Actively Recruiting
Single cEll pRofiling PErsistaNce To ImmuNothErapy
Led by Vall d'Hebron Institute of Oncology · Updated on 2024-11-08
60
Participants Needed
1
Research Sites
195 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The SERPENTINE trial (ESR 21-21165) is a phase II clinical study aiming to evaluate the efficacy of durvalumab and tremelimumab, alone or in combination, in patients with colorectal or endometrial cancer. The trial targets patients with microsatellite instability-high (MSI-H) tumors and those with microsatellite stable (MSS) tumors. Colorectal and endometrial cancers present significant challenges due to their heterogeneity and variable responses to treatment. Immunotherapy, particularly checkpoint inhibitors like durvalumab and tremelimumab, has shown promise in some patients, but predicting response remains elusive. The SERPENTINE trial aims to address this gap by investigating the effectiveness of these immunotherapies in a carefully selected patient population.
CONDITIONS
Official Title
Single cEll pRofiling PErsistaNce To ImmuNothErapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give signed informed consent and comply with study requirements
- Age over 18 years at study entry
- ECOG performance status of 0 or 1
- Cohort 1: Recurrent or metastatic colorectal or endometrial cancer with MSI-H or dMMR status
- Cohort 2: Recurrent or metastatic colorectal cancer with MSS or pMMR status after progression on at least 2 prior therapy lines, or recurrent/metastatic endometrial cancer with MSS or pMMR status after platinum and taxane treatment
- Life expectancy greater than 12 weeks
- Body weight over 30 kg
- Adequate organ and bone marrow function as defined by specific blood counts and lab values
- Post-menopausal status or negative pregnancy test for pre-menopausal females, with specific criteria based on age and hormonal status
- Able and willing to comply with study protocol and visits
- At least one tumor lesion of 10 mm or larger suitable for biopsy
- At least one measurable lesion according to RECIST v1.1 apart from biopsy lesion
- Use of effective contraception during and after treatment as specified
You will not qualify if you...
- Participation in another investigational study or therapy within 4 weeks before treatment
- Immunodeficiency or recent systemic immunosuppressive therapy within 14 days, with some exceptions
- Prior anti-cancer monoclonal antibody within 4 weeks or unresolved side effects from earlier monoclonal antibody treatment
- Recent chemotherapy, targeted therapy, hormonal therapy, or radiation within 2 weeks before study start
- Unresolved toxicity Grade 2 or higher from previous cancer treatment, with some exceptions
- Major surgery within 28 days prior to first treatment dose unless for palliative local surgery
- Active or progressing additional malignancy except certain skin or cervical cancers
- History of allogenic organ transplantation
- Active central nervous system metastases or carcinomatous meningitis, with limited exception
- Active or prior autoimmune or inflammatory disorders, with some exceptions
- Evidence or history of interstitial lung disease or pneumonitis requiring steroids
- Active infection requiring treatment, including certain viral infections
- Known HIV infection
- Conditions or illnesses that could interfere with participation or safety
- Psychiatric or substance abuse disorders affecting cooperation
- Pregnancy, breastfeeding, or intention to conceive during study period
- Prior therapy with anti-PD-1, anti-PD-L1 including durvalumab, or anti-CTLA-4 agents
- Live vaccine within 30 days before study treatment
- Investigator judgment of unsuitability for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Vall d'Hebron Institute of Oncology
Barcelona, Spain
Actively Recruiting
Research Team
E
Elena Elez, MD PhD
CONTACT
S
Susana Muñoz
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here