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
Overview
- Phase
- Phase 1
- Intervention
- Tremelimumab
- Conditions
- Part A and B: Advanced Solid Malignancies
- Sponsor
- AstraZeneca
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- Adverse event
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Japanese aged at least 20 years old at a time of enrollment.
- •Histological or cytological confirmation of a solid malignant tumor excluding lymphoma that is refractory to standard therapies or for which no standard therapies exist.
- •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.
- •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.
- •Adequate bone marrow, hepatic, and renal function
- •Willingness to provide consent for archival biopsy samples if available.
Exclusion Criteria
- •Received any prior treatment with monoclonal antibody against Programmed death 1 (PD1), Programmed death ligand 1 (PD-L1) and CTLA-4 (eg, ipilimumab)
- •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.
- •Receipt of live attenuated vaccination within 30 days of starting tremelimumab treatment
- •Active, untreated central nervous system (CNS) metastasis (subjects with brain metastases who are identified at screening
- •History of other malignancy unless the subject has been disease-free for at least 3 years.
- •Any unresolved chronic toxicity CTCAE grade ≥2 from previous anticancer therapy at the time of randomization,
- •Major surgical procedure within 30 days of starting
- •Inclusion Criteria:
- •Japanese aged 20 and over at the time of consent
- •Histologically and/or cytologically confirmed pleural or peritoneal malignant mesothelioma
Arms & Interventions
Part A
Dose escalation of tremelimumab mono therapy for advanced solid malignancies
Intervention: Tremelimumab
Part B
Combination therapy of tremelimumab and MEDI4736 for advanced solid malignancies
Intervention: Tremelimumab
Part B
Combination therapy of tremelimumab and MEDI4736 for advanced solid malignancies
Intervention: MEDI4736
Part C
Fixed dose of tremelimumab for malignant mesothelioma
Intervention: Tremelimumab
Outcomes
Primary Outcomes
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