TriangleNCT03914612 · CITED IN SOURCE DOCUMENTS
Testing the Addition of the Immunotherapy Drug Pembrolizumab to the Usual Chemotherapy Treatment (Paclitaxel and Carboplatin) in Stage III-IV or Recurrent 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
- 2026-07-31
This phase III trial studies how well the combination of pembrolizumab, paclitaxel and carboplatin works compared with paclitaxel and carboplatin alone in treating patients with endometrial cancer that is stage III or IV, or has come back after a period of improvement (recurrent). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Paclitaxel and carboplatin are chemotherapy drugs used as part of the usual treatment approach for this type of cancer. This study aims to assess if adding immunotherapy to these drugs is better or worse than the usual approach for treatment of this 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.
Participant flow
Baseline characteristics
Progression-free Survival (PFS)
Adverse Events With Grade 3 (or Higher)
Objective Tumor Response
Duration of Objective Response
Overall Survival (OS)
Quality of Life (QoL) in pMMR Patients Only
Concordance Between Institutional Mismatch Repair (MMR) Immunohistochemistry (IHC) Testing and Centralized MMR IHC
Incidence of Pembrolizumab Treatment and Self-reported Neurotoxicity
Effect of Pembrolizumab on PFS and OS by Program Death Ligand 1 (PD-L1) IHC
Association Between PD-L1 IHC and MMR Status
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Measurable stage III, measurable stage IVA, stage IVB (with or without measurable disease) or recurrent (with or without measurable disease) endometrial cancer. * Pathology report showing results of institutional MMR IHC testing. * Histologic confirmation of the original primary tumor is required (submission of pathology report(s) is required). Patients with the following histologic types are eligible: Endometrioid adenocarcinoma, serous adenocarcinoma, dedifferentiated/undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.). * Submission of tumor specimens for centralized MMR IHC testing is required after Step 1 and before Step 2 registration. * In patients with measurable disease, lesions will be defined and monitored by RECIST version (v) 1.1. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be \>= 10 mm when measured by CT or magnetic resonance imaging (MRI). Lymph nodes must be \>= 15 mm in short axis when measured by CT or MRI. * Patients may have received * NO prior chemotherapy for treatment of endometrial cancer OR * Prior adjuvant chemotherapy (e.g., paclitaxel/carboplatin alone or as a component of concurrent chemotherapy and radiation therapy \[with or without cisplatin\]) provided adjuvant chemotherapy was completed \>= 12 months prior to STEP 2 registration. * Patients may have received prior radiation therapy for treatment of endometrial cancer. Prior radiation therapy may have included pelvic radiation therapy, extended field pelvic/para aortic radiation therapy, intravaginal brachytherapy, and/or palliative radiation therapy. All radiation therapy must be completed at least 4 weeks prior to STEP 2 registration. * Patients may have received prior hormonal therapy for treatment of endometrial cancer. All hormonal therapy must be discontinued at least three weeks prior to STEP 2 registration. * Interval or cytoreductive surgery, after start of treatment on this trial, and prior to documentation of disease progression, is NOT permitted. * Age \>= 18. * Performance status of 0, 1 or 2. * Platelets \>= 100,000/mcl. * Absolute neutrophil count (ANC) \>= 1,500/mcl. * Creatinine =\< 1.5 x institutional/laboratory upper limit of normal (ULN). * Total serum bilirubin level =\< 1.5 x ULN (patients with known Gilbert's disease who have bilirubin level =\< 3 x ULN may be enrolled). * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3 x ULN. * Thyroid stimulating hormone (TSH) within normal limits. If TSH is not within normal range despite no symptoms of thyroid dysfunction, normal Free T4 level is required. * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of Step 2 registration are eligible for this trial. * For patients of child bearing potential: negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test is required. * Administration of study drugs (pembrolizumab \[MK-3475\], paclitaxel, carboplatin) may have an adverse effect on pregnancy and poses a risk to the human fetus, including embryo-lethality. Women of childbearing potential (WOCBP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from at least 14 days prior to Step 2 registration (for oral contraceptives), during treatment, and for 120 days after the last dose of study medication. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. Patients will be considered of nonreproductive potential if they are either: * Postmenopausal (defined as at least 12 months with no menses without an alternative medical cause; in women \< 45 years of age, a high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. In the absence of 12 months of amenorrhea, a single FSH measurement is insufficient); OR * Have a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation/occlusion, at least 6 weeks prior to Step 2 registration; OR * Have a congenital or acquired condition that prevents childbearing. * Patients with a 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. * The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information. Exclusion Criteria: * Patients with prior treatment with anti-PD-1, anti-PD-L1 or anti-CTLA-4 therapeutic antibody or other similar agents. * Patients who have a history of a severe hypersensitivity reaction to monoclonal antibody or pembrolizumab (MK-3475) and/or its excipients; and/or a severe hypersensitivity reaction to paclitaxel and/or carboplatin. * Patients who are currently participating and receiving cancer-directed study therapy or have participated in a study of an investigational agent and received cancer-directed study therapy within 4 weeks prior to Step 2 registration. * Patients who have a diagnosis of immunodeficiency or are receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to Step 2 registration. * Patients who have received steroids 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 patients with orthostatic hypotension or adrenocortical insufficiency is allowed. * The use of physiologic doses of corticosteroids may be approved after consultation with the study chair. * Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression, and they have been off steroids for at least 4 weeks prior to Step 2 registration and remain clinically stable. * Patients with 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, patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (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. * Patients with vitiligo, endocrine deficiencies including type I diabetes mellitus, thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible. * Patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible. * Patients who have a history of (non-infectious) pneumonitis that required steroids, or current pneumonitis. * 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. * Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; and cirrhosis. * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. * Pregnant or lactating patients.
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- FEMALE
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- COMBINATION PHASE: Patients receive placebo IV over 30 minutes on day 1 of each cycle, paclitaxel IV over 3 hours on day 1 of each cycle, and carboplatin IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease may continue treatment for up to a total of 10 cycles (if deemed necessary by the treating physician) in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive placebo IV over 30 minutes on day 1 of each cycle. Treatment repeats every 6 weeks for up to 14 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan throughout the study. On February 6, 2023, all patient treatment assignments were unblinded. Patients randomized to Arm 1 will not receive additional placebo infusions.
- intervention Names
- Drug: Carboplatin
- Procedure: Computed Tomography
- Drug: Paclitaxel
- Other: Placebo Administration
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- label
- Arm I (placebo, paclitaxel, carboplatin)
- type
- ACTIVE_COMPARATOR
- description
- COMBINATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle, paclitaxel IV over 3 hours on day 1 of each cycle, and carboplatin IV over 30 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease may continue treatment for up to a total of 10 cycles (if deemed necessary by the treating physician) in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive pembrolizumab IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 6 weeks for up to 14 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan throughout the study.
- intervention Names
- Drug: Carboplatin
- Procedure: Computed Tomography
- Drug: Paclitaxel
- Biological: Pembrolizumab
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- label
- Arm II (pembrolizumab, paclitaxel, carboplatin)
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Arm I (placebo, paclitaxel, carboplatin)
