A Phase 3, Randomized, Double-blind, Multicenter Study of Dostarlimab (TSR-042) plus Carboplatin-paclitaxel versus Placebo plus Carboplatin-paclitaxel in Patients with Recurrent or Primary Advanced Endometrial Cancer

Purpose

Determine the efficacy and safety of dostarlimab plus carboplatin-paclitaxel versus placebo plus carboplatin-paclitaxel in patients with recurrent or primary advanced (Stage III or IV) endometrial cancer.

Criteria

Subject has histologically or cytologically proven endometrial cancer with recurrent or advanced disease.

Subject must have primary Stage III or Stage IV disease or first recurrent endometrial cancer with a low potential for cure by radiation therapy or surgery alone or in combination, and meet at least one of the following criteria:

Subject has primary Stage IIIA to IIIC1 disease with presence measurable disease per RECIST v.1.1. Lesions that are equivocal or can be representative of postoperational change should be biopsied and confirmed for the presence of tumor.

Subject has primary Stage IIIC1 disease with carcinosarcoma, clear cell, serous, or mixed histology (containing ≥ 10% carcinosarcoma, clear cell, or serous histology) regardless of presence of evaluable or measurable disease on imaging. 

Subject has primary Stage IIIC2 or Stage IV disease. 

Subject has first recurrent disease and is chemotherapy naïve.

You Cannot:        

Have received neo-adjuvant/adjuvant systemic chemotherapy for primary Stage III or IV disease and:

has not had a recurrence or PD prior to entering the study OR

has had a recurrence or PD within 6 months of completing chemo treatment prior to entering the study

Have had > 1 recurrence of endometrial cancer. ·         Received prior anticancer therapy (chemotherapy, targeted therapies, hormonal therapy, radiotherapy, or immunotherapy) within 21 days

Have a concomitant malignancy, or subject has a prior non-endometrial invasive malignancy who has been disease-free for < 3 years or who received any active treatment in the last 3 years for that malignancy. Non-melanoma skin cancer is allowed

Have a known uncontrolled central nervous system metastases, carcinomatosis meningitis, or both

Have known active hepatitis B (eg, hepatitis B surface antigen reactive) or hepatitis C (eg, hepatitis C virus ribonucleic acid [qualitative] is detected).

Have an active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is not considered a form of systemic therapy (eg, thyroid hormone or insulin)

Have a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of systemic immunosuppressive therapy within 7 days prior to the first dose of study treatment.

Details

All patients will be treated with standard of care chemotherapy per the physician judgement for first 6 cycles of treatment. Patients will receive Paclitaxel, Carboplatin and TSR-042 (study medication) infusions every 21 days.  Patients may or may not be prescribed Bevacizumab every 21 days.  The study medication (TSR-042) is an immunotherapy medication and not chemotherapy. The patient will be prescribed TSR-042 infusions every 6 weeks

Interested in more information? Contact Us:

Destin Black, M.D., Principal Investigator
Gynecologic Oncology Associates
(318) 212-8727

IRB: Western
IRB Number:
Trial Type: NA
Sponsor: Tesaro