Study Comparing Dostarlimab with Chemotherapy to Placebo with Chemotherapy in Advanced Endometrial Cancer
Sponsor: Tesaro, Inc.
ClinicalTrials ID:NCT03981796
This clinical trial is testing whether adding the drug dostarlimab to standard chemotherapy is more effective than chemotherapy alone in treating advanced or returning endometrial cancer. The study also explores if combining dostarlimab with another drug, niraparib, offers additional benefits.
Patient Parameters
| Parameter | Options |
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Program Overview
This study is divided into two parts. Part 1 aims to evaluate the effectiveness and safety of dostarlimab combined with chemotherapy drugs carboplatin and paclitaxel, compared to a placebo with the same chemotherapy, in patients with advanced or returning endometrial cancer. Part 2 will assess the combination of dostarlimab and niraparib with chemotherapy against a placebo with chemotherapy to see if it provides better outcomes.
Eligibility Criteria
Inclusion Criteria
- Women aged 18 or older.
- Diagnosed with advanced or returning endometrial cancer.
- Cancer is at Stage III or IV, or has returned after initial treatment, and cannot be cured with surgery or radiation alone.
- Must meet specific criteria based on cancer stage and type.
- Must not have had more than one recurrence of cancer.
- Must be in good overall health with an ECOG performance status of 0 or 1.
- Must have normal organ function.
Part 2 only:
- Must have normal or well-controlled blood pressure.
- Must be able to take oral medication.
Exclusion Criteria
- Have had more than one recurrence of endometrial cancer.
- Have received certain cancer therapies recently or have not recovered from previous treatments.
- Have another active cancer or have had one in the last three years, except for certain skin cancers.
- Have uncontrolled cancer spread to the brain or spinal cord.
- Have not recovered from major surgery complications.
- Are currently in another clinical trial or have been recently.
- Have serious uncontrolled medical conditions or infections.
- Have received a live vaccine recently.
Part 2 only:
- Have received a PARP inhibitor before.
- Have significant heart disease.
- Have a history of certain blood disorders.
- Are at risk of bleeding due to other conditions.
- Have participated in Part 1 of this study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| GSK Investigational Site | 85016 | Phoenix | Arizona |
| GSK Investigational Site | 85016 | Scottsdale | Arizona |
| GSK Investigational Site | 85704 | Tucson | Arizona |
| GSK Investigational Site | 85710 | Tucson | Arizona |
| GSK Investigational Site | 92663 | Newport Beach | California |
| GSK Investigational Site | 94304 | Palo Alto | California |
| GSK Investigational Site | 33442 | Deerfield Beach | Florida |
| GSK Investigational Site | 32207 | Jacksonville | Florida |
| GSK Investigational Site | 33136 | Miami | Florida |
| GSK Investigational Site | 33176 | Miami | Florida |
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