A Phase 2 interventional study of Nivolumab, Pembrolizumab in Hodgkin Lymphoma, sponsored by St. Petersburg State Pavlov Medical University. Recruiting at 4 sites in 2 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by St. Petersburg State Pavlov Medical University · Phase 2, Interventional, and Treatment
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)
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.
1,383 studies on the registry are indexed under Hodgkin Disease; 163 are open to participants now.
This study's planned enrollment of 83 is above the median of 40 across 1,095 interventional studies indexed under Hodgkin Disease.
Browse Hodgkin Disease studies →St. Petersburg State Pavlov Medical University is the lead sponsor of 52 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Nivolumab, Pembrolizumab
Drug pages: 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
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
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
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
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
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)
Incidence of toxicities evaluated according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5
Time frame: observed during therapy and for one year following completion of maintenance therapy.
Started Jan 2024 (actual). Primary completion is estimated for May 2029, 64 months after the start.
Of 183 non-industry phase 2 interventional studies under Hodgkin Disease, half reached primary completion within 80 months of starting (the median), counting those still running; a quarter within 48 and three quarters within 115. This study's planned 64 months is below that.
Counting every sponsor, half of 206 studies reached it within 75 months; a quarter within 42 and three quarters within 111.
How these figures are worked out, and which studies are left out of them.
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Studies of the drugs tested here: Nivolumab · Pembrolizumab
St. Petersburg State Pavlov Medical University