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Chemotherapy
Dostarlimab + Chemotherapy for Endometrial Cancer (RUBY Trial)
Phase 3
Waitlist Available
Research Sponsored by Tesaro, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Participants must be able to take medication orally, by mouth (PO)
Must not have
Participant has had >1 recurrence of endometrial cancer
Participant has clinically significant cardiovascular disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years
Awards & highlights
Pivotal Trial
Summary
This trial is testing a new immunotherapy drug combo against placebo to see if it's more effective in treating endometrial cancer.
Who is the study for?
This trial is for women over 18 with advanced (Stage III or IV) or recurrent endometrial cancer. They should have an ECOG performance status of 0 or 1, indicating they are fully active or restricted in physically strenuous activity but ambulatory and able to carry out work of a light nature. Participants must not have used certain cancer treatments recently, have controlled blood pressure, adequate organ function, and no history of certain other diseases.
What is being tested?
The study tests the effectiveness and safety of dostarlimab combined with chemotherapy drugs carboplatin-paclitaxel followed by either dostarlimab alone or together with niraparib versus placebo versions. The goal is to see if these combinations help those with advanced stages of endometrial cancer.
What are the potential side effects?
Potential side effects may include immune-related reactions due to dostarlimab (like inflammation in various organs), typical chemotherapy side effects from carboplatin-paclitaxel such as nausea, hair loss, fatigue, increased risk of infection, and possible complications from niraparib like bone marrow suppression.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My endometrial cancer is advanced and not likely cured by surgery or radiation alone.
Select...
I can take medication by mouth.
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My cancer has returned for the first time and I haven't had any cancer drugs yet.
Select...
My blood pressure is normal or well-controlled under 140/90 mmHg.
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My cancer is Stage IIIC1 with specific cell types and may not show on scans.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My cancer is at stage IIIC2 or IV.
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My cancer is at stage IIIA to IIIC1 and can be measured or evaluated.
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My endometrial cancer has come back or spread and is confirmed by tests.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My endometrial cancer has come back more than once.
Select...
I have a serious heart condition.
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I have untreated brain metastases or carcinomatous meningitis.
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I have a serious health condition that is not under control.
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I have not had, nor plan to have, a live vaccine around the time of my treatment.
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I have been treated with a PARP inhibitor before.
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I have a history or current diagnosis of MDS or AML.
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I have been treated with drugs targeting the PD-1 or PD-L1/L2 pathways.
Select...
My cancer has not worsened or returned before starting this study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Parts 1 and 2: Number of participants with Eastern Cooperative Oncology Group (ECOG) Performance Status Scores
Parts 1 and 2: PROs in the EORTC Quality of Life Questionnaire (Endometrial Cancer Module [QLQ-EN24])
Parts 1 and 2: PROs in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30 [Core])
+1 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
4Treatment groups
Active Control
Placebo Group
Group I: Arm 1: Participants receiving dostarlimab + Carboplatin-paclitaxel followed by dostarlimabActive Control3 Interventions
Group II: Arm 3: Participants receiving dostarlimab + carboplatin-paclitaxel followed by dostarlimab+niraparibActive Control4 Interventions
Group III: Arm 4: Participants receiving placebo + carboplatin-paclitaxel followed by placeboPlacebo Group4 Interventions
Group IV: Arm 2: Participants receiving placebo + carboplatin-paclitaxel followed by placeboPlacebo Group3 Interventions
Find a Location
Who is running the clinical trial?
GOG FoundationNETWORK
46 Previous Clinical Trials
16,865 Total Patients Enrolled
Tesaro, Inc.Lead Sponsor
56 Previous Clinical Trials
9,771 Total Patients Enrolled
European Network of Gynaecological Oncological Trial Groups (ENGOT)OTHER
39 Previous Clinical Trials
17,421 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,605 Previous Clinical Trials
6,144,286 Total Patients Enrolled
1 Trials studying Tumors
12 Patients Enrolled for Tumors
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My endometrial cancer has come back more than once.My endometrial cancer is advanced and not likely cured by surgery or radiation alone.I have a serious heart condition.I can take medication by mouth.I have a higher risk of bleeding due to other health conditions.My cancer has returned for the first time and I haven't had any cancer drugs yet.I have untreated brain metastases or carcinomatous meningitis.I have recovered from previous cancer treatment side effects and haven't had blood transfusions or certain medications in the last 3 weeks.I have a serious health condition that is not under control.My blood pressure is normal or well-controlled under 140/90 mmHg.My cancer returned or worsened within 6 months after finishing my last cancer treatment.I still have side effects from recent major surgery.My cancer is Stage IIIC1 with specific cell types and may not show on scans.I have not had, nor plan to have, a live vaccine around the time of my treatment.I have been treated with a PARP inhibitor before.I have a history or current diagnosis of MDS or AML.I haven't had cancer treatment within the last 21 days or less than 5 half-lives of my last therapy.I am fully active or restricted in physically strenuous activity but can do light work.I have been treated with drugs targeting the PD-1 or PD-L1/L2 pathways.My cancer has not worsened or returned before starting this study.I have another cancer type or was treated for a non-skin cancer in the last 3 years.I have not been in a clinical trial for a new treatment or device within the last 4 weeks.My cancer is at stage IIIC2 or IV.My cancer returned 6 months or more after finishing initial treatment.I had treatment before or after surgery for stage III or IV cancer.My cancer is at stage IIIA to IIIC1 and can be measured or evaluated.I am a woman aged 18 or older.My endometrial cancer has come back or spread and is confirmed by tests.My organs are functioning well.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 4: Participants receiving placebo + carboplatin-paclitaxel followed by placebo
- Group 2: Arm 1: Participants receiving dostarlimab + Carboplatin-paclitaxel followed by dostarlimab
- Group 3: Arm 2: Participants receiving placebo + carboplatin-paclitaxel followed by placebo
- Group 4: Arm 3: Participants receiving dostarlimab + carboplatin-paclitaxel followed by dostarlimab+niraparib
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.