Ovarian Clear Cell CarcinomaPhase 1/2NCT06065462
Safety and Efficacy of Targeting PP2A in Ovarian Clear Cell Carcinoma Using Dostarlimab and LB-100
A Phase 1/2 study testing Dostarlimab and LB-100 in people with Ovarian Clear Cell Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn if the combination of dostarlimab and LB-100 can help to control ovarian clear cell carcinoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ovarian Clear Cell Carcinoma
- What is being tested?
- Dostarlimab and LB-100
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2023to 1 Oct 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusion criteria will be assessed within 28 days of starting study treatment:
- Ability to provide signed informed consent
- Age 18-75 years at time of study entry
- Willingness and ability to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
- Histology showing recurrent clear cell ovarian, peritoneal, or fallopian tube cancer (mixed histology with predominant clear cell component is acceptable).
- Receipt of at least one prior line of therapy for recurrent disease or development of platinum resistant or refractory disease, defined by progression of disease on a platinum-containing regimen or recurrence of disease within 180 days of previous platinum treatment
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- Available somatic mutation testing results (CLIA source) that reveal no PPP2R1A mutations
- Measurable disease based on modified RECIST v1.1. For the purposes of this study measurable disease is defined at least one "target lesion" that can be accurately measured in at least one dimension (longest dimension to be recorded). Each target lesion must be >20 mm when measured by conventional techniques, including palpation, plain x-ray, computed tomography (CT), and magnetic resonance imaging (MRI), or >10 mm when measured by spiral CT. The target lesion must be distinct from other tumor areas selected for pre-treatment biopsies. Second lesion selected for pre-treatment biopsy must be biopsy accessible.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. See Section 14.
- Life expectantly of ≥12 weeks
- Adequate normal organ and bone marrow function as defined below.
- Hemoglobin ≥8.0 g/ dL
- Absolute neutrophil count (ANC) ≥ 1000/mm3
- Platelet count ≥100 x 109/L (>100,000/mm3)
- Serum bilirubin ≤1.5 x ULN. This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.
- AST (SGOT)/ALT (SGPT) ≤2.5 x ULN unless liver metastases are present, in which case it must be ≤5 x ULN
- Measured creatinine clearance (CL) ≥ 50 mL/min or Calculated creatinine CL ≥ 50 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance:
- Creatinine CL (mL/min) = Weight (kg) x (140 - Age) x 0.85 72 x serum creatinine (mg/dL)
- Evidence of post-menopausal status or negative serum pregnancy test for female pre-menopausal patients. The effects of dostarlimab and LB-100 on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception (See Section 5.6.2).
- Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
- Women <50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy)
- Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy)
Who cannot join
- Exclusion criteria will be assessed within 28 days of starting study treatment:
- Participation in another clinical study with an investigational product (IP) during the last 28 days.
- Prior treatment with anti-CTLA-4 or anti-PDL-1/PD-1 antibodies.
- Patients with mismatch repair deficient (dMMR) by IHC or microsatellite instability-high tumors
- Concurrent treatment on another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
- Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies) ≤21 days prior to the first dose of study drug. If sufficient wash-out time has not occurred due to the schedule or PK properties of the agent, a longer wash-out period will be required, as agreed by study sponsors and the investigators.
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- Any unresolved toxicity NCI CTCAE Grade 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.
- Subjects with Grade 2 neuropathy will be evaluated on a case-by-case basis after consultation with the principal investigator.
- Subjects with irreversible toxicity not reasonably expected to be exacerbated by the treatment with investigational therapy may be included only after consultation with the primary investigator.
- Any concurrent chemotherapy, immunotherapy, or hormonal therapy for cancer treatment.
- Major surgical procedure (defined by the investigator) within 28 days prior to the first dose of treatment. Note: Local surgery of isolated lesions for palliative intent is acceptable.
- History of allogenic or hematologic organ transplantation.
- Active or prior documented autoimmune or inflammatory disorders, including inflammatory bowel disease (e.g., colitis or Crohn's disease), diverticulitis in the last 6 months (with the exception of diverticulosis), systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome.
- The following exceptions to this criterion are listed below. i. Subjects with vitiligo or alopecia. ii. Subjects with hypothyroidism stable on hormone replacement. iii. Any chronic skin condition that does not require systemic therapy. iv. Subjects without active disease in the last 5 years may be included but only after consultation with the primary investigator.
