MMRd/MSI-H Stage II-III Endometrial CancerPhase 2NADIANCT07013851

Clinical Trial to Assess the Efficacy of Dostarlimab as Neoadjuvant Therapy in Patients With MMRd/MSI-H Stage II-III Endometrial Cancer

A Phase 2 study testing Dostarlimab in people with MMRd/MSI-H Stage II-III Endometrial Cancer, run by Grupo Español de Investigación en Cáncer de Ovario at 1 site in Spain.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

The study for which participation is requested is a phase II clinical trial to assess the efficacy of dostarlimab as neoadjuvant therapy in patients with MMRd/MSI-H stage II-III endometrial cancer. The study is conducted in Spain with an estimated number of 25 patients for phase II. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: MMRd/MSI-H Stage II-III Endometrial Cancer
What is being tested?: Dostarlimab
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteSpain
Study dates: 1 Oct 2025to 1 Oct 2029
Phase: Phase 2
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

Female subjects at least 18 years of age, who are able to understand the study procedures and agree to participate in the study by providing written informed consent.
Histologically confirmed new diagnosis of endometrial adenocarcinoma (endometrioid subtype only) by central pathology review.
MMRd status confirmed by IHC by central laboratory.
Subject must provide adequate tumor tissue sample at screening for MMR/MSI status testing. The quality of the tumor tissue sample must be confirmed by the central laboratory during screening.
Subjects must have primary stage II or III (FIGO 2023) disease. Pelvic involvement is included. Stage IIIB2 patients with metastasis to pelvic peritoneum are excluded.
ECOG performance status of 0 or 1.

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Treatment naïve patients without previous radiation or systemic therapy, including hormonal therapy.
Participants should have adequate organ function defined as:
ANC ≥1.5×109/L
Hemoglobin ≥9 g/dL ≥5.6 mmol/L
Platelets ≥100×109/L
AST and ALT ≤2.5×ULN
Bilirubin ≤1.5×ULN (isolated bilirubin >1.5×ULN is acceptable if bilirubin is fractionated and direct bilirubin is <35%)
For patients not taking anticoagulant: INR ≤ 1.5x or PT ≤1.5× ULN. Activated partial thromboplastin time (aPTT) ≤1.5× ULN. Participants receiving anticoagulants PT or PTT are within therapeutic range of intended use of anticoagulants.
Renal function parameters of GFR ≥30 mL/min/1.73m2 (institutional creatinine ≤1.5×ULN) Note: Blood count test should be performed without transfusion or receipt of colony stimulating factors within 4 weeks prior to obtaining the blood sample.
Contraceptive use by subjects should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
The participant is a woman of nonchildbearing potential OR
The participant is a woman of childbearing potential, using a contraceptive method that is highly effective (with a failure rate of <1% per year) during the study treatment period and for at least 120 days after the last dose of study treatment and agrees not to donate eggs (ova or oocytes) for the purpose of reproduction during this period.

Who cannot join

Diagnosis of clear cell, serous, undifferentiated or carcinosarcoma or other uterine mesenchymal tumor such as endometrial stromal sarcoma, leiomyosarcoma, or other types of sarcomas. Adenosarcomas and neuroendocrine tumors are not allowed either.
Any previous radiation or systemic therapy.
ECOG performance status ≥2.
Immunodeficiency or treatment with chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy.
Subject has a concomitant malignancy, or a prior non-endometrial invasive malignancy who has been disease-free for <3 years or who received any active treatment in the last 3 years for that malignancy. Non-melanoma skin cancer is allowed.
Participants have current active or history of pneumonitis or interstitial lung disease.

