✦ Cancer Clinical Trials

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Ovarian Cancer

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May 25 – Jun 01, 2026

PiggyBac-engineered membrane-bound IL-7 TILs combined with anti-PD-1 antibody demonstrates efficacy in recurrent ovarian cancer: a first-in-human phase 1 trial.
CLIN CANCER RES · Q1 JOURNAL - RANK #29/326TOP-TIER
This first-in-human phase 1 clinical trial evaluated the safety, tolerability, and efficacy of the GC203 regimen, which combines piggyBac-engineered membrane-bound IL-7 (mbIL-7) autologous tumor-infiltrating lymphocytes (TILs) with an anti-PD-1 antibody, in 18 heavily pretreated recurrent ovarian cancer (rOC) patients. Participants underwent lymphodepletion followed by GC203 infusion, and treatment-related adverse events were predominantly transient and hematologic (57% had grade ≥3 lymphopenia and neutropenia). Results showed an unconfirmed objective response rate (ORR) of 33.3% and a disease control rate (DCR) of 83.3%, with a median progression-free survival (PFS) of 7.2 months and overall survival (OS) of 17.1 months. Exploratory analysis revealed that the Morisita Overlap Index (MOI) predicted treatment response, supporting further development of GC203 for rOC management.
10.1158/1078-0432.CCR-25-4130

Overall survival and long-term safety of olaparib maintenance in patients with platinum-sensitive relapsed ovarian cancer: final analyses of phase III L-MOCA trial.
J OVARIAN RES · Q1 JOURNAL - RANK #6/42
This study aimed to evaluate overall survival and long-term safety of olaparib maintenance therapy in Asian patients with platinum-sensitive recurrent ovarian cancer (PSROC). As a prospective, open-label, single-arm, Phase IIIb clinical trial, it followed patients taking oral olaparib (300 mg twice daily) until disease progression or unacceptable toxicity, with a median follow-up of 73.4 months. The median overall survival (mOS) reached 51.0 months (95% CI: 42.7–56.1), with subgroup analysis showing mOS of 64.4 months (BRCA-mutated) and 40.9 months (BRCA wild-type). Long-term safety data revealed no new safety concerns, with 1.3% experiencing myelodysplastic syndrome or acute myeloid leukemia (MDS/AML).
10.1186/s13048-026-02144-4

May 11 – May 18, 2026

Trastuzumab deruxtecan in HER2-expressing gynecologic cancers from DESTINY-PanTumor02: antitumor activity, safety, and exploratory biomarker analyses.
J GYNECOL ONCOL · Q1 JOURNAL - RANK #14/140
This study assessed the antitumor activity, safety, and exploratory biomarker analyses of trastuzumab deruxtecan (T-DXd) in HER2-expressing gynecologic cancers through the DESTINY-PanTumor02 phase 2 clinical trial. Pretreated patients with locally advanced, metastatic, or unresectable HER2-expressing gynecologic cancers received 5.4 mg/kg of T-DXd, and outcomes such as confirmed objective response rates (ORR), safety, progression-free survival, and overall survival were measured. Investigator-assessed ORRs were 57.5% (endometrial), 50.0% (cervical), and 45.0% (ovarian) cancer cohorts, with safety data revealing interstitial lung disease/pneumonitis occurrence in 10.8% of patients. The findings demonstrate clinically meaningful efficacy of T-DXd and support its use in pretreated HER2-expressing gynecologic cancers, with a manageable safety profile.
10.3802/jgo.2026.37.e65

Maveropepimut-S, pembrolizumab and low dose cyclophosphamide in metastatic ovarian cancer: phase 1/2 PESCO trial.
NAT COMMUN · Q1 JOURNAL - RANK #10/135TOP-TIER
This investigator-initiated, open-label phase 1/2 trial (NCT03029403) tested maveropepimut‑S (survivin vaccine) plus pembrolizumab and low‑dose cyclophosphamide in recurrent epithelial ovarian cancer. Primary endpoints were safety and efficacy (ORR, DCR); secondary endpoints included RP2D, PFS, OS, and survivin‑specific immunity; 47 enrolled, 44 evaluable. Treatment was generally well tolerated (mostly grade 1–2 adverse events, commonly injection‑site reactions), and the RP2D was 0.25 mL, with ORR 23% and DCR 67% overall. Median PFS was 6.3 months in platinum‑sensitive versus 1.2 months in platinum‑resistant disease, and 62.5% mounted survivin‑specific immune responses that correlated with clinical benefit, indicating tolerability and sustained activity.
10.1038/s41467-026-72125-0

