search
Back to results

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

Primary Purpose

Nasopharyngeal Carcinoma, Nasopharyngeal Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Fluzoparib and Camrelizumab
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring PARP inhibitor, Fluzoparib, checkpoint inhibitor, PD-1 inhibitor, Camrelizumab

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. Hypersensitivity to Fluzoparib or Camrelizumab;
  2. Symptomatic spinal cord compression, or high-risk to develop pathological fracture that requires urgent surgery or radiation;
  3. Necrotic disease, high-risk of massive bleeding;
  4. Suffered from malignant tumors, except cervical carcinoma in situ, papillary thyroid carcinoma, or skin cancer (non- melanoma) within five years;
  5. 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;
  6. Previous treatment of PD-1/L1 inhibitors, CTLA-4 inhibitors, other checkpoint inhibitors or immune modulation therapy, or PARP inhibitors;
  7. Receive vaccine or live vaccine within 28 days prior to signing the informed consent;
  8. Still suffered from adverse effect (more than CTCAE grade 1), that results from previous treatment;
  9. Severe, uncontrolled infections within 28 days prior to signing inform consent;
  10. 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;
  11. HIV positive;
  12. 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;
  13. Hepatitis B surface antigen (HBsAg) positive and HBV-DNA ≥500IU/ml, or 2500cps/ml; Positive HCV RNA;
  14. History of drug abuse, drug taking, alcohol abuse;
  15. Other diseases which may influence the safety or compliance of the clinical trial, such as mental illness, or their family and society factors;
  16. Women of child-bearing potential who are pregnant or breastfeeding.

Sites / Locations

  • Fudan Universtiy Shanghai Cancer CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Combination of Fluzoparib and Camrelizumab

Arm Description

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

Outcomes

Primary Outcome Measures

Overall response rate
Overall response rate, evaluated by independent radiology review board, according to RECIST 1.1 Criteria

Secondary Outcome Measures

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

Full Information

First Posted
July 25, 2021
Last Updated
June 4, 2022
Sponsor
Fudan University
search

