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NCT03981796 · CITED IN SOURCE DOCUMENTS

A Study to Evaluate Dostarlimab Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Participants With Recurrent or Primary Advanced Endometrial Cancer

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
ACTIVE NOT RECRUITING
Registry last update
2025-09-03

This is a 2 part study. Part 1 is to evaluate the efficacy and safety of dostarlimab plus carboplatin-paclitaxel followed by dostarlimab versus placebo plus carboplatin-paclitaxel followed by placebo; and Part 2 is to evaluate the efficacy and safety of dostarlimab plus carboplatin-paclitaxel followed by dostarlimab plus niraparib versus placebo plus carboplatin-paclitaxel followed by placebo in participants with recurrent or primary advanced (Stage III or IV) endometrial cancer.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
Inclusion Criteria: Part 1 and Part 2: * Female participant is at least 18 years of age. * Participant has histologically or cytologically proven endometrial cancer with recurrent or advanced disease. * 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; 1. Participant has primary Stage IIIA to IIIC1 disease with presence of evaluable or measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v).1.1 based on Investigator's assessment. Lesions that are equivocal or can be representative of post-operative change should be biopsied and confirmed for the presence of tumor; 2. Participant has primary Stage IIIC1 disease with carcinosarcoma, clear cell, serous, or mixed histology (containing greater than or equal to \[\>=\] 10 percent carcinosarcoma, clear cell, or serous histology) regardless of presence of evaluable or measurable disease on imaging; 3. Participant has primary Stage IIIC2 or Stage IV disease regardless of the presence of evaluable or measurable disease; 4. Participant has first recurrent disease and is naïve to systemic anticancer therapy; 5. Participant has received prior neo-adjuvant/adjuvant systemic anticancer therapy and had a recurrence or progression of disease (PD) \>=6 months after completing treatment (first recurrence only). * Participant has an ECOG performance status of 0 or 1. * Participant has adequate organ function. Part 2 only: * Participants must have normal blood pressure (BP) or adequately treated and controlled hypertension (systolic BP lesser than or equal to \[\<=\] 140 millimeter of mercury \[mmHg\] and diastolic BP \<=90 mmHg). * Participants must be able to take medication orally, by mouth (PO). Exclusion Criteria: Part 1 and Part 2: * Participant has received neo-adjuvant/adjuvant systemic anticancer therapy for primary Stage III or IV disease and: 1. has not had a recurrence or PD prior to first dose on the study OR 2. has had a recurrence or PD within 6 months of completing systemic anticancer therapy treatment prior to first dose on the study. * Participant has had \>1 recurrence of endometrial cancer. * Participant has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-PD-ligand 1 (anti-PD-L1), or anti-PD-ligand 2 (anti-PD-L2) agent. * Participant has received prior anticancer therapy (chemotherapy, targeted therapies, hormonal therapy, radiotherapy, or immunotherapy) within 21 days or \<5 times the half-life of the most recent therapy prior to Study Day 1, whichever is shorter. * Participant has a concomitant malignancy, or participant has 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. * Participant has known uncontrolled central nervous system metastases, carcinomatosis meningitis, or both. * Participant has not recovered (that is \[i.e.\], to Grade \<=1 or to Baseline) from cytotoxic therapy induced AEs or has received transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including granulocyte colony-stimulating factor \[G-CSF\], granulocyte macrophage colony-stimulating factor \[GM-CSF\], or recombinant erythropoietin) within 21 days prior to the first dose of study drug. * Participant has not recovered adequately from AEs or complications from any major surgery prior to starting therapy. * Participant 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. * Participant is considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active infection requiring systemic therapy. * Participant 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. Part 2 only: * Participant has received prior therapy with a poly (adenosine diphosphate \[ADP\]-ribose) polymerase (PARP) inhibitor. * Participant has clinically significant cardiovascular disease. * Participant has any known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). * Participant is at increased bleeding risk due to concurrent conditions. * Participant has participated in Part 1 of this study