First-In-Human Trial of Encapsulated Cells Constitutively Expressing Localized IL-2 in Patients with High-Grade Serous Ovarian Carcinoma.
CLIN CANCER RES · Q1 JOURNAL - RANK #29/326TOP-TIER
This phase I dose-escalation trial (NCT05538624) evaluated AVB-001, an encapsulated allogeneic cell system constitutively expressing localized IL-2, administered intraperitoneally via laparoscopy to 14 patients with platinum-resistant high-grade serous ovarian carcinoma. Safety was assessed using NCI CTCAE v5.0, and efficacy via RECIST v1.1 and iRECIST. Grade 3 treatment-related adverse events occurred in 21.4% of patients with no grade 4-5 events, and one dose-limiting toxicity was observed; there were no confirmed responses (ORR 0%), stable disease in seven patients (median 2.57 months), and a 14.3% clinical benefit rate. The authors conclude AVB-001 is safe and activates cytotoxic T cells, warranting further investigation.
10.1158/1078-0432.CCR-25-4142

Apr 20 – Apr 27, 2026

Health-related quality of life in patients with newly diagnosed advanced ovarian cancer receiving maintenance olaparib plus bevacizumab (PAOLA-1/ENGOT-ov25).
JNCI-J NATL CANCER I · Q1 JOURNAL - RANK #44/326
This prospective, randomized, double-blind, placebo-controlled phase III trial (PAOLA-1) evaluated health-related quality of life (HRQoL) in 806 patients with newly diagnosed advanced ovarian cancer receiving maintenance olaparib plus bevacizumab (n=537) versus placebo plus bevacizumab (n=269). HRQoL was assessed using EORTC QLQ-C30 and QLQ-OV28 at baseline and every 12 weeks for 2 years, with prespecified TUDD analysis. No clinically meaningful between-group differences in global HRQoL were observed overall (GHS difference 1.65; 95% CI -0.27 to 3.56) or in the HRD-positive subgroup (1.23; 95% CI -1.25 to 3.71), though TUDD favored olaparib in HRD-positive patients (HR 0.70; 95% CI 0.52-0.93). The authors concluded adding maintenance olaparib to bevacizumab had no detrimental effect on global HRQoL.
10.1093/jnci/djag122

Tumor Infiltrating Lymphocyte Therapy Combined With PD-1/LAG-3 Inhibition in Patients With Recurrent Platinum-Resistant Ovarian Cancer.
INT J CANCER · Q1 JOURNAL - RANK #77/326
This pilot clinical trial aimed to assess the safety, feasibility, and early efficacy of tumor-infiltrating lymphocyte (TIL) therapy with PD-1 and LAG-3 blockade in five patients with platinum-resistant recurrent ovarian cancer. Using an interventional design, participants received TIL infusion plus up to four cycles of combined checkpoint inhibitors. Tumor burden decreased in 80% of participants (4/5), including two unconfirmed partial responses, with the treatment showing expected toxicities but a high rate of non-treatment-related complications. Overall, the study supports further investigation of TIL therapy with concurrent checkpoint inhibition across different ovarian cancer histologies.
10.1002/ijc.70510

Apr 13 – Apr 20, 2026

Combinatorial delivery of low-dose radiotherapy and immunotherapy to patients with immune-excluded tumors enhances CD8+ T cell functionality.
CLIN CANCER RES · Q1 JOURNAL - RANK #29/326TOP-TIER
This multi-cohort phase I clinical trial (RACIN) prospectively evaluated the safety, tolerability, and preliminary efficacy of combining low-dose radiotherapy (LDRT) with a backbone of nivolumab, ipilimumab, aspirin or celecoxib, and low-dose cyclophosphamide in 25 patients with multimetastatic immune-excluded solid tumors, incorporating dose-escalation of LDRT and paired pre- and post-LDRT biopsies for single-cell tumor microenvironment profiling. The regimen showed a manageable safety profile with Grade ≥3 adverse events in 12–21% of patients and achieved a disease control rate of 42%, including one ovarian cancer patient with a complete response maintained at three years; secondary endpoints included progression-free and overall survival (not numerically reported). Correlative analyses found that responders exhibited enhanced CD8+ TIL functionality with increased DNA damage response signatures and baseline PD1+CD8+ TILs, whereas non-responders had elevated regulatory innate lymphocytes (CD8 MAIT, regulatory NK), paucity of immune-stimulatory myeloid cells, and increased TIL radiosensitivity after LDRT. The study concludes that LDRT combined with immune-checkpoint blockade is safe and potentially immunomodulatory in immune-excluded tumors, and that TIL dynamics, DNA repair responsiveness, and TME composition may predict response, warranting validation in larger controlled studies.
10.1158/1078-0432.CCR-25-2743