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Participant has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
Participant has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, or persistent jaundice. Note: Stable non-cirrhotic chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) is acceptable if participant otherwise meets entry criteria.
Immunocompromised patients are not allowed.
Allergy: Participant cannot have history of severe allergic and/or anaphylactic reactions to chimeric, human or humanized antibodies or fusion proteins, sensitivity to any of the study treatments or components thereof, or a history of drug or other allergy that contraindicates their participation.
Participant has experienced any of the following with prior immunotherapy: any immune-related AE (irAE) of Grade 3 or higher, immune-related severe neurologic events of any grade (e.g., myasthenic syndrome/myasthenia gravis, encephalitis, Guillain-Barré syndrome, or transverse myelitis), exfoliative dermatitis of any grade (SJS, TEN, or DRESS syndrome), or myocarditis of any grade. Non-clinically significant laboratory abnormalities are not exclusionary.
Participant has clinically significant cardiovascular disease within 6 months of enrolment.
Prohibited medications: Participant has received systemic steroid therapy (>10 mg daily prednisone or equivalent) within 7 days before the first dose of the study treatment or is receiving any other form of immunosuppressive medication. Replacement therapy (adrenal or pituitary insufficiency) is not considered a form of systemic therapy. Use of inhaled corticosteroids, local steroid injection, or steroid eye drops is allowed.
Subject has known uncontrolled central nervous system metastases, carcinomatosis meningitis, or both.
Subject has known active hepatitis B. Participants who are HBsAg positive are eligible if they have undetectable HBV viral load prior to enrolment.
Subject has a positive HCV antibody test result at Screening or within 3 months prior to first dose of study intervention. NOTE: Participants with a positive HCV antibody test result due to prior resolved disease can be enrolled, only if a confirmatory negative HCV RNA test is obtained.
Subject has a positive HCV RNA test result at Screening or within 3 months prior to first dose of study intervention. NOTE: The HCV RNA test is optional and participants with negative HCV antibody test are not required to undergo HCV RNA testing as well.
Participants with known HIV infection are allowed with the following requirements:
Documented evidence of plasma HIV-1 RNA persistently <50 copies/mL ≤3 months prior to AND at Screening. In the >3 to 12 months prior to Screening, plasma HIV-1 RNA consistently <50 c/mL required; if single increases ≥50 c/mL occurred, they cannot have been persistent nor associated with antiretroviral resistance per investigator assessment AND
CD4 cell count >350 cells/mm3 over past 12 months and at Screening (and no measurement ≤350 cells/mm3 during that time period) AND
Must be on an uninterrupted combination antiretroviral therapy regimen for at least 3 months prior to Screening, with combination antiretroviral therapy regimen consistent with locally recommended guidelines.
Participants with history of CDC Stage 3 AIDS-defining disease (CDC, 2014; also known as acquired immunodeficiency syndrome - defining disease) are allowed if AIDS-defining disease has been treated and cured or is stable for ≥3 months prior to study entry. Cutaneous Kaposi's sarcoma not requiring systemic therapy is allowed.
No history of HIV-associated non-Hodgkin lymphoma ≤5 years prior to study entry.
No treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening.
Subject has not recovered adequately (Grade ≤1) from AEs and/or complications from any major surgery prior to starting therapy.
Subject has a known intolerance or hypersensitivity to dostarlimab active substance, infused protein products, or any of its excipients.
Subject is currently participating and receiving study treatment or has participated in a study of an investigational agent and received study treatment or used an investigational device within 4 weeks of the first dose of treatment.
Subject is considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active infection requiring systemic therapy.
Subject has received, or is scheduled to receive, a live vaccine within 30 days before first dose of study treatment, during study treatment, and for up to 180 days after receiving the last dose of study treatment.
Participant is pregnant or breastfeeding.
Participant has received a live vaccine within 30 days of planned start of study therapy. COVID-19 vaccines that do not contain live viruses are allowed. Note: mRNA and adenoviral-based COVID-19 vaccines are considered non-live.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Grupo Español de Investigación en Cáncer Ginecológico contact

+34 910 09 72 58

secretaria@grupogeico.org

Spain1 site

Grupo Español de Investigación en Cáncer Ginecológico (GEICO)
Madrid, Madrid, 28003

Other trials in Spain

About this study

Official title: Phase II Clinical Trial to Assess the Efficacy of Dostarlimab as Neoadjuvant Therapy in Patients With MMRd/MSI-H Stage II-III Endometrial Cancer

Conditions: MMRd/MSI-H Stage II-III Endometrial Cancer
Being tested: Dostarlimab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DostarlimabDrug
Patients will be treated in the neoadjuvant setting with dostarlima 500 mg (30') every 3 weeks for 4 cycles.All participants will undergo surgery within 6 weeks following the final dose of neoadjuvant dostarlimab. After surgery, adjuvant chemotherapy, including dostarlimab, will be administered as follows:
Stage II EC:
VBT/EBRT (completed within >14 weeks after surgery) + Adjuvant dostarlimab 1000 mg Q6W x 9 cycles (54 weeks total).
Stage III EC:
1. Concurrent EBRT+cisplatin followed by carboplatin + paclitaxel OR
2. Sequential: EBRT followed by carboplatin + paclitaxel OR
3. Chemotherapy alone: carboplatin + paclitaxel
- Adjuvant dostarlimab 500 mg Q3W x 4-6 cycles (in combination with chemotherapy) plus 1000 mg Q6W x 6-7 cycles (54 weeks total).

