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

• Status: Recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: California Pacific Medical Center Research Institute
• Collaborators: Huntsman Cancer Institute; Mt. Sinai Medical Center, Miami; Tesaro, Inc.; Vanderbilt-Ingram Cancer Center
• Treatments: Niraparib

Criteria

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)