Pembrolizumab plus weekly paclitaxel in platinum-resistant recurrent ovarian cancer (ENGOT-ov65/KEYNOTE-B96): a multicentre, randomised, double-blind, phase 3 study.
LANCET · Q1 JOURNAL - RANK #1/332TOP-TIER
This multicentre, randomised, double-blind, phase 3 study (ENGOT-ov65/KEYNOTE-B96) investigated whether adding pembrolizumab to weekly paclitaxel improved outcomes in adults with platinum-resistant recurrent ovarian cancer who had received one to two prior systemic regimens. The primary endpoint was investigator-assessed progression-free survival, with overall survival as a key secondary endpoint. Pembrolizumab plus paclitaxel significantly improved progression-free survival in the overall population (median 8.3 vs 6.4 months; HR 0.70, 95% CI 0.58-0.84, p<0.0001) and overall survival (median 17.7 vs 14.0 months; HR 0.82, 95% CI 0.69-0.97, p=0.011), with grade 3 or worse treatment-related adverse events occurring in 68% versus 55% of participants. The authors concluded that pembrolizumab plus weekly paclitaxel significantly improved both progression-free and overall survival, supporting it as a new treatment option for this population.
10.1016/S0140-6736(26)00602-1

Overall survival with relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA): a phase 3 randomised controlled trial.
LANCET · Q1 JOURNAL - RANK #1/332TOP-TIER
The primary objective was to assess the efficacy and safety of relacorilant plus nab-paclitaxel versus nab-paclitaxel monotherapy in patients with platinum-resistant ovarian cancer, using a phase 3 randomised controlled trial methodology across 117 clinical sites in 14 countries. Eligible patients were randomly assigned to two groups and followed for a median of 24.8 months, with dual primary endpoints of progression-free and overall survival; blinded central review was used for progression assessment. Key findings showed a statistically and clinically significant improvement in overall survival with the combination arm (median overall survival: 16.0 months vs. 11.9 months, HR=0.65, p=0.0004; 18-month OS: 46% vs. 27%), and safety outcomes and subsequent treatments were comparable between groups. The combination of relacorilant and nab-paclitaxel is concluded to provide a significantly longer overall survival and to constitute a potential new standard of care in this patient population.
10.1016/S0140-6736(26)00462-9

Apr 06 – Apr 13, 2026

Phase Ib trial of SL-172154, a bispecific CD47 inhibitor and CD40 agonist Fc-fusion protein, in combination with mirvetuximab soravtansine or pegylated liposomal doxorubicin in patients with platinum-resistant ovarian cancer.
BRIT J CANCER · Q1 JOURNAL - RANK #47/326
This Phase Ib trial prospectively investigated the bispecific CD47 inhibitor and CD40 agonist SL-172154 in combination with mirvetuximab soravtansine or pegylated liposomal doxorubicin in patients with platinum-resistant ovarian cancer. The methodology involved administering SL-172154 on days 8 and 15 of each cycle, with mirvetuximab given on a 21-day cycle and pegylated liposomal doxorubicin on a 28-day cycle. Key findings showed objective response rates ranging from 15% to 33% in the mirvetuximab cohort depending on folate receptor alpha levels, and 20% in the doxorubicin cohort. Investigators concluded that SL-172154 combined with mirvetuximab did not improve previously reported response rates for mirvetuximab, while combination with liposomal doxorubicin yielded modest increases in response, possibly limited by incomplete tumor penetration and T-cell exhaustion.
10.1038/s41416-026-03430-0

Rational adjustment of dose to reduce adverse reactions (RADAR) in patients with platinum-sensitive recurrent ovarian cancer: Results from the phase II NEWTON trial (ENGOT-ov49).
EUR J CANCER · Q1 JOURNAL - RANK #45/326
The primary objective of this phase II trial was to assess the safety of a personalized RADAR dosing strategy of niraparib compared to a standard regimen in patients with platinum-sensitive recurrent ovarian cancer. In this prospective study, participants were assigned to receive either 200 mg or 300 mg of niraparib based on baseline weight and platelet count, with potential dose escalation under specific conditions. Results showed a significantly lower incidence of grade 3 or higher thrombocytopenia in the RADAR group compared to the standard dose arm (4.2% vs. 41.7%, p=0.0044), with median progression-free survival of 10.3 and 11.7 months, respectively. The investigators concluded that the RADAR strategy reduced severe thrombocytopenia without compromising efficacy.
10.1016/j.ejca.2026.116685