2024-516005-23-00
Not yet recruiting
Phase 2
SPARTANA : Spartalizumab, mDCF (docetaxel, cisplatin and 5-fluorouracil) and radiotherapy in patients with metastatic squamous cell anal carcinoma. A Phase IIA study
Centre Hospitalier Regional Universitaire5 sites in 1 country34 target enrollmentStarted: August 22, 2024Last updated:
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Centre Hospitalier Regional Universitaire
- Enrollment
- 34
- Locations
- 5
- Primary Endpoint
- The primary endpoint is the Progression Free Survival (PFS) rate at 1 year evaluated by RECIST criteria v1.1. PFS rate at 1 year is defined as the number of patients alive without progression at 1 year divided by the overall number of patients evaluable for PFS status at 1 year.
Overview
Brief Summary
The primary objective of this clinical trial is to evaluate the Progression-Free Survival (PFS) rate at 1 year.
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female, aged ≥18 years,
- •Signed and dated informed consent, to participate indicating that the subject has understood the purpose and the procedures required by the study and that he agrees to participate in the study and to comply with the requirements and restrictions inherent in this study
- •Patient affiliated to or beneficiary of French social security system
- •Ability to comply with the study protocol, in the Investigator’s judgment
- •Performance status Eastern Cooperative Oncology Group World Health Organization (ECOG-WHO) ≤1,
- •Histologically proven metastatic or locally advanced recurrent squamous cell carcinoma of anus (SCCA)Presence of a evaluable lesion on CT-scan/MRI assessed by RECIST v1.1 criteria,
- •Patient eligible to the mDCF regimen
- •No previous systemic (immunotherapy or chemotherapy) treatment.
- •CT scan performed within 30 days prior inclusion,
- •PET scan performed within 30 days prior inclusion
Exclusion Criteria
- •HIV positive patient , CD4 count < 400 cells/mm3 (HIV test mandatory before inclusion)
- •Untreated or symptomatic central nervous system (CNS) lesion. However, patients are eligible if: a) all known CNS lesions have been treated with radiotherapy or surgery and b) patient remained without evidence of CNS disease progression ≥ 4 weeks after treatment and c) patients must be off corticosteroid therapy for ≥ 2 weeks
- •Use of hematopoietic colony-stimulating growth factors (e.g. G-CSF, GMCSF, M-CSF), thrombopoietin mimetics or erythroid stimulating agents ≤ 2 weeks prior start of study treatment. If erythroid stimulating agents were initiated more than 2 weeks prior to the first dose of study treatment and the patient is on a stable dose, they can be maintained.
- •Use of any live vaccines against infectious diseases within 4 weeks of initiation of study treatment
- •Elevated Cardiac troponin T (cTnT) or cardiac troponin I (cTnI) elevation > 2x ULN
- •Systemic chronic steroid therapy (> 10mg/day prednisone or equivalent) or any immunosuppressive therapy 7 days prior to planned date of first dose of study treatment. Note: Topical, inhaled, nasal and ophthalmic steroids are allowed. For patients with adrenal insufficiency, replacement dose of prednisone > 10 mg/ day or equivalent are permitted
- •Active, known or suspected autoimmune disease or a documented history of autoimmune disease Note: Patients with vitiligo, controlled type I diabetes mellitus on stable insulin dose, residual autoimmune-related hypothyroidism only requiring hormone replacement or psoriasis not requiring systemic treatment are permitted.
- •Allogenic bone marrow or solid organ transplant
- •History of severe hypersensitivity reactions to other monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction
- •Pre-existing neuropathy, hearing problem, or cardiorespiratory pathology, which prevent the administration of cisplatin.
Outcomes
Primary Outcomes
The primary endpoint is the Progression Free Survival (PFS) rate at 1 year evaluated by RECIST criteria v1.1. PFS rate at 1 year is defined as the number of patients alive without progression at 1 year divided by the overall number of patients evaluable for PFS status at 1 year.
The primary endpoint is the Progression Free Survival (PFS) rate at 1 year evaluated by RECIST criteria v1.1. PFS rate at 1 year is defined as the number of patients alive without progression at 1 year divided by the overall number of patients evaluable for PFS status at 1 year.
Secondary Outcomes
No secondary outcomes reported
Investigators
Chargé de projet
Scientific
Centre Hospitalier Regional Universitaire
Study Sites (5)
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