Auto-discovered from 2 recent studies; not yet curated.
Human trialTrialReported positiveModerate evidenceTier 4 · clinicaln = 31
Med (New York, N.Y.) · Sep 2025 · Phase 2, single-arm with case-matched control comparison
This phase 2 clinical trial enrolled 31 patients with newly diagnosed glioblastoma after chemoradiation to test adding pembrolizumab to TTFields plus temozolomide. Among 26 patients treated per protocol, median progression-free survival was 12.0 vs. 5.8 months (HR 0.377; p = 0.0026) and median overall survival was 24.8 vs. 14.6 months (HR 0.522; p = 0.0477) compared to case-matched controls. Patients who had biopsy only showed larger PFS and OS benefits than those with maximal resection. Immune analyses suggested TTFields induced a T1IFN-driven clonal T cell expansion while pembrolizumab supported adaptive replacement and sustained T cell activation; severe treatment-related adverse events were reported as 7.5%.
Reported effects: median PFS 12 mo · PFS hazard ratio 0.377 [0.217–0.653], p=0.0026 · +7 more
Studied with: pembrolizumab, temozolomide.
Key findings
- Among 26 patients treated per protocol, median PFS was 12.0 vs. 5.8 months in controls (HR 0.377, 95% CI 0.217-0.653; p = 0.0026).
- Among 26 patients treated per protocol, median OS was 24.8 vs. 14.6 months in controls (HR 0.522, 95% CI 0.301-0.905; p = 0.0477).
- Patients undergoing biopsy had longer PFS (27.2 vs. 9.6 months; HR 0.37, 95% CI 0.16-0.85; p = 0.014) and OS (31.6 vs. 18.8 months; HR 0.4, 95% CI 0.17-0.92; p = 0.023) compared to maximal resection.
- Severe adverse events constituted 7.5% of treatment-related toxicities.
- Immune correlates: TTFields promoted clonal T cell expansion via a T1IFN-driven trajectory, while pembrolizumab supported adaptive replacement of these clones, sustaining T cell activation and memory formation, especially in biopsy-only patients.
Limitations: Small sample size (31 enrolled; 26 treated per protocol).; Phase 2, non-randomized, single-arm design with case-matched controls rather than a randomized control group.; Potential selection or matching biases inherent to case-matched control comparisons.; Follow-up duration not specified in the abstract.; Funded by Novocure (industry support) which may present a conflict of interest..
AI summary of the abstract, human-reviewed · Jul 2026. Describes what this study reported, not medical advice. View on PubMed
Meta-analysisTrialReported positiveModerate evidenceTier 4 · clinicaln = 2456
Cancer treatment reviews · Apr 2024 · meta-analysis of randomized controlled trials (first-line ICI + platinum-based chemotherapy vs chemotherapy alone)
This meta-analysis pooled five randomized trials (2456 patients) comparing addition of anti-PD-1 or anti-PD-L1 agents to standard platinum-based chemotherapy versus chemotherapy alone as first-line treatment for advanced or recurrent endometrial cancer. Adding immune checkpoint inhibitors improved progression-free survival overall and especially in tumors with deficient mismatch repair (dMMR); in mismatch repair–proficient (pMMR) tumors a statistically significant PFS benefit was reported only with anti-PD-1 agents, not anti-PD-L1 agents. The analysis reports PFS outcomes; the impact on overall survival remains to be clarified.
Reported effects: included patients 2456, n=2456 · pooled HR overall 0.63 [0.52–0.76], p <.001, n=2456 · +5 more
Studied with: carboplatin-paclitaxel chemotherapy.
Key findings
- Five randomized trials comprising 2456 patients (1308 received ICIs + chemotherapy and 1148 chemotherapy alone) were included.
- Addition of ICIs to chemotherapy improved PFS in the overall population (pooled HR, 0.63; 95% CI, 0.52–0.76; P < .001).
- In the dMMR subgroup the pooled PFS benefit was larger (pooled HR, 0.34; 95% CI, 0.27–0.44; P < .001).
- In dMMR tumors benefit was seen with both PD-L1 and PD-1 inhibitors (pooled HRs 0.39, 95% CI 0.28–0.55 and 0.34, 95% CI 0.27–0.44, respectively; both P < .001).
- In pMMR patients a statistically significant PFS benefit was observed only with anti-PD-1 agents (anti-PD-1: HR 0.64, 95% CI 0.46–0.90, P = .010) but not with anti-PD-L1 agents (anti-PD-L1: HR 0.87, 95% CI 0.73–1.03, P = .104).
Limitations: Meta-analysis focused on progression-free survival (PFS); impact on overall survival (OS) is not reported and remains uncertain.; Subgroup analyses by dMMR/pMMR and by drug class (anti-PD-1 vs anti-PD-L1) are based on pooled trial-level data and may be limited by heterogeneity and lack of patient-level data.; Three of five trials included endometrial carcinosarcoma, which may affect generalizability to typical endometrial carcinoma populations.; The abstract does not report safety/toxicity or follow-up duration, limiting assessment of risks and long-term outcomes..