- Subjects with celiac disease controlled by diet alone
- Uncontrolled intercurrent illness, including but not limited to: ongoing or active infection; symptomatic congestive heart failure; uncontrolled hypertension; unstable angina pectoris; cardiac arrythmia; interstitial lung disease; chronic obstructive pulmonary disease requiring systemic steroid therapy, oxygen, or hospitalization; serious chronic gastrointestinal conditions associated with diarrhea; or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs, or compromise the ability of the patient to give written informed consent.
- Any medical, social, or psychological condition that would interfere with evaluation of study treatment or interpretation of participant safety or study results.
- Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen, or HBsAg, result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies).
- Subjects with a past or resolved HBV infection (defined as presence of hepatitis B core antibody, or anti-HBc, and absence of HBsAg) are eligible.
- Subjects positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
- Patients with positive results of HIV that meet all of the following eligibility criteria may be enrolled:
- Have a T-cell (CD4+) count ≥350 cells/µL ii. No history of opportunistic infections or other malignancies iii. Have an HIV viral load less than 400 copies/mL prior to enrollment iv. In the opinion of the investigator, their antiretroviral therapy (ART) or other HIV treatments will not interfere with the activity of the investigational product or cause any confusion with the assessment of the investigational drug toxicities
- History of another primary malignancy except for the following histories:
- Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of treatment and of low potential risk of recurrence.
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
- Adequately treated carcinoma in situ without evidence of disease.
- History of leptomeningeal carcinomatosis.
- Untreated brain metastases or spinal cord compression. Subjects with suspected brain metastases at screening should have an MRI (preferred) or CT preferably with IV contrast of the brain prior to study entry.
- Subjects with treated brain metastasis as evidenced by stable findings on brain MRI performed 4-6 weeks after completion of treatment would be eligible.
- QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms
- Current or prior use of immunosuppressive medication within 14 days before the first dose of trial therapies. Listed below are the exceptions to this criterion.
- Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra-articular infection)
- Systemic corticosteroids at physiologic doses not to exceed 10mg/day of prednisone or its equivalent
- Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
- Receipt of live attenuated vaccine within 30 days prior to the first dose of treatment. Note: subjects, if enrolled, should not receive live vaccines whilst receiving treatment and up to 90 days after the last dose of treatment
- Female subjects who are pregnant or breastfeeding or of reproductive potential who are not willing to employ effective birth control from screening to 180 days after the last dose of treatment
- Pregnant women are excluded from this study because the investigational agents have unknown teratogenic or abortifacient effects. Because there is also an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these agents, breastfeeding should be discontinued.
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients
- Unresolved partial or complete small or large bowel obstruction
- Judgment by the investigator that the patient is unsuitable to participate in the study or that the patient is unlikely to comply with study procedures, restrictions, and requirements
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Ljiljana Milojevic, 713-792-8578, lmilojev@mdanderson.org
Amir Jazaeri, M D
About this study
To learn if the combination of dostarlimab and LB-100 can help to control ovarian clear cell carcinoma
Read the detailed description
Primary Objectives:
- To estimate overall survival in patients with recurrent ovarian clear cell carcinoma being treated with LB-100 and dostarlimab, including specific survival probabilities at 6 and 12 months.
Secondary Objectives:
- To describe clinically significant and immune related adverse events (ir-AEs) in the study population.
- To determine the objective response rate (ORR), time to initial response, progression free survival (PFS), and duration of response (DOR) using modified RECIST v1.1 criteria.
- Although the clinical benefit of these drugs has not yet been established, the intent of offering this treatment is to provide a possible therapeutic benefit, and thus the patient will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability.
- Translational:
- To describe PP2A activity and immune changes, using baseline and on-treatment tumor biopsies and peripheral blood mononuclear cells (PBMCs)
- To describe expression of mismatch repair proteins using immunohistochemistry (IHC)
- To correlate circulating tumor DNA (ctDNA) levels with response by modified RECIST v1.1 criteria.
