PREFer

Overview

Sponsor-declared trial summary

Key facts

Sponsor

University Of Cologne

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

1 Jun 2026 → ongoing

Decision date (initial)

2026-02-10

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Deutsche Krebshilfe

External identifiers

EU CT number

2024-520138-31-00

ClinicalTrials.gov

NCT06916416

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

The primary objective is to estimate the efficacy of the experimental treatment with the anti-PD-1 antibody pembrolizumab followed by consolidation radiotherapy (RT) in early-stage favorable classic Hodgkin lymphoma.

Secondary objectives 1

1. Secondary objectives are to assess the safety and feasibility of the treatment regimen.

Conditions and MedDRA coding

Early-stage favorable classic Hodgkin lymphoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Histologically confirmed first diagnosis of cHL
2. Early-stage favorable cHL as assessed by all mandatory imaging examinations as outlined in section 5.1.2.3 of the protocol, i.e.stage I-II without risk factors: Large mediastinal mass; Extranodal involvement; Elevated erythrocyte sedimentation rate (ESR); Involvement of ≥ 3 nodal areas
3. Age ≥ 18 and ≤ 75 years on the day of signing the patient information and informed consent form (ICF)
4. Participants must be willing and capable of giving written informed consent prior to any trial-related activity
5. Adequate blood count (except for cHL-related changes or functional disorders) obtained within 7 days prior to signing the ICF: Hemoglobin (Hb) ≥ 9 g/dL (without red-blood-cell transfusion within the prior 7 days) ; Platelet concentration ≥ 100 x 109/L (without platelet transfusion within the prior 7 days) ; Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to signing the ICF
7. Estimated life expectancy > 3 months
8. Contraception a) Females of childbearing potential must have a negative urine or serum ß-human chorionic gonadotropin (ß-hCG) pregnancy test within 7 days prior to signing the ICF, not be breastfeeding and be willing to use a highly effective method of contraception as described below from enrollment to at least 6 months after the last dose of systemic trial treatment; b) Non-sterile males who are sexually active with WOCBP must be willing to use barrier methods such as a condom for effective contraception and refrain from sperm donation from enrollment to at least 6 months after the last dose of systemic trial treatment.

Exclusion criteria 14

1. Target disease exceptions: Knwon central nervous system lymphoma, subjects with nodular lymphocyte-predominant Hodgkin lymphoma or composite lymphoma
2. Prior cHL-directed treatment
3. Prior chemotherapy, RT or allogeneic stem cell/solid organ transplant
4. Prior or concurrent disease precluding protocol treatment
5. Abnormal laboratory test findings: a) Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection. Patients who receive an antiviral treatment and have no detectable hepatitis B virus (HBV)-DNA or hepatitis C virus (HCV)-RNA can be included in the trial; b) Serum creatinine > 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) < 30 mL/min measured directly or calculated using the CKD-EPI formula; c) Aspartate aminotransferase/alanine aminotransferase (AST/ALT) > 2.5 x ULN. d) Total bilirubin > 1.5 x ULN unless the elevation is due to Gilbert’s syndrome h) International normalized ratio (INR) or prothrombin time (PT), activated partial thromboplastin time (aPTT) > 1.5 x ULN
6. Live vaccine or live-attenuated vaccine within 30 days before signing the ICF. Administration of killed vaccines is allowed.
7. Pregnancy or breastfeeding.
8. History of documented allergic reactions or acute hypersensitivity reaction to antibody treatment.
9. Known hypersensitivity or allergy to any of the excipients in the pembrolizumab formulation.
10. Current or prior participation in another interventional trial that could interact with this trial.
11. Lack of accountability and inability to appreciate the nature, meaning, and consequences of the trial and to formulate their own wishes correspondingly.
12. Non-compliance, for reasons including, but not limited to, the following: Drug dependency or substance abuse that would interfere with cooperation with requirements of the trial; Refusal of blood products during treatment; Any similar circumstances that appear to make compliance with any trial procedures impossible
13. Relationship of dependence or employer-employee relationship to the sponsor or the investigator.
14. Committal to an institution on judicial or official order.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Progression-free survival (PFS) at 1 year

Secondary endpoints 8

1. Remission status after pembrolizumab therapy and after consolidation Radiotherapy
2. Progression-free survival (PFS) at 2 years
3. Overall survival (OS) at 1 year and at 2 years
4. Adverse events during and after anti-PD-1 therapy
5. Patient-reported outcomes at baseline, during treatment and during follow-up
6. Rate of early discontinuation of trial treatment
7. Rate and types of HL-directed treatment administered in addition to trial treatment
8. Event-free survival (EFS) at 1 year and at 2 years

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

University Of Cologne

Sponsor organisation

University Of Cologne

Address

Albertus-Magnus-Platz 1

City

Cologne

Postcode

50923

Country

Germany

Scientific contact point

Organisation

University Of Cologne

Contact name

Dennis Eichenauer

Public contact point

Organisation

University Of Cologne

Contact name

Dennis Eichenauer

Third parties 2

Locations

1 EU/EEA country · 35 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 19 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications