OncoMatch/Clinical Trials/NCT02029001
Adapting Treatment to the Tumor Molecular Alterations for Patients With Advanced Solid Tumors: MyOwnSpecificTreatment
Is NCT02029001 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for malignant solid neoplasms.
Treatment: Nilotinib (400 mg BID) · Everolimus (10 mg QD) · Sorafenib (400 mg BID) · Lapatinib (1500 mg QD) · Pazopanib (800 mg QD) · Olaparib (300 mg BID) · Durvalumab + Tremelimumab — The MOST Plus study is a two-period phase II clinical trial, conducted in patients with all types of progressive solid tumors after at least 1 prior systemic treatment regimen for advanced disease (in the absence of a validated second line therapy). The main goal of this study is to evaluate for these patients the clinical benefit of a maintenance treatment in patients with stable disease (SD) after induction treatment with a selected therapy (Molecular Targeted Therapy (MTT) or with SD, partial response (PR) or complete reponse (CR) with Immunotherapy (IT)). For MTT, the first period of this trial (induction period) will enable to establish whether the identification of genomic alterations in genes encoding for "actionable" targets in the tumor cells, regardless of the histological subtype, can be used to select efficient treatment targeting the pathway activated by the mutation. For Immunotherapy, induction period with durvalumab + tremelimumab is expected to be an innovative therapy for an efficient tumor control and may allow to identify types of cancer or molecular types of cancer that are more receptive to immunotherapy. For all treatments, the second period (maintenance period) will use a randomized design to evaluate the clinical benefit of a maintenance treatment with the targeted therapy or immunotherapy selected based on tumor molecular profile in patients treated by MTT with SD and in patients treated by IT with SD, PR or CR. Each patient enrolled will receive the matching targeted therapy during 12 weeks (MTT) or 52 weeks (IT). At the end of this induction period: MTT cohorts : * patients with a tumor response (CR: complete response or PR: partial response) will continue the targeted therapy, * patients in progression will discontinue the targeted therapy and will be withdrawn from study and oriented towards standard treatments * patients with a stable disease at 12 weeks will be randomized in order to determine if they continue or stop the therapy. IT cohort : \- patients with SD, PR or CR at 52 weeks will be randomized in order to determine if they continue or stop the therapy. For each MTT treatment group: \~80 patients treated in the first step (induction period), 50 patients randomized in the second step (maintenance period, 25 patients per arm). For IT treatment group: \~125 patients treated in the first step (induction period), 50 patients randomized in the second step (maintenance period, 25 patients per arm). In total (for 7 treatment groups): \~ 900 patients treated in the induction period and 350 patients randomized in maintenance period.
Check if I qualifyExtracted eligibility criteria
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic therapy — locally advanced or metastatic
At least one prior systemic treatment regimen for locally advanced or metastatic disease - except for Nilotinib cohort : patients can be treated with Nilotinib in first line systemic treatment. ... As there is no prior systemic treatment regimen available for locally advanced or metastatic PEComa, these tumors are eligible for a MTT treatment in first line of their advanced or metastatic disease.
Cannot have received: immune checkpoint inhibitor (anti-PD1, anti-PDL1, anti-CTLA4, anti-LAG3)
Exception: No previous treatment by immune checkpoint inhibitors (anti-PD1/PDL1, anti-CTLA4, anti-LAG3 etc.) is allowed for IT group.
No previous treatment by immune checkpoint inhibitors (anti-PD1/PDL1, anti-CTLA4, anti-LAG3 etc.) is allowed for IT group.
Cannot have received: investigational therapy inhibiting the same target proteins
Previous treatment in advanced phase with an investigational therapy inhibiting the same target proteins as this recommended for the study.
Lab requirements
Blood counts
ANC ≥ 1 x 10^9/L (for pazopanib and olaparib: ≥ 1.5 x 10^9/L); Platelets ≥ 100 x 10^9/L; Hemoglobin ≥ 9 g/dL (for olaparib: Hemoglobin ≥ 10 g/dL)
Kidney function
Serum creatinine ≤ 1.5x ULN or creatinine clearance ≥ 50 mL/min (for pazopanib: creatinine clearance ≥ 30 mL/min; for olaparib: creatinine clearance ≥ 51 mL/min; for IT: creatinine clearance ≥ 40 mL/min)
Liver function
AST and ALT ≤ 3x ULN in the absence of liver metastases (≤ 5x ULN for patients with liver involvement); total bilirubin ≤ 1.5x ULN. (for pazopanib: AST and ALT ≤ 2.5x ULN; for olaparib and IT: AST and ALT ≤ 2.5x ULN in the absence of liver metastases (≤ 5x ULN for patients with liver involvement) and total bilirubin ≤ 1.5x ULN.)
Cardiac function
Corrected QT (QTc) interval ≤ 450 msecs (≤ 480 msecs if recommended MTT has no known effect on QT interval); for olaparib: QTc < 470 msec on 2 or more time points within a 24 hour period
Adequate organ system function as assessed by the following minimal laboratory requirements: ... (see full criteria for details)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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