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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years
Awards & highlights

RUBY 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.Check my eligibility
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.See study design
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.

RUBY Trial 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 returned 6 months or more after finishing initial treatment.
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My cancer is at stage IIIA to IIIC1 and can be measured or evaluated.
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I am a woman aged 18 or older.
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My endometrial cancer has come back or spread and is confirmed by tests.
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My organs are functioning well.

RUBY Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1: Overall survival
Parts 1 and 2: Progression-Free Survival (PFS) - investigator assessment
Secondary outcome measures
Part 2: Cmin and Cmax at steady state of niraparib (nanograms per milliliter)
Part 2: Cmin and Cmax of niraparib (nanograms per milliliter)
Part 2: Overall survival
+18 more

RUBY 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
41 Previous Clinical Trials
15,342 Total Patients Enrolled
Tesaro, Inc.Lead Sponsor
56 Previous Clinical Trials
9,763 Total Patients Enrolled
European Network of Gynaecological Oncological Trial Groups (ENGOT)OTHER
35 Previous Clinical Trials
15,852 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Arm 1: Participants receiving dostarlimab + Carboplatin-paclitaxel followed by dostarlimab, is this treatment plan FDA approved?

"Arm 1 of this trial, which includes the administration of dostarlimab + Carboplatin-paclitaxel followed by dostarlimab, is estimated to be a 3 on Power's safety scale. This is due to it being a Phase 3 trial, thus having both efficacy and safety data supporting its use."

Answered by AI

What types of cancer are patients in Arm 1: Participants receiving dostarlimab + Carboplatin-paclitaxel followed by dostarlimab typically being treated for?

"melanoma patients often receive dostarlimab + Carboplatin-paclitaxel followed by dostarlimab, which has also been shown to ameliorate neoplasm metastasis, lymphoma, non-hodgkin's sarcoma, and advanced forms of sarcoma."

Answered by AI

What other research has been conducted with subjects who received dostarlimab in combination with Carboplatin-paclitaxel, followed by more dostarlimab?

"As of now, there are 1,328 ongoing studies for arm 1: dostarlimab + Carboplatin-paclitaxel followed by dostarlimab. Phase 3 trials make up a significant portion with 351 cases. Most trial locations for this arm are based in Shanghai however; there are 69,749 total locations running these kinds of trials."

Answered by AI

In how many different locations is this trial being conducted?

"Currently, there are 59 locations worldwide where patients can enroll in this study. Some of these sites include Willow Grove, Sault Ste. Marie and Rio Rancho. To reduce travel-related stressors, it is recommended that you pick the location nearest to you."

Answered by AI

To date, how many individuals have signed up for this experiment?

"Currently, this trial is not taking on new patients. The listing was first posted on 18 July 2019 and was edited last on 11 August 2020. However, there are 2713 cancer trials and 1328 Arm 1 trials (dostarlimab + Carboplatin-paclitaxel followed by dostarlimab) that are still recruiting patients."

Answered by AI

Is there still room for participants in this research?

"2713 cancer trials and 1328 Arm 1 studies are currently looking for participants, but this particular clinical trial is not presently searching for candidates. This study was posted on July 18th, 2019 and last updated on August 11th, 2022."

Answered by AI
~277 spots leftby Nov 2026