✦ Cancer Clinical Trials

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Ovarian Cancer

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Oct 12 – Oct 19, 2026

Personalized neoantigen-targeting cancer vaccines in ovarian cancer: a phase 1 trial.
▼NAT MED · Q1 JOURNAL - RANK #1/195TOP-TIER
This phase 1 clinical trial evaluated the feasibility and safety of personalized neoantigen-targeting cancer vaccines (NeoVax) combined with delayed anti-PD-1 antibody in ten patients with high-grade epithelial ovarian cancer following standard platinum doublet chemotherapy. The study enrolled one newly diagnosed patient (Cohort A) and nine patients at first recurrence (Cohort B), with vaccination achieved in 9 of 12 evaluable Cohort B patients (75%, 90% CI 47-93%) and 1 of 9 Cohort A patients (11%, 90% CI 0.6-43%). No unexpected safety signals occurred and no patients discontinued due to toxicity, while biomarker analysis suggested biologic activity in six of ten patients associated with broader tumor and vaccine-specific immune responses. The authors conclude that the interplay between tumor antigen repertoire and induced immunity breadth appeared to dictate clinical efficacy following vaccination, with resistant tumor clones showing diverse antigen presentation mechanisms indicative of immune-selective pressure.
10.1038/s41591-026-04717-8

Oct 05 – Oct 12, 2026

Sofetabart mipitecan, an antibody drug conjugate targeting folate receptor alpha, in high grade ovarian cancer: Results from the first-in-human phase 1 study.
▼ANN ONCOL · Q1 JOURNAL - RANK #4/326TOP-TIER
This first-in-human, multicenter, open-label phase 1 trial evaluated the novel FRα-targeting antibody-drug conjugate sofetabart mipitecan in 105 heavily pretreated patients with high-grade ovarian cancer, regardless of FRα expression level, at doses of 2, 3, 4, or 6 mg/kg every 21 days. The overall response rate was 50.5% (95% CI 40.5–60.4), with median progression-free survival of 8.1 months, and activity was observed across subgroups including FRα <75% (44.4%) and prior MIRV exposure (57.9%). The most common treatment-emergent adverse events were nausea (64.8%), fatigue (56.2%), and anemia (47.6%), with no keratopathies or grade ≥3 neuropathy and grade ≥3 treatment-related TEAE rates of 35.3% at 3 mg/kg and 56.4% at 4 mg/kg. The authors conclude that sofetabart mipitecan has a favorable tolerability profile with durable clinical activity, supporting 3 mg/kg as the recommended phase 3 dose.
10.1016/j.annonc.2026.10.001

PARAGON-II cohort C: a phase II basket study of letrozole plus ribociclib in hormone receptor-positive, platinum-resistant, high-grade epithelial ovarian cancer.
▼INT J GYNECOL CANCER · Q1 JOURNAL - RANK #8/140
PARAGON-II Cohort C is a multicenter phase II basket trial evaluating letrozole plus ribociclib in 32 patients with hormone receptor-positive, PIK3CA wild-type, platinum-resistant high-grade epithelial ovarian cancer. Participants received letrozole 2.5 mg daily and ribociclib 600 mg (3 weeks on/1 week off) until progression or toxicity, with the primary endpoint of objective response rate by RECIST v1.1 or GCIG CA125 criteria. Among 25 patients with measurable disease, the objective response rate was 4.0% (1 partial response), with a 12-week disease control rate of 27.0% and median progression-free survival of 1.9 months. The authors conclude that letrozole plus ribociclib demonstrated minimal clinical activity, not supporting further evaluation of this specific combination in this population.
10.1016/j.ijgc.2026.105600

Neoadjuvant niraparib monotherapy for unresectable, homologous recombination deficiency-positive, high-grade serous ovarian cancer (NANT): a multicentre, single-arm, phase 2 trial.
▼LANCET ONCOL · Q1 JOURNAL - RANK #8/326TOP-TIER
This multicentre, single-arm, phase 2 trial evaluated neoadjuvant niraparib monotherapy in 67 patients with treatment-naïve, HRD-positive, advanced high-grade serous or endometrioid ovarian cancer initially unsuitable for primary debulking surgery. Patients received oral niraparib for two 28-day cycles, with co-primary endpoints of objective response rate and R0 resection rate after interval debulking surgery. Among 48 response-evaluable patients, the objective response rate was 63% (95% CI 47-76), and among 40 operated patients, the R0 resection rate was 80% (95% CI 64-91). The authors conclude that neoadjuvant niraparib showed anti-tumour activity and enabled R0 resection, but requires randomised validation against standard neoadjuvant chemotherapy.
10.1016/S1470-2045(26)00387-6

