Phase III Study of Camrelizumab in Combination With Chemotherapy in Recurrent/Metastatic Nasopharyngeal Carcinoma

NCT03707509 | Unknown Phase 3

• 1 other identifier: SHR-1210-III-308
• Study Type: interventional
• Target: 263
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized, placebo-controlled, double-blind, multicenter phase III clinical study. Target population is patients with recurrent/metastatic nasopharyngeal carcinoma who had not received systemic chemotherapy. Study objective is to compare the efficacy and safety of camrelizumab in combination with gemcitabine and cisplatin with placebo in combination with gemcitabine and cisplatin in study population in China. camrelizumab is a humanized anti-PD1 IgG4 monoclonal antibody.

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal Carcinoma; PD-1 Antibody; Cisplatin; Gemcitabine

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the Independent Review Committee according to RECIST v1.1 or death from any cause, whichever occurs first.

  up to 24 month

Secondary Outcomes (6)

• Progression-free survival

  up to 24 month

• Objective Response Rate (ORR)

  up to 24 month

• Disease Control Rate (DCR) Disease Control Rate (DCR)

  up to 24 month

• Duration of Response (DoR)

  up to 24 month

• 2 years Overall Survival (OS) rate

  up to 24 month

Other Outcomes (1)

• Antidrug Antibodies (ADAs)

  up to 24 month

Study Arms (2)

Camrelizumab + Gemcitabine + Cisplatin

EXPERIMENTAL

subject will receive camrelizumab 200mg every 3 weeks, cisplatin 80mg/m2 on Day 1 of each 21 day, at most 6 cycles, gemcitabine 1000mg/m2, Day 1 and Day 8 of each 21 day, maximum 6 cycles

Drug: Camrelizumab; Drug: Gemcitabine; Drug: Cisplatin

Placebos + Gemcitabine + Cisplatin

ACTIVE COMPARATOR

subject will receive placebos every 3 weeks, cisplatin 80mg/m2 on Day 1 of each 21 day, at most 6 cycles, gemcitabine 1000mg/m2, Day 1 and Day 8 of each 21 day, maximum 6 cycles

Drug: Placebos; Drug: Gemcitabine; Drug: Cisplatin

Interventions

Camrelizumab DRUG

Maximum 6 cycles for combined therapy. Camrelizumab maintenance.

Also known as: SHR-1210

Camrelizumab + Gemcitabine + Cisplatin

Placebos DRUG

Maximum 6 cycles for combined therapy.

Also known as: Placebo - Concentrate

Placebos + Gemcitabine + Cisplatin

Gemcitabine DRUG

Maximum 6 cycles for combined therapy.

Also known as: Gemcitabine Hydrochloride for Injection

Camrelizumab + Gemcitabine + Cisplatin; Placebos + Gemcitabine + Cisplatin

Cisplatin DRUG

Maximum 6 cycles for combined therapy.

Also known as: Cisplantin Injection

Camrelizumab + Gemcitabine + Cisplatin; Placebos + Gemcitabine + Cisplatin

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years and ≤75 years;
• Subjects with histopathological diagnosis of nasopharyngeal carcinoma;
• Primarily metastatic (stage IVB as defined by the International Union against Cancer and American Joint Committee on Cancer staging system for NPC, eighth edition) or recurrent NPC that is not amenable for local regional treatment or curative treatment;
• Has not received prior systemic treatment;
• Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status
• Subject must have a measurable target lesion based on RECIST v1.1;

You may not qualify if:

• Allergic to monoclonal antibodies, any camrelizumab components, gemcitabine, cisplatin and other platinum drugs;
• Prior therapy as follow:
• Anti-PD-1 or anti-PD-L1;
• Received last dose of anticancer therapy (including chemotherapy, radiotherapy, targeted therapy, etc.) within 4 weeks of the first dose of study medication;
• Concurrent medical condition requiring the use of cortisol (\>10mg/day Prednisone or equivalent dose) or other systematic immunosuppressive medications within 14 days before the study treatment. Except: inhalation or topical corticosteroids. Doses \> 10 mg/day prednisone or equivalent for replacement therapy;
• Received major operations or serious injuries within 4 weeks of the first dose of study medication;
• Not recovered to ≤CTCAE 1 from adverse events (except for hair loss) due to a previously anti-tumor treatment;
• Pregnancy or breast feeding;

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Cancer Center of Sun-Yat Sen University (CCSYSU)

Guangzhou, Guangdong, 510060, China

Location

Related Publications (3)

• Huang Y, Sun D, Zhou H, Zhou T, Qu S, Li J, Hu C, Xu M, Li W, Shen L, Wu H, Lang J, Hu G, Luo Z, Fu Z, Qu S, Feng W, Chen X, Lin S, Xie B, Li X, Sun Y, Lin Z, Lin Q, Lei F, Long J, Hong J, Huang X, Zeng L, Wang P, He X, Zhao S, Chen G, Zhang Y, Zhao Y, Fang W, Huang C, Li X, Hong S, Zhang L, Yang Y. Five-Year Outcome of Camrelizumab Plus Chemotherapy in Recurrent or Metastatic Nasopharyngeal Carcinoma: A Secondary Analysis of the CAPTAIN-1st Randomized Clinical Trial. JAMA Oncol. 2026 Jan 29:e256245. doi: 10.1001/jamaoncol.2025.6245. Online ahead of print.

  PMID: 41609753 DERIVED

• Xiao BJ, Sima XX, Chen G, Gulizeba H, Zhou T, Huang Y. Predictive and prognostic role of early apolipoprotein A-I alteration in recurrent or metastatic nasopharyngeal carcinoma patients treated with anti-PD-1 therapy. Cancer Med. 2023 Aug;12(16):16918-16928. doi: 10.1002/cam4.6321. Epub 2023 Jul 6.

  PMID: 37409613 DERIVED

• Yang Y, Qu S, Li J, Hu C, Xu M, Li W, Zhou T, Shen L, Wu H, Lang J, Hu G, Luo Z, Fu Z, Qu S, Feng W, Chen X, Lin S, Zhang W, Li X, Sun Y, Lin Z, Lin Q, Lei F, Long J, Hong J, Huang X, Zeng L, Wang P, He X, Zhang B, Yang Q, Zhang X, Zou J, Fang W, Zhang L. Camrelizumab versus placebo in combination with gemcitabine and cisplatin as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (CAPTAIN-1st): a multicentre, randomised, double-blind, phase 3 trial. Lancet Oncol. 2021 Aug;22(8):1162-1174. doi: 10.1016/S1470-2045(21)00302-8. Epub 2021 Jun 23.

  PMID: 34174189 DERIVED

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

camrelizumab; Gemcitabine; Injections; Cisplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Drug Administration Routes; Drug Therapy; Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Li Zhang, MD

  Cancer Center of Sun-Yat Sen University (CCSYSU)

  PRINCIPAL INVESTIGATOR

• Qing Yang, MD

  Jiangsu HengRui Medicine Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: October 16, 2018
• Study Start: November 13, 2018
• Primary Completion: August 1, 2021
• Study Completion: December 31, 2022
• Last Updated: July 1, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)