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

Primary Purpose

Nasopharyngeal Carcinoma

Status

Active

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Camrelizumab

Placebos

Gemcitabine

Cisplatin

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Nasopharyngeal Carcinoma, PD-1 Antibody, Cisplatin, Gemcitabine

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;
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;

Sites / Locations

Cancer Center of Sun-Yat Sen University (CCSYSU)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Camrelizumab + Gemcitabine + Cisplatin

Placebos + Gemcitabine + Cisplatin

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Progression-free survival

Progression-free survival (PFS) assessed by investigators according to RECIST V 1.1

Objective Response Rate (ORR)

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)

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)

According to Recist v 1.1 accessed by investigators

2 years Overall Survival (OS) rate

The percentage of patients overall survival in 2 years

Adverse Events (AEs)

All adverse event/Serious adverse event that occurred during the study period according to CTCAE v 4.03

Full Information

NCT ID

NCT03707509

First Posted

September 25, 2018

Last Updated

June 30, 2022

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03707509

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 13, 2018 (Actual)

Primary Completion Date

August 1, 2021 (Actual)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

In this study, eligible subject will be randomized into study arm or control arm to accept study treatment. Treatment cycles of chemotherapy will be at most 6 weeks which will be decided by investigators. Progression-free survival (PFS) determined by the Independent Review Committee (IRC) will be the primary outcome measures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal Carcinoma, PD-1 Antibody, Cisplatin, Gemcitabine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

263 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Camrelizumab + Gemcitabine + Cisplatin

Arm Type

Experimental

Arm Description

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

Arm Title

Placebos + Gemcitabine + Cisplatin

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Camrelizumab

Other Intervention Name(s)

SHR-1210

Intervention Description

Maximum 6 cycles for combined therapy. Camrelizumab maintenance.

Intervention Type

Drug

Intervention Name(s)

Placebos

Other Intervention Name(s)

Placebo - Concentrate

Intervention Description

Maximum 6 cycles for combined therapy.

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Other Intervention Name(s)

Gemcitabine Hydrochloride for Injection

Intervention Description

Maximum 6 cycles for combined therapy.

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Other Intervention Name(s)

Cisplantin Injection

Intervention Description

Maximum 6 cycles for combined therapy.

Primary Outcome Measure Information:

Title

Progression-free survival (PFS)

Description

Time Frame

up to 24 month

Secondary Outcome Measure Information:

Title

Progression-free survival

Description

Progression-free survival (PFS) assessed by investigators according to RECIST V 1.1

Time Frame

up to 24 month

Title

Objective Response Rate (ORR)

Description

The percentage of patients with CR and PR assessed by investigators according to Recist v 1.1

Time Frame

up to 24 month

Title

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

Description

The proportion of patients who have achieved complete response， partial response and Stable disease assessed by investigators according to Recist v 1.1

Time Frame

up to 24 month

Title

Duration of Response (DoR)

Description

According to Recist v 1.1 accessed by investigators

Time Frame

up to 24 month

Title

2 years Overall Survival (OS) rate

Description

The percentage of patients overall survival in 2 years

Time Frame

up to 24 month

Title

Adverse Events (AEs)

Description

All adverse event/Serious adverse event that occurred during the study period according to CTCAE v 4.03

Time Frame

up to 24 month

Other Pre-specified Outcome Measures:

Title

Antidrug Antibodies (ADAs)

Description

To evaluate the incidence and titers of ADAs against camrelizumab

Time Frame

up to 24 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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; 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;

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Li Zhang, MD

Organizational Affiliation

Cancer Center of Sun-Yat Sen University (CCSYSU)

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Qing Yang, MD

Organizational Affiliation

Jiangsu HengRui Medicine Co., Ltd.

Official's Role

Study Director

Facility Information:

Facility Name

Cancer Center of Sun-Yat Sen University (CCSYSU)

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34174189

Citation

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.

Results Reference

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

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