- Arm II (pembrolizumab, paclitaxel, carboplatin)
- description
- Given IV
- name
- Carboplatin
- other Names
- Blastocarb
- Carboplat
- Carboplatin Hexal
- Carboplatino
- Carboplatinum
- Carbosin
- Carbosol
- Carbotec
- CBDCA
- Displata
- Ercar
- JM-8
- type
- DRUG
- arm Group Labels
- Arm I (placebo, paclitaxel, carboplatin)
- Arm II (pembrolizumab, paclitaxel, carboplatin)
- description
- Undergo CT scan
- name
- Computed Tomography
- other Names
- CAT
- CAT Scan
- Computed Axial Tomography
- Computerized Axial Tomography
- Computerized axial tomography (procedure)
- Computerized Tomography
- Computerized Tomography (CT) scan
- CT
- CT Scan
- Diagnostic CAT Scan
- Diagnostic CAT Scan Service Type
- tomography
- type
- PROCEDURE
- arm Group Labels
- Arm I (placebo, paclitaxel, carboplatin)
- Arm II (pembrolizumab, paclitaxel, carboplatin)
- description
- Given IV
- name
- Paclitaxel
- other Names
- Anzatax
- Asotax
- Bristaxol
- Praxel
- Taxol
- Taxol Konzentrat
- type
- DRUG
- arm Group Labels
- Arm II (pembrolizumab, paclitaxel, carboplatin)
- description
- Given IV
- name
- Pembrolizumab
- other Names
- BCD-201
- GME 751
- GME751
- Keytruda
- Lambrolizumab
- MK 3475
- MK-3475
- MK3475
- Pembrolizumab Biosimilar BCD-201
- Pembrolizumab Biosimilar GME751
- Pembrolizumab Biosimilar QL2107
- Pembrolizumab Biosimilar RPH-075
- type
- BIOLOGICAL
- arm Group Labels
- Arm I (placebo, paclitaxel, carboplatin)
- description
- Given IV
- name
- Placebo Administration
- type
- OTHER
- arm Group Labels
- Arm I (placebo, paclitaxel, carboplatin)
- Arm II (pembrolizumab, paclitaxel, carboplatin)
- description
- Ancillary studies
- name
- Quality-of-Life Assessment
- other Names
- Quality of Life Assessment
- type
- OTHER
- arm Group Labels
- Arm I (placebo, paclitaxel, carboplatin)
- Arm II (pembrolizumab, paclitaxel, carboplatin)
- description
- Ancillary studies
- name
- Questionnaire Administration
- type
- OTHER
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- QUADRUPLE
- masking Description
- On February 6, 2023, all patient treatment assignments were unblinded. Patients randomized to Arm I will not receive additional placebo infusions.
- who Masked
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
- primary Purpose
- TREATMENT
Enrollment
- count
- 813
- type
- ACTUAL
Registered outcome plans (not posted results)
- other Outcomes
- description
- Patient-reported neurotoxicity will be measured with FACT/GOG-Ntx subscale (short form).
- measure
- Incidence of Pembrolizumab Treatment and Self-reported Neurotoxicity
- time Frame
- 0-54 weeks from start of treatment
- description
- Will assess the effect of pembrolizumab on PFS and OS by PD-L1 (combined positive score \[CPS\]) within proficient MMR (pMMR) and deficient MMR (dMMR) populations. The effectiveness of pembrolizumab will be compared by PD-L1 status (CPS). A formal test will be conducted by examining the interaction term between pembrolizumab treatment (yes or no) with PD-L1 status. The association between PD-L1 CPS status and MMR IHC status will be assessed with odds ratios. A test may be conducted with a Fisher's Exact Test, and confidence intervals will be provided.
- measure
- Effect of Pembrolizumab on PFS and OS by Program Death Ligand 1 (PD-L1) IHC
- time Frame
- 5 years
- description
- Measures of association between PD-L1 IHC (CPS) and MMR IHC status. The concordance of institutional MMR IHC testing and centralized MMR IHC will be characterized by agreement statistics such as kappa statistics (e.g. Cohen's kappa coefficient).
- measure
- Association Between PD-L1 IHC and MMR Status
- time Frame
- 5 years
- primary Outcomes
- description
- Progression free survival (PFS) Note: For arm 2 (dMMR Cohort), the point estimate and the upper limit of the confidence interval are not able to be estimated due to insufficient events.
- measure
- Progression-free Survival (PFS)
- time Frame
- Duration of time from study entry to time of progression per RECIST criteria or death due to any cause, whichever occurs first. The interquartile range for follow-up was (6.37 months, 30.62 months). The maximum for follow-up was 37.85 months.
- secondary Outcomes
- description
- Assessed by Common Terminology Criteria for Adverse Events (CTCAE V5.0). The endpoint is the count of participants with an adverse event of grade 3 (or higher) by treatment group.
- measure
- Adverse Events With Grade 3 (or Higher)
- time Frame
- For the adverse event time frame, the interquartile range was (0.79 months, 3.42 months); the maximum was 28.39 months.
- description
- Assessed by Response Evaluation Criteria for Solid Tumors (RECIST) 1.1.