Sep 21 – Sep 28, 2026

Randomized Prospective Comparison Between Neoadjuvant Mitomycin C Plus Cisplatin and Paclitaxel Plus Carboplatin in Patients With BRCA1-Associated Ovarian Cancer.
▼INT J CANCER · Q1 JOURNAL - RANK #77/326
This prospective, open-label, randomized Phase II trial compared neoadjuvant mitomycin C plus cisplatin (MP) versus standard paclitaxel-carboplatin (TCbP) in 60 BRCA1 pathogenic variant carriers with ovarian cancer. Grade III-IV anemia and thrombocytopenia were more frequent with MP, while RECIST response rates were similar. Complete cytoreduction was achieved in 80% of MP versus 68% of TCbP patients, with MP requiring fewer cycles (p=0.008) and greater improvement in peritoneal cancer index (p=0.001). At 44.8 months median follow-up, no significant differences in progression-free survival or disease-free interval were observed, though MP produced rapid tumor burden reduction warranting further evaluation.
10.1002/ijc.70750

Sep 14 – Sep 21, 2026

Long-term efficacy and safety of avutometinib + defactinib in recurrent low-grade serous ovarian cancer: Results of a 2-year follow-up of ENGOT-OV60/GOG-3052/RAMP 201.
▼GYNECOL ONCOL · Q1 JOURNAL - RANK #11/140
This 2-year follow-up of the phase 2 ENGOT-OV60/GOG-3052/RAMP 201 trial evaluated avutometinib plus defactinib in 115 patients with recurrent low-grade serous ovarian cancer after ≥1 prior platinum line. The single-arm study administered avutometinib 3.2 mg twice weekly plus defactinib 200 mg twice daily and assessed duration of response and progression-free survival. Median DOR was 31.1 months overall, 31.1 months in KRAS-mutant and 12.0 months in KRAS-wild-type patients; median PFS was 12.9 months overall, 19.6 months in KRAS-mutant and 12.7 months in KRAS-wild-type patients. The combination showed durable efficacy with no new safety signals, though 12% discontinued due to adverse events and grade ≥3 events included increased creatine phosphokinase (26%), diarrhea (8%), and anemia (7%).
10.1016/j.ygyno.2026.09.003

Sep 07 – Sep 14, 2026

Safety and efficacy of cisplatin and nab-paclitaxel pressurised intraperitoneal aerosol chemotherapy (PIPAC) in patients with peritoneal carcinomatosis: Nab-PIPAC phase 1b study.
▼EBIOMEDICINE · Q1 JOURNAL - RANK #13/195TOP-TIER
This phase 1b trial evaluated the safety, tolerability, and pharmacokinetics of combined cisplatin and nab-paclitaxel administered via pressurized intraperitoneal aerosol chemotherapy (PIPAC) in 22 patients with peritoneal carcinomatosis, using a 3+3 dose escalation design for nab-paclitaxel (7.5–70 mg/m²) with fixed cisplatin (10.5 mg/m²). Of 18 patients who received at least one PIPAC, 45 procedures were performed, with 67% completing three cycles; no dose-limiting toxicities occurred, and the most common adverse event was abdominal pain. Median progression-free survival was 3.5 months and median overall survival was 9.4 months, with five gastrointestinal cancer patients surviving beyond one year; pharmacokinetic analysis showed linearity between nab-paclitaxel dose and AUC (R²=0.90). The authors concluded that the combination was safe and well tolerated, warranting further investigation.
10.1016/j.ebiom.2026.106477

Chemotherapy with or without pembrolizumab followed by maintenance pembrolizumab with or without olaparib as first-line treatment of patients with advanced BRCA non-mutated epithelial ovarian cancer (ENGOT-OV43/GOG-3036/KEYLYNK-001): a randomised, double-blind, placebo-controlled, phase 3 trial.
▼LANCET ONCOL · Q1 JOURNAL - RANK #8/326TOP-TIER
This randomized, double-blind, placebo-controlled, phase 3 trial evaluated pembrolizumab plus chemotherapy followed by maintenance pembrolizumab with or without olaparib versus chemotherapy plus placebo in 1367 patients with previously untreated stage III-IV BRCA non-mutated epithelial ovarian cancer. The primary endpoint was progression-free survival (PFS), tested hierarchically in the PD-L1 CPS≥10 population and then the intention-to-treat (ITT) population. At the final analysis (median follow-up 49.6 months), pembrolizumab-olaparib significantly improved PFS versus control in both the CPS≥10 (HR 0.66, 95% CI 0.53-0.83) and ITT populations (HR 0.71, 95% CI 0.61-0.84). The regimen was associated with higher rates of grade 3+ treatment-related adverse events (66% vs 51% for control), leading the authors to conclude it offers a statistically significant and clinically meaningful PFS benefit for this patient population.
10.1016/S1470-2045(26)00223-8

Transcriptomic analysis of a phase 1 trial for intraperitoneal monocytes plus IFNs in ovarian cancer reveals support and recruitment of cell-mediated immunity.
▼J IMMUNOTHER CANCER · Q1 JOURNAL - RANK #12/183TOP-TIER
This phase 1 clinical trial ancillary study analyzed transcriptomic data from patients with recurrent, platinum-resistant ovarian cancer treated with intraperitoneal autologous monocytes plus interferon gamma and alpha (AMIGA). Bulk and single-cell RNA sequencing were performed on circulating immune cells to compare long-term responders versus non-responders, revealing enhanced cell-mediated immunity and upregulated T-cell receptor-beta chain genes in responders. AMIGA treatment increased CXCL10 and CCL2 mRNA in peripheral blood mononuclear cells and ascites, with in vitro co-culture experiments confirming their variable effects on T-cell chemotaxis. The authors conclude that these findings support future combinations of AMIGA with T-cell-based immunotherapies.
10.1136/jitc-2026-014938

