Trial Search Results

A Study to Evaluate Dostarlimab Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Participants With Recurrent or Primary Advanced Endometrial Cancer

Endometrial cancer accounts for greater than 90 percent (%) of all uterine cancer. The majority of participants with endometrial cancer are diagnosed in early stages (Stage I or II) and receive surgery with curative intent; however, approximately 20% are diagnosed with advanced or metastatic disease (Stage III or IV) for which a surgical cure is not possible. Paclitaxel in combination with carboplatin has been shown to be efficacious against a variety of different tumor types, including non-small-cell-lung-carcinoma (NSCLC), ovarian cancer, endometrial cancer, and head and neck cancer. This study will evaluate the efficacy and safety of dostarlimab in combination with carboplatin-paclitaxel, the standard of care for participants with recurrent or primary advanced endometrial cancer. This study consists of a Screening Period, Treatment Period, an End of Treatment (EOT) Visit, a Safety Follow-up Visit, and a Survival Assessment Period. Participants will be randomized in a 1:1 ratio to receive either dostarlimab plus carboplatin paclitaxel or placebo plus carboplatin-paclitaxel.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Tesaro, Inc.

Collaborator: Gynecologic Oncology Group

Stanford Investigator(s):

Intervention(s):

  • Biological: Dostarlimab
  • Drug: Placebo
  • Drug: Carboplatin-paclitaxel

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - Female participant is at least 18 years of age, able to understand the study
   procedures, and agrees to participate in the study by providing written informed
   consent.

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

   - Participant must provide adequate tumor tissue sample at Screening for microsatellite
   instability (MSI) status testing.

   - 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; a) Participant has
   primary Stage IIIA to IIIC1 disease with presence of evaluable or measurable disease
   per RECIST v.1.1 based on Investigator's assessment. Lesions that are equivocal or can
   be representative of postoperational change should be biopsied and confirmed for the
   presence of tumor; b) Participant 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; c) Participant has primary Stage IIIC2 or Stage IV disease; d) Participant
   has first recurrent disease and is chemotherapy naïve; e) Participant has received
   prior neo-adjuvant/adjuvant systemic chemotherapy and had a recurrence or PD >= 6
   months after completing treatment (first recurrence only).

   - Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0
   or 1.

   - Participant has adequate organ function as follows: a) Absolute neutrophil count >=
   1,500 cells/micro Liters (mcL); b) Platelets >= 100,000 cells/mcL; c) Hemoglobin >= 9
   grams per deciliter (g/dL) or >= 5.6 millimoles per Liter (mmol/L); d) Serum
   creatinine <= 1.5× upper limit of normal (ULN) or calculated creatinine clearance >=
   50 milliliter per minute (mL/min) using the Cockcroft-Gault equation for participants
   with creatinine levels > 1.5× institutional ULN; e) Total bilirubin <= 1.5× ULN and
   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
   receiving anticoagulant therapy must have a PT or partial thromboplastin within the
   therapeutic range of intended use of anticoagulants.

   - Participant must have a negative serum pregnancy test within 72 hours of the first
   dose of study medication, unless they are of nonchildbearing potential.
   Nonchildbearing potential is defined as follows: a) Participant is >= 45 years of age
   and has not had menses for > 1 year; b) A follicle-stimulating hormone value in the
   postmenopausal range upon screening evaluation if amenorrheic for < 2 years without a
   hysterectomy and oophorectomy; c) Posthysterectomy, postbilateral oophorectomy, or
   posttubal ligation.

   - Participants of childbearing potential must agree to use 2 adequate methods of
   contraception with their partners starting with the screening visit through 180 days
   after the last dose of study treatment.

Exclusion Criteria:

   - Participant has received neo-adjuvant/adjuvant systemic chemotherapy for primary Stage
   III or IV disease and: a) has not had a recurrence or PD prior to entering the study
   OR b) has had a recurrence or PD within 6 months of completing chemotherapy treatment
   prior to entering the study.

   - Participant has had at least 1 recurrence of endometrial cancer.

   - Participant has received prior therapy with an anti-PD-1, anti-PD-L1, or 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 a known history of human immunodeficiency virus (HIV; HIV 1/2
   antibodies).

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

   - Participant has 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).

   - Participant has 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.

   - Participant has not recovered (ie, to Grade <= 1 or to Baseline) from cytotoxic
   therapy induced AEs.

   - Participant has not recovered adequately from AEs or complications from any major
   surgery prior to starting therapy.

   - Participant has a known hypersensitivity to carboplatin, paclitaxel, or dostarlimab
   components or excipients.

   - 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. Specific examples include, but are not limited to, active, noninfectious
   pneumonitis; uncontrolled ventricular arrhythmia; recent (within 90 days) myocardial
   infarction; uncontrolled major seizure disorder; unstable spinal cord compression;
   superior vena cava syndrome; or any psychiatric or substance abuse disorders that
   would interfere with cooperation with the requirements of the study (including
   obtaining informed consent).

   - Participant is pregnant or breastfeeding or is expecting to conceive children within
   the projected duration of the study, starting with the screening visit through 180
   days after the last dose of study treatment.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Female

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Nimna Ranatunga
1 650-721-4070
Recruiting