Actively Recruiting
AGNOSTIC THERAPY IN A PHASE II SINGLE-ARM STUDY IN FIRST-LINE TREATMENT OF DURVALUMAB IN ASSOCIATION WITH CARBOPLATIN OR CISPLATIN AND ETOPOSIDE IN PATIENTS AFFECTED BY EXTENSIVE STAGE - EXTRAPULMONARY SMALL CELL CARCINOMA
Led by Gruppo Oncologico Italiano di Ricerca Clinica · Updated on 2024-06-18
66
Participants Needed
1
Research Sites
206 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase II, single-arm, multicenter study to evaluate the activity and safety of durvalumab in combination with carboplatin or cisplatin plus etoposide in patients with treated ES-EPSCC.
CONDITIONS
Official Title
AGNOSTIC THERAPY IN A PHASE II SINGLE-ARM STUDY IN FIRST-LINE TREATMENT OF DURVALUMAB IN ASSOCIATION WITH CARBOPLATIN OR CISPLATIN AND ETOPOSIDE IN PATIENTS AFFECTED BY EXTENSIVE STAGE - EXTRAPULMONARY SMALL CELL CARCINOMA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older on the day of signing informed consent
- Written informed consent provided prior to any study procedures
- Histologically or cytologically confirmed extensive stage extrapulmonary small cell carcinoma
- Brain metastases must be asymptomatic or treated and stable off steroids and anti-convulsants for at least 1 month before treatment
- No prior immune-mediated therapy including durvalumab except therapeutic anticancer vaccines
- No prior chemotherapy for advanced disease
- Performance status of 0 or 1 on the ECOG Performance Scale
- Life expectancy of at least 12 weeks at enrollment
- Suitable to receive platinum-based chemotherapy as first-line treatment for ES-EPSCC
- Adequate organ and marrow function based on specific laboratory tests within 14 days before treatment
- Availability of archived tumor tissue at baseline
- Female patients must be post-menopausal or have a negative pregnancy test if premenopausal
- At least one measurable lesion not previously irradiated, suitable for repeated measurements
- Body weight greater than 30 kg
You will not qualify if you...
- Active, known or suspected autoimmune disease requiring systemic treatment within 14 days before first dose of durvalumab, with specified exceptions
- Additional malignancy within the last 5 years except certain skin and cervical cancers treated curatively
- Concurrent chemotherapy, investigational product, biologic, or hormonal therapy for cancer treatment
- History of radiotherapy prior to systemic therapy except completed palliative radiation
- Active or prior autoimmune or inflammatory disorders with listed exceptions
- Major surgery within 28 days before first dose, except local palliative surgery
- History of leptomeningeal carcinomatosis
- History of HIV infection
- Active Hepatitis B or C infection
- Receipt of live, attenuated vaccine within 30 days before first dose
- Uncontrolled illness including active infection, heart failure, unstable angina, arrhythmia, interstitial lung disease, serious gastrointestinal conditions, or psychiatric illness limiting compliance
- History of allogeneic organ transplantation
- QTcF interval 470 ms or higher on ECG
- Positive pregnancy test or pregnant/breastfeeding females
- Patients not willing to use effective birth control from screening to 90 days after last durvalumab dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
AUSL-IRCCS of Reggio Emilia
Reggio Emilia, Italy, 42123
Actively Recruiting
Research Team
C
Carmine Pinto, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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