IPILIMUMAB for Thymoma (type B3) | Thymic carcinoma

Inclusion criteria

• {"criterion_text":"-Relapsed/advanced thymoma B3 or thymic carcinoma not amenable to curative-intent radical treatment\n-Adequate renal function: calculated creatinine clearance ≥50 mL/min (according to Cockroft-Gault, see below); -Female CrCl = ((140 - age in years) x weight in kg x 0.85)/ 72 x serum creatinine in mg/dL; -Male CrCl = ((140 - age in years) x weight in kg x 1.00)/72 x serum creatinine in mg/dL\n-Women of child bearing potential (WOCBP) must have a negative serum pregnancy test within 72 hours prior to the first dose of study treatment\n-Patients of childbearing / reproductive potential should use adequate birth control measures, as defined by the investigator, during the study treatment period and for at least 5 months for a woman and 7 months for a man after the last study treatment.\n-Female patients who are breast feeding should discontinue nursing prior to the first dose of study medication and must not breast feed during the trial treatment and for a period of at least 5 months following the last administration of trial drug(s)\n-Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.\n-At least one previous line of platinum-based chemotherapy for advanced disease\n-Radiological progression documented per RECIST 1.1 during or after completion of previous line therapy\n-Presence of measurable disease according to RECIST 1.1.\n-At least 18 years\n-WHO Performance Status (PS) 0-2\n-Availability of FFPE tumor tissue (preferentially a tumor block or 10 unstained slides), notably for PD-L1 immunohistochemistry (IHC) expression assessment. Archival material is allowed. Tissue must be considered adequate (assessed by a local pathologist) for characterization of PD-L1 status as per procedure manual\n-Adequate hematological function: -White blood count ≥ 2 × 109/L; -Haemoglobin >9 g/dL; -Platelet count >100 × 109/L\n-Adequate liver function: -Total bilirubin <1.5 × ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL); -LT and/or AST <2.5 × ULN (< 4 x ULN in case of liver metastasis) -Alkaline phosphatase <5 × ULN"}

Exclusion criteria

• {"criterion_text":"-Any evidence of active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are clinically stable (i.e. without evidence of progression by imaging for at least four weeks prior to enrollment and any neurologic symptoms have returned to baseline), and have not received steroids (for a total equivalent dose of more than 10 mg of prednisone per day) for at least 7 days prior to enrollment\n-Autoimmune paraneoplastic syndrome requiring immunosuppressive or dedicated treatment. Particular attention should be given to detecting any minor myasthenia signs or positive autoantibodies at enrollment\n-History of any other hematologic or primary solid tumor malignancy, unless in remission for at least 5 years. pT1-2 prostatic cancer Gleason score < 6, superficial bladder cancer, non melanomatous skin cancer or carcinoma in situ of the cervix are allowed\n-Previous allogeneic tissue/solid organ transplant\n-Active infection requiring therapy\n-Surgery or chemotherapy related toxicity that have not resolved to a grade 1, with the exception of alopecia, fatigue, neuropathy and lack of appetite /nausea\n-Severe comorbidities that in the opinion of the investigator might hamper participation to the study and/or treatment administration\n-Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial\n-Prior treatment with anti-PD-1, anti-PD-L1/2, anti-CD137, CTLA-4 modulators\n-Presence of acetylcholine receptor antibodies\n-Current participation in any other clinical research or treatment with an investigational agent or use of an investigational device within 4 weeks of enrollment\n-Known active Hepatitis B (e.g., positive HBsAg result) or C (e.g., HCV RNA[qualitative] is detected) or known history or current evidence of Human Immunodeficiency Virus (HIV) (HIV-1/2 antibodies)\n-If CT has to be used, known contra-indications for CT with IV contrast\n-History of interstitial lung disease (ILD) OR pneumonitis (other than COPD exacerbation) that has required oral or IV steroids\n-Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (i.e., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed\n-Live vaccines within 30 days prior to the first dose of study therapy and while participating in study. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, H1N1 flu, rabies, BCG, and typhoid vaccine."}

Primary endpoints

• {"endpoint_text":"-Progression Free Survival Rate at 6 months (PFSR-6) per independent radiological review","definition_or_measurement_approach":"PFS rate at 6 months assessed by independent radiological review using RECIST 1.1; a blinded independent central review (BICR) will retrospectively assess CT scans for PFS."}

Secondary endpoints

• {"endpoint_text":"-Progression Free Survival Rate at 6 months (PFSR-6) according to RECIST 1.1 per local investigator assessment","definition_or_measurement_approach":"PFS rate at 6 months per RECIST 1.1 assessed by local investigator"}
• {"endpoint_text":"-Safety according to CTCAE v4.0","definition_or_measurement_approach":"Safety assessed using CTCAE v4.0 criteria"}
• {"endpoint_text":"-Overall Response Rate (ORR) according to RECIST 1.1 per local investigator assessment","definition_or_measurement_approach":"ORR per RECIST 1.1 assessed by local investigator"}
• {"endpoint_text":"-Disease Control Rate according to RECIST 1.1 per local investigator assessment (DCR)","definition_or_measurement_approach":"DCR per RECIST 1.1 assessed by local investigator"}
• {"endpoint_text":"-Duration of response according to RECIST 1.1 per local investigator assessment","definition_or_measurement_approach":"Duration of response per RECIST 1.1 assessed by local investigator"}
• {"endpoint_text":"-Progression Free Survival (PFS) according to RECIST 1.1 per local investigator assessment","definition_or_measurement_approach":"PFS per RECIST 1.1 assessed by local investigator"}
• {"endpoint_text":"-Overall Survival (OS)","definition_or_measurement_approach":"Overall survival measured from date of treatment to death (as reported in trial records)"}
• {"endpoint_text":"-Progression Free Survival for patients continuing treatment after progression","definition_or_measurement_approach":"PFS measured for subset of patients who continue treatment after progression (as specified in protocol)"}

Belgium

Earliest CTIS Part Ii Submission Date

13-08-2024

Latest Decision Or Authorization Date

20-08-2024

Processing Time Days

7

Number Of Sites

2

Number Of Participants

16

France

Earliest CTIS Part Ii Submission Date

13-08-2024

Latest Decision Or Authorization Date

22-08-2024

Processing Time Days

9

Number Of Sites

6

Number Of Participants

46

Spain

Earliest CTIS Part Ii Submission Date

13-08-2024

Latest Decision Or Authorization Date

21-08-2024

Processing Time Days

8

Number Of Sites

2

Number Of Participants

25

Netherlands

Earliest CTIS Part Ii Submission Date

13-08-2024

Latest Decision Or Authorization Date

21-08-2024

Processing Time Days

8

Number Of Sites

3

Number Of Participants

12

Primary sponsor

Full Name

European Organisation For Research And Treatment Of Cancer

Organisation Type

Patient organisation/association

Country Of Registered Address

Belgium