AI summary of the abstract, human-reviewed · Jun 2026. Describes what this study reported, not medical advice. View on PubMed
Animal studyReported positivePreclinical onlyTier 2 · animal
Immunology · Nov 2023
The study examined how activation of the PI3K pathway and PIK3CA-E545K mutation affect PD-L1 expression and CD8+ T cells in cervical cancer tissues and cell models. The authors report that PIK3CA-E545K increases PD-L1 via upregulation of IRF1 and represses CD8+ T cell differentiation. A PI3Kα-specific inhibitor activated the tumour immune microenvironment and promoted CD8+ T cell differentiation in PIK3CA-mutant xenografts, and combining the inhibitor with anti-PD-1 increased anti-tumour efficacy in cell-derived and patient-derived xenograft models. A single clinical case of complete remission with pembrolizumab in a PIK3CA-E545K patient is also described.
Studied with: anti-PD-1 antibody (pembrolizumab).
Key findings
- PD-L1 overexpression was more frequent in older women with squamous cervical carcinoma and associated with longer progression-free and overall survival (no numeric values reported in abstract).
- PIK3CA mutation (E545K) increased PD-L1 mRNA and protein levels and repressed CD8+ T cell differentiation in cervical cancer.
- PIK3CA-E545K promotes PD-L1 expression by upregulating the transcription factor IRF1 (shown by luciferase and ChIP assays).
- A PI3Kα-specific inhibitor activated the immune microenvironment, regulated PD-1/PD-L1-related pathways, and promoted CD8+ T cell differentiation and proliferation in Caski CDX models with PIK3CA-E545K mutation.
- PI3Kα inhibitor significantly enhanced the anti-tumour efficacy of PD-1 blockade in both CDX and PDX models.
- A single reported case: continuous pembrolizumab monotherapy induced complete remission in a recurrent metastatic cervical cancer patient with PIK3CA-E545K mutation (single case observation).
Limitations: Predominantly preclinical evidence: in vitro assays and mouse xenograft (CDX/PDX) models; no controlled clinical trial data presented.; Human evidence limited to correlative tissue analyses and a single patient case report; results from one patient cannot establish efficacy.; Abstract does not report sample sizes, dosing, or statistical effect sizes for findings.; Safety, toxicity, and tolerability of PI3Kα inhibitor ± anti-PD-1 not reported in abstract.; Potential selection bias and lack of randomized comparison in described experiments (not specified in abstract)..
AI summary of the abstract, human-reviewed · Jun 2026. Describes what this study reported, not medical advice. View on PubMed
ReviewMechanismMixed resultsLimited evidenceTier 4 · clinical
International journal of gynecological cancer : official journal of the International Gynecological Cancer Society · Feb 2023
This review summarizes current knowledge on endometrial carcinosarcoma, an aggressive high-grade endometrial carcinoma with sarcomatous trans-differentiation that is often diagnosed at an advanced stage. It describes common molecular features (frequent p53 abnormalities; variable POLE/MSI-H) and current management: multimodal therapy with optimal surgery plus chemotherapy and radiotherapy, carboplatin/paclitaxel as first-line systemic therapy for recurrent/metastatic disease, and regulatory approvals for pembrolizumab plus lenvatinib in endometrial cancer generally. The authors note that carcinosarcoma patients were excluded from many immunotherapy trials and that emerging molecular insights may enable more personalized treatments in the future.
Reported effects: proportion_in_endometrioid_components 25% · proportion_in_non-endometrioid_components 3%
Studied with: carboplatin/paclitaxel doublet, pembrolizumab + lenvatinib, concomitant or sequential chemotherapy and radiotherapy, surgery plus chemotherapy and radiotherapy (multimodal).
Key findings
- Endometrial carcinosarcoma is a rare, aggressive high-grade endometrial carcinoma with secondary sarcomatous trans-differentiation.
- Clinical presentation and diagnostic work-up are similar to endometrioid endometrial cancer, but carcinosarcoma is more frequently diagnosed at an advanced stage.
- Endometrial carcinosarcoma encompasses different histological subtypes depending on the carcinomatous and sarcomatous elements.
- The majority of endometrial carcinosarcomas are characterized by p53 abnormalities.
- The proportion of POLE and microsatellite instability-high (MSI-H) is related to the epithelial component, being approximately 25% and 3% in endometrioid and non-endometrioid components.
- Non-metastatic disease management is multimodal with optimal surgery followed by concomitant or sequential chemotherapy and radiotherapy, even for early stages.
- Palliative chemotherapy is recommended for metastatic or recurrent disease, with carboplatin/paclitaxel doublet as the first-line regimen.
