PD-1 Inhibitor Plus G-CSF in Recurrent/Metastatic NPC With First-line Treatment Failure

NCT05222035 | Unknown Phase 2

• 1 other identifier: SYSUCC-CMY-2021-1215
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

Recurrence and metastasis are the main causes of treatment failure of NPC. Preliminary clinical studies have found that the overall response rate of PD-1 inhibitors in treating ≥2 line R/M NPC is about 25%. Recent studies have shown that G-CSF can significantly increase the proportion of effector cells dominated by CD4+ T cells, improve the diversity of peripheral blood TCR, and regulate the immune status of patients. Therefore, we suspect that G-CSF may have a synergistic effect on PD-1 inhibitor, thus enhance the efficacy of PD-1 inhibitor monotherapy.

Conditions

PD-1 Inhibitor; G-CSF

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  Defined as the proportion of patients whose tumors shrink to complete response (CR) or partial response (PR) and remain for a certain period of time according to RECIST 1.1

  1 year

Secondary Outcomes (5)

• The proportion of patients who achieved disease control

  1 year

• The proportion of patients who achieved clinical benefit

  1 year

• median progression-free survival

  1 year

• Duration of response

  1 year

• Adverse events

  1 year

Study Arms (2)

G-CSF+Camrelizumab

EXPERIMENTAL

Drug: Camrelizumab; Drug: G-CSF

Camrelizumab

ACTIVE COMPARATOR

Drug: Camrelizumab

Interventions

Camrelizumab DRUG

PD-1 inhibitor: Camrelizumab, 200 mg, intravenously (IV) , Day 1, Q3W, until progressive disease (PD) or unacceptable toxicity for a maximum of up to 35 cycles (up to approximately 2 years).

Camrelizumab; G-CSF+Camrelizumab

G-CSF DRUG

G-CSF: mecapegfilgrastim, 6 mg, subcutaneous injection, Day 1, Q3W, until stop using Camrelizumab, progressive disease (PD) or unacceptable toxicity.

G-CSF+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:

• Male or female; 18-75 years of age.
• Received one or more lines of therapy, which must include prior treatment with a platinum agent (except for patients who are unfit or refuse platinum-containing regimens) and must not be amenable to potentially curative radiotherapy or surgery. \[Received neoadjuvant/adjuvant/concurrent platinum-containing regimen for radical therapy (radiotherapy or surgery), with recurrence ≤6 months following completion of therapy can be recognized as one line\]
• Subjects diagnosed with pathological confirmed non-keratinizing (WHO-II/III) metastatic NPC, or subjects with recurrent NPC that is unfit for local treatment
• Patients must have at least 1 lesion that is measurable using RECIST v1.1 criteria.
• ECOG performance status of 0 or 1.
• Have recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to any anti-tumor therapy 4 weeks earlier. Except for hair loss, hair color change, nail change, fatigue, etc., which do not pose safety risks to subjects.
• Life expectancy more than 12 weeks.
• Patients must have adequate organ function (without blood transfusion, without growth factor or blood components support within 14 days before enrollment) as determined by:
• Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet count ≥ 75×109/L; Hemoglobin ≥ 9 g/dL; serum total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×upper limit of normal (ULN), (for subjects with liver metastases, TBIL ≤3×ULN ; ALT and AST≤5×ULN); Creatinine ≤1.5×ULN or creatinine clearance rate≥50 ml/min (Cockcroft-Gault formula); serum albumin ≥28 g/L; INR, APTT≤1.5 x ULN.
• Female subjects agree not to be pregnant or lactating from beginning of the study screening through at least 3 months after receiving the last dose of study treatment. Both men and women of reproductive potential must be willing and able to employ a highly effective method of birth control/contraception to prevent pregnancy.
• Be willing and able to provide written informed consent/assent for the trial.

You may not qualify if:

• Subjects who underwent anti-PD-1 /PD-L antibody or anti-CTLA-4 antibody (or any other antibody acting on T cell synergistic stimulation or checkpoint pathway).
• Known history of hypersensitivity to any components of the Camrelizumab and PEG-rhG -CSF formulation or other monoclonal antibodies.
• Prior chemotherapy, targeted small molecule therapy, or radical therapy within 2 weeks prior to Study Day 1
• Diagnosed and/or treated additional malignancy within 5 years of enrollment, with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin, and/or curatively-resected in situ cervical and/or breast carcinoma.
• Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids. Doses \> 10 mg/day prednisone or equivalent are prohibited within 2 weeks before study drug administration.
• Active central nervous system metastases and/or carcinomatous meningitis
• Severe, uncontrolled angiocardiopathy (heart failure \> class II NYHA, unstable angina, myocardial infarction within past 1 year, supraventricular or ventricular arrhythmia which need medical intervention, or QT interval male ≥ 450 ms, female ≥ 470 ms.).
• History of non-infectious pneumonitis that required steroids or current pneumonitis
• Active infection requiring systemic therapy
• Be known to have active tuberculosis.
• Human immunodeficiency virus (HIV) positive
• Hepatitis B or C positive
• Live vaccine within 30 days of planned start of study drug
• Underlying medical condition that, in the Investigator's opinion, would increase the risks of study drug administration or obscure the interpretation of toxicity determination or adverse events.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Interventions

camrelizumab; Granulocyte Colony-Stimulating Factor

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Central Study Contacts

Ming-Yuan Chen, MD, PhD

CONTACT

02087343392; chmingy@mail.sysu.edu.cn

Xi Ding, MD

CONTACT

86-19880836260; dingxi@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician, Proffessor

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 3, 2022
• Study Start: January 24, 2022
• Primary Completion: December 24, 2022
• Study Completion: June 1, 2023
• Last Updated: February 3, 2022

Record last verified: 2022-01

Locations

CN (1)