Ovarian Cancer Clinical Trial Landscape

Key Phase 3 programs active in 2026

Selected active Phase 3 ovarian cancer trials as of early 2026:

Why ovarian cancer trial monitoring matters

Ovarian cancer — encompassing high-grade serous ovarian carcinoma (HGSOC), clear cell, endometrioid, low-grade serous, fallopian tube, and primary peritoneal subtypes — accounts for approximately 19,000 new diagnoses and 13,000 deaths in the US annually, making it the deadliest gynecologic malignancy. The clinical development landscape has undergone a structural shift over the past decade with the establishment of PARP inhibitor maintenance therapy: olaparib (Lynparza, AstraZeneca/MSD), niraparib (Zejula, GSK), rucaparib (Rubraca, Clovis/Pfizer), and veliparib have all reached Phase 3 and, in most cases, approval in BRCA-mutant or HRD-positive populations.

With approximately 189 recruiting trials currently on ClinicalTrials.gov, ovarian cancer is an intensely active development space. Monitoring new trial registrations is essential for gynecologic oncologists, pharma BD teams, and biotech investors. Key signals to track include:

• PARP inhibitor combinations with ATR inhibitors, WEE1 inhibitors, and anti-angiogenics to overcome acquired resistance
• Antibody-drug conjugate programs — mirvetuximab soravtansine (IMGN853, ImmunoGen/AbbVie), HER3-DXd, and next-generation FOLR1-targeting payloads
• Immunotherapy combinations — pembrolizumab, dostarlimab, and checkpoint doublets in platinum-sensitive and platinum-resistant disease
• Homologous recombination deficiency (HRD) biomarker strategies expanding the eligible population beyond BRCA mutation
• Neoantigen vaccines and KRAS-targeted agents entering ovarian cancer-specific cohorts
• Histology-specific trials for clear cell (mTOR/PI3K pathway) and low-grade serous (MEK/BRAF/RAS pathway) disease
• Maintenance therapy sequencing studies in post-PARP-progression populations

What we monitor for ovarian cancer

Our pipeline pulls directly from the ClinicalTrials.gov API every day. For an ovarian cancer watch profile, you can configure:

• Condition keywords: "ovarian cancer", "ovarian carcinoma", "high-grade serous ovarian cancer", "HGSOC", "fallopian tube cancer", "primary peritoneal cancer", "clear cell ovarian", "low-grade serous ovarian", "endometrioid ovarian carcinoma"
• Intervention keywords: "PARP inhibitor", "olaparib", "niraparib", "mirvetuximab", "FOLR1", "HER3-DXd", "WEE1 inhibitor", "ATR inhibitor", "pembrolizumab", "dostarlimab", "bevacizumab", "adavosertib"
• Phase filter: Phase 1 only, Phase 2/3, or all phases
• Sponsor filter: Industry-sponsored only (for competitive intelligence) or all sponsors
• Status filter: Recruiting only, all active studies, or any status

The ovarian cancer treatment landscape in 2026

PARP inhibitors: established maintenance, emerging resistance strategies

PARP inhibitor maintenance therapy is now standard of care in first-line and recurrent settings for BRCA-mutant and HRD-positive ovarian cancer. Olaparib (Lynparza) received FDA approval for first-line maintenance in BRCA-mutant disease following SOLO-1 (NCT01844986), and the PAOLA-1 trial (NCT02477644) established olaparib plus bevacizumab in HRD-positive patients. Niraparib (Zejula) achieved approval in the broader HRD-positive population via PRIMA (NCT02655016). The pipeline focus has shifted decisively toward overcoming acquired PARP inhibitor resistance — a critical unmet need affecting most patients within 2–3 years of maintenance initiation. Combination strategies with ATR inhibitors (ceralasertib), WEE1 inhibitors (adavosertib, ZN-c3), and VEGF pathway agents are generating active Phase 1/2 programs.

ADCs: mirvetuximab, rinatabart, and the FOLR1 wave

The approval of mirvetuximab soravtansine (Elahere, ImmunoGen/AbbVie) for FOLR1-high platinum-resistant ovarian cancer — based on SORAYA (NCT04296890) and MIRASOL (NCT04209855) — established ADCs as a validated modality in this disease. Mirvetuximab is now standard of care in the FOLR1-high platinum-resistant setting, and the GLORIOSA Phase 3 trial (NCT05445778) is evaluating mirvetuximab plus bevacizumab as maintenance therapy in FOLR1-high platinum-sensitive disease, potentially expanding the label further up the treatment continuum.

Rinatabart sesutecan (Rina-S, Genmab), a FRα-targeting ADC with a next-generation exatecan-derived payload, has entered a Phase 3 program (NCT06619236) in FRα-positive platinum-resistant ovarian cancer. The competitive positioning relative to mirvetuximab will depend on activity in FRα-medium/low populations and tolerability profile. HER3-DXd (patritumab deruxtecan, Daiichi Sankyo/AstraZeneca) has entered ovarian cancer-specific Phase 2 cohorts. Multiple additional FOLR1-targeting ADCs with differentiated linker-payload combinations are in Phase 1, seeking to improve on mirvetuximab's activity in FOLR1-medium and FOLR1-low populations.

