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

Primary Purpose

Part A and B: Advanced Solid Malignancies, Part C: Malignant Mesothelioma

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Tremelimumab
MEDI4736
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Part A and B: Advanced Solid Malignancies

Eligibility Criteria

20 Years - 130 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Part A

Part B

Part C

Arm Description

Dose escalation of tremelimumab mono therapy for advanced solid malignancies

Combination therapy of tremelimumab and MEDI4736 for advanced solid malignancies

Fixed dose of tremelimumab for malignant mesothelioma

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 14, 2014
Last Updated
December 11, 2018
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT02141347
Brief Title
Ph1 to Assess Safety, Tolerability of Tremelimumab/ Tremelimumab+MEDI4736 in Japanese Solid Malignancies/ Mesothelioma
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
May 22, 2014 (Actual)
Primary Completion Date
January 27, 2017 (Actual)
Study Completion Date
January 27, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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- 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Part A and B: Advanced Solid Malignancies, Part C: Malignant Mesothelioma

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part A
Arm Type
Other
Arm Description
Dose escalation of tremelimumab mono therapy for advanced solid malignancies
Arm Title
Part B
Arm Type
Other
Arm Description
Combination therapy of tremelimumab and MEDI4736 for advanced solid malignancies
Arm Title
Part C
Arm Type
Other
Arm Description
Fixed dose of tremelimumab for malignant mesothelioma
Intervention Type
Drug
Intervention Name(s)
Tremelimumab
Intervention Description
Tremelimumab administered intravenously
Intervention Type
Drug
Intervention Name(s)
MEDI4736
Intervention Description
MEDI4736 administered intravenously.
Primary Outcome Measure Information:
Title
Adverse event
Description
To investigate the safety and tolerability of tremelimumab and/ or MEDI4736 when given to Japanese patients
Time Frame
From time of informed consent to 90 days after the last dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Research Site
City
Bunkyo-ku
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
Research Site
City
Chuo-ku
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Research Site
City
Hiroshima-shi
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Research Site
City
Nagoya-shi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Research Site
City
Nishinomiya-shi
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
Research Site
City
Okayama-shi
ZIP/Postal Code
702-8055
Country
Japan
Facility Name
Research Site
City
Osaka-shi
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
Research Site
City
Sapporo-shi
ZIP/Postal Code
003-0804
Country
Japan
Facility Name
Research Site
City
Sunto-gun
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
Research Site
City
Ube-shi
ZIP/Postal Code
755-0241
Country
Japan
Facility Name
Research Site
City
Yokohama-shi
ZIP/Postal Code
236-0051
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
35671201
Citation
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.
Results Reference
derived

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

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