Actively Recruiting
Safety and Efficacy of Targeting PP2A in Ovarian Clear Cell Carcinoma Using Dostarlimab and LB-100
Led by M.D. Anderson Cancer Center · Updated on 2025-12-24
21
Participants Needed
1
Research Sites
203 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
G
GSK Pharma
Collaborating Sponsor
AI-Summary
What this Trial Is About
To learn if the combination of dostarlimab and LB-100 can help to control ovarian clear cell carcinoma
CONDITIONS
Official Title
Safety and Efficacy of Targeting PP2A in Ovarian Clear Cell Carcinoma Using Dostarlimab and LB-100
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide signed informed consent
- Age between 18 and 75 years at study entry
- Willing and able to follow study protocol including treatment, visits, and exams
- Diagnosis of recurrent clear cell ovarian, peritoneal, or fallopian tube cancer (mixed histology with predominant clear cell allowed)
- Received at least one prior therapy for recurrent disease or have platinum resistant/refractory disease
- Somatic mutation testing shows no PPP2R1A mutations
- Measurable disease with at least one target lesion (≥20 mm by conventional techniques or ≥10 mm by spiral CT)
- ECOG performance status of 0 or 1
- Life expectancy of at least 12 weeks
- Adequate organ and bone marrow function including specific lab value thresholds
- Post-menopausal status or negative pregnancy test for pre-menopausal women
- Women of childbearing potential must agree to use effective contraception
You will not qualify if you...
- Participation in another investigational study within 28 days
- Prior treatment with anti-CTLA-4 or anti-PD-1/PD-L1 antibodies
- Tumors with mismatch repair deficiency or microsatellite instability-high
- Concurrent treatment in another interventional clinical study
- Last anticancer therapy dose within 21 days prior to study drug start without adequate washout
- Unresolved toxicities from prior therapy Grade 2 or higher (exceptions apply)
- Concurrent chemotherapy, immunotherapy, or hormonal cancer therapy
- Major surgery within 28 days before starting study drug (except local palliative surgery)
- History of allogenic or hematologic organ transplant
- Active or recent autoimmune or inflammatory disorders (with listed exceptions)
- Uncontrolled illnesses including active infections, heart failure, severe lung disease, or psychiatric conditions
- Medical, social, or psychological conditions interfering with study participation
- Active tuberculosis, hepatitis B or C, or HIV infection (with specified exceptions)
- History of other primary cancers unless treated and disease-free for at least 5 years
- History of leptomeningeal carcinomatosis
- Untreated brain metastases or spinal cord compression (treated stable brain metastases allowed)
- QTcF interval ≥470 ms
- Use of immunosuppressive medication within 14 days before study drug (with specified exceptions)
- Live vaccine within 30 days before study drug
- Pregnant or breastfeeding women or those not willing to use effective birth control
- Known allergy to study drugs or their components
- Unresolved bowel obstruction
- Investigator judgment that patient is unsuitable or unlikely to comply with study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
L
Ljiljana Milojevic
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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