- Patients with endometrial carcinosarcoma were excluded from most studies evaluating single-agent immunotherapy or combinations, although pembrolizumab and lenvatinib have FDA and EMA approvals in endometrial cancer after progression on chemotherapy (and single-agent immunotherapy in MSI-H cancers).
- Emerging molecular knowledge is opening promising therapeutic options for more personalized treatment.
Limitations: This article is a narrative review rather than primary clinical trial data.; Endometrial carcinosarcoma is a rare and heterogeneous disease, limiting generalizable high-quality evidence.; Patients with carcinosarcoma were excluded from most immunotherapy studies, resulting in limited direct trial evidence for these agents in this histotype.; The abstract does not present new quantitative clinical trial outcomes specific to carcinosarcoma..
AI summary of the abstract, human-reviewed · Jun 2026. Describes what this study reported, not medical advice. View on PubMed
ReviewReported positiveLimited evidenceTier 4 · clinical
Current treatment options in oncology · Dec 2022
This narrative review summarizes targeted therapy options for uterine serous carcinoma. It states that adding trastuzumab to conventional chemotherapy is indicated for HER2-positive advanced or recurrent disease, and that pembrolizumab plus lenvatinib showed about a 50% response rate in women with recurrent disease. The review highlights several emerging targeted approaches (ADCs, PARP, WEE1, AKT inhibitors and combinations of immunotherapy and TKIs) and recommends enrollment in clinical trials.
Reported effect: response_rate (pembrolizumab + lenvatinib) 50%
Studied with: chemotherapy (trastuzumab + chemotherapy), pembrolizumab + lenvatinib, combinations of immunotherapies and tyrosine kinase inhibitors.
Key findings
- For HER2-positive uterine serous carcinoma, the addition of trastuzumab to conventional chemotherapy is indicated in advanced stage and/or recurrent disease.
- Treatment with pembrolizumab and lenvatinib suggests a 50% response rate in women with recurrent disease.
- Emerging targeted options include antibody-drug conjugates targeting HER2, folic acid receptor alpha, or Trop-2; combinations of immunotherapies and tyrosine kinase inhibitors; PARP inhibitors; WEE1 inhibitors; and AKT inhibitors.
- Several trials evaluating these targeted agents are ongoing and results are pending.
- The authors recommend enrollment of patients in clinical trials to provide more personalized care.
Limitations: Narrative review rather than primary clinical trial data; no new patient-level data presented in this abstract.; Many discussed agents are investigational and the abstract notes that several trials are ongoing (mature results not presented).; Abstract provides limited quantitative data and no methodological details (search strategy, inclusion criteria) are described.; Heterogeneity and quality of the underlying studies are not detailed in the abstract..
AI summary of the abstract, human-reviewed · Jun 2026. Describes what this study reported, not medical advice. View on PubMed
ReviewReported positiveModerate evidenceTier 4 · clinical
International journal of gynecological cancer : official journal of the International Gynecological Cancer Society · Aug 2021 · Review
This review summarizes molecular drivers and recent therapeutic advances for uterine serous carcinoma. It highlights HER2 amplification as an actionable target and notes that adding trastuzumab to standard chemotherapy is associated with improved survival in advanced/recurrent HER2-positive disease. The authors also report a phase II study suggesting a 50% response rate for pembrolizumab plus lenvatinib in recurrent disease.
Studied with: trastuzumab + conventional chemotherapy, pembrolizumab + lenvatinib.
Key findings
- Incidence and mortality from endometrial cancer are increasing worldwide; uterine serous carcinoma accounts for a small fraction of cases but nearly 40% of endometrial cancer deaths.
- Black women are disproportionately affected, with higher rates of advanced disease at diagnosis.
- Frequent molecular alterations include TP53, PIK3CA, ERBB2 (HER2) amplification, CCNE1 amplification, FBXW7 mutation/deletion, PPP2R1A mutation, and somatic mutations in homologous recombination genes.
- Clinical risk factors include advancing age, history of breast cancer, tamoxifen use, and hereditary breast-ovarian cancer syndrome.
- Surgery remains the cornerstone of treatment.
- HER2 overexpression/amplification is an actionable target; adding trastuzumab to conventional chemotherapy is associated with improved survival in women with advanced and recurrent HER2-positive disease.
- The combination of pembrolizumab and lenvatinib is a promising strategy, with a phase II study suggesting a 50% response rate in women with recurrent disease.
- Multiple additional targeted-agent trials are ongoing.
Limitations: This is a review article summarizing prior studies and does not present new primary patient-level data.; Some clinical evidence cited (e.g., a phase II study) is early-phase and may have limited sample size or non-randomized design.; The abstract does not provide sample sizes, statistical details, or full trial designs for the cited studies.; Uterine serous carcinoma is an uncommon subtype, which can limit the size and generalizability of studies..
