A Study of Zimberelimab(GLS-010) Combined With AVD for Newly Diagnosed Early-stage Hodgkin's Lymphoma

A Multicenter, Open-label Phase II Study on the Treatment of Newly Diagnosed Early-stage Hodgkin's Lymphoma With Zimberelimab (GLS-010) Combined With AVD Regimen (Doxorubicin, Vindesine, Dacarbazine) Under the Guidance of PET/CT

This is a multicenter, open-label single-arm phase II study to evaluate the efficacy and safety of Zimberelimab (GLS-010) combined with AVD for newly diagnosed early-stage Hodgkin's lymphoma under the guidance of PET/CT.

Study Overview

• Status: Recruiting
• Conditions: Classical Hodgkin Lymphoma
• Intervention / Treatment: Drug: Zimberelimab 240mg

Detailed Description

Despite achieving good disease control and long-term survival rates for over 80% of classical Hodgkin lymphoma (cHL) patients who receive first-line therapy, approximately 10% of early-stage and 30% of advanced cHL patients experience disease relapse or refractoriness after initial treatment, and only half of the patients can be cured through high-dose therapy (HDT) and autologous stem cell transplantation (ASCT). Meanwhile, the current standard first-line treatment still centers around conventional chemotherapy with cytotoxic agents. As such, the clinical challenge of cHL first-line treatment lies in striking a balance between efficacy and toxicity, and developing low-toxicity, high-efficiency treatment strategies to achieve the optimal treatment goal of maximizing efficacy while minimizing short- and long-term toxicities.

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Zhiming Li; Phone Number: +8613719189172; Email: lizhm@sysucc.org.cn
• Study Contact Backup: Name: Yu Wang; Phone Number: +86-20-87343765; Email: wangyu@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Department of Medical Oncology, Sun Yat-Sen University Cancer Center
      • Contact: Zhiming Li, MD; Phone Number: +86-13719189172; Email: lizhm@sysucc.org.cn
      • Contact: Yu Wang, MD; Phone Number: +86-20-87343765; Email: wangyu@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Diagnosed with primary classical Hodgkin lymphoma (HL) based on histopathology.
2. Stage I-II .
3. At least one measurable target lesion（Lugano 2014）.
4. Age 18 years or older (including 18 years) to 45 years (recent fertility requirements and concern about chemotherapy side effects), or age >60 years (older patients who are frail and unwilling to undergo chemotherapy), male or female.
5. ECOG PS 0-3,
6. Expected survival ≥ 3 months.

Exclusion Criteria:

1. Hodgkin's lymphoma with nodular lymphocyte predominant type.
2. Patients who are scheduled to undergo subsequent autologous stem cell transplantation.
3. Contraindications to radiotherapy.
4. With central nervous system (meningeal or parenchymal) involvement.
5. Contraindications to immune checkpoint inhibitors.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Zimberelimab combined with or without AVD sequential radiotherapy; Combination therapy： Subjects received Zimberelimab 240mg Q3W 2 cycle.According to the results of PET/CT evaluation:CR: Additional 2 cycles of Zimberelimab (4 cycles of Zimberelimab monotherapy in total); PR: 2 cycles of Zimberelimab+ AVD therapy (only PR patients combined with AVD). Subjects who did not achieve a Partial Response (PR) or Complete Response (CR) in their initial or subsequent efficacy evaluations, and whose potential for benefit was deemed unlikely by the investigator, were discontinued from the study.; Radiotherapy treatment period (patients with CR/PR): Sequentially radiation therapy 20-30Gy.

Drug: Zimberelimab 240mg; AVD regimen: Doxorubicin 25mg/m2, d1, d15, IV; Vincristine 3mg/m2, d1, d15 IV; Dacarbazine 0.375mg/m2, d1, d15 IV; Other Names: GLS-010

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete response rate (CRR) after 2 cycles	Percentage of the sum of the number of patients in complete remission (CR), complete remission without confirmation (CRu) to the total number of patients in the full analysis set	Up to approximately 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR) after 4 cycles ( Lugano2014)	ORR is proportion of subjects with complete response(CR) or partial response(PR)	Up to approximately 2 years
Complete response rate (CRR) after 4 cycles ( Lugano2014)	Percentage of the sum of the number of patients in complete remission (CR), complete remission without confirmation (CRu) to the total number of patients in the full analysis set	Up to approximately 2 years
Total ORR and CRR after Zimberelimab treatment + radiotherapy	ORR is proportion of subjects with complete response(CR) or partial response(PR); Percentage of the sum of the number of patients in complete remission (CR), complete remission without confirmation (CRu) to the total number of patients in the full analysis set	Up to approximately 2 years
Duration of response (DOR)	Duration of response (DoR) is defined as the period from the first documentation of confirmed response (CR or PR) to the first documentation of progressive disease(PD) or death due to any cause, whichever occurs first	Up to approximately 2 years
Progression-free survival time (PFS)	Progression-free survival (PFS) is defined as the time from the first dose of investigational products until documentation of PD or death due to any cause, whichever occurs first	Up to approximately 2 years
Overall survival (OS)	Overall survival (OS) is defined as the time from the first dose of investigational products until death due to any cause	Up to approximately 2 years
Incidence and severity of adverse events(AEs)	Incidence and severity of AEs is aim to evaluate the safety of Zimberelimab(GLS-010) Combined With AVD	Up to approximately 2 years

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Collaborators: Guangzhou Gloria Biosciences Co., Ltd.
• Investigators: Principal Investigator: Zhiming Li, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2023
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: June 2, 2023
• First Submitted That Met QC Criteria: June 12, 2023
• First Posted (Actual): June 13, 2023

Study Record Updates

• Last Update Posted (Estimated): June 16, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Zimberelimab; AVD; PD-1 Checkpoint Inhibitor
• 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: B2023-134-01

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