Fluzoparib in Combination With Camrelizumab and Temozolomide in Advanced Melanoma

NCT05983237 | Recruiting Phase 1

• 1 other identifier: MA-MM-Ⅱ-005
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma

Keywords

Homologous recombination (HR); PARP inhibitor; anti PD-1 antibody

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  ORR of Fluzoparib in combination with Camrelizumab and Temozolomide in patients with advanced melanoma with genetic homologous recombination (HR) mutation/ alteration using RECIST v1.1

  6 months

Study Arms (1)

Camre+Fluzo+TMZ

EXPERIMENTAL

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

Drug: Fluzoparib Camrelizumab Temozolomide

Interventions

Fluzoparib Camrelizumab Temozolomide DRUG

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

Camre+Fluzo+TMZ

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Jun Guo: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Melanoma

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

• Jun Guo

  Peking University Cancer Hospital & Institute

  STUDY DIRECTOR

Central Study Contacts

Jun Guo

CONTACT

86-10-88121122; guoj307@126.com

Bin Lian

CONTACT

86-10-88121122; lianbin0214@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: August 9, 2023
• Study Start: August 15, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 5, 2025

Record last verified: 2025-02

Locations

CN (1)