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Nasopharyngeal CarcinomaPhase 2NCT04978012

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

A Phase 2 study testing Fluzoparib and Camrelizumab in people with Nasopharyngeal Carcinoma and Nasopharyngeal Cancer, run by Fudan University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Fluzoparib and Camrelizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteChina
Study dates
25 Jul 2021to 31 Dec 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country.

Chaosu Hu, M.D. contact

+8621-64175590 ext. 81400

hucsu62@163.com

Xiaomin Ou, M.D. contact

+8618017317872

0456218@fudan.edu.cn

China1 site, 1 recruiting

  • Fudan Universtiy Shanghai Cancer Centre

    Shanghai, Shanghai Municipality, 200032

    Chaosu Hu, M.D., +8621-64175590 ext. 81400, hucsu62@163.com

    Recruiting

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Fluzoparib and Camrelizumab
Keywords
PARP inhibitor, Fluzoparib, checkpoint inhibitor, PD-1 inhibitor, Camrelizumab
Medical subject headings
Nasopharyngeal Carcinoma, Nasopharyngeal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fluzoparib and CamrelizumabDrug

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

Study groups in NCT04978012
Study groupRoleWhat they receive
Combination of Fluzoparib and CamrelizumabExperimentalFluzoparib,150mg bid po, d1-21, q3w Camrelizumab 200mg iv, d1, q3w
Receives: Drug: Fluzoparib and Camrelizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate

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

    Measured: Within 2 year post-treatment

Secondary outcomes (11)

  1. Disease control rate

    Disease control rate, evaluated by independent radiology review board, according to RECIST 1.1 Criteria

    Measured: Within 2 year post-treatment

  2. Duration of response

    Duration of response, evaluated by independent radiology review board, according to RECIST 1.1 Criteria

    Measured: Within 2 year post-treatment

  3. Progression-free survival rate at 6 month post-treatment

    Progression-free survival rate at 6 month post-treatment

    Measured: 6 month post-treatment

  4. Overall survival rate at 6 month post-treatment

    Overall survival rate at 6 month post-treatment

    Measured: 6 month post-treatment

  5. Progression-free survival rate at 12 month post-treatment

    Progression-free survival rate at 12 month post-treatment

    Measured: 12 month post-treatment

  6. Overall survival rate at 12 month post-treatment

    Overall survival rate at 12 month post-treatment

    Measured: 12 month post-treatment

  7. Median progression-free survival

    Median progression-free survival

    Measured: Within 2 year post-treatment

  8. Median overall survival

    Median overall survival

    Measured: Within 2 year post-treatment

  9. Adverse effect

    Adverse effect, according to CTCAE 4.0.03 criteria

    Measured: Within 2 year post-treatment

  10. 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%）)

    Measured: Within 2 year post-treatment

  11. 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)

    Measured: Within 2 year post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2021
  2. Study start25 Jul 2021
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04978012
Sponsor's protocol ID
NPC-PAPRi 1.0
Status last verified
Jun 2022
First submitted
25 Jul 2021
Last updated
7 Jun 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33492986

  • 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.

    PubMed 29584545

  • 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.

    PubMed 29230817

  • 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.

    PubMed 30662441

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fluzoparib and Camrelizumab in people with Nasopharyngeal Carcinoma and Nasopharyngeal Cancer, run by Fudan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Chaosu Hu, M.D. (+8621-64175590 ext. 81400, hucsu62@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (time frame: Within 2 year post-treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04978012, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2022.

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