PD-1 Inhibitors Maintenance for cHL Post-autoHCT

NCT06812858 | Recruiting Phase 2 DMC

• 1 other identifier: 29/24-н
• Study Type: interventional
• Target: 83
• Locations: 2 countries
• Sites: 4

Brief Summary

This phase II study is designed to determine the clinical efficacy of PD-1 inhibitors, administered as maintenance therapy after autologous stem cell transplant (autoHCT), in patients with relapsed or refractory (R/R) classical Hodgkin Lymphoma (cHL)

Conditions

Hodgkin Lymphoma

Keywords

Classic Hodgkin lymphoma; autologous hematopoietic stem cell transplantation; nivolumab; pembrolizumab

Outcome Measures

Primary Outcomes (1)

• Assess the efficacy of PD-1 inhibitors as maintenance therapy after autoHCT in patients with r/r cHL, as assessed by 24-month progression-free surviva

  From the first dose of study treatment to the first observation of disease relapse/progression or death from any cause, whichever occurs first, assessed at 24 months

Secondary Outcomes (4)

• To determine the 12- and 18-month PFS in patients with r/r cHL receiving PD-1 inhibitors as maintenance therapy following auto-HSCT.

  From the first dose of study treatment to the first observation of disease relapse/progression or death from any cause, whichever occurs first, assessed at 12 or 18 months

• To determine the 12-, 18-, and 24-month overall survival (OS) in patients with r/r cHL receiving PD-1 inhibitors as maintenance therapy following auto-HSCT.

  From the first dose of study treatment to death from any cause, assessed up to 12, 18 and 24 months

• To determine the 12-, 18-, and 24-month cumulative incidence of relapse (CIR) in patients with r/r cHL receiving PD-1 inhibitors as maintenance therapy following auto-HSCT.

  Up to 12, 18 and 24 months

• To establish the safety and tolerability of PD-1 inhibitors in the maintenance setting, defined as the frequency, severity, and spectrum of adverse events (AEs)

  observed during therapy and for one year following completion of maintenance therapy.

Study Arms (1)

PD-1 Inhibitors maintenance

EXPERIMENTAL

Drug: Nivolumab, Pembrolizumab

Interventions

Nivolumab, Pembrolizumab DRUG

The choice of drug and its dose for maintenance therapy is at the discretion of the study centre (e.g. nivolumab, pembrolizumab). Maintenance therapy should be initiated no later than 60 days after D0, exceptions may be made due to reasonable justification in consultation with the Study PI and will not be considered a protocol deviation. Nivolumab maintenance therapy regimens: * Nivolumab (40 mg, fixed dose) IV D1 of each 14-days cycle up to 12 cycles * Nivolumab (3 mg/kg) IV D1 of each 14-days cycle up to 12 cycles Pembrolizumab maintenance therapy regimen: -Pembrolizumab (200 mg, fixed dose) IV D1 of each 21-days cycle up to 8 cycles

PD-1 Inhibitors maintenance

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years;
• Diagnosis of r/r cHL with auto-HCT being performed as consolidation of 2 or later therapy lines;
• High-risk cHL (Primary refractoriness after first-line therapy / Relapse after first line therapy within 12 months / PET/CT-positive status at the time of auto-HCT / Late relapse (\> 12 months) with unfavourable prognosis factors (extranodal lesion and/or bulky and/or B-symptoms) / More than one salvage regimen performed)
• Complete or partial response by PET/CT after auto-HSCT
• Achieved recovery of peripheral blood counts after auto-HSCT (white blood cell count\> 1 109/L, absolute neutrophil count\> 0.5 109/L, platelets \> 25 109/L);
• ECOG 0-2; The decision to include patients that do not fulfil the criteria of hight-risk cHL is made in consultation with the PI

You may not qualify if:

• Patients who have received PD1-inhibitor therapy in the previous lines of treatment and had to interrupt treatment early due to the development of adverse events of therapy;
• Severe organ failure: creatinine values more than 2 ULN; ALT, AST more than 5 ULN; bilirubin more than 1.5 ULN;
• Active autoimmune diseases (subjects with type 1 diabetes mellitus and hypothyroidism requiring only hormone replacement therapy, and skin diseases such as vitiligo, allopecia, or psoriasis that do not require systemic therapy may be eligible);
• Pregnancy or breastfeeding, or planning pregnancy or parenthood during the study period;
• Somatic or psychiatric pathology that prevents the signing of informed consent;

Sponsors & Collaborators

• St. Petersburg State Pavlov Medical University: lead

Study Sites (4)

National Research Oncology Center

Astana, Kazakhstan

RECRUITING

National Medical and Surgical Center named after N.I. Pirogov

Moscow, Russia

RECRUITING

RecruitingP. Hertsen Moscow Oncology Research Institute (MORI) for administrative and economic work - the branch of the FSBI "National Medical Research Radiological Centre" (NMRRC) of the Ministry of Health of the Russian Federation

Moscow, Russia

RECRUITING

RM Gorbacheva Research Institute, Pavlov University

Saint Petersburg, Russia

RECRUITING

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Nivolumab; pembrolizumab

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Natalia Mikhailova, MD

  St. Petersburg State Pavlov Medical University

  STUDY CHAIR

Central Study Contacts

Polina Kotseliabina, MD

CONTACT

+78123386265; md.FedorovaL@gmail.com

Liudmila Fedorova, MD, PhD

CONTACT

+78123386265; md.FedorovaL@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice-director of RM Gorbacheva Research Institute

Study Record Dates

• First Submitted: February 2, 2025
• First Posted: February 6, 2025
• Study Start: September 2, 2024
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2030
• Last Updated: April 30, 2026

Record last verified: 2025-04

Locations

KA (1); RU (3)