None listed
Conditions
Interventions
Drug : * Subjects are randomly assigned 1:1:1 to one of three groups.
1) Group A: Dostarlimab monotherapy
- First 3 cycles: Dostalimab 500mg every 3 weeks, IV
- 4 cycles ~ up to 24 months: Dostalimab
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Female patient is at least 18 years of age, 2. Patient has signed the Informed Consent (ICF) and is able to comply with protocol requirements. 3. Patient with histologically proven confirmed recurrent or persistent clear cell carcinoma of the ovary, endometrium, cervix, vagina, and vulva ? Local review by gynecologic pathologist required ? =50% clear cell histology in case of mixed carcinoma ? WT-1 neg (Only in case of ovarian cancer) Note: In the case of including non-ovarian clear cell carcinoma with more than 20 cases, the decision is made through discussion with the SPONSOR. 4. Patient with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 5. Disease progression within 12 months of completing platinum-based chemotherapy 6. 1-5 prior lines of therapies 7. Patient with measurable disease according RECIST 1.1 criteria 8. Availability of Tumor tissue for translational research . - A formalin-fixed paraffin-embedded (FFPE) tumor block(preferred) or at least 20 slides (unstained, freshly cut, serial sections) must be submitted. 9. Patients who consent to fresh tumor biopsies - Confirmed with at least one lesion with location accessible to safely biopsy per the clinical judgement of the investigator - Note: If mandatory biopsies cannot be performed as per investigator’s clinical judgement, discussion and agreement between investigator and Sponsor are required. 10. Patient has adequate organ function, defined as follows: a) Absolute neutrophil count = 1,500 cells/µL b) Platelets = 100,000 cells/µL c) Hemoglobin = 9 g/dL or = 5.6 mmol/L d) Serum creatinine = 1.5× upper limit of normal (ULN) or calculated creatinine clearance = 50 mL/min using the Cockcroft-Gault equation for patients with creatinine levels > 1.5× institutional ULN e) Total bilirubin = 1.5× ULN (= 2.0 x ULN in patients with known Gilbert’s syndrome) or direct bilirubin = 1× ULN f) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5× ULN unless liver metastases are present, in which case they must be = 5× ULN g) International normalized ratio or prothrombin time (PT) =1.5× ULN and activated partial thromboplastin time =1.5× ULN.Participants taking anticoagulants may be included on a stable dose with a therapeutic INR 1 year. b) A follicle-stimulating hormone value in the postmenopausal range upon screening evaluation if amenorrhoeic for < 2 years without a hysterectomy and oophorectomy. c) Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation: - Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound, MRI, or CT scan. - Tubal ligation must be confirmed with medical records of the actual procedure. - Information must be captured appropriately within the site’s source documents. 12. Patient of childbearing potential must agree to use a highly effective method of contraception with their partners starting from time of consent through 180 days after the last dose of study treatment. Note: Abstinence is acceptable if this is the established and
Exclusion criteria
Exclusion criteria: 1. Patient has had = 6 prior lines of chemotherapy. Surgery of the recurrence is allowed. 2. Patient has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent. 3. Patient has received prior anticancer therapy (chemotherapy, targeted therapies, hormonal therapy, radiotherapy) within 21 days or 4 weeks before study enrollment. 11. Patient with presence of hepatitis B surface antigen or a positive hepatitis C antibody test result at screening or within 3 months before first dose of dostarlimab treatment. - Participants who are hepatitis B surface antigen positive may be enrolled if their HBV-DNA level is below the institutional lower limit. - Participants with chronic hepatitis B virus (HBV) infection who meet the criteria for anti-HBV therapy may be eligible if the participant is on a suppressive antiviral therapy before initiation of cancer therapy. - Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled only if a confirmatory negative hepatitis C RNA polymerase chain reaction is obtained. Hepatitis C participants may be eligible if they both have completed curative therapy and have a hepati
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate;Clinical benefit reate;Progression free survival 2;Overall survival;Duration of response rate;Safety and tolerability;Time to first subsequent treatment;Time to second subsequent treatment;Response rate of subsequent therapies | — |
Countries
Korea, Republic of
Contacts
Public ContactEUNYEONG YANG
Yonsei University Health System, Severance Hospital
Outcome results
None listed