1st or 2nd platinum-sensitive recurrent ovarian cancer with controlled disease after platinum based chemotherapy. MedDRA version: 20.0 Level: PT Classification code 10033128 Term: Ovarian cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: PT Classification code 10066697 Term: Ovarian cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: OSE2101 TEDOPI
Product Code: OSE2101
Pharmaceutical Form: Emulsion for injection
INN or Proposed INN: (empty)
Other descriptive name: OSE2101
Concentration unit: mg/ml milligram(s)/milli
Sponsors
ARCAGY-GINECO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Signed and dated informed consent document for the study, willing and able to comply with protocol requirements, including: a. HLA-A2 phenotype determination by genetic test (blood) b. participation in translational research in HLA-A2 positive c. authorization for long term follow up if HLA-A2 negative 2) Histologically or cytologically proven non-mucinous epithelial ovarian cancer 3) Positive HLA-A2 phenotype 4) Age = 18 years 5) ECOG Performance Status (PS) 0-1 6) First or second clinical or radiological relapse of a platine sensitive ovarian cancer in complete response, partial response or stable disease according to RECIST 1.1 at the end of a platinum based chemotherapy. Patient must have received at least 4 cycles of platinum during this chemotherapy 7) Previously treated with a PARP inhibitor or not eligible to PARPi 8) Prior therapy with bevacizumab or with contra-indication to bevacizumab 9) Randomization must be within 8 weeks of last dose of platinum 10) Adequate organ function: - Adequate marrow function - White blood cell (WBC) = 3000/ mm3 - Neutrophils = 1500/ mm3 - Platelets = 100 × 103/mm3 (in the absence of transfusion within 2 weeks from before randomization) - Haemoglobin => 9 g/dL (in the absence of transfusion within 2 weeks from before randomization) - Adequate other organ functions - ALT and AST = 2.5 × ULN, unless liver metastases are presents in which case they must be ==65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Prior treatment with any immune checkpoint inhibitor, including anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody 2) Patient with contra-indications to immune therapies 3) Ongoing immunotherapy (checkpoint inhibition, antigen immunotherapy that would be scheduled to continue concomitantly to the study) 4) Use of any of the following immunomodulatory agents in 30 days prior the first dose of study drug: • Systemic corticosteroids (at dose higher than 10 mg/day equivalent prednisone); if systemic corticoid use, corticoid must be stopped at least 7 days before study treatment start • Interferons • Interleukins • Live vaccine Examples of live vaccines include not limited to: measles, mumps, rubella, varicella/zoster, yellow fever, rabies, BCG, typhoid vaccine. Seasonal influenza vaccines for injection are mostly killed virus vaccines and allowed as other killed vaccines, if done at least 2 weeks prior the first dose of study drug; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and not allowed. 5) Prior cancer vaccine therapy 6) Prior radiotherapy in 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (=2 weeks of radiotherapy) to non-CNS disease. 7) Patient with active autoimmune disease that required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency...) is not considered a form of systemic treatment and allowed. 8) History of serious adverse reactions, including anaphylaxis and related symptoms like hives and respiratory difficulty after administration of any vaccines, or a history of hypersensitivity, specifically to any components of study vaccine 9) Prior history of other malignancies other than study disease (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or other in situ cancer considered as cured) unless the patient has been free of the disease for at least 5 years. 10) Immune-deficient status (patients with HIV, immunosuppressive treatment, haematological malignancies, and previous organ transplantation) 11) History of (non-infectious) pneumonitis/ interstitial lung disease required steroids or has current pneumonitis/ interstitial lung disease that requires steroids. 12) History of any chronic hepatitis : • Positive test for hepatitis B surface antigen • Positive test for qualitative hepatitis C viral load by PCR Note: Subjects with positive hepatitis C antibody and negative quantitative hepatitis C by PCR are eligible. History of resolved hepatitis A virus infection is not an exclusion criterion 13) Uncontrolled or significant cardiovascular disease not limited to: • Myocardial infarction or stroke/transient ischemic attack in the past 6 months • Uncontrolled angina in the past 3 months • History of other clinically significant heart disease (eg, cardiomyopathy, congestive heart failure with New York Heart Association functional classification III-IV, pericarditis, significant pericardial effusion, or myocarditis) • Any history of clinically significant arrhythmias (like ventricular tachycardia, ventricular fibrillation, or torsades de pointes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the benefit by the Progression Free Survival (PFS) according to RECIST 1.1 of maintenance OSE2101 alone or in combination with PD1 inhibition after platinum based chemotherapy in relapsed ovarian cancer. ;Secondary Objective: •To compare the best Overall Response Rate for patients with measurable disease at randomization using RECIST1.1 •To assess the Safety profile •To determine the time to subsequent first treatment (TTST-1) •To determine the time to subsequent second treatment (TTST-2) •To assess Overall Survival (OS) ;Primary end point(s): Progression Free Survival (PFS) is the time from randomization to progression, assessed radiologically using RECIST 1.1 by the investigator, or death whatever the cause, whichever comes first. Patients alive and free of progression at the cut-off date will be censored at the last tumor assessment date.;Timepoint(s) of evaluation of this end point: date of disease progression according RESIST 1.1 of last patient (Event driven trial) Estimated date Q1 2025 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Objective response is defined using the RECIST 1.1. The best overall response is defined as the best radiological response observed over the whole treatment period before progression or subsequent anti-cancer treatment. Proportion of partial and complete responses over the treated population will be computed. • Safety will be assessed based on NCI CTC-AE version 5.0 • Time to subsequent first treatment (TTST-1) is defined as time from randomization to initiation of first subsequent treatment (including treatment change due to toxicity or investigator’s decision). Deaths will be counted as events. Patients alive and not receiving a subsequent treatment will be censored at the last assessment date. • Time to subsequent second treatment (TTST-2) is defined as time from randomization to initiation of second subsequent treatment (including treatment change due to toxicity or investigator’s decision). Deaths will be counted as events. Patients alive and not receiving a subsequent treatment will be censored at the last assessment date. • Overall survival is defined as time from randomization to the date of death, whatever the cause. Patients alive at the cut-off date will be censored at the last date they are known to be alive. ;Timepoint(s) of evaluation of this end point: Same as primary end point : estimated date Q1 2025 | — |
Countries
Belgium, France, Germany
Contacts
Public ContactProject Manager
ARCAGY-GINECO
Outcome results
None listed