Pembro-FLASH

Overview

Sponsor-declared trial summary

Key facts

Sponsor

University Of Cologne

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

29 Apr 2026 → ongoing

Decision date (initial)

2025-09-30

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Takeda Pharmaceutical · Merck Sharp and Dohme (MSD)

External identifiers

EU CT number

2022-501458-13-01

ClinicalTrials.gov

NCT06045159

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

The primary objective of this trial is to estimate efficacy of the novel regimen. The primary endpoint is the 1-year Progression-free Survival rate after treatment with one dose of pembrolizumab followed by four to six cycles of immunochemotherapy with P-BrECADD and PET-guided radiotherapy as per standard of care.

Secondary objectives 1

1. Secondary objectives of this phase II trial are to further describe efficacy, safety and feasibility of the new regimen. Correlative scientific substudies will be performed in participants giving separate informed consent.

Conditions and MedDRA coding

Advanced Stage of Classic Hodgkin Lymphoma

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Histologically confirmed first diagnosis of cHL
2. Advanced-stage disease: Stage IIB with one or both of the following risk factors [Large mediastinal mass (≥ 1/3 of the maximum transverse thoracic diameter), Extranodal disease] or Stage III-IV
3. Age at enrollment: 18-60 years
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) ≥ 8 g/dL (without red-blood-cell transfusion within the prior 7 days) • White blood cell (WBC) concentration ≥ 3 x 109/L • Platelet concentration ≥ 100 x 109/L (without platelet transfusion within the prior 7 days) • Absolute neutrophil count (ANC) ≥ 1.0 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 female patient is eligible to participate if she is not pregnant (see 11.1.6), not breastfeeding, and either: a) Not a woman of childbearing potential (WOCBP) as defined in 11.1.6 OR b) A WOCBP who agrees to follow the guidance on contraception and pregnancy testing in section 11.1.6 from enrollment until at least 6 months after the last dose of trial treatment. A male patient must agree to use contraception as detailed in section 11.1.6 of this protocol from enrollment until at least 6 months after the last dose of trial treatment and refrain from donating sperm during this period.

Exclusion criteria 15

1. Nodular lymphocyte-predominant Hodgkin lymphoma or composite lymphoma
2. Prior cHL-directed treatment except for a corticosteroid pre-phase
3. Chemotherapy, radiotherapy or allogenic stem cell/solid organ transplant in medical history
4. Prior or concurrent disease precluding protocol treatment
5. Abnormal laboratory findings (except for HL-related changes or functional disorders; values must be obtained within 28 days prior to signing the ICF): • Total bilirubin > 1.5 x upper limit of normal (ULN); patients with total bilirubin > 5 mg/dl are not eligible irrespective of cause. • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 x ULN • Creatinine clearance or calculated creatinine clearance < 60 mL/minute (24-hour urine or calculation based on Modification of Diet in Renal Disease (MDRD) formula/ Cockroft-Goult formula); patients with creatinine clearance < 10 mL/minute are not eligible irrespective of cause. • Fasting blood sugar > 200 mg/dL • International normalized ratio or activated partial thromboplastin time (aPTT) > 1.5 × ULN
6. Live vaccine within 30 days prior to signing the ICF.
7. Pregnancy, breastfeeding, or expecting to conceive or father children during the treatment period and for at least 6 months after the last dose of trial treatment
8. Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, hypersensitivity to pembrolizumab and/ or excipients, or prior therapy with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. CTLA-4, OX-40, CD137)
9. Prior therapy with brentuximab vedotin or known hypersensitivity to brentuximab vedotin
10. Diagnosis of immunodeficiency or chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of antineoplastic or immunosuppressive therapy within 7 days prior to signing the IC
11. Current or prior participation in a study of an investigational agent or use of investigational device within 4 weeks prior to signing the ICF.
12. Lack of accountability and inability to appreciate the nature, meaning and consequences of the trial and to formulate their own wishes correspondingly
13. 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
14. Relationship of dependence or employer-employee relationship to the sponsor or the investigator
15. Committal to an institution on judicial or official order

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 1-year PFS estimate

Secondary endpoints 5

1. Adverse events
2. Target number of P-BrECADD cycles per 100 participants
3. Remission status after 1x P (PET-1), 1x P + 2x P-BrECADD (PET-3) and after completion of PET-guided chemo-immunotherapy (PET-5 or PET-7, respectively)
4. Overall survival after one year
5. Patient-reported outcomes (PRO-CTCAE, Fatigue, QLQ-C30 and Quality of Life)

Investigational products

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

Test 1

Auxiliary 6

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

Peter Borchmann

Public contact point

Organisation

University Of Cologne

Contact name

Peter Borchmann

Third parties 2

Locations

1 EU/EEA country · 10 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 18 files

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

Application history

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