Aug 24 – Aug 31, 2026

Molecular Response Assessment From Circulating Tumor DNA in Patients With Ovarian Cancer Treated With the WEE1 Inhibitor Azenosertib.
▼JCO PRECIS ONCOL · Q1 JOURNAL - RANK #57/326
This prospective biomarker study evaluated circulating tumor DNA (ctDNA)-based molecular response (MR) as an early efficacy biomarker in 123 patients with recurrent high-grade serous ovarian cancer treated with the WEE1 inhibitor azenosertib across clinical trials. Plasma ctDNA was collected at baseline and after cycles 1-2, with MR defined as >50% reduction in variant allelic fraction. Molecular responders demonstrated higher objective response rates (p=0.012, OR=0.26), greater tumor shrinkage (p=5.1e-5), and longer time to progression (median 5.49 vs 2.69 months, HR=0.43, p=3.8e-5). MR predicted prolonged survival among stable disease patients (HR=0.44, p=3.8e-3) and was evaluable in more patients than CA-125 (88% vs 71%). The authors conclude ctDNA-based MR represents a valid, minimally invasive early surrogate endpoint.
10.1200/PO-25-00844

SHR-2004, a Humanized Monoclonal Antibody Targeting Factor XI, for Preventing Venous Thromboembolism After Ovarian Cancer Surgery: A Randomized, Active-Controlled Phase 2 Study.
▼AM J HEMATOL · Q1 JOURNAL - RANK #10/98
This multicenter, randomized, open-label, exploratory Phase 2 trial assessed the anti-FXI antibody SHR-2004 versus enoxaparin-rivaroxaban for preventing venous thromboembolism (VTE) after ovarian cancer surgery across 25 Chinese sites. Patients (n=198 safety population) were randomly assigned to subcutaneous SHR-2004 (180 mg day 1, 120 mg day 15) or standard anticoagulation (enoxaparin 40 mg daily during hospitalization, then rivaroxaban 10 mg until day 28). VTE occurred in 11/90 (12.6%) SHR-2004 patients and 19/108 (20.2%) control patients (difference -8.4%, 95% CI -19.9 to 3.1), with major/clinically relevant non-major bleeding in 2.2% vs 1.9%. The authors concluded SHR-2004 showed comparable efficacy with similar bleeding risk and a potential dosing advantage, warranting Phase 3 investigation.
10.1002/ajh.70481

Aug 17 – Aug 24, 2026

Comparing niraparib versus platinum-taxane doublet chemotherapy as neoadjuvant treatment in patients with newly diagnosed homologous recombination-deficient stage III/IV ovarian cancer: Findings from cohort C of the OPAL phase 2 trial.
▼GYNECOL ONCOL · Q1 JOURNAL - RANK #11/140
This phase 1b/2 OPAL trial cohort C randomized 36 patients with newly diagnosed homologous recombination-deficient stage III/IV ovarian cancer to neoadjuvant niraparib or platinum-taxane chemotherapy (19 vs. 17 patients). The primary endpoint was pre-IDS unconfirmed overall response rate (ORR), which was 31.6% for niraparib versus 70.6% for platinum-taxane (difference -39.0%, 80% CI -56.8% to -17.7%). Grade ≥3 adverse events occurred in 42% (niraparib) versus 59% (platinum-taxane) of patients during the neoadjuvant period. The trial was closed early for futility as niraparib did not improve ORR, though safety was consistent with prior PARP inhibitor studies.
10.1016/j.ygyno.2026.07.023

Effects of traditional Chinese medicine directional drug penetration therapy on gastrointestinal function, gut microbiota, and sleep quality in postoperative ovarian cancer patients: a randomized controlled trial.
▼SUPPORT CARE CANCER · Q1 JOURNAL - RANK #17/173
This randomized controlled trial evaluated the effects of traditional Chinese medicine (TCM) directional drug penetration therapy on gastrointestinal function, gut microbiota, and sleep quality in 112 postoperative ovarian cancer patients, randomly assigned to an observation group (n=56) receiving the therapy until first bowel movement plus conventional rehabilitation, or a control group (n=56) receiving conventional care only. The observation group showed significantly shorter recovery times to first bowel sounds, anal flatus, and defecation (P<0.05). The intervention also altered gut microbiota composition (e.g., Veillonellales-Selenomonadales, Megasphaera, Corynebacterium) and reduced the phosphotransferase system pathway abundance, while Pittsburgh Sleep Quality Index scores were significantly lower in the observation group (P<0.05). The authors concluded that TCM directional drug penetration therapy accelerates postoperative gastrointestinal recovery, modulates gut microbiota, and alleviates sleep quality decline, suggesting the study is a prospective interventional clinical trial.
10.1007/s00520-026-11096-w