Phase III Study of Camrelizumab in Combination With Chemotherapy in Recurrent/Metastatic Nasopharyngeal Carcinoma
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ClinicalTrials.gov Identifier: NCT03707509 |
Recruitment Status :
Active, not recruiting
First Posted : October 16, 2018
Last Update Posted : July 1, 2022
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Condition or disease | Intervention/treatment | Phase |
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Nasopharyngeal Carcinoma | Drug: Camrelizumab Drug: Placebos Drug: Gemcitabine Drug: Cisplatin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 263 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase III, Randomized, Double-Blind, Multi-center Study to Investigate the Efficacy and Safety of Camrelizumab+Gemcitabine+Cisplatin Versus Placebo+Gemcitabine+Cisplatin in Subjects With Recurrent/Metastatic Nasopharyngeal Carcinoma |
Actual Study Start Date : | November 13, 2018 |
Actual Primary Completion Date : | August 1, 2021 |
Estimated Study Completion Date : | December 31, 2022 |
Arm | Intervention/treatment |
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Experimental: Camrelizumab + Gemcitabine + Cisplatin
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
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Drug: Camrelizumab
Maximum 6 cycles for combined therapy. Camrelizumab maintenance.
Other Name: SHR-1210 Drug: Gemcitabine Maximum 6 cycles for combined therapy.
Other Name: Gemcitabine Hydrochloride for Injection Drug: Cisplatin Maximum 6 cycles for combined therapy.
Other Name: Cisplantin Injection |
Active Comparator: Placebos + Gemcitabine + Cisplatin
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
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Drug: Placebos
Maximum 6 cycles for combined therapy.
Other Name: Placebo - Concentrate Drug: Gemcitabine Maximum 6 cycles for combined therapy.
Other Name: Gemcitabine Hydrochloride for Injection Drug: Cisplatin Maximum 6 cycles for combined therapy.
Other Name: Cisplantin Injection |
- Progression-free survival (PFS) [ Time Frame: up to 24 month ]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.
- Progression-free survival [ Time Frame: up to 24 month ]Progression-free survival (PFS) assessed by investigators according to RECIST V 1.1
- Objective Response Rate (ORR) [ Time Frame: up to 24 month ]The percentage of patients with CR and PR assessed by investigators according to Recist v 1.1
- Disease Control Rate (DCR) Disease Control Rate (DCR) [ Time Frame: up to 24 month ]The proportion of patients who have achieved complete response, partial response and Stable disease assessed by investigators according to Recist v 1.1
- Duration of Response (DoR) [ Time Frame: up to 24 month ]According to Recist v 1.1 accessed by investigators
- 2 years Overall Survival (OS) rate [ Time Frame: up to 24 month ]The percentage of patients overall survival in 2 years
- Adverse Events (AEs) [ Time Frame: up to 24 month ]All adverse event/Serious adverse event that occurred during the study period according to CTCAE v 4.03
- Antidrug Antibodies (ADAs) [ Time Frame: up to 24 month ]To evaluate the incidence and titers of ADAs against camrelizumab
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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;
Exclusion Criteria:
- Allergic to monoclonal antibodies, any camrelizumab components, gemcitabine, cisplatin and other platinum drugs;
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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;
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03707509
China, Guangdong | |
Cancer Center of Sun-Yat Sen University (CCSYSU) | |
Guangzhou, Guangdong, China, 510060 |
Principal Investigator: | Li Zhang, MD | Cancer Center of Sun-Yat Sen University (CCSYSU) | |
Study Director: | Qing Yang, MD | Jiangsu HengRui Medicine Co., Ltd. |
Responsible Party: | Jiangsu HengRui Medicine Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT03707509 |
Other Study ID Numbers: |
SHR-1210-III-308 |
First Posted: | October 16, 2018 Key Record Dates |
Last Update Posted: | July 1, 2022 |
Last Verified: | June 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Nasopharyngeal Carcinoma PD-1 Antibody Cisplatin Gemcitabine |
Carcinoma Nasopharyngeal 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 Gemcitabine Antineoplastic Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |