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Tests treatment safety and results for Ovarian Clear Cell Carcinoma
Official title Safety and Efficacy of Targeting PP2A in Ovarian Clear Cell Carcinoma Using Dostarlimab and LB-100
ClinicalTrials.gov ID: NCT06065462
What this study is testing
What is Dostarlimab?
Dostarlimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ovarian clear cell carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To learn if the combination of dostarlimab and LB-100 can help to control ovarian clear cell carcinoma
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Histology showing recurrent clear cell ovarian, peritoneal, or fallopian tube cancer (mixed histology with predominant clear cell component is...
You likely can't join if
- 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-treatment) clinical study or during the follow-up period of an...
- Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor...
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
What rules you out
- 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-treatment) clinical study or during the follow-up period of an treatment 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...
- 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.
- people with Grade 2 neuropathy will be evaluated on a case-by-case basis after consultation with the principal investigator.
- people 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)...
- Uncontrolled intercurrent illness, including but not limited to: ongoing or active infection; symptomatic congestive heart failure; uncontrolled hypertension; unstable angina pectoris; cardiac arrythmia; interstitial...
- 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...
- people with a past or resolved HBV infection (defined as presence of hepatitis B core antibody, or anti-HBc, and absence of HBsAg) are eligible.
- people 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: i. Have a T-cell (CD4+) count ≥350 cells/µL ii. No history of opportunistic infections or other malignancies...
- 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. people with suspected brain metastases at screening should have an MRI (preferred) or CT preferably with IV contrast of the brain prior to study entry. a. people...
- 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: people, if enrolled, should not receive live vaccines whilst receiving treatment and up to 90 days after the last dose of...
- Female people 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 a. Pregnant women are...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.