Study of Camrelizumab (SHR-1210) vs. Chemotherapy in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma

A Randomized,Open-label Phase III Study of Camrelizumab (SHR-1210) vs. Investigator's Choice of Chemotherapy in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (cHL)

This is an open-label, multicenter, randomized, phase3 trial to evaluate the efficacy of Camrelizumab in patients with relapsed or refractory classic Hodgkin's lymphoma. Participants will be randomized to receive either Camrelizumab monotherapy or chemotherapy of investigators' choice.

The primary hypotheses of this study are that treatment with Camrelizumab prolongs Progression-free Survival (PFS) in participants with relapsed or refractory Classical Hodgkin Lymphoma compared to treatment with Chemotherapy.

Study Overview

• Status: Recruiting
• Conditions: Classical Hodgkin Lymphoma
• Intervention / Treatment: Drug: Camrelizumab; Drug: Investigator's choice of Chemotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 56
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Weiwei Wang, Ph.D.; Phone Number: 86-021-23511999; Email: wangweiwei@hrglobe.cn

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Recruiting
      • Jiangsu Cancer Hospital
      • Contact: Jianqiu Wu, M.D; Phone Number: +86 13951671579; Email: drwujq@vip.126.com
      • Contact: Jifeng Feng, M.D; Phone Number: +86 13901581264; Email: fjif@vip.sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• With histologically confirmed classic Hodgkin's lymphoma ;

• Relapsed or refractory cHL meet either of the following criteria:

  1. Did not achieve remission or progressed after autologous hematopoietic stem cell transplantation.
  2. Received at least 2 lines of systemic chemotherapy, failed to achieve remission or progressed after the most recent chemotherapy.
• Have measurable disease according to Lugano 2014 criteria
• Eastern Cooperative Oncology Group (ECOG) performance scale of 0 or 1;
• Life expectancy ≥ 12 weeks;
• Has adequate organ function;
• Women of childbearing potential（WOCBP） must be willing and able to employ a highly effective method of birth control/contraception to prevent pregnancy while on treatment and for at least 60 days after the last dose of study treatment. Women of childbearing potential with pregnancy test negative within 7days before entering the group and not in in lactation. Male subjects with WOCBP partner should receive Surgical sterilization or consent to employ a highly effective method of birth control/contraception to prevent pregnancy while on treatment and for at least 120 days after receiving the last dose of study treatment.
• Able to understand and sign an informed consent form (ICF).

Exclusion Criteria:

• Active, known or suspected autoimmune disease. Subjects who were in a stable state, do not need systemic immunosuppressive therapy were allowed to participate.
• Concurrent medical condition requiring the use of immunosuppressive medications or glucocorticoids exceeds a daily dose of 10mg prednisone or equivalent within 14 days before drug administration. Topical use of glucocorticoids is allowed.
• Received anti-tumor vaccines or other anti-tumor therapy with immune stimulatory effects within 3 months before the first dose SHR-1210.
• Prior exposure to any PD-1/PD-L1/PD -L 2 or CTLA -4 antibody .
• Participating in other clinical studies or less than 4 weeks by the end of the most recent clinical trial participation;
• Known or suspected interstitial pneumonia;
• Concurrent or history of other malignancies. (Except for patients with skin basal cell carcinoma, superficial bladder cancer, skin squamous cell carcinoma or cervical carcinoma who received radical treatment and did not relapse in 5 years since treatment initiation).
• Received chemotherapy, radiotherapy,immunotherapy, including topical therapy within 4 weeks. Previous anti-tumor therapy related adverse reactions (except hair loss) did not recover to CTCAE ≤1.
• Prior allo-HSCT.
• ASCT within 90 days.
• Impact of major surgery or severe trauma had been eliminated for less than 14 days.
• Active pulmonary tuberculosis.
• Severe acute or chronic infection requiring systemic therapy.
• Suffering from heart failure (New York Heart Association standard III and given appropriate medical treatment.Uncontrolled coronary artery disease and arrhythmia. History of myocardial infarction within 6 months.
• Live vaccine within 4 weeks before the first dose SHR-1210.Inactivated vaccines against seasonal influenza is allowed.Live attenuated influenza vaccines were not approved for intranasal administration.
• HIV test(s) positive or known AIDS.
• Untreated active hepatitis; Hepatitis B and hepatitis C infection in common.
• Other factors that may lead to the study termination, such as severe disease or abnormal laboratory tests or family or social factors affecting subjects safety or test data and sample collection .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Camrelizumab for Injection; Participants receive Camrelizumab 200mg intravenously (IV) on Day 1 of each 2-week cycle	Drug: Camrelizumab; A humanized monoclonal immunoglobulin; Other Names: SHR-1210
Active Comparator: Chemotherapy; Participants receive investigator's choice of chemotherapy (Gemox, IGEV or DHAP) for up to 6 cycles.	Drug: Investigator's choice of Chemotherapy; Participants will receive one of the following chemotherapies for up to 6 cycles: Gemox: Gemcitabine and Oxaliplatin； IGEV: Ifosfamide, Gemcitabine, Vinorelbine, and Prednisolone； DHAP: Dexamethasone, high-dose Cytarabine (Ara-C) and Cisplatin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS)	Time from randomisation to radiologically confirmed progressive disease	anticipated 16 months

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2020
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: April 10, 2020
• First Submitted That Met QC Criteria: April 10, 2020
• First Posted (Actual): April 13, 2020

Study Record Updates

• Last Update Posted (Actual): February 8, 2021
• Last Update Submitted That Met QC Criteria: February 4, 2021
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Hodgkin Disease
• Other Study ID Numbers: SHR-1210-III-317

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No