- measure
- Objective Tumor Response
- time Frame
- For the time frame for tumor response, the interquartile range was (2.27 months, 8.66 months) and the maximum was 36.37 months.
- description
- The time difference between the dates of first response and first progression; patients who do not progress are considered censored. Note: for Arm 2 (dMMR Cohort), the upper limit of the confidence interval is not able to be estimated due to an insufficient number of events.
- measure
- Duration of Objective Response
- time Frame
- For the duration of objective response, the interquartile range is (4.24 months, 7.92 months); the maximum is 28.68 months.
- description
- Overall Survival (OS). This endpoint will be assessed by Kaplan-Meier.
- measure
- Overall Survival (OS)
- time Frame
- Time from study entry to time of death or the date of last contact, assessed up to 5 years
- description
- QoL are collected in pMMR patients only and measured with the Function Assessment of Cancer Therapy -Endometrial Trial Outcome Index (FACT En-TOI). The FACT-En TOI scores range 0 - 120 with a larger score suggesting better or favorable state of QOL.
- measure
- Quality of Life (QoL) in pMMR Patients Only
- time Frame
- 0-54 weeks from start of treatment
- description
- Concordance between institutional MMR IHC testing and centralized MMR IHC. The concordance of institutional MMR IHC testing and centralized MMR IHC will be characterized by agreement statistics including the kappa statistic (e.g. Cohen's kappa coefficient).
- measure
- Concordance Between Institutional Mismatch Repair (MMR) Immunohistochemistry (IHC) Testing and Centralized MMR IHC
- time Frame
- IHC testing values (for both central and institutional) were collected at baseline.
Full study description
- brief Summary
- This phase III trial studies how well the combination of pembrolizumab, paclitaxel and carboplatin works compared with paclitaxel and carboplatin alone in treating patients with endometrial cancer that is stage III or IV, or has come back after a period of improvement (recurrent). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Paclitaxel and carboplatin are chemotherapy drugs used as part of the usual treatment approach for this type of cancer. This study aims to assess if adding immunotherapy to these drugs is better or worse than the usual approach for treatment of this cancer.
- detailed Description
- PRIMARY OBJECTIVE: I. To evaluate the efficacy of pembrolizumab (MK-3475) in combination with paclitaxel and carboplatin in patients with advanced stage (measurable stage III or IVA), stage IVB and recurrent endometrial cancer. SECONDARY OBJECTIVES: I. To determine the nature, frequency and degree of toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) for each treatment arm. II. To evaluate blinded independent central review (BICR) assessed or investigator assessed objective response rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by treatment arm and by mismatch repair (MMR) immunohistochemistry (IHC) status in patients who enter the study with measurable disease. III. To evaluate BICR assessed or investigator assessed duration of response (DOR) by treatment arm and by MMR IHC status in patients who enter the study with measurable disease. IV. To evaluate the effect of pembrolizumab (MK-3475) on overall survival (OS) in patients with mismatch repair protein proficient (pMMR) or mismatch repair deficiency (dMMR). V. To determine whether the addition of pembrolizumab (MK-3475) to standard combination chemotherapy is associated with improved patient reported physical function as measured with the Patient-Reported Outcomes Measurement Information System (PROMIS)-physical function scale (short form), quality of life as measured with the Functional Assessment of Cancer Therapy (FACT) - Endometrial Trial Outcome Index (En TOI) and worsened fatigue as measured with the PROMIS-Fatigue scale (short form) in the pMMR patients. VI. To determine concordance between institutional MMR IHC testing and centralized MMR IHC. EXPLORATORY OBJECTIVES: I. To explore the correlation between patient-reported physical function as measured with the PROMIS-physical function scale (short form) and quality of life as measure with the FACT-En TOI. II. To explore whether the addition of pembrolizumab (MK-3475) to standard combination chemotherapy is associated with self-reported neurotoxicity as measured with the FACT/Gynecologic Oncology Group Neurotoxicity (GOG-Ntx) subscale (short) and the extent to which patients differ on their self-reported bother from side effects of cancer therapy in the pMMR patients. III. To evaluate the efficacy of pembrolizumab (MK-3475) in combination with paclitaxel and carboplatin in patients with advanced stage (measurable stage III or IVA), stage IVB and recurrent endometrial cancer by Programmed Death Ligand 1 (PD-L1) IHC (positive versus \[vs\] negative). IV. To assess the association between PD-L1 IHC (positive vs negative) and mismatch repair status (pMMR and dMMR). OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: COMBINATION PHASE: Patients receive placebo intravenously (IV) over 30 minutes on day 1 of each cycle, paclitaxel IV over 3 hours on day 1 of each cycle, and carboplatin IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with stable disease (SD) or partial response (PR) who still have measurable disease may continue treatment for up to a total 10 cycles (if deemed necessary by the treating physician) in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive placebo IV over 30 minutes on day 1 of each cycle. Treatment repeats every 6 weeks for up to 14 cycles in the absence of disease progression or unacceptable toxicity. On February 6, 2023, all patient treatment assignments were unblinded. Patients randomized to Arm I will not receive additional placebo infusions. ARM II: COMBINATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle, paclitaxel IV over 3 hours on day 1 of each cycle, and carboplatin IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease may continue treatment for up to a total of 10 cycles (if deemed necessary by the treating physician) in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 6 weeks for up to 14 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) scan throughout the study. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
Source references
- references
- citation
- Eskander RN, Sill MW, Beffa L, Moore RG, Hope JM, Musa FB, Mannel RS, Shahin MS, Cantuaria GH, Girda E, Lokich E, Kavecansky J, Leath CA 3rd, Gien LT, Hinchcliff EM, Lele SB, Landrum LM, Backes F, O'Cearbhaill RE, Baghdadi TA, Hill EK, Thaker PH, John VS, Welch S, Fader AN, Powell MA, Aghajanian C. Pembrolizumab plus chemotherapy in advanced or recurrent endometrial cancer: overall survival and exploratory analyses of the NRG GY018 phase 3 randomized trial. Nat Med. 2025 May;31(5):1539-1546. doi: 10.1038/s41591-025-03566-1. Epub 2025 Mar 5.
- pmid
- 40044930
- type
- DERIVED
- citation
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- pmid
- 38431043
- type
- DERIVED
- 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
- citation
- Eskander RN, Sill MW, Beffa L, Moore RG, Hope JM, Musa FB, Mannel R, Shahin MS, Cantuaria GH, Girda E, Mathews C, Kavecansky J, Leath CA 3rd, Gien LT, Hinchcliff EM, Lele SB, Landrum LM, Backes F, O'Cearbhaill RE, Al Baghdadi T, Hill EK, Thaker PH, John VS, Welch S, Fader AN, Powell MA, Aghajanian C. Pembrolizumab plus Chemotherapy in Advanced Endometrial Cancer. N Engl J Med. 2023 Jun 8;388(23):2159-2170. doi: 10.1056/NEJMoa2302312. Epub 2023 Mar 27.
- pmid
- 36972022
- type
- DERIVED
Source notices and limitations
Discovery and provenance
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- frequent serious side effect in the experimental group was hypertension. </li></ul></div></li><li>The double-blind placebo-controlled <a href="/clinicaltrials/NCT03914612">KEYNOTE-868</a> study (NCT03914612) included 810 patients with advanced (stage III, stage IVA, or stage IVB) or recurrent endometrial cancer.[<a href="#cit/se
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- experimental group was hypertension. </li></ul></div></li><li>The double-blind placebo-controlled <a href="/clinicaltrials/NCT03914612">KEYNOTE-868</a> study (NCT03914612) included 810 patients with advanced (stage III, stage IVA, or stage IVB) or recurrent endometrial cancer.[<a href="#cit/section_6.31">31</a>] Patients were ra
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- Advanced or Recurrent Endometrial Carcinoma The efficacy of KEYTRUDA in combination with paclitaxel and carboplatin was investigated in KEYNOTE-868/NRG-GY018 (NCT03914612), a multicenter, randomized, double-blind, placebo-controlled trial in 810 patients with advanced or recurrent endometrial carcinoma. The study design included
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Preserved source evidence · Not medical advice