremelimumab in Second… Read more about this study

Who is it for?
Ages 20 to 130 years
What is being tested?
Tremelimumab and MEDI4736
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
11 sitesJapan
Study dates
22 May 2014to 27 Jan 2017
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

Part A and B:

Inclusion Criteria: 1. Japanese aged at least 20 years old at a time of enrollment. 2. Histological or cytological confirmation of a solid malignant tumor excluding lymphoma that is refractory to standard therapies or for which no standard therapies exist. 3. ECOG Performance Status 0-1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks at a time of randomization. 4. At least one lesion (measurable and/or non-measurable) that can be accurately assessed at baseline by CT, MRI or plain X-ray and is suitable for repeated assessment. 5. Adequate bone marrow, hepatic, and renal function 6. Willingness to provide consent for archival biopsy samples if available.

Exclusion Criteria: 1. Received any prior treatment with monoclonal antibody against Programmed death 1 (PD1), Programmed death ligand 1 (PD-L1) and CTLA-4 (eg, ipilimumab) 2. The last dose of prior chemotherapy or radiation therapy was received less than 2 weeks prior to randomization 3 Currently receiving systemic corticosteroids or other immunosuppressive medications or has a medical condition that requires the chronic use of corticosteroids. 4. Receipt of live attenuated vaccination within 30 days of starting tremelimumab treatment 5. Active, untreated central nervous system (CNS) metastasis (subjects with brain metastases who are identified at screening 6. History of other malignancy unless the subject has been disease-free for at least 3 years. 7. Any unresolved chronic toxicity CTCAE grade ≥2 from previous anticancer therapy at the time of randomization, 8. Major surgical procedure within 30 days of starting

Part C:

Inclusion Criteria: 1. Japanese aged 20 and over at the time of consent 2. Histologically and/or cytologically confirmed pleural or peritoneal malignant mesothelioma 3. Disease not amenable to curative surgery 4. ECOG Performance status 0-1 5. Progressed after previous receipt of 1-2 prior systemic treatments for advanced disease that included a first-line pemetrexed (or anti-folate)-based regimen in combination with platinum agent. 6. Measurable disease, defined as at least 1 lesion (measurable) that can be accurately assessed at baseline by computed tomography CT or MRI and is suitable for repeated assessment. 7. Adequate bone marrow, hepatic, and renal function Exclusion Criteria: 1. Subjects who failed more than 2 prior systemic treatment regimens for advanced malignant mesothelioma 2. Received any prior mAb against CTLA-4, PD1 or PD-L1 3. History of chronic inflammatory or autoimmune disease. 4. Symptomatic, untreated CNS metastasis. 5. Any serious uncontrolled medical disorder or active infection that would impair the subject's ability to receive investigational product. 6. History of other malignancy. 7. History of diverticulitis, inflammatory bowel disease, sarcoidosis syndrome 8. Currently receiving systemic corticosteroids or other immunosuppressive medications. 9. Vaccinated with live attenuated vaccines within 30 days prior to starting tremelimumab treatment 10. Not recovered from all toxicities associated with prior cancer treatment to acceptable baseline status, or a NCI CTCAE ver.3.0 Grade of 0 or 1

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Japan11 sites
  • Research Site

    Bunkyō City, 113-8431

  • Research Site

    Chūōku, 104-0045

  • Research Site

    Hiroshima, 734-8551

  • Research Site

    Nagoya, 464-8681

  • Research Site

    Nishinomiya-shi, 663-8501

  • Research Site

    Okayama, 702-8055

  • Research Site

    Osaka, 541-8567

  • Research Site

    Sapporo, 003-0804

  • Research Site

    Sunto-gun, 411-8777

  • Research Site

    Ube-shi, 755-0241

  • Research Site

    Yokohama, 236-0051

Other trials in Japan

About this study

Official title: A Ph1 Open-Label Multicentre Study to Assess Safety, Tolerability, PK and Anti-tumor Activity of Tremelimumab /Tremelimumab With MEDI4736 in Japanese With Advanced Solid Malignancies or Tremelimumab in Japanese With Malignant Mesothelioma

A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, PK and Preliminary Anti-tumor Activity when given as a monotherapy of Tremelimumab or Tremelimumab in combination with MEDI4736 in Japanese Patients with Advanced Solid Malignancies, and when given as a monotherapy of tremelimumab in Second- or Third-line Treatment of Japanese Subjects with Unresectable Pleural or Peritoneal Malignant Mesothelioma

Read the detailed description

Primary objectives Part A: To investigate the safety and tolerability of tremelimumab when given to Japanese patients with advanced solid malignancies and define the dose(s) for further clinical evaluation.

Part B: To investigate the safety and tolerability of tremelimumab in combination with MEDI4736 when given to Japanese patients with advanced solid malignancies and to define the dose(s) for further clinical evaluation.

Part C: To investigate the safety and tolerability of tremelimumab when given to Japanese patients with unresectable pleural or peritoneal malignant mesothelioma.

Being tested
Tremelimumab, MEDI4736

What participants receive

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

  • TremelimumabDrug

    Tremelimumab administered intravenously

  • MEDI4736Drug

    MEDI4736 administered intravenously.

Study groups in NCT02141347
Study groupRoleWhat they receive
Part AOtherDose escalation of tremelimumab mono therapy for advanced solid malignancies
Receives: Drug: Tremelimumab
Part BOtherCombination therapy of tremelimumab and MEDI4736 for advanced solid malignancies
Receives: Drug: Tremelimumab; Drug: MEDI4736
Part COtherFixed dose of tremelimumab for malignant mesothelioma
Receives: Drug: Tremelimumab

What is being measured

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

  1. Adverse event

    To investigate the safety and tolerability of tremelimumab and/ or MEDI4736 when given to Japanese patients

    Measured: From time of informed consent to 90 days after the last dose

Timeline

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

  1. First posted19 May 2014 (estimated)
  2. Study start22 May 2014
  3. Primary completion27 Jan 2017
  4. Study completion27 Jan 2017

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
Other
Allocation
Non-randomised
Masking
None (open label)
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02141347
Sponsor's protocol ID
D4880C00010
Status last verified
Dec 2018
First submitted
14 May 2014
Last updated
12 Dec 2018
Results posted
No
Data monitoring committee
No

Publications

  • Fujiwara Y, Takahashi Y, Okada M, Kishimoto T, Kondo S, Fujikawa K, Hayama M, Sugeno M, Ueda S, Komuro K, Lanasa M, Nakano T. Phase I Study of Tremelimumab Monotherapy or in Combination With Durvalumab in Japanese Patients With Advanced Solid Tumors or Malignant Mesothelioma. Oncologist. 2022 Sep 2;27(9):e703-e722. doi: 10.1093/oncolo/oyac099.

    PubMed 35671201

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tremelimumab and MEDI4736 in people with Part A and B: Advanced Solid Malignancies and Part C: Malignant Mesothelioma, run by AstraZeneca at 11 sites in Japan.

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

Who may be eligible to take part?

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 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Japan. 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?

Adverse event (time frame: From time of informed consent to 90 days after the last dose). 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 NCT02141347, 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 Dec 2018.

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