Clinical trial · Interventional
Efficacy and Safety Study of Niraparib in Melanoma With Genetic Homologous Recombination (HR) Mutation
A Phase II Study of Niraparib in Patients With Advanced Melanoma With Genetic Homologous Recombination (HR) Mutation / Alteration
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This open-label phase II trial studies how well niraparib works in treating patients with advanced, metastatic melanoma with the homologous recombination (HR) pathway gene mutation / alteration. Niraparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The trial is designed to assess the efficacy and safety of niraparib in patients with HR mutation/ alteration whose disease progressed on prior immunotherapy and/or BRAF-targeting therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Niraparib | Drug | Niraparib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Niraparib
- description
- Patients receive niraparib PO daily
- interventionNames
- Drug: Niraparib
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- 6 months
- description
- ORR of niraparib in patients with advanced melanoma with genetic homologous recombination (HR) mutation/ alteration using RECIST v1.1
Secondary outcomes (3)
- measure
- Progression-free survival (PFS)
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Have genetic homologous recombination (HR) mutation/ alteration including ARID1A/B, ARID2, ATM, ATR, ATRX, BARD1, BRCA1/2, BAP1, BRIP1, CHEK2, FANCD2, MRN11A, PALB2, RAD50, RAD51, RAD54B * Disease must have progressed on the standard systemic therapies or they could not have tolerated the standard therapies. * ECOG PS \>/=1 * Have measurable metastatic disease according to RECIST 1.1 * Prior systemic cytotoxic therapy up to 1 regimens is allowed; There is no limit on the number of prior immunotherapy or targeted therapy regimens. * All adverse events associated with prior treatment must have resolved to ≤ Grade 1 prior to day 1 of the study drug administration. Exclusion Criteria: * Previously treated with a PARP inhibitor * Symptomatic brain metastasis or active brain lesions ≥6 mm size or those * Require steroid treatment for brain lesions or leptomeningeal disease * Systemic cancer therapy within 14 days prior to day 1 of the study drug administration * Any major surgery ≤ 3 weeks of starting the study and patient must have recovered from any effects of any major surgery * Investigational therapy administered ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational * Prior radiotherapy encompassing \> 20% of the bone marrow within 2 weeks; or any radiation therapy within 1 week prior to Day 1 of protocol therapy * Medical history of immunocompromised condition * Systemic treatment of another type of cancer ≤ 2 years prior to registration * Known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
References
Publications (1)
- DERIVEDKim KB, Desprez PY, de Semir D, Woo RWL, Sharma A, Jones R, Caressi C, Nosrati M, Janiczek E, Rivera Penafiel J, Kashani-Sabet M. Phase II Study of Niraparib in Patients With Advanced Melanoma With Homologous Recombination Pathway Gene Mutations. JCO Precis Oncol. 2025 May;9:e2400658. doi: 10.1200/PO-24-00658. Epub 2025 May 15. PMID 40373259