Immunotherapy: checkpoint combinations and neoantigen vaccines

Ovarian cancer has historically been considered immunologically cold, with limited single-agent checkpoint inhibitor activity. The KEYNOTE-100 trial established modest pembrolizumab activity in platinum-resistant disease, and DUO-O (NCT03737643) evaluated durvalumab combinations in first-line settings. Active development now centers on combinations pairing checkpoint blockade with PARP inhibitors, ADCs, anti-angiogenics, and novel innate immune agonists (STING, TLR) to increase tumor immunogenicity. Dostarlimab (Jemperli, GSK) is being evaluated in ovarian cancer populations following its approval in dMMR/MSI-H endometrial cancer. Neoantigen vaccine programs — including mRNA-based platforms from Moderna/MSD — are entering ovarian cancer-specific cohorts with a focus on TP53-mutant HGSOC, where shared neoantigens may enable population-scale vaccination strategies.

WEE1 and ATR inhibitors: DNA damage response combinations

WEE1 kinase inhibition — most advanced with adavosertib (AstraZeneca) and ZN-c3 (Zentalis) — exploits replication stress in HGSOC, a histology characterized by near-universal TP53 mutation and high chromosomal instability. Phase 2 trials of WEE1 inhibitor plus PARP inhibitor combinations are designed to create synthetic lethality in both BRCA-mutant and BRCA-wild-type HRD populations. ATR inhibitor combinations (ceralasertib/olaparib) have shown clinical activity in PARP-resistant settings. Monitoring WEE1 and ATR program trial registrations is critical for companies developing DNA damage response agents across oncology, as ovarian cancer often serves as the lead indication.

Histology-specific programs: clear cell and low-grade serous

Clear cell ovarian carcinoma and low-grade serous ovarian carcinoma (LGSOC) are biologically distinct from HGSOC and have historically been underserved by trials designed around the predominant high-grade serous histology. Clear cell carcinoma, enriched in ARID1A mutations and PIK3CA alterations, is being targeted with mTOR and PI3K inhibitors in dedicated cohorts. LGSOC, driven by RAS/RAF/MEK pathway activation, has been the focus of MEK inhibitor trials — binimetinib demonstrated activity in the MILO trial (NCT01849874), and next-generation RAS/RAF inhibitors are entering ovarian cancer-specific expansions. Histology-specific trials represent a growing share of the registrant base and are important to track separately from broad HGSOC-dominant programs.

HRD biomarker strategies: expanding patient selection beyond BRCA

The approved PARP inhibitors target BRCA-mutant and, in broader label expansions, HRD-positive patients as defined by genomic scar scores (Myriad myChoice, Foundation Medicine CDx). Approximately 50% of HGSOC patients harbor HRD by genomic scar criteria, but optimal biomarker cutoffs, assay platforms, and patient selection strategies remain active areas of investigation. Trials are increasingly stratifying on HRD status, BRCA somatic versus germline mutation, RAD51 foci, and replication fork stability assays. Understanding the evolving biomarker landscape requires monitoring not just efficacy trials but also biomarker qualification and companion diagnostic co-development studies.

Who uses ovarian cancer trial monitoring

Gynecologic oncologists and academic medical centers

Gynecologic oncologists at NCI-designated cancer centers and major academic medical institutions track new trial registrations to identify investigator-initiated trial opportunities, match patients to appropriate protocols, and stay current on competitive programs before data become public. With approximately 36 recruiting ovarian cancer trials active at any given time, systematic monitoring is more efficient than manual ClinicalTrials.gov searches. Tumor boards increasingly rely on current trial landscape knowledge to inform treatment sequencing decisions for heavily pretreated patients exhausting standard-of-care options.

Pharma and biotech BD teams

Business development teams at AstraZeneca, GSK, AbbVie, Daiichi Sankyo, Pfizer, and emerging ADC biotechs track competitor trial registrations to inform partnership strategy, asset valuation, and indication prioritization. A new Phase 1 trial registration for a FOLR1 ADC or a PARP/WEE1 combination may precede a public clinical readout or licensing announcement by 18–36 months. Early intelligence on mechanism-of-action differentiation is essential for BD decisions in the crowded post-mirvetuximab gynecologic oncology landscape.

Oncology investors and portfolio managers

Investors with exposure to gynecologic oncology assets — ADC platforms, DNA damage response programs, and checkpoint combinations — monitor ovarian cancer trial activity as a leading indicator of clinical strategy and regulatory timelines. Trial enrollment rates, protocol amendments, and dose escalation disclosures in Phase 1 registrations provide signal on program advancement. Given the concentrated competitive landscape in PARP maintenance and the emerging ADC race centered on FOLR1 and HER3, tracking trial activity is a meaningful input into ovarian cancer franchise valuation and competitive positioning analysis.

Frequently asked questions