Efficacy and Safety Study of Niraparib in Melanoma With Genetic Homologous Recombination (HR) Mutation

NCT03925350 | Unknown Phase 2 FDA Drug

• 1 other identifier: CPMC17-MEL01
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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

Metastatic Melanoma

Keywords

Homologous recombination (HR); Mutation; Niraparib; PARP inhibitor

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  ORR of niraparib in patients with advanced melanoma with genetic homologous recombination (HR) mutation/ alteration using RECIST v1.1

  6 months

Secondary Outcomes (3)

• Progression-free survival (PFS)

  2 years

• overall survival (OS)

  2 years

• Number of Participants With Adverse Events as a Measure of Safety and Tolerability

  2 years

Study Arms (1)

Niraparib

EXPERIMENTAL

Patients receive niraparib PO daily

Drug: Niraparib

Interventions

Niraparib DRUG

300 mg PO daily

Niraparib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• California Pacific Medical Center Research Institute: lead
• Tesaro, Inc.: collaborator
• Vanderbilt-Ingram Cancer Center: collaborator
• Huntsman Cancer Institute: collaborator

Study Sites (1)

California Pacific Medical Center Research Institute

San Francisco, California, 94115, United States

RECRUITING

Related Publications (1)

• Kim 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 DERIVED

MeSH Terms

Conditions

Melanoma

Interventions

niraparib

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Kevin Kim, MD

  California Pacific Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emilia Janiczek

CONTACT

415-600-1544; janicze@sutterhealth.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: April 24, 2019
• Study Start: March 20, 2019
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2023
• Last Updated: October 22, 2021

Record last verified: 2021-10

Locations

US (1)