gender Based
true
healthy Volunteers
false
minimum Age
18 Years
sex
FEMALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. intervention Names
    1. Biological: Dostarlimab
    2. Drug: Carboplatin
    3. Drug: Paclitaxel
    label
    Arm 1: Participants receiving dostarlimab + Carboplatin-paclitaxel followed by dostarlimab
    type
    ACTIVE_COMPARATOR
  2. intervention Names
    1. Drug: Placebo matching dostarlimab
    2. Drug: Carboplatin
    3. Drug: Paclitaxel
    label
    Arm 2: Participants receiving placebo + carboplatin-paclitaxel followed by placebo
    type
    PLACEBO_COMPARATOR
  3. intervention Names
    1. Biological: Dostarlimab
    2. Drug: Carboplatin
    3. Drug: Paclitaxel
    4. Drug: Niraparib
    label
    Arm 3: Participants receiving dostarlimab + carboplatin-paclitaxel followed by dostarlimab+niraparib
    type
    ACTIVE_COMPARATOR
  4. intervention Names
    1. Drug: Placebo matching dostarlimab
    2. Drug: Carboplatin
    3. Drug: Paclitaxel
    4. Drug: Placebo matching Niraparib
    label
    Arm 4: Participants receiving placebo + carboplatin-paclitaxel followed by placebo
    type
    PLACEBO_COMPARATOR
interventions
  1. arm Group Labels
    1. Arm 1: Participants receiving dostarlimab + Carboplatin-paclitaxel followed by dostarlimab
    2. Arm 3: Participants receiving dostarlimab + carboplatin-paclitaxel followed by dostarlimab+niraparib
    description
    Participants will be administered dostarlimab
    name
    Dostarlimab
    other Names
    1. TSR-042
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Arm 2: Participants receiving placebo + carboplatin-paclitaxel followed by placebo
    2. Arm 4: Participants receiving placebo + carboplatin-paclitaxel followed by placebo
    description
    Participants will be administered placebo matching dostarlimab
    name
    Placebo matching dostarlimab
    type
    DRUG
  3. arm Group Labels
    1. Arm 1: Participants receiving dostarlimab + Carboplatin-paclitaxel followed by dostarlimab
    2. Arm 2: Participants receiving placebo + carboplatin-paclitaxel followed by placebo
    3. Arm 3: Participants receiving dostarlimab + carboplatin-paclitaxel followed by dostarlimab+niraparib
    4. Arm 4: Participants receiving placebo + carboplatin-paclitaxel followed by placebo
    description
    Participants will be administered carboplatin
    name
    Carboplatin
    type
    DRUG
  4. arm Group Labels
    1. Arm 1: Participants receiving dostarlimab + Carboplatin-paclitaxel followed by dostarlimab
    2. Arm 2: Participants receiving placebo + carboplatin-paclitaxel followed by placebo
    3. Arm 3: Participants receiving dostarlimab + carboplatin-paclitaxel followed by dostarlimab+niraparib
    4. Arm 4: Participants receiving placebo + carboplatin-paclitaxel followed by placebo
    description
    Participants will be administered paclitaxel
    name
    Paclitaxel
    type
    DRUG
  5. arm Group Labels
    1. Arm 3: Participants receiving dostarlimab + carboplatin-paclitaxel followed by dostarlimab+niraparib
    description
    Participants will be administered niraparib
    name
    Niraparib
    type
    DRUG
  6. arm Group Labels
    1. Arm 4: Participants receiving placebo + carboplatin-paclitaxel followed by placebo
    description
    Participants will be administered placebo matching Niraparib
    name
    Placebo matching Niraparib
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
QUADRUPLE
masking Description
The participant, Investigator, study staff, and the Sponsor study team and its representatives will be blinded to the assigned treatment.
who Masked
  1. PARTICIPANT
  2. CARE_PROVIDER
  3. INVESTIGATOR
  4. OUTCOMES_ASSESSOR
primary Purpose
TREATMENT
Enrollment
count
785
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Parts 1 and 2: Progression-Free Survival (PFS) - investigator assessment
    time Frame
    Up to 6 years
  2. measure
    Part 1: Overall survival
    time Frame
    Up to 6 years
secondary Outcomes
  1. measure
    Part 2: Overall survival
    time Frame
    Up to 6 years
  2. measure
    Parts 1 and 2: Progression free survival (PFS) blinded independent central review (BICR)
    time Frame
    Up to 6 years
  3. measure
    Parts 1 and 2: Objective response rate (ORR) - BICR and Investigator assessment
    time Frame
    Up to 6 years
  4. measure
    Parts 1 and 2: Duration of response (DOR) - BICR and Investigator assessment
    time Frame
    Up to 6 years
  5. measure
    Parts 1 and 2: Disease control rate (DCR) - BICR and Investigator assessment
    time Frame
    Up to 6 years
  6. description
    EQ-5D-5L is a validated questionnaire to assess the overall health-related quality of life in participants across diseases.