AI summary of the abstract, human-reviewed · Jun 2026. Describes what this study reported, not medical advice. View on PubMed
ReviewMixed resultsModerate evidenceTier 4 · clinical
CA: a cancer journal for clinicians · Jul 2019
This review summarizes current recommendations and recent progress in endometrial cancer care. It highlights ongoing controversies about surgical lymph node assessment and selection of patients for adjuvant radiation or chemotherapy. The abstract notes that pembrolizumab is FDA-approved for the subset of women with microsatellite-instable metastatic disease and that multiple trials are building on this development.
Studied with: radiation, chemotherapy.
Key findings
- Endometrial cancer is the most common gynecologic cancer in the United States, and its incidence is rising.
- Significant recent advances in understanding biology have occurred, but many treatment aspects remain controversial, including the role of surgical lymph node assessment and selection for adjuvant radiation or chemotherapy.
- For the subset of women with microsatellite-instable, metastatic disease, anti-programmed cell death protein 1 immunotherapy (pembrolizumab) is now FDA-approved.
- Numerous trials are attempting to build on the early success of pembrolizumab in this subset.
Limitations: Review article; no new primary data reported in the abstract.; Abstract provides limited methodological detail and no quantitative trial data or sample sizes.; Does not resolve the noted controversies or provide definitive clinical recommendations in the abstract..
AI summary of the abstract, human-reviewed · Jun 2026. Describes what this study reported, not medical advice. View on PubMed
ReviewMixed resultsLimited evidenceTier 4 · clinical
Gynecologic oncology · Dec 2018 · literature review
This is a literature review of uterine leiomyosarcoma covering epidemiology, presentation, diagnosis, pathology, and management. The authors state that early-stage management is surgical (hysterectomy) and that routine oophorectomy or lymph node dissection appear to provide little benefit; adjuvant therapy remains controversial with trials failing to show overall survival benefit. They note recent progress in advanced/recurrent disease with novel chemotherapeutics, targeted agents (olaratumab, pazopanib) and immune checkpoint inhibitors (nivolumab, pembrolizumab) showing promise.
Key findings
- Uterine leiomyosarcoma is an aggressive malignancy with poor overall prognosis.
- Preoperative diagnosis is difficult and often only made at time of surgical resection.
- Early stage management entails hysterectomy and complete resection of gross tumor; routine oophorectomy or lymph node dissection do not appear to confer much clinical benefit.
- Adjuvant therapy for early stage disease is controversial; multiple clinical trials have failed to demonstrate benefit on overall survival.
- Recent progress has been made for advanced and recurrent disease with novel chemotherapeutics, targeted therapies such as olaratumab and pazopanib, and immunotherapies such as nivolumab and pembrolizumab demonstrating promise.
Limitations: This article is a narrative literature review and does not present new primary patient data.; No systematic review or meta-analysis methods are described in the abstract.; Uterine leiomyosarcoma is a rare disease, limiting the size and power of available trials summarized.; Adjuvant therapy efficacy is uncertain because multiple trials failed to show overall survival benefit..
AI summary of the abstract, human-reviewed · Jul 2026. Describes what this study reported, not medical advice. View on PubMed
ReviewReported positiveModerate evidenceTier 4 · clinical
Immunotherapy · Jun 2016
This is a review of PD-1 and PD-L1 immune checkpoint inhibitors in non-small-cell lung cancer (NSCLC). The abstract states that anti-PD-1 antibodies nivolumab and pembrolizumab are FDA-approved for NSCLC and other tumor types, and that additional agents targeting this pathway are in clinical development. The review summarizes updates on these agents being evaluated in NSCLC patients.
Key findings
- Immune checkpoint inhibitors act by inhibiting negative T-cell regulators and exert antitumor effects.
- The anti-PD-1 antibodies nivolumab and pembrolizumab are approved by the US FDA for treatment of patients with NSCLC and other tumor types.
- Additional PD-1/PD-L1 agents are in clinical development for NSCLC.
- The article provides an update on PD-1 and PD-L1 immune checkpoint inhibitors currently being evaluated in NSCLC patients.
Limitations: Review article — does not present original patient-level data or new primary results.; Abstract provides no quantitative efficacy or safety outcomes, trial details, or comparative results.; No specific clinical trial data, dosing, or follow-up durations are reported in the abstract..
AI summary of the abstract, human-reviewed · Jul 2026. Describes what this study reported, not medical advice. View on PubMed
Evidence at a glance: Pembrolizumab by cancer
A deterministic grade of what published studies report for each: strength of evidence, the reported direction, and the largest credible effect, strongest-evidence first. This summarizes findings; it is not a claim that anything works.
Inclusion here is not an endorsement. OncoForge makes no claim beyond what the linked studies show. Discuss anything on this page with your oncology team before acting on it.