Fluzoparib in Combination With Camrelizumab and Temozolomide in Advanced Melanoma

NCT ID: NCT05983237

Last Updated: 2025-03-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-15
• Study Completion Date: 2027-12-31

Brief Summary

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.

Conditions

Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Camre+Fluzo+TMZ

This arm will enroll patients who has advanced melanoma with a genetic HR mutation/ alteration .

Group Type: EXPERIMENTAL

Fluzoparib Camrelizumab Temozolomide

Intervention Type: DRUG

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

Interventions

Fluzoparib Camrelizumab Temozolomide

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Histologically confirmed diagnosis of unresectable or metastatic stage III or IV melanoma;

2. Must have genetic HR and/or SF3B1 mutation/ alteration;

3. Must have measurable disease based on RECIST 1.1;

4. Must have an ECOG performance status of 0 to 1;

5. Must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline;

6. Anticipated overall survival more than 3 months;

7. Male and no pregnant female, able to adapt birth control methods during treatment.

Exclusion Criteria

1. Previously treated with a PARP inhibitor;

2. Hypersensitivity to Fluzoparib or Camrelizumab or Temozolomide;

3. 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;

4. 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;

5. Patients with a history of other (including unknown primary) malignancies within 5 years prior to the first dose of trial treatment;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jun Guo

OTHER

Sponsor Role: lead

Responsible Party

Jun Guo

Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jun Guo

Role: STUDY_DIRECTOR

Peking University Cancer Hospital & Institute

Locations

Beijing Cancer Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Jun Guo

Role: CONTACT

guoj307@126.com

86-10-88121122

Bin Lian

Role: CONTACT

lianbin0214@126.com

86-10-88121122

Facility Contacts

Jun Guo

Role: primary

guoj307@126.com

Other Identifiers

MA-MM-Ⅱ-005

Identifier Type: -

Identifier Source: org_study_id