    measure
    Parts 1 and 2: Patient-reported outcomes (PROs) in the European Quality of Life scale, 5-Dimensions, 5-Levels (EQ-5D-5L)
    time Frame
    Up to 6 years
  7. description
    EORTC QLQ-C30 is validated questionnaire to assess overall health-related quality of life in participants with cancer.
    measure
    Parts 1 and 2: PROs in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30 [Core])
    time Frame
    Up to 6 years
  8. description
    EORTC QLQ-EN24 is a validated questionnaire to assess the overall health-related quality of life in participants with all stages of endometrial cancer.
    measure
    Parts 1 and 2: PROs in the EORTC Quality of Life Questionnaire (Endometrial Cancer Module [QLQ-EN24])
    time Frame
    Up to 6 years
  9. measure
    Parts 1 and 2: Progression-free survival 2 (PFS2)
    time Frame
    Up to 6 years
  10. measure
    Parts 1 and 2: Number of participants with adverse events (AEs), Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs)
    time Frame
    Up to 6 years
  11. measure
    Parts 1 and 2: Number of participants with clinically significant changes in clinical laboratory parameters, physical examination, electrocardiogram (ECG) and participants reporting the intake of concomitant medication
    time Frame
    Up to 6 years
  12. measure
    Parts 1 and 2: Change from Baseline in vital sign: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) (Millimeters of mercury)
    time Frame
    Baseline and up to 6 Years
Full study description
brief Summary
This is a 2 part study. Part 1 is to evaluate the efficacy and safety of dostarlimab plus carboplatin-paclitaxel followed by dostarlimab versus placebo plus carboplatin-paclitaxel followed by placebo; and Part 2 is to evaluate the efficacy and safety of dostarlimab plus carboplatin-paclitaxel followed by dostarlimab plus niraparib versus placebo plus carboplatin-paclitaxel followed by placebo in participants with recurrent or primary advanced (Stage III or IV) endometrial cancer.
Source references
references
  1. citation
    Mirza MR, Chase DM, Slomovitz BM, dePont Christensen R, Novak Z, Black D, Gilbert L, Sharma S, Valabrega G, Landrum LM, Hanker LC, Stuckey A, Boere I, Gold MA, Auranen A, Pothuri B, Cibula D, McCourt C, Raspagliesi F, Shahin MS, Gill SE, Monk BJ, Buscema J, Herzog TJ, Copeland LJ, Tian M, He Z, Stevens S, Zografos E, Coleman RL, Powell MA; RUBY Investigators. Dostarlimab for Primary Advanced or Recurrent Endometrial Cancer. N Engl J Med. 2023 Jun 8;388(23):2145-2158. doi: 10.1056/NEJMoa2216334. Epub 2023 Mar 27.
    pmid
    36972026
    type
    BACKGROUND
  2. citation
    Chen Y, Lubinga SJ, Ramsey S, Hurteau J, Reynolds J, Carlson JJ. Molecular Testing in Primary Advanced or Recurrent Endometrial Cancer: A Cost-Effectiveness Analysis. JCO Precis Oncol. 2026 Jul;10(7):e2501110. doi: 10.1200/PO-25-01110. Epub 2026 Jul 6.
    pmid
    42407008
    type
    DERIVED
  3. citation
    Chase DM, Herrstedt J, Miller EM, Gilbert L, Zub O, Mathews C, Angioli R, Teneriello M, Gropp-Meier M, Powell MA, Reyners AKL, Cloven NG, Eminowicz G, Gill SE, Mackowiak-Matejczyk B, Pothuri B, Samouelian V, Jain A, Boone J, Bouberhan S, Trinidad J, Braly P, Buttin B, Backes FJ, Sawyer B, Antony G, Garside J, Allonby O, McCourt CK, Mirza MR. Quality-adjusted time without symptoms of disease progression or toxicity of treatment in patients with primary advanced or recurrent endometrial cancer treated with dostarlimab plus carboplatin-paclitaxel versus carboplatin-paclitaxel. Int J Gynecol Cancer. 2025 Aug;35(8):101935. doi: 10.1016/j.ijgc.2025.101935. Epub 2025 May 21.
