Fluzoparib and Camrelizumab in Treating Patients With R/M NPC That Progressed After First-line Chemotherapy

Sponsor

Fudan University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04978012

Collaborator

(none)

Enrollment

Location

Arm

53.2

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to define the efficacy and safety of Fluzoparib and Camrelizumab in treating patients with recurrent/metastatic nasopharyngeal carcinoma that progressed after first-line chemotherapy.

Condition or Disease	Intervention/Treatment	Phase
Nasopharyngeal Carcinoma Nasopharyngeal Cancer	Drug: Fluzoparib and Camrelizumab	Phase 2

Detailed Description

Currently, the standard first-line treatment for recurrent/metastatic nasopharyngeal carcinoma is cisplatin-based chemotherapy. The recommended subsequent line therapy is single-agent chemotherapy or single-agent PD-1 antibody (nivolumab or pembrolizumab), according to NCCN guidelines (head and neck cancer, version 2021.3). However, the efficacy of nivolumab or pembrolizumab in subsequent line setting is limited, range from 20-30%. In order to improve the efficacy, we launch this study to evaluate whether combination treatment of PARP inhibitor (Fluzoparib) and PD-1 antibody (Camrelizumab) has the potential to increase efficacy in the subsequent line treatment, meanwhile has tolerable adverse effect.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Single-site the Study of the Efficacy and Safety of Fluzoparib and Camrelizumab in Treating Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma That Progressed After First-line Chemotherapy

Actual Study Start Date :

Jul 25, 2021

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Combination of Fluzoparib and Camrelizumab Fluzoparib,150mg bid po, d1-21, q3w Camrelizumab 200mg iv, d1, q3w	Drug: Fluzoparib and Camrelizumab Maintenance therapy of Fluzoparib and Camrelizumab, until disease progression or intolerable adverse effect.

Arm

Intervention/Treatment

Experimental: Combination of Fluzoparib and Camrelizumab

Fluzoparib,150mg bid po, d1-21, q3w Camrelizumab 200mg iv, d1, q3w

Drug: Fluzoparib and Camrelizumab

Maintenance therapy of Fluzoparib and Camrelizumab, until disease progression or intolerable adverse effect.

Outcome Measures

Primary Outcome Measures

Overall response rate [Within 2 year post-treatment]
Overall response rate, evaluated by independent radiology review board, according to RECIST 1.1 Criteria

Secondary Outcome Measures

Disease control rate [Within 2 year post-treatment]
Disease control rate, evaluated by independent radiology review board, according to RECIST 1.1 Criteria
Duration of response [Within 2 year post-treatment]
Duration of response, evaluated by independent radiology review board, according to RECIST 1.1 Criteria
Progression-free survival rate at 6 month post-treatment [6 month post-treatment]
Progression-free survival rate at 6 month post-treatment
Overall survival rate at 6 month post-treatment [6 month post-treatment]
Overall survival rate at 6 month post-treatment
Progression-free survival rate at 12 month post-treatment [12 month post-treatment]
Progression-free survival rate at 12 month post-treatment
Overall survival rate at 12 month post-treatment [12 month post-treatment]
Overall survival rate at 12 month post-treatment
Median progression-free survival [Within 2 year post-treatment]
Median progression-free survival
Median overall survival [Within 2 year post-treatment]
Median overall survival
Adverse effect [Within 2 year post-treatment]
Adverse effect, according to CTCAE 4.0.03 criteria
Overall response rate by different PD-L1 TPS subgroups [Within 2 year post-treatment]
Overall response rate by different PD-L1 TPS subgroups (≥1% vs. <1%; ≥20% vs. <20%; ≥50% vs. <50%）)
Overall response rate by different homologous recombination repair status (HRR) [Within 2 year post-treatment]
Overall response rate by different homologous recombination repair status(germline BRCA mutation/wildtype, HRD positive/negative, germline HRR genes mutations status)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Sign an informed consent;
Age older than 18 years old and younger than 75 years old;
Patients with histologically confirmed recurrent/metastatic nasopharyngeal carcinoma, that progressed after at least first-line chemotherapy, according to RECIST 1.1 criteria;
No previous treatment of PD-1/L1 inhibitors, CTLA-4 inhibitors, other checkpoint inhibitors or immune modulation therapy, or PARP inhibitors;
At least one lesion that fulfills the criteria of "Evaluable Disease" per RECIST 1.1 Criteria;
Anticipated overall survival more than 3 months;
Satisfactory performance status: ECOG (Eastern Cooperative Oncology Group) scale 0-2;
Normal organ function;
HBV DNA<500 IU/mL（or 2500 copies/mL）and HCV RNA negative ;
Male and no pregnant female, able to adapt birth control methods during treatment.

Exclusion Criteria:

Hypersensitivity to Fluzoparib or Camrelizumab;
Symptomatic spinal cord compression, or high-risk to develop pathological fracture that requires urgent surgery or radiation;
Necrotic disease, high-risk of massive bleeding;
Suffered from malignant tumors, except cervical carcinoma in situ, papillary thyroid carcinoma, or skin cancer (non- melanoma) within five years;
Severe, uncontrolled heart disease, such as more than NYHA II heart failure, unstable angina pectoris, myocardial infarction within 1 year prior to signing inform consent, severe arrhythmia that requires urgent intervention;
Previous treatment of PD-1/L1 inhibitors, CTLA-4 inhibitors, other checkpoint inhibitors or immune modulation therapy, or PARP inhibitors;
Receive vaccine or live vaccine within 28 days prior to signing the informed consent;
Still suffered from adverse effect (more than CTCAE grade 1), that results from previous treatment;
Severe, uncontrolled infections within 28 days prior to signing inform consent;
Active, known or suspected autoimmune disease; Type I Diabetes, hypothyroidism those only need hormone replacement therapy, vitiligo or inactive asthma who don't need systemic therapy can recruit;
HIV positive;
Diagnosed as active pulmonary tuberculosis within one year before signing inform consent; or diagnosed as active pulmonary tuberculosis more than one year, but did not receive standardized anti-tuberculosis treatment;
Hepatitis B surface antigen (HBsAg) positive and HBV-DNA ≥500IU/ml, or 2500cps/ml; Positive HCV RNA;
History of drug abuse, drug taking, alcohol abuse;
Other diseases which may influence the safety or compliance of the clinical trial, such as mental illness, or their family and society factors;
Women of child-bearing potential who are pregnant or breastfeeding.