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Recruiting NCT05983237

Fluzoparib in Combination With Camrelizumab and Temozolomide in Advanced Melanoma

Phase I / Phase II Interventional Melanoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fluzoparib Camrelizumab Temozolomide.
Who it may be relevant to
Registry conditions: Melanoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Phase Ib Study of Fluzoparib in Combination With Camrelizumab and Temozolomide in Advanced Melanoma With Homologous Recombination (HR) Mutation ，a Single-center Open-label Exploratory Clinical Trial

Overview

The purpose of this study is to evaluate how well fuzoparib in combination with camrelizumab and temozolomide works in treating patients with advanced, metastatic melanoma with the homologous recombination (HR) pathway gene mutation / alteration.

Detailed description

Treatment with PARP inhibitors could represent a novel opportunity to selectively kill a subset of cancer cells with deficiencies in DNA repair pathways. Non-BRCA deficiencies in homologous recombination DNA repair genes could also enhance tumor cell sensitivity to PARP inhibitors. Therefore, PARP inhibitors are also selectively cytotoxic for cancer cells with deficiencies in DNA repair proteins other than BRCA1 and BRCA2.

In melanoma, genetic HR mutation/ alterations are rather common. Retrospective data showed that nearly18-40% of melanoma harbors a mutation in at least 1 of the HR genes in their tumor. The commonly altered genes were ARID1A, FANCA, ATM, BRCA1, ATRX and BRCA2, ATR, BRCA1 BRIP1 and SF3B1. These findings indicate that HR mutations / alterations are frequently observed in metastatic melanoma, and they suggest that PARP inhibitors could potentially be of a great clinical value in a substantial portion of the patients with advanced melanoma.

In this clinical study, clinical efficacy of fluzoparib in combination with camrelizumab and temozolomide will be evaluated by assessing an objective clinical response rate in patients with advanced, metastatic melanoma with the homologous recombination (HR) pathway gene mutation / alteration.

Interventions

  • Drug Fluzoparib Camrelizumab Temozolomide
    Fluzoparib 50-150mg bid po, d1-21, q3w Camrelizumab 200mg iv, d1, q3w Temozolomide 50mg/m2-200mg/m2 d1-5,q3w

Primary outcome measures

  • Objective Response Rate (ORR) [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • Histologically confirmed diagnosis of unresectable or metastatic stage III or IV melanoma;
  • Must have genetic HR and/or SF3B1 mutation/ alteration;
  • Must have measurable disease based on RECIST 1.1;
  • Must have an ECOG performance status of 0 to 1;
  • Must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline;
  • Anticipated overall survival more than 3 months;
  • Male and no pregnant female, able to adapt birth control methods during treatment.

Exclusion criteria

  • Previously treated with a PARP inhibitor;
  • Hypersensitivity to Fluzoparib or Camrelizumab or Temozolomide;
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug;
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug;
  • Patients with a history of other (including unknown primary) malignancies within 5 years prior to the first dose of trial treatment;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Cancer Hospital — Beijing

Identifiers

NCT: NCT05983237 · MA-MM-Ⅱ-005

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