    pmid
    40616865
    type
    DERIVED
  4. citation
    Banerjee S, Ingles Russo Garces A, Garside J, Rahman T, Pearson C, Heffernan K. Real-world patient characteristics and survival outcomes in patients with advanced or recurrent endometrial cancer in England: a retrospective, population-based study. BMJ Open. 2024 Nov 24;14(11):e083540. doi: 10.1136/bmjopen-2023-083540.
    pmid
    39581729
    type
    DERIVED
  5. citation
    Auranen A, Powell MA, Sukhin V, Landrum LM, Ronzino G, Buscema J, Bauerschlag D, Lalisang R, Bender D, Gilbert L, Armstrong A, Safra T, Nevadunsky N, Sebastianelli A, Slomovitz B, Ring K, Coleman R, Podzielinski I, Stuckey A, Teneriello M, Gill S, Pothuri B, Willmott L, Sharma S, Dabrowski C, Antony G, Stevens S, Mirza MR, Fleming E. Safety of dostarlimab in combination with chemotherapy in patients with primary advanced or recurrent endometrial cancer in a phase III, randomized, placebo-controlled trial (ENGOT-EN6-NSGO/GOG-3031/RUBY). Ther Adv Med Oncol. 2024 Sep 28;16:17588359241277656. doi: 10.1177/17588359241277656. eCollection 2024.
    pmid
    39346117
    type
    DERIVED
  6. citation
    Valabrega G, Powell MA, Hietanen S, Miller EM, Novak Z, Holloway R, Denschlag D, Myers T, Thijs AM, Pennington KP, Gilbert L, Fleming E, Zub O, Landrum LM, Ataseven B, Gogoi R, Podzielinski I, Cloven N, Monk BJ, Sharma S, Herzog TJ, Stuckey A, Pothuri B, Secord AA, Chase D, Vincent V, Meyers O, Garside J, Mirza MR, Black D. Patient-reported outcomes in the subpopulation of patients with mismatch repair-deficient/microsatellite instability-high primary advanced or recurrent endometrial cancer treated with dostarlimab plus chemotherapy compared with chemotherapy alone in the ENGOT-EN6-NSGO/GOG3031/RUBY trial. Int J Gynecol Cancer. 2025 Jun;35(6):101852. doi: 10.1136/ijgc-2024-005484. Epub 2025 Apr 19.
    pmid
    39322611
    type
    DERIVED
  7. citation
    Mirza MR, Chase DM, Slomovitz BM, Christensen RD, Novak Z, Black D, Gilbert L, Sharma S, Valabrega G, Landrum LM, Hanker LC, Stuckey A, Boere I, Gold MA, Auranen A, Pothuri B, Cibula D, McCourt C, Raspagliesi F, Shahin MS, Gill SE, Monk BJ, Buscema J, Herzog TJ, Copeland LJ, Tian M, He Z, Stevens S, Zografos E, Coleman RL, Powell MA. A Plain Language Summary of "Dostarlimab for primary advanced or recurrent endometrial cancer". Future Oncol. 2025 Jan;21(2):151-168. doi: 10.2217/fon-2023-0940. Epub 2024 Jul 11.
    pmid
    38990090
    type
    DERIVED
  8. citation
    Bogani G, Monk BJ, Powell MA, Westin SN, Slomovitz B, Moore KN, Eskander RN, Raspagliesi F, Barretina-Ginesta MP, Colombo N, Mirza MR. Adding immunotherapy to first-line treatment of advanced and metastatic endometrial cancer. Ann Oncol. 2024 May;35(5):414-428. doi: 10.1016/j.annonc.2024.02.006. Epub 2024 Feb 29.
    pmid
    38431043
    type
    DERIVED
  9. citation
    You M, Zeng X, Zhang J, Huang Y, Zhang Y, Cai Z, Hu Y. Cost-effectiveness analysis of dostarlimab plus carboplatin-paclitaxel as first-line treatment for advanced endometrial cancer. Front Immunol. 2023 Sep 4;14:1267322. doi: 10.3389/fimmu.2023.1267322. eCollection 2023.
    pmid
    37731489
    type
    DERIVED
  10. citation
    Morton M, Marcu I, Levine M, Cosgrove C, Backes F, O'Malley D, Chambers L. Evaluation of Efficacy and Adverse Events After Second Immunotherapy Exposure in Endometrial and Cervical Carcinoma. Obstet Gynecol. 2023 Aug 1;142(2):360-363. doi: 10.1097/AOG.0000000000005243. Epub 2023 Jul 5.
    pmid
    37411031
    type
    DERIVED
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