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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 below
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My endometrial cancer is advanced and not likely cured by surgery or radiation alone.
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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.
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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.
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I am fully active or restricted in physically strenuous activity but can do light work.
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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:
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My endometrial cancer has come back more than once.
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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.
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My cancer has not worsened or returned before starting this study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 years for reporting.

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 more

Awards & 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
16,945 Total Patients Enrolled
Tesaro, Inc.Lead Sponsor
56 Previous Clinical Trials
9,734 Total Patients Enrolled
European Network of Gynaecological Oncological Trial Groups (ENGOT)OTHER
38 Previous Clinical Trials
17,191 Total Patients Enrolled

Media Library

Carboplatin (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03981796 — Phase 3
Tumors Research Study Groups: Arm 4: Participants receiving placebo + carboplatin-paclitaxel followed by placebo, Arm 1: Participants receiving dostarlimab + Carboplatin-paclitaxel followed by dostarlimab, Arm 2: Participants receiving placebo + carboplatin-paclitaxel followed by placebo, Arm 3: Participants receiving dostarlimab + carboplatin-paclitaxel followed by dostarlimab+niraparib
Tumors Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT03981796 — Phase 3
Carboplatin (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03981796 — Phase 3
~126 spots leftby Nov 2025
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