Combining PD-1 treatment with chemotherapy and radiotherapy for high-risk nasopharyngeal cancer

A Multicenter Randomized Clinical Phase 3 Trial of Induction Chemotherapy Plus Concurrent Chemo-radiotherapy With or Without Camrelizumab for High Risk Nasopharyngeal Carcinoma

This study is testing if adding a new immune therapy to chemotherapy and radiotherapy can help people with high-risk nasopharyngeal cancer live longer and feel better.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 388 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: chemotherapy, camrelizumab
• Locations: 6 sites (Guangzhou, Guangdong and 5 other locations)
• Trial ID: NCT04453826 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of combining camrelizumab, a PD-1 inhibitor, with chemotherapy and radiotherapy in patients with high-risk nasopharyngeal carcinoma. It is a multicenter, open-label, randomized trial where participants are assigned to receive either the combination treatment or chemotherapy and radiotherapy alone. The study focuses on patients who have specific staging criteria and have shown disease progression or high levels of EBV DNA after initial chemotherapy. The primary goal is to determine if the addition of PD-1 therapy can reduce disease progression and improve survival rates.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with histologically confirmed non-keratinizing nasopharyngeal carcinoma at specific stages and with certain disease characteristics.

Not a fit: Patients with keratinized squamous cell carcinoma or those with recurrent or metastatic nasopharyngeal carcinoma may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve survival outcomes for patients with high-risk nasopharyngeal carcinoma.

How similar studies have performed: Other studies have shown promising results with PD-1 inhibitors in combination with chemotherapy and radiotherapy, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

1. Histologically confirmed non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III).
2. Staged as T4N0-2M0,T1-4N3M0 (stage IVa) at diagnosis (according to the 8th AJCC edition).
3. Staged as T1-3N1-2M0, T2-3N0M0 (stage II-III) with SD/PD according to RECIST criteria or EBV DNA of \>0 copies/mL after 3 cycles of GP induction chemotherapy.
4. Aged between 18-70 years.
5. Karnofsky scale (KPS)≥70.
6. Normal bone marrow function.
7. Normal liver and kidney function:

   1. total bilirubin, AST and ALT levels of no more than 2.5 times the upper normal limit;
   2. creatinine clearance rate of at least 60 mL/min or creatinine of no more than 1.5 times the upper normal limit.
8. Given written informed consent.

Exclusion Criteria:

1. Histologically confirmed keratinized squamous cell carcinoma (WHO type I) or basal squamous cell carcinoma.
2. Recurrent or metastatic nasopharyngeal carcinoma.
3. Staged as II-III which is evaluated as PR or CR and EBV DNA of 0 copies/mL after 3 cycles of GP induction chemotherapy.
4. Has known allergy to large molecule protein products or any compound of study therapy.
5. Has known subjects with other malignant tumors.
6. Has any active autoimmune disease or history of autoimmune disease.
7. Has a history of psychiatric substance abuse, alcoholism, or drug addiction.
8. The laboratory examination value does not meet the relevant standards within 7 days before enrollment
9. Received a systematic glucocorticoid therapy within 4 weeks of the first dose of study medication.
10. Has a known history of active TB (bacillus tuberculosis) within 1 year; patients with adequately treated active TB with 1 year.
11. Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent.
12. Has active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy). Patients with skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia) will be allowed to enroll.
13. Has a known history of human immunodeficiency virus (HIV).
14. Has hepatitis B surface antigen (HBsAg) positive with HBV DNA copy number of ≥1000cps/ml or hepatitis C virus (HCV) antibody positive.
15. Has received a live vaccine within 4 weeks of planned start of study therapy.
16. Pregnancy or breast feeding.

Where this trial is running

Guangzhou, Guangdong and 5 other locations

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
• Cancer Center of Guangzhou Medical University — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Yuebei People's Hospital — Shaoguan, Guangdong, China (Not_yet_recruiting)
• Zhongshan People's Hospital — Zhongshan, Guangdong, China (Recruiting)
• The Fifth Affiliated Hospital of Sun Yat-sen University — Zhuhai, Guangdong, China (Recruiting)
• Wuzhou Red Cross Hospital — Wuzhou, Guangxi, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Ming-Yuan Chen, MD, PhD

Conditions Nasopharyngeal Cancer; Chemotherapy; Radiotherapy; PD-1 Therapy