- Conditions
- Ovarian Clear Cell Carcinoma
- Being tested
- Dostarlimab, LB-100
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DostarlimabDrug
Given by vein (IV)
LB-100Drug
GIven by vein (IV)
| Study group | Role | What they receive |
|---|---|---|
| Dostarlimab + LB-100 | Experimental | Dostarlimab will be given by vein over about 30 minutes on Day 1 of each cycle. LB-100 will be given by vein on Days 1-3 of each cycle. The first doses will be given over about 2 hours. After that, doses may be given over as little as 30 minutes. Receives: Drug: Dostarlimab; Drug: LB-100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start10 Nov 2023
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian Clear Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- GSK Pharma, Lixte
- Responsible party
- Sponsor
- Investigators
- Amir Jazaeri, M D, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065462
- Sponsor's protocol ID
- 2022-1047
- Other IDs
- NCI-2023-07922
- Status last verified
- Jun 2026
- First submitted
- 26 Sep 2023
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Clark MC, Lu RO, Ho WS, Dias MH, Bernards R, Forman SJ. A combination of protein phosphatase 2A inhibition and checkpoint immunotherapy: a perfect storm. Mol Oncol. 2024 Oct;18(10):2333-2337. doi: 10.1002/1878-0261.13687. Epub 2024 Jun 26.
PubMed 38932511
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Targeting PP2A in Ovarian Clear Cell Carcinoma Using Dostarlimab and LB-100
- ClinicalTrials.gov ID
- NCT06065462
- Acronym / sponsor ID
- 2022-1047
- Conditions
- Ovarian Clear Cell Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- GSK Pharma, Lixte
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 4 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To learn if the combination of dostarlimab and LB-100 can help to control ovarian clear cell carcinoma
Detailed description
Primary Objectives:
- To estimate overall survival in patients with recurrent ovarian clear cell carcinoma being treated with LB-100 and dostarlimab, including specific survival probabilities at 6 and 12 months.
Secondary Objectives:
- To describe clinically significant and immune related adverse events (ir-AEs) in the study population.
- To determine the objective response rate (ORR), time to initial response, progression free survival (PFS), and duration of response (DOR) using modified RECIST v1.1 criteria.
- Although the clinical benefit of these drugs has not yet been established, the intent of offering this treatment is to provide a possible therapeutic benefit, and thus the patient will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability.
- Translational:
- To describe PP2A activity and immune changes, using baseline and on-treatment tumor biopsies and peripheral blood mononuclear cells (PBMCs)
- To describe expression of mismatch repair proteins using immunohistochemistry (IHC)
- To correlate circulating tumor DNA (ctDNA) levels with response by modified RECIST v1.1 criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dostarlimab + LB-100 | Experimental | Drug: Dostarlimab, Drug: LB-100Dostarlimab will be given by vein over about 30 minutes on Day 1 of each cycle. LB-100 will be given by vein on Days 1-3 of each cycle. The first doses will be given over about 2 hours. After that, doses may be given over as little as 30 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Ability to provide signed informed consent
- Age 18-75 years at time of study entry
- Willingness and ability to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
- Histology showing recurrent clear cell ovarian, peritoneal, or fallopian tube cancer (mixed histology with predominant clear cell component is acceptable).
- Receipt of at least one prior line of therapy for recurrent disease or development of platinum resistant or refractory disease, defined by progression of disease on a platinum-containing regimen or recurrence of disease within 180 days of previous platinum treatment
Key exclusion criteria (40 listed)
- Participation in another clinical study with an investigational product (IP) during the last 28 days.
- Prior treatment with anti-CTLA-4 or anti-PDL-1/PD-1 antibodies.
- Patients with mismatch repair deficient (dMMR) by IHC or microsatellite instability-high tumors
- Concurrent treatment on another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
- Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies) ≤21 days prior to the first dose of study drug. If sufficient wash-out time has not occurred due to the schedule or PK properties of the agent, a longer wash-out period will be required, as agreed by study sponsors and the investigators.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DostarlimabGiven by vein (IV) | Drug | Dostarlimab + LB-100 |
| LB-100GIven by vein (IV) | Drug | Dostarlimab + LB-100 |
Primary outcome
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame: through study completion; an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Derived from this study: PubMed 38932511Clark MC, Lu RO, Ho WS, Dias MH, Bernards R, Forman SJ. A combination of protein phosphatase 2A inhibition and checkpoint immunotherapy: a perfect storm. Mol Oncol. 2024 Oct;18(10):2333-2337. doi: 10.1002/1878-0261.13687. Epub 2024 Jun 26.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amir Jazaeri, M D principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Dostarlimab and LB-100 in people with Ovarian Clear Cell Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ljiljana Milojevic ((713) 792-8578, lmilojev@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 (time frame: through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06065462, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.