Spots Global Cancer Trial Database for A Modular Multi-Basket Trial to Improve Personalized Medicine in Cancer Patients (Basket of Baskets)

Study Description

Brief Summary: The global objective of this Basket of Basket study is to evaluate the antitumor activity of each matched therapies that will be evaluated through the study in small molecularly selected populations. The objective of module 1 wil be to determine the overall response rate (ORR) at 12 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of atezolizumab in each of the arms of the module. All patients in genomically selected populations will receive atezolizumab 1200 mg IV every 3 weeks. The objective of module 2 wil be to determine the overall response rate (ORR) at 16 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of futibatinib in each of the arms of the module. All patients in genomically selected populations will receive will receive futibatinib, 20 mg, once daily (QD) in 28-day cycles. The objective of module 3 wil be to determine the overall response rate (ORR) at 12 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of amivantamab in each of the arms of the module. All patients in genomically selected populations will receive amivantamab 1050 mg intravenously (IV) for body weight \< 80 kg and 1400 mg for body weight \>= 80 kg mg once weekly in Cycle 1 (with a split dose on Days 1-2) and then every 2 weeks in subsequent cycles (28-day cycles).

Detailed Description: Basket studies are a new sort of clinical studies to identify patients with the same kind of mutations and treat them with the same drug, irrespective of their specific cancer type. In basket studies, depending on the mutation types, patients are classified into "baskets". Targeted therapies that block that mutation are then identified and assigned to baskets where patients are treated accordingly. This protocol has two parts: part A (iPROFILER), which includes the common procedures for tumor molecular profiling and treatment recommendation, and part B (iBASKET), which corresponds to the therapeutic portion. The purpose of part A (iPROFILER) of this study is to test participants' tumour tissue in order to identify whether their tumour has certain mutations in cancer-related genes. It is known that gene mutations of tumours contribute to their origin and growth and determine whether the tumour will respond to particular cancer drugs. This test will provide information about potential targeted therapies that specifically attack those gene mutations. The purpose of part B (iBASKET) of this study is to offer participants a personalised anti-cancer treatment based on the gene mutations that are found in their tumour. Participants taking part in module 1 of part B (iBASKET) will receive atezolizumab 1200 mg IV every 3 weeks, following the analysis of their tumour in part A (iPROFILER). Participants will be able to take atezolizumab for as long as their tumour doesn't grow and for as long as they don't have any side-effects which prevent them from continuing treatment. Module 1 will have a 2-year recruitment period. The aim of the study is to determine which genomically selected populations respond effectively to the targeted treatment, atezolizumab. Approximately 1000 participants will be enrolled into part A (iPROFILER), with approximately 120 participants being recruited into module 1 of part B (iBASKET). Participants taking part in module 2 of part B (iBASKET) will receive will receive futibatinib, 20 mg, once daily (QD) in 28-day cycles, following the analysis of their tumour in part A (iPROFILER). Participants will be able to take futibatinib for as long as their tumour doesn't grow and for as long as they don't have any side-effects which prevent them from continuing treatment. Module 2 will have a 2-year recruitment period. The aim of the study is to determine which genomically selected populations respond effectively to the targeted treatment, futibatinib. Approximately 1000 participants will be enrolled into part A (iPROFILER), with approximately 80 participants being recruited into module 2 of part B (iBASKET). Participants taking part in module 3 of part B (iBASKET) will receive amivantamab 1050 mg IV for body weight \< 80 kg and 1400 mg for body weight \>= 80 kg mg once weekly in Cycle 1 (with a split dose on Days 1-2) and then every 2 weeks in subsequent cycles (28-day cycles), following the analysis of their tumour in part A (iPROFILER). Participants will be able to take amivantamab for as long as their tumour doesn't grow and for as long as they don't have any side-effects which prevent them from continuing treatment. Module 3 will have a 2.5-year recruitment period. The aim of the study is to determine which genomically selected populations respond effectively to the targeted treatment, amivantamab. Approximately 1725 participants will be enrolled into part A (iPROFILER), with approximately 69 participants being recruited into module 3 of part B (iBASKET).

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Useful links and downloads for this trial