DOSTARLIMAB for Cervical cancer | Locally advanced cervical cancer

Inclusion criteria

• {"criterion_text":"- Signed informed consent before any study-specific procedure.\n- Patients must have completed definitive treatment, namely chemoradiation, up to 12 weeks prior to sign the Informed Consent form.\n- Toxicities resulting from chemo-radiation must resolve to ≤ Grade 1 prior to randomization.\n- Participant must have adequate organ function, defined as follows: - Absolute neutrophil count ≥ 1,500/μL - Platelets ≥ 100,000/μL - Hemoglobin ≥ 9 g/dL - Serum creatinine ≤ 1.5× upper limit of normal (ULN) or calculated creatinine clearance ≥ 50 mL/min using Cockcroft-Gault equation for patients with creatinine levels > 1.5× institutional ULN - Total bilirubin ≤ 1.5× ULN OR direct bilirubin ≤ 1× ULN - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5× ULN - International normalized ratio (INR) or prothrombin time (PT) ≤1.5× ULN. Activated partial thromboplastin time (aPTT) ≤1.5× ULN\n- Participant must agree to not donate blood during the study or for 90 days after the last dose of study treatment.\n- Negative Test Results for Hepatitis\n- Female participant has a negative serum pregnancy test within 72 hours prior to taking study treatment if of childbearing potential and agrees to abstain from activities that could result in pregnancy from screening through 150 days after the last dose of study treatment, or is of nonchildbearing potential.of nonchildbearing potential.\n- Participant must agree to not breastfeed during the study or for 150 days after the last dose of study treatment\n- Male partners must agree to use an adequate method of contraception starting with the first dose of study treatment through 150 days after the last dose of study treatment.\n- Participant must be able to understand the study procedures and agree to participate in the study by providing written informed consent.\n- Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.\n- Participant must be a female ≥ 18 years of age.\n- Life expectancy ≥3 months.\n- Participant must have biopsy-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix.\n- Patients must have archival tumor tissue available that is formalinfixed and paraffin embedded.\n- At diagnosis: • FIGO 2009 stages IB2, IIA2, IIB with pelvic lymph node involvement. • FIGO 2009 stages IIIA, IIIB, IVA. • Any FIGO 2009 stage with para-aortic lymph node involvement\n- Subjects must have received combination chemotherapy and radiotherapy (CCRT) with curative intent. Patients must have received at least 4 doses of weekly cisplatin.\n- Patients must had achieved a partial (PR) or a complete response (CR) after concurrent chemo-radiation therapy (CCRT)."}

Exclusion criteria

• {"criterion_text":"- Histological types other than in inclusion criteria, like sarcomas, small cell carcinoma with neuroendocrine differentiation, non-epithelial cancers\n- History of interstitial lung disease.\n- Active tuberculosis.\n- Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1.\n- Administration of a live, attenuated vaccine within 14 days before Cycle 1, Day 1 or anticipation that such a live attenuated vaccine will be required during the study.\n- Treatment with systemic immunostimulatory agents within 6 weeks or 5 half-lives of the drug, whichever is shorter, prior to Cycle 1, Day 1.\n- Treatment with systemic immunosuppressive medications within 2 weeks prior to Cycle 1, Day 1.\n- Women that are breastfeeding or pregnant.\n- Demonstration of any other disease, neurological or metabolic dysfunction, found upon physical examination or laboratory tests involving a reasonable suspicion of the existence of a disease or condition that contraindicates the use of an experimental drug, or that involves an increased risk to the patient of treatment-related complications.\n- No medical or psychiatric illness that may impede the performance of a systemic or surgical treatment.\n- Participant must not be simultaneously enrolled in any interventional clinical trial.\n- FIGO 2009 Stage IVB\n- Participant must not have had major surgery ≤ 3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects.\n- Participant must not have received investigational therapy ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, prior initiating protocol therapy.\n- Participant has had radiation therapy encompassing >20% of the bone marrow within 2 weeks; or any radiation therapy within 1 week prior to Day 1 of protocol therapy.\n- Participant must not have a known hypersensitivity to dostarlimab components or excipients.\n- Participant must not have a serious, uncontrolled medical disorder or nonmalignant systemic disease.\n- Participant must not have known, symptomatic brain or leptomeningeal metastases.\n- Patient experienced ≥ Grade 3 immune-related AE with prior immunotherapy, with the exception of non-clinically significant lab abnormalities.\n- Participant has a known history of human immunodeficiency virus (type 1 or 2 antibodies).\n- Subjects who have undergone a previous hysterectomy defined as removal of the entire uterus or will have a hysterectomy as part of their initial cervical cancer therapy.\n- Has not achieved at least a partial response by RECIST v1.1 after completion of CCRT administered with curative intent.\n- Patients previously treated with chemotherapy except when used concurrently with radiation therapy\n- Prior treatment with any anti-VEGF drug, including bevacizumab, CD137 agonists or immune checkpoint blockade therapies, anti-PD1, or anti-PDL1 therapeutic antibodies or anti-CTLA 4.\n- Patients with a concomitant malignancy other than non-melanoma skin cancer.\n- History of autoimmune disease\n- History of idiopathic pulmonary fibrosis, organizing pneumonia, druginduced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan."}

Primary endpoints

• {"endpoint_text":"- Progression Free Survival (PFS)","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Overall survival (OS)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Health-related quality of life (HRQOL) measure by the Functional Assessment of Cancer Therapy-Cervix (FACT-Cx) and EQ-5D-5L.","definition_or_measurement_approach":"Measured by the Functional Assessment of Cancer Therapy-Cervix (FACT-Cx) and EQ-5D-5L instruments."}
• {"endpoint_text":"- Fatigue measure by the PROMIS-Cancer-Fatigue Short Form 4a","definition_or_measurement_approach":"Measured by the PROMIS-Cancer-Fatigue Short Form 4a."}
• {"endpoint_text":"- Pain measure by a single item of the Brief Pain Inventory (BPI).","definition_or_measurement_approach":"Measured by a single item of the Brief Pain Inventory (BPI)."}

Spain

Earliest CTIS Part Ii Submission Date

12-01-2024

Latest Decision Or Authorization Date

16-01-2026

Processing Time Days

735

Number Of Sites

23

Number Of Participants

132

Primary sponsor

Full Name

Grupo Espanol De Investigacion En Cancer De Ovario

Organisation Type

Patient organisation/association

Country Of Registered Address

Spain

Third parties

• {"country":"Spain","full_name":"Apices Soluciones S.L.","duties_or_roles":"Sponsor duties codes: 1,10,11,5,6,8","organisation_type":"Pharmaceutical company"}