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.
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
- Conditions the study is for
- Part A and B: Advanced Solid Malignancies, Part C: Malignant Mesothelioma
- 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
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 group | Role | What they receive |
|---|---|---|
| Part A | Other | Dose escalation of tremelimumab mono therapy for advanced solid malignancies Receives: Drug: Tremelimumab |
| Part B | Other | Combination therapy of tremelimumab and MEDI4736 for advanced solid malignancies Receives: Drug: Tremelimumab; Drug: MEDI4736 |
| Part C | Other | Fixed 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.
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.
- First posted19 May 2014 (estimated)
- Study start22 May 2014
- Primary completion27 Jan 2017
- Study completion27 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Part A and B: Advanced Solid MalignanciesStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02141347
- Acronym / sponsor ID
- D4880C00010
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 22 May 2014 (actual)
- Primary completion
- 27 Jan 2017 (actual)
- Study completion
- 27 Jan 2017 (actual)
- First posted
- 19 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A | Other | Drug: TremelimumabDose escalation of tremelimumab mono therapy for advanced solid malignancies |
| Part B | Other | Drug: Tremelimumab, Drug: MEDI4736Combination therapy of tremelimumab and MEDI4736 for advanced solid malignancies |
| Part C | Other | Drug: TremelimumabFixed dose of tremelimumab for malignant mesothelioma |
Who may qualify
- Ages
- 20 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TremelimumabTremelimumab administered intravenously | Drug | Part A, Part B, Part C |
| MEDI4736MEDI4736 administered intravenously. | Drug | Part B |
Primary outcome
Adverse event
Time frame: From time of informed consent to 90 days after the last dose
To investigate the safety and tolerability of tremelimumab and/ or MEDI4736 when given to Japanese patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2018.
- Derived from this study: PubMed 35671201Fujiwara 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
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.