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Chemotherapy
Chemo + Radiation Therapy + Dostarlimab for Endometrial Cancer
Phase 1
Recruiting
Led By Pamela Soliman, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will study if combination chemo & radiation therapy followed by maintenance therapy can help control endometrial cancer. It'll also assess safety & effects.
Who is the study for?
This trial is for adults over 18 with stage IIIC, node-positive endometrial cancer who've had surgery. They should have good blood counts, kidney and liver function, and no major illnesses that could affect the study. People can't join if they've had certain vaccines recently, uncontrolled diseases, prior treatment with specific antibodies like Dostarlimab or have autoimmune diseases.
What is being tested?
The trial tests a combination of chemotherapy drugs (Paclitaxel and Carboplatin) with radiation therapy followed by maintenance therapy using Dostarlimab to see if it controls endometrial cancer better and what side effects it might cause.
What are the potential side effects?
Possible side effects include reactions to the infusion of drugs, fatigue, hair loss from chemotherapy, skin changes from radiation therapy. Dostarlimab may also cause immune-related issues such as inflammation in various organs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Immunotherapy after Radiation and ChemoExperimental Treatment4 Interventions
Participants will receive an active treatment for 6 cycles. Participants will be on maintenance for 14 cycles, as long as the disease does not get worse. Follow-up will then occur every 6 months for 5 years (from your enrollment date).
Group II: Adjuvant Therapy During RadiationExperimental Treatment4 Interventions
Participants will receive an active treatment for 6 cycles. Participants will be on maintenance for 14 cycles, as long as the disease does not get worse. Follow-up will then occur every 6 months for 5 years (from your enrollment date).
Group III: Adjuvant Therapy After RadiationExperimental Treatment4 Interventions
Participants will receive an active treatment for 6 cycles. Participants will be on maintenance for 14 cycles, as long as the disease does not get worse. Follow-up will then occur every 6 months for 5 years (from your enrollment date).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5450
Carboplatin
2014
Completed Phase 3
~6120
Cisplatin
2013
Completed Phase 3
~3120
Dostarlimab
2019
Completed Phase 3
~2180
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,074 Previous Clinical Trials
1,803,524 Total Patients Enrolled
22 Trials studying Endometrial Cancer
6,240 Patients Enrolled for Endometrial Cancer
GlaxoSmithKlineIndustry Sponsor
4,815 Previous Clinical Trials
8,384,169 Total Patients Enrolled
7 Trials studying Endometrial Cancer
1,338 Patients Enrolled for Endometrial Cancer
Pamela Soliman, MDPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
731 Total Patients Enrolled
3 Trials studying Endometrial Cancer
143 Patients Enrolled for Endometrial Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman who can still have children and have not been sterilized.I have brain complications from cancer, like swelling or bleeding.I still have side effects from previous cancer treatments.I have an autoimmune disease that could come back or affects my organs.I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.My blood clotting levels are within the normal range or properly managed if I'm on blood thinners.My liver is functioning well according to recent tests.I have had lung conditions not caused by infections, except those from radiation.I have been treated with specific immune therapy drugs before.I have not received a live vaccine in the last 30 days.I have had cancer before, but it won't affect this treatment's safety or results.I have stage IIIC endometrial cancer confirmed by surgery and am eligible for additional treatment.I am 18 years old or older.I am fully active or restricted in physically strenuous activity but can do light work.I have a significant liver disease, such as hepatitis or cirrhosis.My kidney function is within the normal range based on recent tests.I joined the trial within 8 weeks and started treatment within 10 weeks of my surgery.I haven't had surgery or investigational therapy within the last 3 to 4 weeks.I do not have any severe ongoing illnesses that could interfere with the study.
Research Study Groups:
This trial has the following groups:- Group 1: Adjuvant Therapy During Radiation
- Group 2: Adjuvant Therapy After Radiation
- Group 3: Immunotherapy after Radiation and Chemo
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.