Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
This is a 2 part study. Part 1 is to evaluate the efficacy and safety of dostarlimab plus
carboplatin-paclitaxel followed by dostarlimab versus placebo plus carboplatin-paclitaxel
followed by placebo; and Part 2 is to evaluate the efficacy and safety of dostarlimab plus
carboplatin-paclitaxel followed by dostarlimab plus niraparib versus placebo plus
carboplatin-paclitaxel followed by placebo in participants with recurrent or primary advanced
(Stage III or IV) endometrial cancer.
Phase
Phase 3
Funding Agency/Sponsor
Industrial
Disease
Gynecologic Cancer
Enrollment Eligibility
Inclusion Criteria:
Part 1 and Part 2:
- Female participant is at least 18 years of age.
- Participant has histologically or cytologically proven endometrial cancer with
recurrent or advanced disease.
- Participant 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;
1. Participant has primary Stage IIIA to IIIC1 disease with presence of evaluable or
measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST)
version (v).1.1 based on Investigator's assessment. Lesions that are equivocal or
can be representative of post-operative change should be biopsied and confirmed
for the presence of tumor;
2. Participant has primary Stage IIIC1 disease with carcinosarcoma, clear cell,
serous, or mixed histology (containing greater than or equal to [>=] 10 percent
carcinosarcoma, clear cell, or serous histology) regardless of presence of
evaluable or measurable disease on imaging;
3. Participant has primary Stage IIIC2 or Stage IV disease regardless of the
presence of evaluable or measurable disease;
4. Participant has first recurrent disease and is naïve to systemic anticancer
therapy;
5. Participant has received prior neo-adjuvant/adjuvant systemic anticancer therapy
and had a recurrence or progression of disease (PD) >=6 months after completing
treatment (first recurrence only).
- Participant has an ECOG performance status of 0 or 1.
- Participant has adequate organ function.
Part 2 only:
- Participants must have normal blood pressure (BP) or adequately treated and controlled
hypertension (systolic BP lesser than or equal to [<=] 140 millimeter of mercury
[mmHg] and diastolic BP <=90 mmHg).
- Participants must be able to take medication orally, by mouth (PO).
Exclusion Criteria:
Part 1 and Part 2:
- Participant has received neo-adjuvant/adjuvant systemic anticancer therapy for primary
Stage III or IV disease and:
1. has not had a recurrence or PD prior to first dose on the study OR
2. has had a recurrence or PD within 6 months of completing systemic anticancer
therapy treatment prior to first dose on the study.
- Participant has had >1 recurrence of endometrial cancer.
- Participant has received prior therapy with an anti-programmed cell death protein 1
(anti-PD-1), anti-PD-ligand 1 (anti-PD-L1), or anti-PD-ligand 2 (anti-PD-L2) agent.
- Participant has received prior anticancer therapy (chemotherapy, targeted therapies,
hormonal therapy, radiotherapy, or immunotherapy) within 21 days or <5 times the
half-life of the most recent therapy prior to Study Day 1, whichever is shorter.
- Participant has a concomitant malignancy, or participant 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.
- Participant has known uncontrolled central nervous system metastases, carcinomatosis
meningitis, or both.
- Participant has not recovered (that is [i.e.], to Grade <=1 or to Baseline) from
cytotoxic therapy induced AEs or has received transfusion of blood products (including
platelets or red blood cells) or administration of colony-stimulating factors
(including granulocyte colony-stimulating factor [G-CSF], granulocyte macrophage
colony-stimulating factor [GM-CSF], or recombinant erythropoietin) within 21 days
prior to the first dose of study drug.
- Participant has not recovered adequately from AEs or complications from any major
surgery prior to starting therapy.
- Participant is currently participating and receiving study treatment or has
participated in a study of an investigational agent and received study treatment or
used an investigational device within 4 weeks of the first dose of treatment.
- Participant is considered a poor medical risk due to a serious, uncontrolled medical
disorder, nonmalignant systemic disease, or active infection requiring systemic
therapy.
- Participant has received, or is scheduled to receive, a live vaccine within 30 days
before first dose of study treatment, during study treatment, and for up to 180 days
after receiving the last dose of study treatment.
Part 2 only:
- Participant has received prior therapy with a poly (adenosine diphosphate
[ADP]-ribose) polymerase (PARP) inhibitor.
- Participant has clinically significant cardiovascular disease.
- Participant has any known history or current diagnosis of myelodysplastic syndrome
(MDS) or acute myeloid leukemia (AML).
- Participant is at increased bleeding risk due to concurrent conditions.
- Participant has participated in Part 1 of this study