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
N/A
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
Researchers are evaluating the combination of dostarlimab and LB-100 to see if they can help control ovarian clear cell carcinoma, a type of cancer that has come back after previous treatment. This study aims to estimate overall survival rates at 6 and 12 months, and also to monitor safety by tracking adverse events, tumor response, and immune system changes. Participants will have recurrent ovarian, peritoneal, or fallopian tube cancer with a clear cell component and will be carefully observed over the course of the trial. Participants will receive dostarlimab and LB-100 intravenously. Dostarlimab is given once on the first day of each cycle over about 30 minutes, while LB-100 is administered on the first three days of each cycle, initially over about 2 hours and possibly shorter for later doses. The study includes detailed evaluations of tumor response using imaging and biopsies to understand the effects of the treatments and immune changes. Throughout the study, participants will undergo regular assessments including scans, blood tests, and biopsies to track tumor changes and immune activity. Safety is closely monitored by documenting any side effects or immune-related reactions. The study also collects data on tumor DNA in the blood to correlate with treatment response. The total duration includes treatment cycles and follow-up to assess overall survival and safety outcomes, aiming to provide detailed information on how these drugs work in this cancer type.
CONDITIONS
Brief 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...
- Signed informed consent is required
- Age between 18 and 75 years at study entry
- Willingness and ability to follow the study protocol, including treatments and visits
- Diagnosis of recurrent clear cell ovarian, peritoneal, or fallopian tube cancer, including mixed histology with clear cell predominance
- At least one prior treatment for recurrent disease or platinum resistant/refractory disease
- Somatic mutation testing available showing no PPP2R1A mutations
- Measurable disease with at least one target lesion meeting size criteria
- ECOG performance status of 0 or 1
- Life expectancy of at least 12 weeks
- Adequate organ and bone marrow function based on lab tests
- Evidence of post-menopausal status or negative pregnancy test for women of childbearing potential
- Women must use effective contraception if of reproductive potential
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 high microsatellite instability
- Concurrent treatment in another interventional clinical study
- Recent anticancer therapy within 21 days before study drug
- Unresolved Grade 2 or higher toxicity from prior cancer treatment (with some exceptions)
- Current chemotherapy, immunotherapy, or hormonal therapy
- Major surgery within 28 days before first treatment dose
- History of allogeneic or hematologic organ transplantation
- Active or recent autoimmune or inflammatory disorders (with some exceptions)
- Uncontrolled illness or infection including tuberculosis, hepatitis B or C, HIV (with criteria)
- Other primary malignancies within 5 years except certain treated cancers
- Untreated brain metastases or spinal cord compression
- QTcF interval greater than 470 ms
- Recent use of immunosuppressive medications (with exceptions)
- Receipt of live vaccines within 30 days before treatment
- Pregnancy or breastfeeding or unwillingness to use birth control
- Allergy to study drugs or excipients
- Unresolved bowel obstruction
- Investigator judgment of unsuitability or inability to comply with study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated cycles until disease progression or discontinuation
Participants receive intravenous dostarlimab on Day 1 and LB-100 intravenously on Days 1 to 3 of each cycle. Treatment cycles are repeated with monitoring for tumor response, symptom relief, and safety.
1 visit per cycle (in-person)
Duration - Up to 1 year after treatment completion
Participants are monitored for safety and overall survival after completing treatment.
Visits approximately every few months during follow-up
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
L
Ljiljana Milojevic
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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