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

NCT04978012 | Unknown Phase 2 DMC

• 1 other identifier: NPC-PAPRi 1.0
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasopharyngeal Carcinoma; Nasopharyngeal Cancer

Keywords

PARP inhibitor; Fluzoparib; checkpoint inhibitor; PD-1 inhibitor; Camrelizumab

Outcome Measures

Primary Outcomes (1)

• Overall response rate

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

  Within 2 year post-treatment

Secondary Outcomes (11)

• Disease control rate

  Within 2 year post-treatment

• Duration of response

  Within 2 year post-treatment

• Progression-free survival rate at 6 month post-treatment

  6 month post-treatment

• Overall survival rate at 6 month post-treatment

  6 month post-treatment

• Progression-free survival rate at 12 month post-treatment

  12 month post-treatment

Study Arms (1)

Combination of Fluzoparib and Camrelizumab

EXPERIMENTAL

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

Drug: Fluzoparib and Camrelizumab

Interventions

Fluzoparib and Camrelizumab DRUG

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

Combination of Fluzoparib and Camrelizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan Universtiy Shanghai Cancer Centre

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 33492986 BACKGROUND

• 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.

  PMID: 29584545 BACKGROUND

• 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.

  PMID: 29230817 BACKGROUND

• 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.

  PMID: 30662441 BACKGROUND

MeSH Terms

Conditions

Nasopharyngeal Carcinoma; Nasopharyngeal Neoplasms

Interventions

fluzoparib; camrelizumab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Chaosu Hu, M.D.

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chaosu Hu, M.D.

CONTACT

+8621-64175590; hucsu62@163.com

Xiaomin Ou, M.D.

CONTACT

+8618017317872; 0456218@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Professor

Study Record Dates

• First Submitted: July 25, 2021
• First Posted: July 27, 2021
• Study Start: July 25, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: June 7, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)