Advanced Solid Malignancies Clinical Trial
Official title:
An Open-Label, Multi-Centre, Safety Study of Fixed-Dose Durvalumab + Tremelimumab Combination Therapy or Durvalumab Monotherapy in Advanced Solid Malignancies.
To evaluate the safety, tolerability, and anti-tumor activity of the combination of durvalumab + tremelimumab or durvalumab alone in different solid tumors.
This is an open-label, multi-center, study to determine the short and long term safety of fixed doses of durvalumab 1500 mg + tremelimumab 75 mg combination therapy or durvalumab 1500 mg monotherapy in patients with advanced solid malignancies. This study is modular in design, one or more of the modules will be opened in a given country / region based on local patient population prevalence, and results of feasibility studies. The total number of patients to be enrolled overall and in each module will depend on the types and number of tumor modules added to the main study and country-specific ancillary studies. The number of patients and sites to be involved in individual countries will be dependent on each module or ancillary study. This study consisted of a screening period, a treatment period, a 90 day safety follow-up period and a survival follow-up period. Patients will receive the investigation product (IP) via intravenous (IV) infusion once every 4 weeks (Q4W) in combination therapy or monotherapy as mentioned below - Combination therapy: Durvalumab 1,500 mg + tremelimumab 75 mg on Week 0, for up to a maximum of 4 doses (or cycles) followed by durvalumab 1,500 mg starting 4 weeks after the last infusion of the combination or discontinuation of tremelimumab. Monotherapy: Durvalumab 1,500 mg on week 0. Patients will attend a safety follow-up visit 90 days after study treatment discontinuation. Thereafter, patients will be contacted by phone or electronic communication every 3 months for survival status up to 5 years following date of first patient treatment initiation. All patients will be followed for a minimum of 6 months following enrolment of last patient. It is anticipated that the total enrolment period for the overall study will be approximately 2 to 3 years, with an overall duration of approximately 5 years ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT02080078 -
A Phase I Dose Escalation Study of Erlotinib in Combination With Theophylline
|
Phase 1 | |
Completed |
NCT00981721 -
A Study to Determine the Pharmacokinetics of Cediranib in Chinese Patients With Advanced Solid Malignancies
|
Phase 1 | |
Terminated |
NCT00351325 -
A Study of BMS-663513 Administered in Combination With Chemotherapy to Subjects With Advanced Solid Malignancies
|
Phase 1 | |
Completed |
NCT00295243 -
Phase I Study of GW572016 With Topotecan to Treat Advanced Solid Malignancies
|
Phase 1 | |
Recruiting |
NCT02347228 -
Evaluate Safety, Tolerability, PK, Preliminary Clinical Activity of OB318 in Patients With Advanced Solid Malignancies
|
Phase 1 | |
Terminated |
NCT00979134 -
Study is Designed to Assess the Safety and Tolerability of AZD4547 at Increasing Doses in Patients With Advanced Tumours
|
Phase 1 | |
Completed |
NCT00997945 -
10mg ZD4054 (Zibotentan) PK Study in Male, Elderly Chinese Patients With Advanced Solid Malignancies
|
Phase 1 | |
Completed |
NCT05573724 -
Drug-drug Interaction Study With AZD5305 and Itraconazole in Patients With Advanced Solid Malignancies
|
Phase 1 | |
Completed |
NCT03736473 -
A Phase I Study of MEDI9447 (Oleclumab) in Japanese Patients
|
Phase 1 | |
Completed |
NCT02260661 -
Phase I, Dose Study to Look at the Safety and Pharmacokinetics of AZD8835 in Patients With Advanced Solid Tumours
|
Phase 1 | |
Terminated |
NCT01219543 -
A Phase I Study of AZD1480 in Patients With Advanced Solid Malignancies and Advanced Hepatocellular Carcinoma in the Escalation Phase,Non-Small Cell Lung Cancer(NSCLC) and Non-smokers With Lung Metastasis and Gastric Cancer and Solid Tumour in the Expansion Phase.
|
Phase 1 | |
Completed |
NCT01213160 -
Study to Assess Safety and Tolerability of AZD4547 in Japanese Patient
|
Phase 1 | |
Completed |
NCT00572364 -
Open Label, Dose Escalation Phase I Study of AZD2281
|
Phase 1 | |
Completed |
NCT03363893 -
Modular Study to Evaluate CT7001 Alone in Cancer Patients With Advanced Malignancies
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04606381 -
A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies
|
Phase 1 | |
Recruiting |
NCT05315167 -
A Phase I/II Study to Evaluate the Safety, Pharmacokinetics and Efficacy of PRJ1-3024 in Subjects With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT00879905 -
A Study of HSP990 Administered by Mouth in Adult Patients With Advanced Solid Tumors
|
Phase 1 | |
Terminated |
NCT00473616 -
Phase I Single Ascending Dose/Multiple Ascending Dose in Patients Treated With AZD7762 and Irinotecan
|
Phase 1 | |
Recruiting |
NCT05159700 -
A Phase I Study, Evaluating the Safety, Pharmacokinetics and Efficacy of PRJ1-3024 in Subjects With Advanced Solid Tumors
|
Phase 1 | |
Completed |
NCT01813474 -
Investigate the Safety and Tolerability of Olaparib Tablet in Japanese Patients With Advanced Solid Malignancies
|
Phase 1 |