Endometrial CancerPhase 1NCT05819892
Phase I Trial Testing the Safety and Tolerability of Chemoradiation Followed by Chemotherapy + Dostarlimab for Stage IIIC, Node Positive, Endometrial Cancer
A Phase 1 study testing Paclitaxel, Carboplatin and Dostarlimab in people with Endometrial Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn if chemotherapy given in combination with radiation therapy, followed by maintenance therapy, can help to control endometrial cancer. The safety and effects of this study treatment will also be studied Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Paclitaxel, Carboplatin and Dostarlimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2023to 1 Mar 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are eligible to participate on this study only if they meet all of the following inclusion criteria.
- Has read and understands the informed consent form (ICF) and has given written informed consent prior to any study procedures
- Have surgically staged IIIC, pathologically confirmed endometrial cancer of any histologic subtype and be eligible for adjuvant chemoradiation followed by chemotherapy (Note: Surgical staging is defined as total hysterectomy and lymph node assessment.)
- Enrolled within 8 weeks of surgery and started treatment within 10 weeks of surgery
- Age ≥ 18 years
- Performance Status of ECOG 0 or 1 (see Performance Status Criteria)
Show all 17Show fewer
- Adequate hematologic function within 14 days prior to enrollment defined as follows:
- Hemoglobin ≥ 9 g/dL
- Platelets ≥ 100,000/mcl
- Absolute neutrophil count (ANC) ≥ 1,500/mcl
- Adequate renal function within 14 days prior to enrollment defined as follows: Creatinine
- ≤ 2 x laboratory upper limit of normal (ULN) or CrCl ≥60ml/min
- Adequate hepatic function within 14 days prior to enrollment defined as follows:
- Bilirubin ≤ 1.5 x ULN (patients with known Gilbert's disease who have bilirubin level ≤ 2 x ULN may be enrolled)
- ALT and AST ≤ 2.5 x ULN
- Adequate coagulation within 14 days prior to enrollment defined as INR or PT/aPTT ≤ 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants.
- Prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial (i.e. non-melanomatous skin cancer).
Who cannot join
- Patients are not eligible to participate on this study if they meet any of the following exclusion criteria.
- Has not recovered (i.e., to Grade ≤ 1 or to baseline) from prior radiation, major surgery and chemotherapy-induced AEs.
- Surgery ≤ 3 weeks prior to initiating protocol therapy Investigational therapy ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, prior to initiating protocol therapy.
- Has received prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapeutic antibody or other similar agents.
- Has a history of a severe hypersensitivity reaction to monoclonal antibody or dostarlimab and/or its excipients.
- Have active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids. This includes, but is not limited to: a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, GuillainBarre syndrome, myasthenia gravis, systemic autoimmune disease such as SLE, connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome because of the risk of recurrence or exacerbation of disease.
Show all 20Show fewer
- History of interstitial lung disease or non-infectious pneumonitis except for those induced by radiation therapies.
- Have a diagnosis of immunodeficiency or are receiving daily systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to enrollment:
- Steroids received as CT scan contrast premedication may be enrolled.
- The use of inhaled or topical corticosteroids is allowed.
- The use of mineralocorticoids (e.g., fludrocortisone) for orthostatic hypotension or adrenocortical insufficiency is allowed.
- The use of physiologic doses of corticosteroids may be allowed and in consultation with the study chair (e.g. 10 mg of prednisone used for replacement therapy for adrenal insufficiency).
- Have received a live vaccine within 30 days of starting trial therapy.
- Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; and cirrhosis.
- --Evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load, tested positive for the presence of hepatitis B surface antigen, or have a positive hepatitis C antibody test result at screening or within 3 months prior to the first dose of study treatment.
- Uncontrolled intercurrent illness including (but not limited to): ongoing or active infection (except for uncomplicated urinary tract infection), interstitial lung disease or active, non-infectious pneumonitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Have received any of the prohibited medications listed in Section 7.2.
- Has leptomeningeal disease, carcinomatous meningitis, symptomatic brain metastases, or radiologic signs of CNS hemorrhage. Note: Asymptomatic brain metastases (i.e, off corticosteroids and anticonvulsants for at least 7 days) are permitted.