Study groups in NCT07013851
Study group	Role	What they receive
1	Experimental	Patients will be treated in the neoadjuvant setting with dostarlima 500 mg (30') every 3 weeks for 4 cycles.All participants will undergo surgery within 6 weeks following the final dose of neoadjuvant dostarlimab. After surgery, adjuvant chemotherapy, including dostarlimab, will be administered as follows: Stage II EC: VBT/EBRT (completed within >14 weeks after surgery) + Adjuvant dostarlimab 1000 mg Q6W x 9 cycles (54 weeks total). Stage III EC: 1. Concurrent EBRT+cisplatin followed by carboplatin + paclitaxel OR 2. Sequential: EBRT followed by carboplatin + paclitaxel OR 3. Chemotherapy alone: carboplatin + paclitaxel * Adjuvant dostarlimab 500 mg Q3W x 4-6 cycles (in combination with chemotherapy) plus 1000 mg Q6W x 6-7 cycles (54 weeks total). Receives: Drug: Dostarlimab

What is being measured

The primary outcome is the main question the study is designed to answer.

To evaluate the clinical complete response (cCR) after neoadjuvant dostarlimab.
cCR: Efficacy measured by the proportion of patients who had cCR after neoadjuvant dostarlimab. cCR is defined as the absence of tumor persistence evaluated by MRI, CT, PET scan, pelvic exam, and review of surgical specimen.
Measured: 43 months

Secondary outcomes (5)

To evaluate the pathologic complete response (pCR) after neoadjuvant dostarlimab.
pCR: Efficacy measured by the proportion of patients who had pCR having undergone surgery after neoadjuvant dostarlimab. pCR is defined as the absence of invasive tumor in the surgical specimen by local pathology review.
Measured: 51 months
To evaluate the overall response rate (ORR) of neoadjuvant dostarlimab.
ORR: Efficacy measured by ORR, which is defined as the number of patients with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of response evaluable patients (according to RECIST v1.1).
Measured: 51 months
To evaluate disease-free survival (DFS).
DFS: Efficacy measured by DFS, which is defined as the time in months from date of dostarlimab's first dose to date of local or distant recurrence (assessed radiologically by the investigator or by histopathologic confirmation), or death due to any cause, whichever occurs first.
Measured: 51 months
To evaluate the median of overall survival (mOS).
mOS: Efficacy measured by mOS, which is defined as the median of time in months from date of dostarlimab's first dose to date of death due to any cause. OS will be censored on the last date a patient was known to be alive.
Measured: 51 months
To evaluate the safety and tolerability of dostarlimab in the neoadjuvant setting.
Toxicity will be assessed by adverse events related to study drugs, detected through physical examinations and laboratory tests, and graded according to CTCAE v5.0.
Measured: 51 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 20251 Oct 2029

First posted10 Jun 2025
Study start1 Oct 2025 (estimated)
Primary completion1 Mar 2029 (estimated)
Study completion1 Oct 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for MMRd/MSI-H Stage II-III Endometrial CancerStudies of the same condition, open and under way.
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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 25 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07013851
Sponsor's protocol ID: GEICO 137-E
Other IDs: 2024-512021-81-00
Acronym: NADIA
Status last verified: Jun 2025
First submitted: 28 May 2025
Last updated: 10 Jun 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Clinical Trial to Assess the Efficacy of Dostarlimab as Neoadjuvant Therapy in Patients With MMRd/MSI-H Stage II-III Endometrial Cancer
ClinicalTrials.gov ID: NCT07013851
Acronym / sponsor ID: NADIA / GEICO 137-E
Conditions: MMRd/MSI-H Stage II-III Endometrial Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 25 participants (estimated)
Lead sponsor: Grupo Español de Investigación en Cáncer de OvarioUniversity, hospital or other
Collaborators: GlaxoSmithKline
Study start: 1 Oct 2025 (estimated)
Primary completion: 1 Mar 2029 (estimated)
Study completion: 1 Oct 2029 (estimated)
First posted: 10 Jun 2025 (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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Drug: DostarlimabPatients will be treated in the neoadjuvant setting with dostarlima 500 mg (30') every 3 weeks for 4 cycles.All participants will undergo surgery within 6 weeks following the final dose of neoadjuvant dostarlimab. After surgery, adjuvant chemotherapy, including dostarlimab, will be administered as follows: Stage II EC: VBT/EBRT (completed within >14 weeks after surgery) + Adjuvant dostarlimab 1000 mg Q6W x 9 cycles (54 weeks total). Stage III EC: 1. Concurrent EBRT+cisplatin followed by carboplatin + paclitaxel OR 2. Sequential: EBRT followed by carboplatin + paclitaxel OR 3. Chemotherapy alone: carboplatin + paclitaxel * Adjuvant dostarlimab 500 mg Q3W x 4-6 cycles (in combination with chemotherapy) plus 1000 mg Q6W x 6-7 cycles (54 weeks total).

