A combination of protein phosphatase 2A inhibition and checkpoint immunotherapy: a perfect storm.
Mary C Clark, Rongze Olivia Lu, Winson S Ho...
https://pubmed.ncbi.nlm.nih.gov/38932511/Actively Recruiting
Led by M.D. Anderson Cancer Center · Updated on 2026-06-23
21
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating the combination of dostarlimab and LB-100 in patients with recurrent ovarian clear cell carcinoma. This study aims to estimate overall survival at 6 and 12 months, describe immune-related side effects, and assess tumor response and progression using modified RECIST v1.1 criteria. It also explores biological markers such as PP2A activity, mismatch repair protein expression, and circulating tumor DNA levels for correlation with treatment response. Participants receive dostarlimab by vein over about 30 minutes on Day 1 of each cycle and LB-100 by vein on Days 1 through 3. The first doses are given over about 2 hours, with later doses possibly shortened to around 30 minutes. The study includes repeated treatment cycles with careful monitoring of tumor changes and immune responses. During the study, participants undergo tumor biopsies and blood sample collection to analyze immune and molecular changes. Safety is monitored by tracking adverse events graded by standard criteria. Researchers measure overall survival, tumor response rates, progression-free survival, and duration of response. The study lasts up to approximately one year with ongoing assessments to understand treatment effects and safety.
CONDITIONS
Safety and Efficacy of Targeting PP2A in Ovarian Clear Cell Carcinoma Using Dostarlimab and LB-100
L
Ljiljana Milojevic
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M.D. Anderson Cancer Center
Lead Sponsor
GSK Pharma
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Dostarlimab + LB-100 (Investigational) | Standard Chemotherapy (Guideline-Based Current Care) |
|---|---|---|
| What it is | A combination regimen of dostarlimab (an anti-PD-1 antibody for immunotherapy) plus LB-100 (a protein phosphatase 2A inhibitor) given intravenously to adults with recurrent, mainly clear cell, ovarian, peritoneal, or fallopian tube cancer. | Combination or sequential platinum-based chemotherapy (e.g., carboplatin and paclitaxel), which is the established standard care for patients with recurrent ovarian clear cell carcinoma. |
| Role in trial | Investigational therapy—every eligible participant receives both dostarlimab and LB-100 as combination immunotherapy and targeted therapy. | Standard therapy option outside trial; not received by trial participants but would be considered as routine care based on guidelines. |
| Primary use / clinical purpose | To evaluate the safety and preliminary effectiveness of targeting immune checkpoints and PP2A inhibition in chemoresistant ovarian clear cell carcinoma. | To control recurrent or resistant ovarian clear cell carcinoma, aiming for tumor response or disease stabilization. |
| How it is given or performed | Both drugs are given intravenously on a regular schedule, as specified in the research protocol. All participants are closely monitored during therapy. | Chemotherapy drugs such as carboplatin and paclitaxel are given by vein (IV) every 3 to 4 weeks, with the number of cycles depending on response and tolerability. |
| Evidence status | Safety and efficacy in this population are currently under clinical investigation. Published evidence is limited to preclinical and early-phase study rationale. | Supported by multiple clinical studies and guideline recommendations; response rates vary and chemoresistance is common in clear cell subtypes. |
| Important limitations | Limited to early clinical evidence and investigational use only; side effects and benefit-risk profile are not fully characterized for this combination in ovarian clear cell carcinoma. | Clear cell ovarian cancers often show poorer response to standard chemotherapy compared with other histologies, and chemoresistance is a major challenge. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Varies by participant
Participants receive dostarlimab intravenously on Day 1 and LB-100 intravenously on Days 1 through 3 of each cycle. Treatment cycles repeat with monitoring for tumor response and side effects.
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Mary C Clark, Rongze Olivia Lu, Winson S Ho...
https://pubmed.ncbi.nlm.nih.gov/38932511/M.D. Anderson Cancer Center
Lead Sponsor
GSK Pharma
Collaborating Sponsor