- Known human immunodeficiency virus (HIV)-infected patients.
- Women of childbearing potential (WoCBP) who have been not been permanently or surgically sterilized and are capable of procreation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Pamela Soliman, MD, 713-745-2352, psoliman@mdanderson.org
Pamela Soliman, MD
About this study
To learn if chemotherapy given in combination with radiation therapy, followed by maintenance therapy, can help to control endometrial cancer. The safety and effects of this study treatment will also be studied
Read the detailed description
Primary Objectives:
The primary objective of this study is to describe the safety and toxicity of chemoradiation with concurrent immunotherapy, followed by chemotherapy plus concurrent immunotherapy, followed by immunotherapy maintenence in patients with stage IIIC endometrial cancer.
Secondary Objectives:
The secondary objectives are listed below.
- To estimate progression free survival
- To describe the time to recurence and the recurrence patterns including extent and location (i.e. isolated versus multi-focal, pelvic versus distant)
- To estimate disease specific survival and overall survival
Exploratory:
- To determine if the presence of deficient mismatch repair (dMMR) or microsatellite instability correlates with progression free survival, disease free survival and 5-year overall survival
- To assess patient reported outcomes (PROs) during the course of treatment and follow up
- Conditions
- Endometrial Cancer
- Being tested
- Paclitaxel, Carboplatin, Dostarlimab, Cisplatin
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
Also called Taxol
Given by IV (vein)
CarboplatinDrug
Also called Paraplatin®
Given by IV (vein)
DostarlimabDrug
Given by IV (vein)
CisplatinDrug
Also called Platinol®-AQ, Platinol®, CDDP
Given by IV (vein)
| Study group | Role | What they receive |
|---|---|---|
| Adjuvant Therapy During Radiation | Experimental | Participants will receive an active treatment for 6 cycles. Participants will be on Immunotherapy (Dostarlimab) up to 2 years (starting with Dostarlimab treatment at cycle 3), as long as the disease does not get worse or have unacceptable toxicity. Follow- up will then occur every 6 months for 5 years from active treatment. Receives: Drug: Paclitaxel; Drug: Carboplatin; Drug: Dostarlimab; Drug: Cisplatin |
| Adjuvant Therapy After Radiation | Experimental | Participants will receive an active treatment for 6 cycles. Participants will be on Immunotherapy (Dostarlimab) up to 2 years (starting with Dostarlimab treatment at cycle 3), as long as the disease does not get worse or have unacceptable toxicity. Follow- up will then occur every 6 months for 5 years from active treatment. Receives: Drug: Paclitaxel; Drug: Carboplatin; Drug: Dostarlimab; Drug: Cisplatin |
| Immunotherapy after Radiation and Chemo | Experimental | Participants will receive an active treatment for 6 cycles. Participants will be on Immunotherapy (Dostarlimab) up to 2 years (starting with Dostarlimab treatment at cycle 3), as long as the disease does not get worse or have unacceptable toxicity. Follow- up will then occur every 6 months for 5 years from active treatment. Receives: Drug: Paclitaxel; Drug: Carboplatin; Drug: Dostarlimab; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start17 Jul 2023
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Pamela Soliman, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05819892
- Sponsor's protocol ID
- 2021-0618
- Other IDs
- NCI-2023-03071
- Status last verified
- Jun 2026
- First submitted
- 6 Apr 2023
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial Testing the Safety and Tolerability of Chemoradiation Followed by Chemotherapy + Dostarlimab for Stage IIIC, Node Positive, Endometrial Cancer
- ClinicalTrials.gov ID
- NCT05819892
- Acronym / sponsor ID
- 2021-0618
- Conditions
- Endometrial Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 19 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To learn if chemotherapy given in combination with radiation therapy, followed by maintenance therapy, can help to control endometrial cancer. The safety and effects of this study treatment will also be studied
Detailed description
Primary Objectives:
The primary objective of this study is to describe the safety and toxicity of chemoradiation with concurrent immunotherapy, followed by chemotherapy plus concurrent immunotherapy, followed by immunotherapy maintenence in patients with stage IIIC endometrial cancer.
Secondary Objectives:
The secondary objectives are listed below.
- To estimate progression free survival
- To describe the time to recurence and the recurrence patterns including extent and location (i.e. isolated versus multi-focal, pelvic versus distant)
- To estimate disease specific survival and overall survival
Exploratory:
- To determine if the presence of deficient mismatch repair (dMMR) or microsatellite instability correlates with progression free survival, disease free survival and 5-year overall survival
- To assess patient reported outcomes (PROs) during the course of treatment and follow up
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adjuvant Therapy During Radiation | Experimental | Drug: Paclitaxel, Drug: Carboplatin, Drug: Dostarlimab, Drug: CisplatinParticipants will receive an active treatment for 6 cycles. Participants will be on Immunotherapy (Dostarlimab) up to 2 years (starting with Dostarlimab treatment at cycle 3), as long as the disease does not get worse or have unacceptable toxicity. Follow- up will then occur every 6 months for 5 years from active treatment. |
| Adjuvant Therapy After Radiation | Experimental | Drug: Paclitaxel, Drug: Carboplatin, Drug: Dostarlimab, Drug: CisplatinParticipants will receive an active treatment for 6 cycles. Participants will be on Immunotherapy (Dostarlimab) up to 2 years (starting with Dostarlimab treatment at cycle 3), as long as the disease does not get worse or have unacceptable toxicity. Follow- up will then occur every 6 months for 5 years from active treatment. |
| Immunotherapy after Radiation and Chemo | Experimental | Drug: Paclitaxel, Drug: Carboplatin, Drug: Dostarlimab, Drug: CisplatinParticipants will receive an active treatment for 6 cycles. Participants will be on Immunotherapy (Dostarlimab) up to 2 years (starting with Dostarlimab treatment at cycle 3), as long as the disease does not get worse or have unacceptable toxicity. Follow- up will then occur every 6 months for 5 years from active treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients are eligible to participate on this study only if they meet all of the following inclusion criteria.
- Has read and understands the informed consent form (ICF) and has given written informed consent prior to any study procedures
- Have surgically staged IIIC, pathologically confirmed endometrial cancer of any histologic subtype and be eligible for adjuvant chemoradiation followed by chemotherapy (Note: Surgical staging is defined as total hysterectomy and lymph node assessment.)
- Enrolled within 8 weeks of surgery and started treatment within 10 weeks of surgery
- Age ≥ 18 years
Key exclusion criteria (20 listed)
- Patients are not eligible to participate on this study if they meet any of the following exclusion criteria.
- Has not recovered (i.e., to Grade ≤ 1 or to baseline) from prior radiation, major surgery and chemotherapy-induced AEs.
- Surgery ≤ 3 weeks prior to initiating protocol therapy Investigational therapy ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, prior to initiating protocol therapy.
- Has received prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapeutic antibody or other similar agents.
- Has a history of a severe hypersensitivity reaction to monoclonal antibody or dostarlimab and/or its excipients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PaclitaxelAlso: TaxolGiven by IV (vein) | Drug | Adjuvant Therapy After Radiation, Adjuvant Therapy During Radiation, Immunotherapy after Radiation and Chemo |
| CarboplatinAlso: Paraplatin®Given by IV (vein) | Drug | Adjuvant Therapy After Radiation, Adjuvant Therapy During Radiation, Immunotherapy after Radiation and Chemo |
| DostarlimabGiven by IV (vein) | Drug | Adjuvant Therapy After Radiation, Adjuvant Therapy During Radiation, Immunotherapy after Radiation and Chemo |
| CisplatinAlso: Platinol®-AQ, Platinol®, CDDPGiven by IV (vein) | Drug | Adjuvant Therapy After Radiation, Adjuvant Therapy During Radiation, Immunotherapy after Radiation and Chemo |
Primary outcome
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame: through study completion; an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
Related trials for Endometrial Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Active, not recruitingPhase 3
Endometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line
Endometrial Cancer
RecruitingPhase 3
Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer
Advanced Endometrial Carcinoma, Recurrent Endometrial Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 3
Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer
Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pamela Soliman, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Paclitaxel, Carboplatin and Dostarlimab in people with Endometrial Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pamela Soliman, MD (713-745-2352, psoliman@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 (time frame: through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.