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

Female subjects at least 18 years of age, who are able to understand the study procedures and agree to participate in the study by providing written informed consent.
Histologically confirmed new diagnosis of endometrial adenocarcinoma (endometrioid subtype only) by central pathology review.
MMRd status confirmed by IHC by central laboratory.
Subject must provide adequate tumor tissue sample at screening for MMR/MSI status testing. The quality of the tumor tissue sample must be confirmed by the central laboratory during screening.
Subjects must have primary stage II or III (FIGO 2023) disease. Pelvic involvement is included. Stage IIIB2 patients with metastasis to pelvic peritoneum are excluded.

Key exclusion criteria (31 listed)

Diagnosis of clear cell, serous, undifferentiated or carcinosarcoma or other uterine mesenchymal tumor such as endometrial stromal sarcoma, leiomyosarcoma, or other types of sarcomas. Adenosarcomas and neuroendocrine tumors are not allowed either.
Any previous radiation or systemic therapy.
ECOG performance status ≥2.
Immunodeficiency or treatment with chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy.
Subject has a concomitant malignancy, or a prior non-endometrial invasive malignancy who has been disease-free for <3 years or who received any active treatment in the last 3 years for that malignancy. Non-melanoma skin cancer is allowed.

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
DostarlimabPatients will be treated in the neoadjuvant setting with dostarlima 500 mg (30') every 3 weeks for 4 cycles.All participants will undergo surgery within 6 weeks following the final dose of neoadjuvant dostarlimab. After surgery, adjuvant chemotherapy, including dostarlimab, will be administered as follows: Stage II EC: VBT/EBRT (completed within >14 weeks after surgery) + Adjuvant dostarlimab 1000 mg Q6W x 9 cycles (54 weeks total). Stage III EC: 1. Concurrent EBRT+cisplatin followed by carboplatin + paclitaxel OR 2. Sequential: EBRT followed by carboplatin + paclitaxel OR 3. Chemotherapy alone: carboplatin + paclitaxel * Adjuvant dostarlimab 500 mg Q3W x 4-6 cycles (in combination with chemotherapy) plus 1000 mg Q6W x 6-7 cycles (54 weeks total).	Drug	1

Primary outcome

To evaluate the clinical complete response (cCR) after neoadjuvant dostarlimab.
Time frame: 43 months
cCR: Efficacy measured by the proportion of patients who had cCR after neoadjuvant dostarlimab. cCR is defined as the absence of tumor persistence evaluated by MRI, CT, PET scan, pelvic exam, and review of surgical specimen.

5 secondary outcomes

To evaluate the pathologic complete response (pCR) after neoadjuvant dostarlimab.
Time frame: 51 months
To evaluate the overall response rate (ORR) of neoadjuvant dostarlimab.
Time frame: 51 months
To evaluate disease-free survival (DFS).
Time frame: 51 months
To evaluate the median of overall survival (mOS).
Time frame: 51 months
To evaluate the safety and tolerability of dostarlimab in the neoadjuvant setting.
Time frame: 51 months

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 10 Jun 2025.
Individual participant dataSharing planned: No

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.

Grupo Español de Investigación en Cáncer Ginecológico contact

+34 910 09 72 58

secretaria@grupogeico.org

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dostarlimab in people with MMRd/MSI-H Stage II-III Endometrial Cancer, run by Grupo Español de Investigación en Cáncer de Ovario at 1 site in Spain.

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 18 inclusion and 31 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: opening soon, as of the sponsor's last update on 10 Jun 2025. 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 Spain. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Grupo Español de Investigación en Cáncer Ginecológico (+34 910 09 72 58, secretaria@grupogeico.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the clinical complete response (cCR) after neoadjuvant dostarlimab. (time frame: 43 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07013851.

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 10 Jun 2025.