PD-1 Inhibitors Maintenance for cHL Post-autoHCT

May 20, 2026 updated by: Ivan S Moiseev, St. Petersburg State Pavlov Medical University

A Multicenter Prospective Phase II Study Evaluating the Efficacy and Safety of PD-1 Inhibitors Maintenance in Patients With Refractory/Relapsed Classical Hodgkin Lymphoma After Autologous Hematopoietic Stem Cell Transplantation

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Classic Hodgkin lymphoma (cHL) accounts for about 10-30% of all malignant lymphomas and predominantly occurs in individuals of working age. Thanks to modern chemoradiotherapy methods, a durable remission is achieved in 80% of patients. However, for a significant proportion of patients, achieving a sustained remission after first-line chemotherapy is not possible. The standard treatment for patients with refractory/relapsed cHL is second-line intensified chemotherapy followed by high-dose chemotherapy with autologous hematopoietic stem cell transplantation (auto-HSCT). While this approach allows some patients to achieve long-lasting remission, more than 50% of them experience disease progression or relapse. Current therapeutic strategies for such patients are limited and often fail to produce long-term remission. Given that most relapses occur within the first two years after auto-HSCT, a maintenance therapy strategy aimed at preventing relapse and disease progression is a promising avenue for improving outcomes in this patient group.

In 2015, based on the results of the AETHERA study, the U.S. Food and Drug Administration (FDA) approved the use of brentuximab vedotin (BV) as consolidation therapy for patients with cHL at high risk of relapse or progression following auto-HSCT. BV demonstrated an increase in median progression-free survival (PFS), with 42.9 months in the BV group compared to 24.1 months in the placebo group. However, despite this improvement, the two-year PFS among patients receiving BV was only 63%. Moreover, in the AETHERA study, with a planned 16 cycles of BV therapy, 23% of patients discontinued maintenance therapy due to severe adverse events, and 31% required dose reductions because of peripheral neuropathy.

Currently, there are data from several studies on the safety and efficacy of PD-1 inhibitor maintenance therapy for patients with cHL. In a small phase II trial, 30 patients (90% with high-risk factors) received up to 8 cycles of pembrolizumab (200 mg every 3 weeks) as maintenance therapy after auto-HSCT. The 18-month PFS rate was 82%, with an overall survival (OS) of 100% (Armand et al.). Similar results were obtained with nivolumab (240 mg every 3 weeks) as maintenance therapy. Preliminary findings showed a 6-month PFS of 92% and OS of 100%. These studies also demonstrated an acceptable toxicity profile: therapy discontinuation due to adverse events occurred in 17% of patients receiving pembrolizumab and in 10% of those on nivolumab maintenance therapy.

Data have also been obtained on the efficacy of a fixed-dose nivolumab regimen (40 mg every 2 weeks) for patients with r/r cHL: the objective response rate was 70%, and the 18-month PFS was 53.6%. Based on these results, the fixed-dose 40 mg nivolumab regimen, which showed comparable efficacy for this patient group, has been included in the draft Russian clinical guidelines for the diagnosis and treatment of patients with r/r cHL.

Thus, the use of PD-1 inhibitors, having a favorable toxicity profile, may achieve durable remissions in patients with cHL after auto-HSCT. Moreover, the available data indicating comparable efficacy of a fixed-dose nivolumab regimen versus the standard approach increases the accessibility of this treatment option. Employing PD-1 inhibitors is an important step in modifying the therapy strategy for patients with r/r cHL and in preventing relapses in this patient population.

Study Type

Interventional

Enrollment (Estimated)

83

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Kazakhstan
      • Astana, Kazakhstan
        • Recruiting
        • National Research Oncology Center
        • Contact:
  • Russia
      • Moscow, Russia
        • Recruiting
        • National Medical and Surgical Center named after N.I. Pirogov
        • Contact:
      • 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
        • Contact:
      • Saint Petersburg, Russia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18-70 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
  • No evidence of grade 3-4 adverse events (CTCAEs) after auto-HCT at the time of inclusion in the study;
  • 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

Exclusion Criteria:

  • 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;
  • Respiratory failure of more than 1 degree at the time of inclusion in the study;
  • Unstable haemodynamics at the time of inclusion in the study;
  • Acute bacterial, viral or fungal infection at the time of inclusion;
  • 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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PD-1 Inhibitors maintenance
Drug: Nivolumab, Pembrolizumab

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the 12- and 18-month PFS in patients with r/r cHL receiving PD-1 inhibitors as maintenance therapy following auto-HSCT.
Time Frame: 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
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.
Time Frame: From the first dose of study treatment to death from any cause, assessed up to 12, 18 and 24 months
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.
Time Frame: Up to 12, 18 and 24 months
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)
Time Frame: observed during therapy and for one year following completion of maintenance therapy.
Incidence of toxicities evaluated according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5
observed during therapy and for one year following completion of maintenance therapy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Petersburg State Pavlov Medical University

Investigators

  • Study Chair: Natalia Mikhailova, MD, St. Petersburg State Pavlov Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2024

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

September 1, 2030

Study Registration Dates

First Submitted

February 2, 2025

First Submitted That Met QC Criteria

February 2, 2025

First Posted (Actual)

February 6, 2025

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29/24-н

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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