1. Study Identification

Unique Protocol Identification Number
NCT04978012
Brief Title
Fluzoparib and Camrelizumab in Treating Patients With R/M NPC That Progressed After First-line Chemotherapy
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 25, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma, Nasopharyngeal Cancer
Keywords
PARP inhibitor, Fluzoparib, checkpoint inhibitor, PD-1 inhibitor, Camrelizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combination of Fluzoparib and Camrelizumab
Arm Type
Experimental
Arm Description
Fluzoparib,150mg bid po, d1-21, q3w Camrelizumab 200mg iv, d1, q3w
Intervention Type
Drug
Intervention Name(s)
Fluzoparib and Camrelizumab
Intervention Description
Maintenance therapy of Fluzoparib and Camrelizumab, until disease progression or intolerable adverse effect.
Primary Outcome Measure Information:
Title
Overall response rate
Description
Overall response rate, evaluated by independent radiology review board, according to RECIST 1.1 Criteria
Time Frame
Within 2 year post-treatment
Secondary Outcome Measure Information:
Title
Disease control rate
Description
Disease control rate, evaluated by independent radiology review board, according to RECIST 1.1 Criteria
Time Frame
Within 2 year post-treatment
Title
Duration of response
Description
Duration of response, evaluated by independent radiology review board, according to RECIST 1.1 Criteria
Time Frame
Within 2 year post-treatment
Title
Progression-free survival rate at 6 month post-treatment
Description
Progression-free survival rate at 6 month post-treatment
Time Frame
6 month post-treatment
Title
Overall survival rate at 6 month post-treatment
Description
Overall survival rate at 6 month post-treatment
Time Frame
6 month post-treatment
Title
Progression-free survival rate at 12 month post-treatment
Description
Progression-free survival rate at 12 month post-treatment
Time Frame
12 month post-treatment
Title
Overall survival rate at 12 month post-treatment
Description
Overall survival rate at 12 month post-treatment
Time Frame
12 month post-treatment
Title
Median progression-free survival
Description
Median progression-free survival
Time Frame
Within 2 year post-treatment
Title
Median overall survival
Description
Median overall survival
Time Frame
Within 2 year post-treatment
Title
Adverse effect
Description
Adverse effect, according to CTCAE 4.0.03 criteria
Time Frame
Within 2 year post-treatment
Title
Overall response rate by different PD-L1 TPS subgroups
Description
Overall response rate by different PD-L1 TPS subgroups (≥1% vs. <1%; ≥20% vs. <20%; ≥50% vs. <50%))
Time Frame
Within 2 year post-treatment
Title
Overall response rate by different homologous recombination repair status (HRR)
Description
Overall response rate by different homologous recombination repair status(germline BRCA mutation/wildtype, HRD positive/negative, germline HRR genes mutations status)
Time Frame
Within 2 year post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chaosu Hu, M.D.
Phone
+8621-64175590
Ext
81400
Email
hucsu62@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaomin Ou, M.D.
Phone
+8618017317872
Email
0456218@fudan.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chaosu Hu, M.D.
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan Universtiy Shanghai Cancer Centre
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chaosu Hu, M.D.
Phone
+8621-64175590
Ext
81400
Email
hucsu62@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33492986
Citation
Wang FH, Wei XL, Feng J, Li Q, Xu N, Hu XC, Liao W, Jiang Y, Lin XY, Zhang QY, Yuan XL, Huang HX, Chen Y, Dai GH, Shi JH, Shen L, Yang SJ, Shu YQ, Liu YP, Wang W, Wu H, Feng H, Yao S, Xu RH. Efficacy, Safety, and Correlative Biomarkers of Toripalimab in Previously Treated Recurrent or Metastatic Nasopharyngeal Carcinoma: A Phase II Clinical Trial (POLARIS-02). J Clin Oncol. 2021 Mar 1;39(7):704-712. doi: 10.1200/JCO.20.02712. Epub 2021 Jan 25.
Results Reference
background
PubMed Identifier
29584545
Citation
Ma BBY, Lim WT, Goh BC, Hui EP, Lo KW, Pettinger A, Foster NR, Riess JW, Agulnik M, Chang AYC, Chopra A, Kish JA, Chung CH, Adkins DR, Cullen KJ, Gitlitz BJ, Lim DW, To KF, Chan KCA, Lo YMD, King AD, Erlichman C, Yin J, Costello BA, Chan ATC. Antitumor Activity of Nivolumab in Recurrent and Metastatic Nasopharyngeal Carcinoma: An International, Multicenter Study of the Mayo Clinic Phase 2 Consortium (NCI-9742). J Clin Oncol. 2018 May 10;36(14):1412-1418. doi: 10.1200/JCO.2017.77.0388. Epub 2018 Mar 27. Erratum In: J Clin Oncol. 2018 Aug 1;36(22):2360.
Results Reference
background
PubMed Identifier
29230817
Citation
Lung RW, Hau PM, Yu KH, Yip KY, Tong JH, Chak WP, Chan AW, Lam KH, Lo AK, Tin EK, Chau SL, Pang JC, Kwan JS, Busson P, Young LS, Yap LF, Tsao SW, To KF, Lo KW. EBV-encoded miRNAs target ATM-mediated response in nasopharyngeal carcinoma. J Pathol. 2018 Apr;244(4):394-407. doi: 10.1002/path.5018. Epub 2018 Feb 16.
Results Reference
background
PubMed Identifier
30662441
Citation
Tatfi M, Hermine O, Suarez F. Epstein-Barr Virus (EBV)-Related Lymphoproliferative Disorders in Ataxia Telangiectasia: Does ATM Regulate EBV Life Cycle? Front Immunol. 2019 Jan 4;9:3060. doi: 10.3389/fimmu.2018.03060. eCollection 2018.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs